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LTUM >>> Starting to move up with volume/price increases. Lithium use increasing. No other news. Suggest keeping on your watch lists. Just a FYI. HAWK
$CYCA News: CyttaAIR Partners with FIZUAS to Dominate the American Drone Reseller and Advanced Streaming Technology Market
Massive Florida Demand for CyttaCOMMS and Drones Drives Partnership
LAS VEGAS, NV / ACCESSWIRE / June 13, 2024 / Cytta Corp (OTCQB:CYCA), a leading provider of innovative technology solutions for public safety and cybersecurity industries, is excited to announce that CyttaAIR, in an expansion of its longstanding reseller partnership with FIZUAS Unmanned Aircraft Systems, a premier national drone reseller, is now entering the drone reseller market. This strategic joint venture aims to meet the growing demand for American-made drones, particularly from law enforcement agencies transitioning away from foreign drones.
A Strategic Move in Response to Growing Demand
This expanded partnership with FIZUAS comes at a critical time when numerous law enforcement agencies in Florida are seeking guidance on which drone brands and models to purchase. This transition to American-made drones is driven by legislative changes and a heightened focus on data security. Through this joint venture, CyttaAIR will provide these agencies with top-tier, compliant drone options, enhancing their operational capabilities and ensuring adherence to new regulations.
Quote from Mike Elliott, VP of Business Development
"We are thrilled to be partnering with a premiere national drone reseller like FIZUAS," said Mike Elliott, VP of Business Development at Cytta Corp. "The number of law enforcement agencies in Florida asking about which drone brands and models to purchase has skyrocketed. This joint venture allows CyttaAIR to expand into this rapidly growing market, providing our clients with the best in American-made drone technology and our leading CyttaCOMMS secure video streaming solution."
Expanding CyttaAIR's Reach
This collaboration is poised to position CyttaAIR as a dominant player in the drone reseller market. By leveraging FIZUAS's extensive reseller network and expertise, CyttaAIR/FIZUAS will jointly offer a comprehensive range of drones equipped with the secure and collaborative capabilities of CyttaCOMMS. This move underscores Cytta Corp.'s commitment to providing cutting-edge technology solutions that meet the evolving needs of law enforcement and other critical sectors.
About Cytta Corp:
Cytta Corp. is a leading technology solutions provider dedicated to delivering innovative products and services across various industries and revolutionizes the integration, streaming, transfer, and storage of video and audio data. With a focus on safety, security, and efficiency, Cytta Corp strives to develop cutting-edge solutions that address real-world challenges in large markets.
The Company's proprietary CyttaCOMMS incident management system offers real-time integration of video and audio streams, enabling improved collaboration and providing ongoing, relevant, actionable intelligence. Their innovative new product, CyttaCARES , is a game-changer in ensuring the safety and well-being of children in educational institutions and beyond. CyttaAIR, a groundbreaking platform designed to innovate and consolidate the best of drone hardware, software, and resources for Federal and State Law Enforcement Agencies. Cytta's CyttaCOMP ISTAR (Intelligence, Surveillance, Target Acquisition and Reconnaissance) technology delivers real-time compression of video streams with ultra-low latency.
About FIZUAS Unmanned Aircraft Systems
FIZUAS is a leading national drone reseller known for providing high-quality, reliable drone solutions to various industries. Their extensive network and extensive first responder and industry expertise make them a trusted partner for organizations looking to integrate drone technology into their operations.
Contact Information
Investor/Shareholder Contact:
Gary Zwetchkenbaum
PlumTree Consulting, LLC.
gzplumtree@gmail.com
Direct: (516)-455-7662
Cytta Corp.
Toll free #: 1 877 CYTTAUS (298 8287)
Call Local: 1 740 CYTTAUS (298 8287)
http://www.cytta.com
info@cytta.com
Gary Campbell, CEO
Direct (702) 900-7022 (or message)
Gary@cytta.com
Mike Elliott, VP of Business Development
mikeelliott@cytta.com
(689) 222-8708
SOURCE: Cytta Corp.
https://finance.yahoo.com/news/cyttaair-partners-fizuas-dominate-american-120000070.html
$MMMW is making serious financial preparation in advance of a marketable product announcement.
$NRXP News: NRx Pharmaceuticals (NASDAQ:NRXP) Appoints Neuroscience, Information Technology and Medical Technology Veteran to its Board of Directors
Dr. Dennis McBride brings extensive experience in Neuroscience and its interface with Information and Medical Technology
Retired at a rank that is the civilian equivalent of a senior flag officer from the United States Navy
RADNOR, Pa., June 18, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company has added Dr. Dennis McBride to its Board of Directors. Dr. McBride brings deep experience in Neuroscience, Medical and Information Technology and digital therapeutics to the Company.
"I am delighted to welcome Dennis to the Board of NRx. His unique background in both Neuroscience and Medical Technology will be an important asset to the company as we seek to develop more advanced treatments for patients," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "I have worked with Dennis previously on a highly successful digital therapeutic and know the quality he brings to our company."
"I am proud to join the Board of NRx at such an exciting time for the company – the opportunities have never been greater in Neuroscience to advance and improve novel therapies," commented Dr. McBride. "I look forward to using my experience to help advance its strategy and further the development of NRx's impressive pipeline of CNS products and leading its initiative in digital therapeutics."
Dr. Dennis McBride has led numerous national and international initiatives in neuroscience and its interface with information technology, national security, and medical technology/drug development both within the federal government and in the private sector, three of which are now multi-billion-dollar enterprises. He has formative experience in CNS-focused digital therapeutics, having participated with NRx founders in developing now military-proven digital therapeutic technology for reduction of stress and depression. He was instrumental to the founding of InQTel and other private sector-focused initiatives.
Dr. McBride dedicated his Navy career to Aerospace Medicine and ergonomics, during which he served in leadership roles at six nationally-prominent laboratories, including the Defense Advanced Research Projects Agency (DARPA), Naval Aerospace Medical Research Lab, Naval Research Lab, the Office of Naval Research, and the Naval Medical Research Institute. Upon retiring as a highly decorated Navy Captain, he assumed leadership of the Potomac Institute for Policy Studies, where he continues to serve as President Emeritus. He then joined the National Defense University as a Professor to lead the Center for Technology and National Security Policy, completing his term as a Senior Executive-4 (Civilian equivalent to Vice Admiral). Most recently, he served a tour of duty in the Office of the Secretary of Defense. Dr. McBride has served as an adviser to Cabinet Secretaries, US Congressional Committees, and to corporate C-Suite executives. His educational background includes the University of Georgia, Naval Aerospace Medical Institute, the University of Southern California, the London School of Economics, and Harvard Business School, earning a Ph.D. in experimental psychology and four master's degrees.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
$NRXP News: NRx Pharmaceuticals (NASDAQ:NRXP) Publishes Shareholder Update Letter
The June 2024 meeting of the American Society for Clinical Psychopharmacology (ASCP) focused heavily on increasing use of intravenous ketamine and intranasal S-ketamine as the emerging standard of care for treating severe depression and suicidality
Presenters from 3 open label studies at the ASCP suggested that intravenous ketamine is at least equivalent and may have advantages over intranasal S-ketamine
NRx Pharmaceuticals has now reached the 9-month stability point with its ketamine formulation (NRX-100) and has initiated 3 manufacturing lots for future drug release. Nonclinical safety for short term use of NRX-100 has recently been published and submitted to FDA
FDA leadership, in public comments at ASCP, focused on the need for nonclinical safety data for intravenous ketamine as a condition of ketamine approval
The short-term need for intravenous ketamine as an already-approved, schedule 3 drug, is heightened by recent regulatory decisions that may delay the path of potent, schedule 1 psychedelic drugs that may require more complicated clinical trial designs.
