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Looking great AHRO
$AHRO is ready to fly IMHO
$BKTPF Spin-out expected this quarter. The project being spun out is the Hector Silver and Cobalt project. New Company will be Makinita. Shareholders of record will receive shares of the new company. This is trading under 3 cents so probably a lot more upside than down side at this point. Cruz is also drilling phase 5 on their lithium asset here in 2024 and will complete the maiden resource estimate on the Solar Lithium project. This is a trade, should do well. https://www.stockwatch.com/News/Item/Z-C!CRUZ-3597149/C/CRUZ
MVIS>>>>Just a FYI to keep on your watch lists. HAWK
ASII... HUGE NEWS> https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175041997
Penny Land here we come
$SNNAF News: Increased Stonesthrow project size up to ~32k acres. Highly prospective for Gold, located bordering Ramp Metals Inc. who had some fantastic results recently and has received a 4.5 million investment from Eric Sprott. Company says more news is coming as well as marketing over the next 2 months so worth a look for a trade.
$NRXP News: NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) and HOPE Therapeutics, Inc. Announce Participation at the H.C. Wainwright 26th Annual Global Investment Conference September 9-11, 2024
MIAMI, Sept. 3, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, ("NRx," the "Company") and HOPE Therapeutics, Inc., a medical and technology driven company and wholly-owned subsidiary of NRx, today announced they will be featured as a presenting companies at the H.C. Wainwright 26th Annual Global Investment Conference. The conference is being held on September 9-11, 2024.
The in-person venue for the event is the Lotte New York Palace Hotel in New York City located at 455 Madison Avenue. Virtual participation will be staged simultaneously with over 550 company presentations scheduled as live feed or available on-demand.
Jonathan Javitt, MD, MPH, Chairman and Chief Scientist of NRx and Co-CEO of Hope, will provide an overview of the Company's business during the presentation.
If you are an institutional investor, and would like to listen to the Company's presentation, please click on the following link (www.hcwevents.com/annualconference) to register for the conference.
Event: H.C. Wainwright 26th Annual Global Investment Conference
Date: September 9-11, 2024
Location: Virtual to start on-demand on September 9 at 7:00 A.M. (ET) or in-person at the Lotte New York Palace Hotel, New York, NY.
Access to the presentation can also be found at https://ir.nrxpharma.com/events beginning at 7:00AM ET Monday September 9, 2024.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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) for 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 healthcare delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About H.C. Wainwright & Co.
H.C. Wainwright is a full–service investment bank dedicated to providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. H.C. Wainwright & Co. also provides research and sales and trading services to institutional investors. According to Sagient Research Systems, H.C. Wainwright's team is ranked as the #1 Placement Agent in terms of aggregate CMPO (confidentially marketed public offering), RD (registered direct offering) and PIPE (private investment in public equity) executed cumulatively since 1998.
For more information visit H.C. Wainwright & Co. on the web at www.hcwco.com
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.
For further information:
CORPORATE CONTACTS:
Jeremy Feffer, LifeSci Advisors, Inc.
jfeffer@lifesciadvisors.com
Matthew Duffy
Chief Business Officer, NRx Pharmaceuticals
Co-CEO, HOPE Therapeutics, Inc.
mduffy@nrxpharma.com
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SOURCE NRx Pharmaceuticals, Inc.
$NRXP News: HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Potential Acquisition and Financing Agreements for $30 Million in Currently-Operating Interventional Psychiatry Clinics
$30 million Term Sheet from qualified lender for non-dilutive financing for first clinic acquisitions; anticipated closing within 60 days
Executed Non-Binding Term Sheet with initial clinic partners generating annual revenue of over $10 million, with additional partners to be selected under this initial funding agreement
Company projects annualized revenues of $100 million through continued acquisition by mid 2025
Additional information to be presented at upcoming HC Wainwright Annual Global Investment Conference in New York, September 9-11, 2024
MIAMI, Aug. 26, 2024 /PRNewswire/ -- HOPE Therapeutics, Inc., a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("HOPE," the "Company"), a medical and technology driven company, today announced signing a non-binding Term Sheet for non-dilutive, nonconvertible debt acquisition funding of its first interventional psychiatry clinics (ketamine clinic acquisitions), together with the signing of a Term Sheet for five currently operational clinics in the Western United States. In addition to the currently-signed non-binding Term Sheet, the Company has been offered non-binding lending commitments it believes are sufficient to assemble/acquire a network of operational clinics with revenues in excess of $100 million. The Company anticipates potential operations in the United States, France, and the United Kingdom.