RADNOR, Pa., June 10, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company posted a new Shareholder Update Letter on its website NRx Shareholder Update and further invites interested parties to subscribe to their email alert service to stay up to date on company's progress here: NRx Email Alerts . (Note: not all updates will be included in a Press Release in the future).
Today's update highlights potential implications of the Company's recent activities at the annual meeting of the American Society of Clinical Psychopharmacology. The key points include:
Intravenous and intranasal ketamine were highlighted as emerging standards of care for severe depression and suicidality
Planned NDA filing for NRX-100, our preservative free IV ketamine, for Suicidal Depression in 2024, is based on well controlled trials against both placebo and active comparator. Fast Track Designation was previously granted
An independent FDA advisory panel recently voted against MDMA, a potent, class I psychedelic, refocusing attention on already-approved Schedule 3 drugs such as ketamine for treatment of suicidal depression. The FDA panel and emerging guidance highlights the complexity of clinical trials of DEA Schedule 1 hallucinogens that do not have already-approved human uses
NRx anticipates that an important issue for longer term use of ketamine in depression will be the current multidose vial presentation that contains potentially toxic preservatives previously acceptable for one time use but less suitable for repeated use. NRX-100 is planned as a single-dose, preservative-free medication.
Please subscribe to the Company's email for future updates. NRX Email Alerts Not all of these will be the subject of a Press Release in the future.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine), in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals, focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
$IVDN News on sales surge for superior, energy saving house wrap: Innovative Designs Sales Update
PITTSBURGH, PA- (NewMediaWire) - May 30, 2024 - Innovative Designs, Inc. (OTCQB: IVDN) continues its upward sales trend into the end of May 2024. Year-to-date sales have already surpassed FYE2023 by over 33% with 5 months remaining in FYE2024. The growth is attributed to a substantial increase in the number of new retailers that are now carrying the company's Insultex House Wrap®. As new energy codes are implemented across the United States, homebuilders/contractors are using Insultex House Wrap® as a convenient R-Value continuous insulation to a wall system.
Our notable growth in sales can be attributed to Built Link Solutions (Formerly Compound Construction) based in Grand Rapids, MI. Built Link Solutions is working to become the primary source for industry professionals, innovators, and stakeholders to discover, evaluate, and adopt the latest advancements in building materials, tools and technologies. Having curated a comprehensive national distribution network, they bring pioneering solutions like Insultex House Wrap® to market, propelling the evolution of the construction industry towards a future where innovation thrives, and buildings meet the needs of tomorrow. Since coming onboard, Built Link Solutions has:
Established a comprehensive national distribution network to service customers where they are when they need it.
Grown national awareness of product benefits and specifications through their dedicated sales agents and attendance at building industry trade shows across the country.
Conducted in-person sales training and online seminars to educate sales associates on Insultex House Wrap®.
Streamlined the sales process to deliver consistent and superior level service to customers of all sizes and needs.
Implemented volume pricing models and incentive discounts to meet the needs for scale and demand.
As building codes and exterior R-Value requirements are quickly evolving across the country, Built Link Solutions has proven highly proactive in contacting prospective accounts, notifying them of the cost-effective solution that our Insultex House Wrap® provides.
Randy Kimbler, Director of Business Development for Built Link Solutions, commented, "Insultex House Wrap® is gaining traction in the market as it provides a timely and effective solution. Its cost-effectiveness, innovation, and ability to address today's building challenges are driving positive feedback nationwide."
About Innovative Designs, Inc.
Innovative Designs, Inc. manufactures the Insultex® House Wrap and Arctic Armor® Line, under the "i.d.i.gear" label featuring INSULTEX®. Patented INSULTEX® is the thinnest, lightest, and warmest insulator in the market today. For more information, please visit:
http://www.idigear.comorhttp://www.insultexhousewrap.com.
Disclaimer
Certain statements in this press release constitute "forward-looking" statements as defined by federal law. Such statements are based on assumptions, but there is no assurance that actual outcomes will not be materially different as those implied. Any such statements are made in reliance on the "Safe Harbor" protections provided under the Private Securities Reform Act of 1995 and are subject to various factors, including the risks and matters discussed in the Company's SEC filings available athttp://www.sec.gov.
CONTACT:
Innovative Designs, Inc.
Joseph Riccelli, CEO
412-799-0350
joer@idigear.com
http://www.insultexhousewrap.com
Built Link Solutions
Randy Kimbler, Dir. Business Development
616-443-3200
RandyK@Builtlinksolutions.com
News Source: Innovative Designs Inc
Amen to that my friend🙏🙏
God got me thru man!!!
Guessing you put up a hell of a fight brother!!
Hope all is well!!!
Hey bro been a long time! Spent the last year fighting cancer 💪🙏
Less games more technical!!
Options for me bud.
Maybe 2-3 otc with Petey and the gang just for shits and giggles!!
Hope you’re doing great mang!!!!
FYI no more OTC picks from me forever and ever, amen. Enjoying these sub dollar nasdaqs way too much.
$VERB have loaded some down here in .15 range
$NIO looks to be coming off bottom back over $5
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Presents Landmark Trial of NRX-101 in Suicidal Bipolar Depression At the American Society of Clinical Psychopharmacology Annual Meeting: NRX-101 is the First Oral Antidepressant Demonstrated to Reduce Suicidality in Bipolar Depression
Poster presentation of "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior"
NRX-101 demonstrated a similar antidepressant effect (MADRS reduction ~50%) compared to lurasidone, the Standard of Care drug
NRX-101 demonstrated a 58% relative reduction in time to sustained remission from suicidality (P=.05) compared to lurasidone
NRX-101 demonstrated a 76% reduction in symptoms of akathisia (p=0.03), a side effect linked to suicide, compared to lurasidone
This represents the second trial of NRX-101 demonstrating reduction in suicidality and akathisia associated with NRX-101 compared to lurasidone
RADNOR, Pa., May 28, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx", the "Company"), a clinical stage pharmaceutical company, today announced presentation of its Phase 2b/3 trial of NRX-101, entitled "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior" at the American Society of Clinical Psychopharmacology (ASCP) in Miami Beach, FL. The lead author is Prof. Andrew Nierenberg, Director, Dauten Family Center for Bipolar Treatment Innovation, Massachusetts General Hospital and Professor of Psychiatry, Harvard Medical School.
"Presentation of these data at this highly respected conference is another important step toward bringing a life-saving product to patients in tremendous need," said Dr. Jonathan Javitt, Chairman and Chief Scientist of NRx. "We believe that NRX-101 may offer a paradigm changing approach to treatment of Bipolar Depression, with a product highly effective in both treating depression and reducing suicidality and associated side effects. We will continue working to bring hope to life with life-saving medications."
The presentation will be held at 11:15 AM, Wednesday May 29, 2024.
W89 A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior
CONCLUSIONS of the Poster are:
NRX-101 and lurasidone both demonstrated > 50% response for treating bipolar depression with no difference seen on primary efficacy endpoint (MADRS)
A clinically meaningful difference was observed on both primary and secondary safety endpoints favoring NRX-101NRX-101 was associated with 58% relative reduction in time to sustained remission from suicidality as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) when stratified by sex, mood stabilizer use, antipsychotic use, lifetime suicide event (P=0.05).NRX-101 was associated with a relative 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size 0.37; P=0.03) on the Barnes Akathisia Rating Scale
Akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone.
NRX-101 showed superiority to lurasidone in akathisia starting at day 7 and continuing through day 42/ET.
No treatment-related serious adverse event was observed in either group. No safety issues were detected except for MedDRA General disorders: NRX-101 - 18.2% vs lurasidone - 0% (p=0.002).
Based on these findings, together with the earlier STABIL-B trial, the Company believes that NRX-101 has potential to become a standard of care drug for treating bipolar depression, an addressable population of 7 million patients in the US and many times that around the world.
This study represents the second trial conducted under FDA Good Clinical Practices guidelines to demonstrate large and meaningful advantages of NRX-101 vs lurasidone on akathisia and suicidality and clears the path for a registration trial of NRX-101 vs. placebo to treat bipolar depression together with earlier accelerated approval for those with akathisia. An additional academic trial conducted by Chen and co-workers similarly demonstrated a statistically-significant reduction in suicidality associated with D-cycloserine, the active ingredient in NRX-101, compared to various standard of care antidepressants.
To the Company's knowledge, this trial and its prior STABIL-B study represent the only clinical trials in which an oral antidepressant has been demonstrated to cause meaningful reductions in suicidality and akathisia. All currently approved antidepressant drugs carry FDA-mandated "black box" warnings on their labels indicating that they may increase the risk of suicide. Similarly, akathisia – a side effect in which patients are agitated and frequently experience involuntary movement – is a side effect that occurs in 10-15% of patients who take the lurasidone class of drugs and is closely linked to suicide. As shown in the clinical trial, those randomized to lurasidone experienced a substantial increase in akathisia from baseline, whereas those randomized to NRX-101 demonstrated a statistically-significant reduction in akathisia (see Figure).
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
https://c212.net/c/img/favicon.png?sn=CL24282&sd=2024-05-28 View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-presents-landmark-trial-of-nrx-101-in-suicidal-bipolar-depression-at-the-american-society-of-clinical-psychopharmacology-annual-meeting-nrx-101-is-the-first-oral-antidepressant-demonstrated-to-re-302156419.html
SOURCE NRx Pharmaceuticals, Inc.
HNRC :::: Looks like pps has bottomed. Getting some hits on the ask. Just a FYI. HAWK
IGPK... Today could be the record of largest merging company ever to be on OTC. New merger today will file the first 1st quarter Fins that will show the Revs and some say it's going to be HUGE. Guesses range from hundreds of Millions to Billions in Revs last year. They merged in January and since then clean up the shell. Deleted the yield sign to Pink now, had the release of defunct and dark removed, got all of the old filings finished to bring it up to date. All everyone has been waiting on should be today is the release of the 1st quarter fins to see what the Revs are. They are like a Amazon and Alibaba combined in running platforms... they are very large in China and want to break into the American markets. Today is the last of the cheapies. It's like buying Amazon for .0163...
$AVRW News: Avenir Wellness Solutions Reports Fourth Quarter 2023 Results
New Initiatives Showing Encouraging Results
SHERMAN OAKS, CA / ACCESSWIRE / May 17, 2024 / Avenir Wellness Solutions, Inc. (OTCQB:AVRW) ("Avenir" or the "Company"), a proprietary broad platform technology and wellness company, today announced results for the fourth fiscal quarter ended December 30, 2023.
Key financial highlights for the fourth quarter included the following:
Net revenue in the fourth quarter of 2023 increased to $1.1 million from the same period in 2022 by $0.2 million, or 11.7%, and also increased sequentially from Q3 2023 by $43 thousand, or 4.4%. Overall growth was lower than expected due to the continued delay in receiving the expected remainder of the asset sale proceeds to be used for advertising and marketing to drive sales. The quarter did, however, benefit from a new relationship with leading online and beauty subscription box retailer, FabFitFun.
Gross margin increased 407 basis points year over year in the fourth quarter of 2023 due to improved working capital management offset in part by a higher proportion of sales coming from our wholesale channel of distribution with its lower margins than our higher-margin direct-to-consumer sales channel.
Gross margin for the third quarter of 2023 decreased sequentially from the second quarter of 2023 by 26 basis points due to a shift in sales channel mix with a higher proportion of wholesale sales to Amazon and FabFitFun which resulted in shipments of approximately $0.3 million.
Cost containment initiatives led to a favorable impact on SG&A expenses (excluding non-cash charges) for the fourth quarter with a decrease of $357 thousand in 2023 compared to 2022 driven by decreased spend on advertising and promotion of $325 thousand lower overhead by $32 thousand.
Net operating loss from continuing operations (excluding non-cash charges) improved by $0.9 million in 2023.
"Our products continue to maintain sales levels which is encouraging given that we have been unable to fully execute on our marketing initiatives pending receipt of the balance of the proceeds from the July 2022 asset sale. As mentioned in our third quarter earnings announcement, the proceeds from the July 2022 asset sale allow us to invest in the future of the Company, but the delay in receiving the balance of the proceeds continued to have an impact on our operating performance. We expect accelerating sales will reaffirm the improving overall trajectory of the business. Further, our margin expansion initiatives continue to deliver results with improvement from third quarter, and we continue our overall cost containment initiatives to further reduce SG&A expenses and to maximize operating leverage.
Fine tuning our Search Engine Optimization (SEO), bringing our media buying in house and achieving successful monthly campaigns like theSkimm continue to deliver for us as we execute on our strategy to build our brands," said Nancy Duitch, Avenir CEO.
Operational Highlights
Other operational highlights during the fourth quarter of 2023 included:
Our newly formulated Seratopical Revolution Cracked Heel Souffle was selected for inclusion in FatFitFun's Summer 2024 subscription box selling out an astonishing 80,000 units in under 43 minutes. Click link to view Instagram videos on our Cracked Heel Souffle.
Our DNA Complex hero product continues to perform as our subscription based grows.
Wholesale sales led by Amazon continue to grow with all the positive product reviews.
We began development of our new TikTok shop to capitalize on the evolving digital ecommerce landscape which launched in the second quarter of 2024.
For further details, please visit our website to review our most recent Form 10-K filed on May 17, 2024 at: http://www.avenirwellness.com/sec-filings/
About Avenir Wellness Solutions, Inc.
Avenir Wellness Solutions, Inc. (OTCQB:AVRW) is a broad platform technology company that develops proprietary wellness, nutraceutical, and topical delivery systems which are integrated into our wellness and beauty products and sold directly to the consumer. The technology, which is based on (15) fifteen current patents, offers a number of unique immediate- and controlled-release delivery vehicles designed to improve product efficacy, safety, and consumer experience for a wide range of active ingredients. The Company will continue down the path of creating new technologies that is part of its incubator strategy in order to monetize its intellectual property as well as expand our product lines utilizing the technology. As a vertically integrated platform company, Avenir looks to partner or license its IP technology with wellness companies worldwide. For more information visit: www.avenirwellness.com.
About The Sera Labs, Inc.
Sera Labs, a wholly owned subsidiary of Avenir, is a trusted leader in the health, wellness, and beauty sectors of innovative products with cutting-edge technology. Sera Labs creates high-quality products that use science-backed, proprietary formulations. More than 25 products are sold under the brand names Seratopical™, Seratopical Revolution™, SeraLabs™, and Nutri-Strips™. Sera Labs sells its products at affordable prices, making them easily accessible on a global scale. Strategically positioned in the growth market categories of beauty, health and wellness, Sera Labs products are sold direct-to-consumer (DTC) via online website orders, including a subscribe and save option, and also sold online and in-store at major national drug, grocery chains, convenience stores, and mass retailers and on Amazon.com. For more information visit: www.seralabshealth.com and follow Sera Labs on Facebook, Instagram and TikTok at @seratopical as well as on X (Twitter) at @sera_labs.
Forward Looking Statement
This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which statements are subject to considerable risks and uncertainties. Forward-looking statements include all statements other than statements of historical fact contained in this press release, including statements regarding the future growth and success of our organization. We have attempted to identify forward-looking statements by using words such as "anticipate," "believe," "could," "estimate," "expected," "intend," "may," "plan," "predict," "project," "should," "will," or "would," and similar expressions or the negative of these expressions.