The non-dilutive acquisition funding announced today is in addition to the over $60 million in potential equity funding previously offered upon public listing of HOPE Therapeutics shares on a public exchange.
Ketamine is increasingly used to treat suicidal depression, treatment resistant depression (TRD) and Post Traumatic Stress Disorder (PTSD). Until now there has been no unified entity organized around delivering consistent outpatient care for suicidal depression, TRD and PTSD that combines pharmaceutical therapy, FDA approved and proven medical technologies such as Transcranial Magnetic Stimulation (TMS), digital therapeutics and access to clinical trial protocols for the newest potential treatments, delivered by properly licensed medical professionals to optimize care of people with these conditions. Collectively, these conditions represent a crisis that results in the death of someone around the globe every minute. HOPE aims to bring a unified, patient-centric and science-based approach to the care of patients and their families.
"HOPE is dedicated to providing an accessible platform to help caregivers address the critical needs of those suffering from suicidal thoughts, TRD, PTSD and related challenges. We are delighted to take the critical first steps towards developing a network of clinics that can provide the highest possible level of care and demonstrate best-practices for mental health professionals around the world," said Jonathan Javitt and Matthew Duffy, Co-CEOs of HOPE Therapeutics. "These clinics, and others under review, are planned to provide the foundation for a network generating revenue of approximately $100 million annually in the coming year."
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a healthcare delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
About NRx Pharmaceuticals, Inc.
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 plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. 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) for 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.
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SOURCE NRx Pharmaceuticals, Inc.
$SHOT News: Safety Shot Releases Second Quarter 2024 Results and Corporate Highlights
- Q2 Revenues Increased 40%
- Q2 Operating Expenses Decreased 17.7%
- Recent Clinical Trial Confirms Dramatic Reduction of Blood Alcohol Content
- Revolutionary Formula to be Soon Released in Convenient 4-ounce Bottles
- Powdered Version of Alcohol-reducing Nutraceutical to be Released in Q4
JUPITER, Fla., Aug. 16, 2024 (GLOBE NEWSWIRE) -- Safety Shot, Inc. (Nasdaq: SHOT) (the Company) the revolutionary wellness and dietary supplement company dedicated to the promotion of responsible consumption of alcohol, has released its financial results for its second quarter ended June 30, 2024 as well as a corporate highlights for the quarter.
"We are very excited about our financial performance and our achievements for the second quarter of 2024. A dramatic increase in our revenues with a dramatic decrease in our operating expenses only showcases Safety Shot’s determination to bring value to stakeholders,” stated CEO Jarrett Boon. “We have exciting things expected in the next couple of quarters and believe they will serve as catalysts to further strengthen the company’s financial results going forward. As we continue to execute our business strategy, we remain focused on enhancing our growth potential. This is illustrated by the promising clinical results the company reported this month as well as new partnerships and new product lines the company will be launching in the near future.”
Second Quarter 2024 Highlights:
Company reports a 40% increase in sales in the second quarter compared to the first quarter.
Company reports a 17.7% decrease in operating expenses in the second quarter compared to the first quarter, highlighting significant progress in Safety Shot’s financial health.
Company reveals significant new findings from a recent clinical trial conducted at The Center for Applied Health Sciences ("CAHS"). The double-blind, randomized, placebo-controlled study evaluated the acute impact of Safety Shot on consumer's Blood Alcohol Content ("BAC"), successfully demonstrating remarkable and statistically significant results in various measures related to alcohol consumption and the subsequent rapid reduction of BAC. Within 30 minutes of consuming Safety Shot, participants showed a 30%-50% faster rate of alcohol reduction compared to the placebo group. Safety Shot's proprietary blend of vitamins, minerals and botanical ingredients is now clinically proven as the world's first formula to aid in the rapid reduction of alcohol within the body.
Company is advancing several product formats and formulations to continue to offer a wide array of products that can be purchased at various locations that coincide with consumer shopping habits.
Company announced that its revolutionary formula will be released in new, convenient 4-ounce bottles. Designed for easy on-the-go use, this new format ensures that customers can enjoy the benefits of Safety Shot's groundbreaking formula anytime, anywhere. The 4-ounce bottles are anticipated to launch in Q3.