Forward-looking statements represent our management's current expectations and predictions about trends affecting our business and industry and are based on information available as of the time such statements are made. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy or completeness. Forward-looking statements involve numerous known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements predicted, assumed or implied by the forward-looking statements. Some of the risks and uncertainties that may cause our actual results to materially differ from those expressed or implied by these forward-looking statements are described in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as well as in our Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.
Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Except as required by applicable law, we expressly disclaim any intent or obligation to update any forward-looking statements, or to update the reasons actual results could differ materially from those expressed or implied by these forward-looking statements, whether to conform such statements to actual results or changes in our expectations, or as a result of the availability of new information.
CONTACTS:
Investor Relations
Hanover International Inc.
T: (760) 564-7400
E: investor@avenirwellness.com
I am interested in (TWOH ) Two Hands Corporation.. Can anyone tell me anything about this one?
$NILIF is starting to breakout. Work begins on the highest grade lithium deposit in North America in a couple weeks. Easy gains on this one. If you want to take advantage of the area, $SNNAF is a year lows and will be drilling on their Elko project bordering Surge Battery Metals impressive discovery. Worth a trade.
PSHG >>>> I've seen book value estimates at around $18. Just a FYI. Suggest keeping on your watch lists.
$RENB News: Transforming Cancer Detection: RenovaroCube Introduces Flamingo, a novel AI model based on Fragmentomics
LOS ANGELES and AMSTERDAM, April 30, 2024 (GLOBE NEWSWIRE) -- RenovaroCube, wholly owned subsidiary of Renovaro, Inc. (Nasdaq: RENB), a company at the forefront of AI-driven healthcare innovation, proudly unveils Flamingo, a potentially groundbreaking multi-cancer detection model contributing to its mission to transform early cancer diagnostics. Leveraging ultra-low pass whole genome sequencing (ULP-WGS) of cell-free DNA (cfDNA), Flamingo represents a promising leap forward in the fight against cancer.
Traditional cancer detection methods often fall short in identifying cancers at an early stage when treatment is the most effective. However, Flamingo has the potential to overcome these limitations by harnessing the power of AI to analyze minute amounts of cfDNA data that is highly accurate.
"At RenovaroCube, we believe in pushing the boundaries of possibility," states Daan Vessies, senior scientist at RenovaroCube. "Flamingo undescores our commitment to change cancer diagnostics in a transformative way, ultimately offering clinicians a powerful tool to detect cancer across diverse omic layers."
The Company believes that no single model or molecular modality will reach the requisite sensitivity and specificity throughout the entire patient journey for personalized, precision medicine, from early detection, to predicting the effectiveness of various treatment options, to monitoring the response to therapy within days of starting it, to detecting recurrence at the earliest possible moment. Therefore, our AI/machine learning platform, The Cube, integrates multi-omic data, offering a uniquely comprehensive approach to cancer detection by leveraging a library of trained models for multiple omic layers. One such model Flamingo focuses on is the detection of cancer from ultra-low pass whole genome sequencing (ULP-WGS) cfDNA data using fragmentomics.
Flamingo's development marks a significant milestone in the quest for early cancer detection with RenovaroCube’s engine. By utilizing as few as only 200,000 cell-free DNA fragments per sample, integrating fragment lengths, sequence motifs and employing a meticulously designed neural network, Flamingo achieves remarkable performance in distinguishing cancer from healthy samples.
By augmenting The Cube's arsenal of models operating across various omic layers, Flamingo contributes to the development of non-invasive diagnostics to detect cancer early, enabling timely interventions and improving patient outcomes.
"Adding Flamingo to our Cube will accelerate our efforts to realize a paradigm shift in cancer detection," affirms Frank van Asch, CTO, RenovaroCube. "With its introduction, we are one step closer to realizing our vision of a world where cancer is detected and treated swiftly, saving countless lives in the process."
RenovaroCube invites interested doctors and scientists from international research institutions, clinical cancer centers and all stakeholders to join in the early research use application of our AI/machine learning platform to advance cancer diagnostics and pave the way for a healthier future.
About Renovaro:
Please see a recent interview with Avram Miller, Member of, and Advisor to, the Board of Directors, former co-founder of Intel Capital and SVP of Business Development for Intel:
https://techbullion.com/avram-miller-talks-ab...es-with-ai
Renovaro aims to accelerate precision and personalized medicine for longevity powered by mutually reinforcing AI and biotechnology platforms for early diagnosis, better-targeted treatments, and drug discovery. Renovaro includes RenovaroBio, with its advanced cell-gene immunotherapy company, and RenovaroCube. RenovaroCube has developed an award-winning AI platform that is committed to the early detection of cancer and its recurrence and monitoring subsequent treatments. RenovaroCube intervenes at a stage where potential therapy can be most effective. RenovaroCube is a molecular data science company with a background in FinTech and a 10-year history. It brings together proprietary artificial intelligence (AI) technology, multi-omics, multi-modal data, and the expertise of a carefully selected multidisciplinary team to radically accelerate precision medicine and enable breakthrough changes in cancer care.
Upon the closing of the previously announced acquisition of Cyclomics (winner of the Health Holland Venture Challenge), RenovaroCube will be capable of performing liquid biopsies using proprietary technologies to identify single cancer DNA molecules in only one vial of blood. In combination with Oxford Nanopore Technology, genetic information can be retrieved over multiple genetic layers to develop the next generation of cancer diagnostics. This will transform cancer care by enabling faster and more accurate diagnosis throughout the patient journey.
https://www.renovarogroup.com
https://www.renovarobio.com
https://www.renovarocube.com
About Cyclomics:
Cyclomics is a Dutch company founded in 2018, winner of the Health Holland Venture Challenge (startup of the year) by scientists of the UMC Utrecht. Its ambition is to transform cancer care by enabling faster and more reliable diagnoses, particularly in the context of cancer recurrence thanks to its proprietary circulating tumor DNA (ctDNA) detection technology.
https://www.cyclomics.com/
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline and platform. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Renovaro’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Renovaro Inc. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For media inquiries, please contact: karen@renovarocube.com
Source: Renovaro Inc.
$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Announces Promising Findings in Phase 2b/3 Clinical Trial of NRX-101 vs. Lurasidone for Treatment of Suicidal Bipolar Depression
NRX-101 is first oral antidepressant to show 33% advantage in sustained remission in suicidality (not statistically significant at this sample size) and 75% advantage in relief from Akathisia relative to lurasidone - never previously shown with an oral antidepressant. Suicidality signal met the study's promising zone criteria and the akathisia signal approached statistical significance (P=0.076)
Both NRX-101 and lurasidone, an accepted standard of care in Bipolar Depression, demonstrated approximately 50% reduction in symptoms of depression
These data are comparable to previous statistically-significant finding of reduced suicidality and in the published STABIL-B trial and support an approval pathway via a 300-person registrational trial with sustained remission in suicidality as the primary endpoint
Company believes that an oral antidepressant that demonstrates reduction in suicidality has potential to become standard of care for treatment of bipolar depression.
Data from this study expand the potential utility of NRx-101 to treat both patients with suicidal bipolar depression (who will require prior use of ketamine) and those without subacute suicidality (nearly 7 million patients in the US).
RADNOR, Pa., April 30, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company today that its Breakthrough Therapy designated investigational drug NRX-101 vs lurasidone demonstrated a promising, though not yet statistically significant 33% reduction in suicidality together with a 70% reduction (P=.076) reduction in symptoms of akathisia – a side effect of antidepressants that is closely linked to suicide and considered a medical emergency. Because of the high-risk nature of these patients, a placebo group could not be employed, and NRX-101, a fixed dose combination of D-cycloserine (DCS) and lurasidone, was compared to lurasidone alone (the standard of care). In the Company's previously published STABIL-B trial (STABIL-B), NRX-101 was demonstrated to be superior to lurasidone in reducing both depression and suicidality after ketamine while showing a trend towards reducing akathisia (a side effect involving restlessness and agitation that is considered a warning sign of impending suicide). In this trial, without prior use of ketamine, NRX-101 and lurasidone were comparable in their effect on depression. The trial was a randomized, prospective, double-blind study conducted at multiple sites in the Unites States whose protocol and statistical analysis plan may be viewed on www.clinicaltrials.gov (NCT03395392).
"We are gratified by these results, which extend the findings of the STABIL-B trial in suggesting that NRX-101 has the potential to be the first oral antidepressant to decrease potential for suicide, whereas all currently approved oral antidepressants are known to increase the risk of suicide," said Prof. Jonathan Javitt, MD, MPH, the Company's Chairman and Chief Scientist. "Should these findings be confirmed in a registrational trial of 300 patients, NRX-101 has the potential to represent a paradigm-changing blockbuster drug. The finding of a dramatic difference in akathisia was also seen in the STABIL-B trial and provides important mechanistic support for the difference seen on the Columbia Suicide Severity Rating Scale. Many of the patients who tragically die from suicide in bipolar depression are taking traditional antidepressants at the time of their death, a tragedy we have seen within the families of our investors and board members, as well as the many patients we have known. If today's findings are replicated in a registration-sized trial, we will change the world for patients who currently have a 50% lifetime risk of suicide attempt, a 20% lifetime risk of death by suicide, and whose only approved treatment option today is electroshock therapy."
"These findings are consistent with our original Phase 2 objectives and promising zone methodology in terms of a demonstrable advantage of NRX-101 compared to the standard of care in treating patients with bipolar depression who are known to be at high risk of suicide. We originally proposed to test suicidality, rather than depression as the primary endpoint for this trial and took the advice of senior FDA leadership that demonstrating a difference in suicidality might be too challenging. Today's findings demonstrate that differences in suicidality and akathisia can be demonstrated compared to best available antidepressant therapy in a properly sized registration trial and that superiority over placebo on the depression scale may readily be demonstrated in a less acute patient population where it would be safe to do so," said Dr. Philip Lavin, the study's Lead Methodologist. Dr. Lavin is one of the world's most widely published statisticians who has led the approval/clearance of more than 80 drugs, devices, and biologics.
In the current study, without prior use of ketamine, NRX-101 and lurasidone exhibited comparable antidepressant effects, each reducing depression (the primary endpoint) on the Montgomery Asberg Depression Rating Scale (MADRS) by about 50% from baseline. Lurasidone is known to reduce symptoms of depression by approximately 4 points in multiple registration trials compared to placebo.
Analysis of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS) demonstrated a sustained 33% advantage in remission from suicidality favoring NRX-101 (see figure). This difference was not statistically significant at the phase 2 sample size but met the study's original promising zone criteria and, if sustained in a registration trial of 300 or more patients, would be powered to yield a statistically significant result. The reduction in suicidality is comparable to that demonstrated after ketamine, both in the Company's STABIL-B trial and in an independently conducted trial comparing DCS to placebo after ketamine (Chen, et. al.). A meaningful remission in suicidality has not been demonstrated with any prior oral antidepressant drug – indeed, antidepressant drugs carry a Black Box warning of increased suicide risk.
Reduction in akathisia was first identified in the laboratory as a distinguishing feature of DCS and is the basis of the approved claims in the Company's Composition of Matter patents. Akathisia is often characterized as a state of agitation and motor restlessness that is associated with particularly impulsive and tragically effective attempts at suicide, such as hanging, shooting, jumping from buildings and in front of vehicles and trains. In this trial, a 75% relative difference was seen on the Barnes Akathisia Rating Scale (BARS), with two-sided P=0.076, which would be expected to achieve significance in a properly powered registration-sized trial. While reduction in akathisia is not proposed as a primary labeled indication, continued finding of a statistically significant reduction in this side effect would be highly supportive of a demonstrated primary endpoint of reduced suicidality and would provide clinical corroboration.
Based on these findings and widespread adoption of ketamine as initial treatment for suicidal depression, the Company believes that NRX-101 may become the drug of choice for potentiating the effect of ketamine in patients with acute and subacute suicidality. The FDA recently affirmed to the Company that the Special Protocol Agreement for this indication remains in place, subject to the Company filing a New Drug Approval for ketamine, which is expected by July 2024. Moreover the Company aims to explore the role of NRX-101 as primary treatment for the much larger population (approximately 7 million in the US) of patients with bipolar depression who do not have active suicidality and, therefore, do not require prior treatment with intravenous ketamine.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE NRx Pharmaceuticals
$AGBA - AGBA and Triller Merge to Create a $4 Billion Powerhouse, Unleashing a Game-Changing Power in Digital Content and Financial Services.
https://www.marketwatch.com/press-release/agba-and-triller-merge-to-create-a-4-billion-powerhouse-unleashing-a-game-changing-power-in-digital-content-and-financial-services-85d7c8f5?mod=mw_quote_news_seemore
$GVH -Experience Effortless E-commerce Shipping: Globavend Holdings Limited (NASDAQ:GVH) Tailored Solutions from Hong Kong to Your Doorstep in Australia & New Zealand!
Click here: https://axecapitalusa.com/gvh/
Welcome to the future of logistics with Globavend Holdings Limited (NASDAQ:GVH), where innovation meets opportunity in the bustling e-commerce landscape of Asia-Pacific. As pioneers in direct injection from Hong Kong & Southern China to Australia and New Zealand, we offer investors a gateway to a market projected to witness exponential growth. Our integrated cross-border logistics solutions ensure seamless parcel consolidation, air freight forwarding, and customs clearance, catering to the evolving needs of online businesses.
Strategic Expansion: With plans to establish ground transportation and customs clearance teams, we are poised to capture a significant market share.
Profitable Partnerships: As an IATA-accredited cargo agent with strong ties to top air freight carriers, we guarantee cost-effective solutions.
Robust Growth: Amidst a booming e-commerce market, our stable business model promises lucrative returns for investors seeking long-term opportunities.
Innovative Solutions: Our all-in-one shipping solution ensures operational efficiency and customer satisfaction, positioning us as industry leaders.
Invest in Globavend today and be part of a transformative journey reshaping the future of global logistics.
$AVRW New and Perfect Skincare Product, Seratopical Solutions' "Harmony Toner", is Now Available on the Seratopical Website!
Great video with Facial Plastic Surgeon Dr. Michael Persky
Link: https://seralabshealth.com/products/
$NRXP News: NRx Pharmaceuticals (NASDAQ:NRXP) Announces Development of New, Proprietary Formulation of HTX-100 (IV Ketamine)
Formulation based on prior patents by NRx founder
Achieved pH neutral formulation of ketamine, potentially enabling both intravenous (IV) and subcutaneous (SQ) administration
Company expects Composition of Matter patent protection
Company previously executed joint development agreement with US manufacturer of insulin pumps
RADNOR, Pa., April 15, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company has developed a novel, proprietary formulation of IV Ketamine for use as HTX-100. This new formulation has the key advantage of achieving neutral pH, in contrast to the acidic pH of generic formulations of ketamine. Acidic substances are tolerated when diluted for intravenous use, but cause pain and may cause skin ulcers if administered subcutaneously. This patentable invention may enable the administration of ketamine in insulin pump-like devices in the clinic setting, eliminating the requirement for intravenous infusion personnel. NeuroRx, Inc. previously executed a joint development agreement with a manufacturer of insulin pumps but has been awaiting a suitable, pH neutral formulation of ketamine.
With this proprietary formulation, developed with our partner Nephron Pharmaceuticals, a leading sterile products manufacturer, NRx is expected to generate one or more patents, such as composition of matter or formulation.
HTX-100 is expected to be marketed by HOPE Therapeutics, Inc., a wholly owned subsidiary of NRx.