Company’s R&D team has successfully found a powdered solution that maintains 100% of the efficacy of the world’s first alcohol-reducing product. Safety Shot will offer a convenient stick pack in Q4.
Company announced a partnership with Capital Drugs as the brand expands its nationwide availability. Making strides in connecting the brand to its overarching wellness purpose, Safety Shot will be available in all 300 of the drugstore chain's pharmacies across the United States.
Company announced a strategic partnership with Mr. Checkout, a national network of independent distributors, full-line grocery distributors, and wagon-jobbers. This partnership marks a significant milestone in Safety Shot's mission to provide a revolutionary solution for responsible alcohol consumption to the masses. Additional partnerships include GoPuff, BevMo, and more.
About Safety Shot, Inc.
Safety Shot, Inc., a wellness and dietary supplement company, has developed Safety Shot, the first patented wellness product on Earth that lowers blood alcohol content by supporting its metabolism, while boosting clarity, energy, and overall mood. Safety Shot is available for purchase online at DrinkSafetyShot.com and Amazon. The Company is introducing business-to-business sales of Safety Shot to distributors, retailers, restaurants, and bars throughout 2024.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding Safety Shot’s ability to develop and commercialize a product that lowers blood alcohol content, the timing, progress and results of non-clinical studies and clinical trials, including our product development plans and strategies, Safety Shot’s future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Safety Shot’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, our ability to comply with applicable U.S. and foreign laws, rules, and regulations, product liability claims, our ability to develop and market Safety Shot and the risks and uncertainties that are described more fully in the section titled “Risk Factors” in Safety Shot’s annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on April 1, 2024, and its other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Safety Shot undertakes no duty to update such information except as required under applicable law.
Media and Investor Contact:
Autumn Communications
Jess Weinberger
Phone: 201-213-3239
Email: shot@autumncommunications.com
Investor Relations
Medon Michaelides
Phone: 561-244-7100
Email: investors@drinksafetyshot.com
https://www.globenewswire.com/newsroom/ti?nf=OTIwNjE3NCM2NDI3Njg3IzUwMDExNzExOA==
https://ml.globenewswire.com/media/YzBjY2FmNDAtMzk3My00YTg1LWIxZTYtNzc2MmNmNTM2MTMwLTUwMDExNzExOA==/tiny/Safety-Shot-Inc-.png
Source: Safety Shot, Inc.
$SHOT News: Safety Shot Announces Powerful Data Analysis From Recent Clinical Trial Confirming Dramatic Reduction of Blood Alcohol Content
First-of-its-kind wellness company Safety Shot announces clinical trials solidifying the brand's dietary supplement's ability to significantly reduce Blood Alcohol Content
JUPITER, Fla., Aug. 12, 2024 /PRNewswire/ -- Safety Shot, Inc. (Nasdaq: SHOT) (the "Company"), the revolutionary wellness and dietary supplement company dedicated to the promotion of responsible consumption of alcohol, announces significant new findings from a recent clinical trial conducted at The Center for Applied Health Sciences ("CAHS"). The double-blind, randomized, placebo-controlled study evaluated the acute impact of Safety Shot on consumer's Blood Alcohol Content ("BAC"), successfully demonstrating remarkable and statistically significant results in various measures related to alcohol consumption and the subsequent rapid reduction of BAC.
The study found that within 30 minutes [of the consumption of Safety Shot], monitored participants reported a highly significant drop in BAC and peak changes in several of the markers responsible for the metabolism of alcohol. Participants between the ages of 24 and 46 with bodyweight ranging between 95 and 225 lbs. showed a dramatic and remarkable difference of 30%-50% faster in the rate at which alcohol was reduced and cleared from the body with the consumption of Safety Shot over the placebo. Participants continued to see measurable drops in successive 30-minute increments, indicating Safety Shot's proprietary blend of vitamins, minerals and botanical ingredients is clinically proven as the world's first formula to aid in the rapid reduction of alcohol within the body.
"This marks a significant change in consumer behavior by providing a safer experience to consume alcohol, as well as better controlled drinking habits to allow for a healthier and more enjoyable environment for the consumer. We are thrilled to finally share the news that after nearly a decade of research and development, our study has successfully confirmed what we have seen in many of our own non-clinical trials," said Chief Operations Officer and co-inventor, David Sandler. "These results are revolutionizing the wellness space as we continue to pioneer the world's most innovative functional beverages," continued Sandler.