"The current formulation of IV Ketamine was developed for battlefield use in the 1960s and has remained relatively static since then. With our new formulation, and Nephron's state of the art manufacturing expertise, we are pleased to be approaching the market with an improved formulation ready for use in modern medicine," said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. "Development of a pH-neutral, subcutaneous form of ketamine administration enables a significantly less complex route of administration in the outpatient setting. Moreover, advances in insulin pump technology create the potential to monitor the brain wave activity and other physiologic parameters associated with ketamine administration and modulate ketamine therapy based on the patient's individual physiologic response."
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (http://www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRx Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE NRx Pharmaceuticals, Inc.
$IVDN News on Rising Sales of Superior Insulation Product: Innovative Designs Vendor Growth
PITTSBURGH, PA, April 10, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Innovative Designs, Inc. (OTCQB: IVDN) continues to gain market share through its growing vendor base. Since the beginning of this fiscal year (November 1, 2023), Innovative Designs has added over 30 new accounts that have purchased its Insultex House Wrap®. This has resulted in a comp sales increase of 318% as compared to the same time period last year (November 2022 – April 2023). With 7 months remaining in FY2024, sales for the first 5 months are approaching 88% of last year's total.
Randy Kimbler, a National Distributor of Insultex, commented, “The introduction of Insultex® House Wrap to several major building supply companies has been very well-received. The product is being placed in the retail locations of these organizations, as well as many local building supply companies. The R-6 insulation value provided by this very thin product has proven to be an affordable solution for builders facing economic challenges in states where energy codes require R-5 Continuous insulation for new construction.”
About Innovative Designs, Inc.
Innovative Designs, Inc. manufactures the Insultex® House Wrap and Arctic Armor® Line, under the "i.d.i.gear" label featuring INSULTEX®. Patented INSULTEX® is the thinnest, lightest and warmest insulator in the market today. For more information, please visit http://www.idigear.com or http://www.insultexhousewrap.com.
Disclaimer
Certain statements in this press release constitute "forward-looking" statements as defined by federal law. Such statements are based on assumptions, but there is no assurance that actual outcomes will not be materially different as those implied. Any such statements are made in reliance on the "Safe Harbor" protections provided under the Private Securities Reform Act of 1995 and are subject to various factors, including the risks and matters discussed in the Company's SEC filings available at http://www.sec.gov.
CONTACT:
Innovative Designs, Inc.
Joseph Riccelli, CEO
412-799-0350
joer@idigear.com
Website: http://www.insultexhousewrap.com
Link: https://finance.yahoo.com/news/innovative-designs-vendor-growth-173800119.html
$IQST is heating up, and word is, $1 is within reach when they announce their latest acquisition.
https://www.prnewswire.com/news-releases/iqst--iqstel-q1-record-breaking-revenue-exceeds-50m-not-including-recent-acquisition-302114251.html
$NRXP News: NRx Pharmaceuticals (NASDAQ:NRXP) Announces Data-Lock of Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression
https://finance.yahoo.com/news/nrx-pharmaceuticals-nasdaq-nrxp-announces-123000217.html
$GDHG News: Golden Heaven Group Holdings Ltd. Enters into a Collaboration Agreement with Nanping City Dacheng Culture Communication Co., Ltd.
NANPING, China, April 2, 2024 /PRNewswire/ -- Golden Heaven Group Holdings Ltd. (the "Company" or "Golden Heaven") (Nasdaq: GDHG), an amusement park operator in China, today announced that on March 29, 2024, it entered into a collaboration agreement (the "Agreement") with Nanping City Dacheng Culture Communication Co., Ltd. ("Dacheng Culture").
Under the Agreement, Golden Heaven has agreed to lease certain land and property to Dacheng Culture to host a range of activities, including wedding photography, family photography, marriage proposal planning, Hanfu (traditional Chinese clothing) photography, and various celebratory events. Dacheng Culture has agreed to compensate the Company with an aggregate lease payment of RMB6 million, payable quarterly, over the contract period, which extends from March 29, 2024 to March 28, 2025.
Mr. Jin Xu, the CEO and Chairman of the Company, commented, "As previously disclosed on March 19, 2024, we entered into a similar collaboration agreement with Zigong City Dragon Culture & Arts Co. Ltd. These collaboration agreements are designed to leverage our park locations and family-oriented attractions, enhance site utilization and strengthen bonds with our guests. The diverse activities that Dacheng Culture plans to introduce to our parks are expected to attract more guests, elevate the guest experience and add to our revenue. We are enthusiastic about embarking on this venture and future collaborations."
About Golden Heaven Group Holdings Ltd.
Golden Heaven Group Holdings Ltd. manages and operates six properties consisting of amusement parks, water parks, and complementary recreational facilities. With approximately 426,560 square meters of land in the aggregate, these parks are located in geographically diverse markets across the south of China and collectively offer approximately 139 rides and attractions. Due to the geographical locations of the parks and the ease of travel, the parks are easily accessible to an aggregate population of approximately 21 million people. Since September 30, 2023, Mangshi Jinsheng Amusement Park, which is one of the six parks, has been temporarily closed. The parks provide a wide range of exciting and entertaining experiences, including thrilling rides, family-friendly attractions, water attractions, gourmet festivals, circus performances, and high-tech facilities. For more information, please visit the Company's website at https://ir.jsyoule.com/.
Forward-Looking Statements
This press release contains "forward-looking statements". Forward-looking statements reflect our current view about future events. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company's current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as "may," "will," "could," "expect," "anticipate," "aim," "estimate," "intend," "plan," "believe," "is/are likely to," "propose," "potential," "continue" or similar expressions. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results in the Company's registration statement and other filings with the U.S. Securities and Exchange Commission.
For investor and media inquiries, please contact:
Golden Heaven Group Holdings Ltd.
Email: group@jsyoule.com
Ascent Investor Relations LLC
Phone: +1-646-932-7242
Email: investors@ascent-ir.com
https://c212.net/c/img/favicon.png?sn=CN77335&sd=2024-04-02 View original content:https://www.prnewswire.com/news-releases/golden-heaven-group-holdings-ltd-enters-into-a-collaboration-agreement-with-nanping-city-dacheng-culture-communication-co-ltd-302105015.html
SOURCE Golden Heaven Group Holdings Ltd.
Potential spike SODE: Annual report and current filing: 1) unrestricted shares a measly 31M only 2) gross profit 3) no change in OS for years 4) no convertible debt...entry pps IMO...spike from under a cent to $1 pps in 2021; spike to 10 cent pps in 2022
https://www.otcmarkets.com/stock/SODE/disclosure
$LQWC LifeQuest’s (OTC Markets: LQWC) Wholly Owned Subsidiary Receives an Order for a 30m3/Day (7,900 Gallons/Day) Sewage Wastewater Treatment Plant From a Hospital in India
https://www.otcmarkets.com/stock/LQWC/news/LifeQuests-Wholly-Owned-Subsidiary-Receives-an-Order-for-a-30m3Day-7900-GallonsDay-Sewage-Wastewater-Treatment-Plant-Fro?id=435813
$EDXC's low price is chance for us, ain't gonna miss that.