Key Findings:
Breath Alcohol Content: Safety Shot proved to consistently lower breath alcohol content at all measured time points compared to the placebo.
Blood Alcohol Content: The study found significant improvements in BAC in the area under the curve (AUC) and maximum concentration (Cmax) for ethanol, acetaldehyde, and aldehyde dehydrogenase levels, favoring Safety Shot.
Physical Results: Trial participants reported significantly less head discomfort, reduced fatigue, increased energy levels, improvements in concentration and reduced feelings of tiredness at multiple time points throughout the study.
These groundbreaking findings indicate Safety Shot's efficacy in supporting user metabolism to reduce BAC and ultimately enhance subjective feelings of well-being and physiological responses post-alcohol consumption. The study's results are currently being compiled into a manuscript, which will be submitted to a biomedical journal for peer review and publication.
Dr. Tim Ziegenfuss, CEO of CAHS stated, "These results are highly encouraging, showcasing Safety Shot's potential as a beneficial supplement for individuals consuming alcohol. The observed reductions in breath and blood alcohol levels, along with the improvements in subjective feelings and physiological measures, highlight the promise of Safety Shot in supporting better outcomes in post-alcohol consumption."
For more information about Safety Shot and the full details of the study, please visit http://www.drinksafetyshot.com.
About Safety Shot, Inc.
Safety Shot, Inc. a wellness and dietary supplement company dedicated to the promotion of responsible drinking, has developed Safety Shot, the first patented wellness product on Earth that lowers blood alcohol content by supporting its metabolism, while boosting clarity, energy and overall mood. Safety Shot is available for purchase online at DrinkSafetyShot.com and Amazon. The Company is introducing business-to-business sales of Safety Shot to distributors, retailers, restaurants and bars throughout 2024.
About CAHS
The Center for Applied Health Sciences is an industry leading CRO (Contract Research Organization) that is committed to providing cost-effective, customized research solutions to suit the needs of natural products, dietary supplements, functional food and beverage industries. www.thecahs.com
Forward-Looking Statements
This press release includes certain disclosures that contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release, including statements regarding Safety Shot's ability to develop and commercialize a product that lowers blood alcohol content, the timing, progress and results of non-clinical studies and clinical trials, including our product development plans and strategies, Safety Shot's future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or the negative of these words or other similar terms or expressions. Forward-looking statements are based on Safety Shot's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, our ability to comply with applicable U.S. and foreign laws, rules, and regulations, product liability claims, our ability to develop and market Safety Shot and the risks and uncertainties that are described more fully in the section titled "Risk Factors" in Safety Shot's annual report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission on April 1, 2024, and its other filings with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and Safety Shot undertakes no duty to update such information except as required under applicable law.
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SOURCE Safety Shot
AIRI>>>>Good numbers out today. PPS has made nice 2-3x moves up in the recent past with good news. Suggest keeping on your watch lists. Just a FYI. HAWK
IGPK... THIS IS HUGE : Jun Fenghuang Group Experiencing Rapid Growth and Expansion... -- https://finance.yahoo.com/news/jun-fenghuang-group-experiencing-rapid-140000992.html
This is huge coming from the company:
The company is committed to consolidating all its divisions under one Jun Fenghuang Group, currently represented by the publicly traded OTC markets ticker IGPK, until the ticker is formally changed to JFHE.
JFH Digital E-Commerce Co., LTD is dedicated to listing on NASDAQ upon completing the merger of all its divisions.
Waiting on the name and symbol ticker to JFHE .......
Up 51% today because of NEWS PR released
$NRXP News: HOPE Therapeutics, Inc. and NRx Pharmaceuticals (Nasdaq:NRXP) Announce Arbitration Order Enabling HOPE Therapeutics Spinoff
Petition for a temporary restraining order brought by Streeterville Capital, LLC seeking injunctive relief to prevent spinoff of 49% of HOPE Therapeutics shares to current NRx Shareholders has been denied by Utah arbitrator.
Petition by Streeterville Capital, LLC seeking injunctive relief to prevent sales of NRx shares has been denied by Utah arbitrator.
NRx to proceed with spinoff of HOPE Therapeutics as previously announced.
RADNOR, Pa., July 29, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced the issuance of an order by a Utah arbitrator denying the petition of Streeterville Capital, LLC to enjoin NRx's planned spinoff of 49% of the shares in HOPE Therapeutics to current shareholders of NRx pharmaceuticals. While the proposed spinoff remains subject to compliance with certain disclosure and other requirements under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, the spinoff is intended to provide NRx shareholders with an opportunity to participate in the anticipated value created as a result of the spinoff and to enable a potential listing of HOPE Therapeutics (currently a wholly-owned subsidiary of NRx) on a national securities exchange. The arbitrator also denied Streeterville's petition to enjoin NRx from selling additional shares of NRx stock to finance ongoing operations.
(PRNewsfoto/NRx Pharmaceuticals)
"As we have previously shared with the public, HOPE Therapeutics is in the process of developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression. This arbitration decision enables us to keep our promise to shareholders to spin out 49% of HOPE Therapeutics shares held by NRx to our shareholders, subject to approval by our Board of Directors and compliance with applicable law. We appreciate the support and loyalty of our shareholders as we work to bring HOPE to life," said Prof. Jonathan Javitt, Founder and Chairman of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics.
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) for 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 care delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal 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.
HOPE Therapeutics, Inc. (PRNewsfoto/NRx Pharmaceuticals, Inc.)
Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-nasdaqnrxp-announce-arbitration-order-enabling-hope-therapeutics-spinoff-302208316.html
SOURCE NRx Pharmaceuticals, Inc.
$LDSN LUDUSON G INC. Announces Plans to Enhance Metaverse Experience in Latest Development Project
https://finance.yahoo.com/news/luduson-g-inc-otc-ldsn-140000815.html
$AVRW: 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.
Source:
https://www.accesswire.com/864776/avenir-wellness-solutions-reports-fourth-quarter-2023-results
$SNNAF just announced summer marketing programs with two marketing companies. Life Water and Hillside. Up 15% to 0.033 on the news with a double likelihood. Seems like an easy trade right now. I expect lots of catalysts over the summer here so worth a look. You don't pay for marketing if you don't have something to talk about. Good things coming. GL all.
$IVDN (16 million float) is about to file a banner quarterly report for its fiscal Q2 which will show that sales of its superior Insultex House Wrap product have already exceeded all of the company's results for the full 2023 fiscal year.
This has been pre-announced in the last two IVDN news releases:
Innovative Designs Sales Update
May 30, 2024
https://finance.yahoo.com/news/innovative-designs-sales-110000236.html
Innovative Designs Vendor Growth
April 10, 2024
https://finance.yahoo.com/news/innovative-designs-vendor-growth-174255528.html
QS >>> Just signed new deal with Volkswagen. Suggest keeping on your watch lists. HAWK
🔥 $AAGC 🔥 Conference call folks!
🔥🔥 $AAGC 🔥🔥 Conference call folks!! 💪💪 https://t.co/DDdqNdtXFE
— Nickeli (@nickeli54) July 9, 2024
🔥$AAGC 🔥 Mega Thread! 💪
@HStarcuts 🔥🔥🔥 $AAGC 🔥🔥🔥🧵 Folks let’s take a look at where we are here:
— Nickeli (@nickeli54) July 9, 2024
✅ MC= $1M
✅ SS = 1.7B OS
✅ No Dilution
✅ No RS Stated many times
✅ Share buybacks monthly
✅ New Locations opening
✅ Audit underway
✅ Qtr over Qtr growth 🔥
✅Annual showed massive growth YOY pic.twitter.com/Bdy0upLSV5
🔥 $AAGC 🔥
💥 $AAGC 💥 Only takes one stock folks to change your life! 8’s hitting 🔥 patience usually plays well if it’s a 💎 Just have to peel back the onion to see what’s inside and this play is as clean as it gets! Take a peek at this annual and note share buy backs 👀 💎🔥💪 pic.twitter.com/kThR84MOuA
— Nickeli (@nickeli54) July 8, 2024
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.
https://c212.net/c/img/favicon.png?sn=CL01020&sd=2024-04-30 View original content to download multimedia:https://www.prnewswire.com/news-releases/nrx-pharmaceuticals-nasdaqnrxp-announces-promising-findings-in-phase-2b3-clinical-trial-of-nrx-101-vs-lurasidone-for-treatment-of-suicidal-bipolar-depression-302131482.html
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
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