$TMSH(.0003)~New JV, Revenue & Tiny A/S and O/S~DD
1) TMSH Pink Current
https://www.otcmarkets.com/stock/TMSH/overview
--------------------
2) TMSH~1.5 Billion A/S, 1.37 Billion O/S
Authorized Shares: 1,500,000,000
Outstanding Shares: 1,376,873,176
Restricted: 118,922,800
Unrestricted: 1,257,950,376
Held at DTC: 1,203,046,402
https://www.otcmarkets.com/stock/TMSH/security
------------------
3) The company generates revenue and gross profit
Most recent as of September 30, 2023
Revenue: 124, 329 dollars
Gross profit: 91,146 dollars
Total asset: 2,709,518 dollars
Total liabilities: 1,635,093 dollars
https://www.otcmarkets.com/otcapi/company/financial-report/386110/content
--------------
4) TMSH: "We invite prospective investors to delve into this transformative investment opportunity by navigating our digital domains:
www.transglobalassets.com,
www.betterhealthsciences.ca,
www.cannascribe.com,
www.synergyhealthservices.ca and
www.betterpets.ca
These platforms reveal the exciting potential within TMSH, providing a unique vantage point into a promising future.
https://finance.yahoo.com/news/transglobal-assets-inc-ventures-pet-164300459.html
----------------
5) Recent news: TransGlobal Assets Inc. Ventures into Pet Health Industry through Strategic Joint Venture
Press Release | 03/21/2024
CHEYENNE, Wyo., March 21, 2024 (GLOBE NEWSWIRE) -- TransGlobal Assets Inc. (OTC: TMSH) is excited to announce a significant milestone as its wholly owned subsidiary, Better Health Sciences Inc., has entered into a Joint Venture Agreement with Better Health Sciences For Pets Corp., otherwise known as the Better Pets brand.
TransGlobal Assets Inc. (OTC: TMSH)
E-Mail: info@TransGlobalAssets.net
Twitter: https://twitter.com/TMSH_OTC
Website: https://betterhealthsciences.ca/
https://www.otcmarkets.com/stock/TMSH/news/TransGlobal-Assets-Inc-Ventures-into-Pet-Health-Industry-through-Strategic-Joint-Venture?id=433992
-----------------
6) TMSH~Joint Venture companies two new products have been approved by Health Canada
Better Pets - Balm
Approved and Coming Soon
Topical Balm
Recommended Use:
Better Pets - Pet Balm, acts as a barrier and moisturizer to support skin health when applied to a pet’s paws, elbows and nose.
NN.I5Q4
Better Pets - Pet Gel
Approved and Coming Soon
Topical Gel
Recommended Use:
Better Pets - Pet Gel, helps to promote and maintain healthy skin.
NN.Y7J0
https://www.betterpets.ca/store
-----------
This is my DD . Please make your DD
$CBMJ Patriot.TV Launch Party Next Week = Loading_Zone_Now
🎉 It’s happening! The http://Patriot.TV Launch Party is here and you're invited!
🌟 Join us and an amazing lineup of speakers including Jason Lewis, Colonel John Mills, Roger Stone, and the esteemed Lt. Gen. Michael Flynn.
📆 Dates: March 29th and 30th
⏰ Times: Friday 7:30 pm-10 pm CT, Saturday 9 am-4 pm CT
Let's unite to celebrate patriotism, lively discussions, and a shared dedication to our nation's future. Share with your friends and let’s make it a weekend to remember! 🇺🇸 #PatriotTV #LaunchParty #CelebrateFreedom
🎉 It’s happening! The https://t.co/5RAXNKPHef Launch Party is here and you're invited! 🌟 Join us and an amazing lineup of speakers including Jason Lewis, Colonel John Mills, Roger Stone, and the esteemed Lt. Gen. Michael Flynn.
— PatriotTVNetwork (@patriottvnet) March 21, 2024
📆 Dates: March 29th and 30th
⏰ Times: Friday… pic.twitter.com/yf5s0awRnt
iQSTEL's Early Q1 Figures!
Have you seen the numbers? $IQST is smashing records with over $46M already in the bag for Q1. And with the roadmap laid out, the $1 billion goal isn't just a dream—it's the destination. Buckle up!
https://www.prnewswire.com/news-releases/iqst--iqstel-announces-record-breaking-revenue-and-gross-margin-reaching-46m-ytd-revenue-before-end-of-q1-302095888.html
$NRXP News: NRx Pharmaceuticals (NASDAQ:NRXP) Initiates Strategy to Combat Short Sales
Initiative is intended to protect shareholder value through continued compliance with Nasdaq listing rules and elimination of naked short sales positions in the Company's securities
The Company is contemplating a reverse split, if needed to maintain NASDAQ listing compliance, to be accompanied by change in corporate name and CUSIP number
Company has retained former SEC enforcement leadership to notify leading brokerages of the need to close all naked short positions in the Company's securities and to prevent future accumulation of naked short positions in the Company's new security
RADNOR, Pa., March 12, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company" today initiated actions to combat short sellers in the Company's stock.
The Company announced a proposal to simultaneously change the CUSIP under which the Company's shares are traded, together with changing the name of the Company to NRx Therapeutics, Inc. The Company plans to accompany these actions with a required exchange of the underlying stock certificates. This certificate change is expected to be seamless for those investors holding NRXP shares in electronic form and similarly for investors who may have established short positions in NRXP by borrowing the underlying shares from a registered shareholder. Any party holding a short position in the Company's shares who has not complied with the legal requirement to borrow the underlying shares of stock (i.e. "a naked short" may be unable to exchange that position for a position in the new security.
The Company is working with attorneys who formerly served in leadership positions at the SEC Division of Enforcement to correspond with corporate counsel and compliance heads at leading brokerages to emphasize the current legal prohibitions against naked short sales. As identified in previous announcements, the Company was advised by ShareIntel in September 2023 that substantial naked short positions in the Company's securities had been identified at major brokerage firms.
"We believe it is in the best interests of our shareholders to have fully-compliant trading in the markets," said Janet Rehnquist, Esq., who chairs the Company's Compliance Committee. "As we focus on the development of potentially life-saving drugs to combat suicidal depression, PTSD, and Chronic Pain, it is critical that we take all steps possible to maximize the value of those who have invested in our Company and provided the resources to address these critical unmet medical needs."
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-initiates-strategy-to-combat-short-sales-302086668.html
SOURCE NRx Pharmaceuticals, Inc.
$NRXP: NRx Pharmaceuticals (NASDAQ:NRXP) Completes Memorandum of Understanding and Collaborations with Distribution Partners for HTX-100 (IV Ketamine)
Company to receive first allocation of ketamine for sale by month end
Partners preparing to ship IV Ketamine to full range of customers via 503a and 503b pharmacies
NRx Pharmaceuticals and HOPE Therapeutics aim to provide highest quality product available to those in need and assure ongoing supply
Important step toward goal of providing full suite of supply options, to ultimately include an FDA approved, and widely reimbursed, solution for patients and clinics, subject to board approval
RADNOR, Pa., March 11, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company") and its wholly owned subsidiary HOPE Therapeutics, clinical-stage biopharmaceutical companies, today announced completion of a Memorandum of Understanding with Conversio Health, a national 503a pharmacy, and a strong, ongoing partnership with Nephron Pharmaceuticals, a manufacturer of Ketamine and 503b pharmacy to provide IV Ketamine to patients and clinics across the country, subject to board approval. These are important steps to providing a full suite of ketamine options for customers across the country, and preparation for potential approval of HTX-100 by regulatory authorities worldwide.
(PRNewsfoto/NRx Pharmaceuticals)
(PRNewsfoto/NRx Pharmaceuticals)
The Company has further entered into a business relationship with an organization that currently serves the business needs of more than 100 ketamine clinics nationwide. The Company has been given a target delivery date prior to the end of this month (March 2024) for initial stock of ketamine for sale to licensed end users. Sales are planned to commence once technical and logistical elements are finalized. Details for ordering will be available on our website as soon as they are available. www.hopetherapeutics.com
In contrast to NRx Pharmaceuticals, which is structured as a Biotechnology research and development company, HOPE Therapeutics is structured as a Specialty Pharmaceutical company that aims to supply a variety of therapeutic products to clinics that are treating suicidal depression and PTSD, including both traditional and digital therapeutics.
"We are pleased to be working with two outstanding organizations in Conversio Health and Nephron Pharmaceuticals to provide this important medication to a market in need of a consistent supply of high-quality, FDA- and DEA- compliant IV ketamine," said Matthew Duffy Chief Business Officer of NRx Pharmaceuticals and co-CEO of HOPE Therapeutics. "Importantly, these efforts will provide a strong foundation for expanding our product offering with our planed filing a New Drug Application with the FDA in the coming months, and the potential launch of HTX-100 in early 2025." The NDA filing currently awaits completion of an additional three months of product stability.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through HOPE Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
Cision
View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-completes-memorandum-of-understanding-and-collaborations-with-distribution-partners-for-htx-100-iv-ketamine-302085271.html
SOURCE NRx Pharmaceuticals, Inc.
SONX... Here's what the excitement is about..... Sonendo, Inc. (“Sonendo”) (OTCQX: SONX), a leading dental technology company and developer of the GentleWave® System, today announced that it will report financial results for the fourth quarter and full year 2023 after the market close on Monday, March 11th, 2024. Management will host a conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss its financial results.
Investors interested in listening to the conference call may do so by dialing (833) 470-1428 for domestic callers or (404) 975-4839 for international callers, using access code: 426330. Live audio of the webcast will be available at: https://investor.sonendo.com.
An archived recording will be available on the “Investors” section of the company’s website at: https://investor.sonendo.com. The webcasts will be available for replay for at least 90 days after the event.
The recorded, final version of the **CBS news covering IFUS tonight is out. It was recorded**. The Text version has a link the front page of the IFUS website that features the SGP+(tm) game changer cattle feed. The story is about IFUS SGP+(tm) cattle feed donation to the North Texas cattle owners to help save what is left of their cattle, and the fact that this new super low cost game changer cattle feed is a huge solution to climate change driven disasters like North Texas suffered last week, that destroyed 1.1 Million acres of grass and cattle industry assets.
https://www.wafb.com/2024/03/07/new-innovative-cattle-feed-being-donated-north-texas/
$NRXP News: NRx Pharmaceuticals (NASDAQ: NRXP) Announces Last Patient, Last Visit in its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression
Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression
The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter
Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported.
Positive data and FDA comment would trigger the next $4 million milestone payment from partners Alvogen and Lotus and their assumption of development costs; agreement provides for up to $329 million in milestone payments and a royalty on Net Sales in the mid-teens
RADNOR, Pa., March 4, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the 74th and last evaluable patient has completed their day 42 visit in its Phase 2b/3 study of NRX-101, the Company's patented combination of the NMDA antagonist D-cycloserine and lurasidone, in Suicidal Treatment Resistant Bipolar Depression. The database is being cleaned, finalized, and locked; statistical analysis will then be performed, with top-line data to follow shortly thereafter. As previously disclosed, positive data from this trial triggers a milestone payment from Alvogen. Alvogen will then be responsible for further development and commercialization costs for this program.
NRX-101 has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of suicidal bipolar depression. It is the only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it.
"This is the first clinical trial, to the company's knowledge, conducted among patients with suicidal bipolar depression in the outpatient setting. Our previous trial measured the ability of NRX-101 to maintain the anti-depressant and anti-suicidal effect of ketamine administered in the hospital setting. These patients, whose clinical need is urgent and extraordinary have routinely been excluded from the clinical trials of all previously-known anti-depressant drugs. said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. Although there were patients whose depression worsened and required hospitalization (we don't yet know whether they were on NRX-101 or comparator), patient safety was maintained, and no trial participant suffered a serious unexpected adverse outcome. Our thanks go out to our investigators, clinics, partners and, most importantly, our amazing patients and their families for seeing this study through to this important milestone," "
The Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof. Andrew Nierenberg of Harvard Massachusetts General Hospital. The primary efficacy endpoint is reduction in depression as measured on the MADRS scale and the secondary endpoint is reduction of suicidal ideation as measured by the Clinical Global Impression Suicidality Scale (CGI-SS). As previously disclosed, treatment compliance and concordance of local raters to central raters scores was in excess of 94%, well above the industry standard that is normally seen in CNS trials.
Top-line results are expected around the end of this quarter.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx has partnered with Alvogen and Lotus around the development and marketing of NRX-101 for the treatment of suicidal bipolar depression. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a Specialty Pharmaceutical Company, wholly-owned by NRX Pharmaceuticals focused on development and marketing of an FDA-approved form of intravenous ketamine for the treatment of acute suicidality and depression together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
https://c212.net/c/img/favicon.png?sn=CL51263&sd=2024-03-04 View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaq-nrxp-announces-last-patient-last-visit-in-its-phase-2b3-trial-of-nrx-101-in-suicidal-treatment-resistant-bipolar-depression-302078041.html
SOURCE NRx Pharmaceuticals, Inc.
Crypto rocketing. Gold surging.
Time to exercise caution in relation to blue chips.
Something is coming. Big money is talking.
Endex Corp. - $EDXC recently experienced a downturn due to a missed filing deadline. However, the exciting part is that once they resolve their paperwork issues, there's significant potential for a substantial upward surge. 🌕 This might just be the rebound opportunity we've all been anticipating, so it's crucial to stay alert. Conduct thorough due diligence, but my intuition suggests that this could be a golden chance for gains. 📈💰 Don't overlook this – it's shaping up to be a promising investment prospect! 🚀
AIRI >>>> Keep on your watch lists. Check out chart. HAWK
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Historic Amazing Calls From This Board
CIRT $.0004 - $.012 $2,000%+
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IAHL $.02 - $.14 700%
SHMM $.0021 - $.012 571%
BNEZ $.001 - $.0055 450%
LNGT $.002 - $.009 350%
MWPE $.0004 - $.0017 325%
PRSU $.0019 - $.0049 258%
ASVN $.0004 - $.0013 225%
SKGT $.0002 - $.0006 200%
AZTC $.006 - $.0018 200%
SPVG $.0011 - $.0032 190%
NSHV $.016 - $.041 157%
ICBM $.0006 - $.0012 100%
MCCI $.001 - $.002 100%
FTCH - .0040 to .18
DIOM - .014 to .051
AMHD - .0011 to .0034
LLEG - .0028 to .0040
VRED - .0050 to .045
SGGC - .0018 to .0065
RVGD - .0020 to .017
EWDI - called at .0001 when you could still buy .0001 (and THAT'simportant!)
MHGI - called at .0003, went to .0008.
CGGP - *YET AGAIN!* - called at .0015, went to .0045
GWOW - 1000%+ gainer - called at .02
BLTA - called at .08...went to .16+
CGGP *again* - called at .0017, went to .0035
UWRL - called at .0006, went to .0012
VSTR - called at .03, went to .08
PNHI - called at .02 and ran to .12
TOFS - called at .02 - hit .075
METP / ITRM - called at .01 -- went to .095
EWDI - called at .0017 -- went to .0037
CGGP - from .0030 to .02
DLAV .0007-.0008 went up 2857%!!!
IACH in at .0014-.002 at .008!!!
LDSR called at .0006 - van was pounding the table on this repeatedly under .001
ADAC called at .025 went to .098
SODE alerted .15 went over .30 could see dollar+
NBDR alerted .05 went over .10 could see much much more
PACV alerted .0075 has seen .032 so far could see big silver
IMTV alerted .0009 has hit .0030 so far looking for MUCH MORE
SAGD alerted .008ish watch what she gonna do!!!
CZNI formerly UHLN alerted .0007 high of .0033 so far
NOUV called at .0003 and went to .0020
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Giving Back!!! Charitable Opportunities!!!
Here are two charities that are close to van man's heart!!! Check em out and feel free to PM me if you have questions about these good peoples!!!
Every Child In A Loving Family Website | Facebook These good peeps made van man a daddy forever! |
Join in with your picks!!
MAKE SURE AND SIGN UP FOR OUR E-MAIL LIST! WE ONLY SEND OUR BEST PICKS AND PLAYS OUT ON IT.
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