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$CBDW a leader in the Ai chatbot industry, is thrilled to announce its successful participation in the recently concluded Planet MicroCap Showcase. https://www.reddit.com/r/PennyStocksWatch/comments/1co3l7m/cbdw_1606_corp_recaps_massive_response_to_ir_chat/
#BreakingNews: $CBDW 1606 Corp. Recaps Massive Response to IR Chat From Planet Microcap Show https://finance.yahoo.com/news/1606-corp-recaps-massive-response-120000119.html
$CBDW GET SOME SHARES WHILE YOU CAN! HEARING BIG NEWS COMING SOON....
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$NRXP News: NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) to Participate in the EF Hutton Annual Global Conference on May 15, 2024
RADNOR, Pa., May 8, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that it will participate in the EF Hutton Annual Global Conference, which will take place on May 15, 2024, at The Plaza Hotel in New York City.
Prof. Jonathan Javitt, MD, MPH, the Company's Chairman and Chief Scientist, and Matthew Duffy, the Company's Chief Business Officer, will hold one-on-one meetings with investors throughout the day. Interested parties can register to attend here.
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.
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SOURCE NRx Pharmaceuticals, Inc.
$CBIA has partnered with Parlevel Systems to assist with the optimization of its vending, micro market, and unattended retail operations. https://finance.yahoo.com/news/canopus-biopharma-inc-cbia-dba-110000520.html
$CBDW NICE BUYING OPPORTUNITY HERE!! https://schrts.co/GHIRQKKW
#BreakingNews: $AURI Presents a Share Reduction Buy-Back and Uplisting Program https://finance.yahoo.com/news/auri-presents-share-reduction-buy-122900467.html
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$NRXP News: NRx Pharmaceuticals (Nasdaq:NRXP) Announces Final Clinical Trial Results: Superior Safety Combined with Similar Efficacy in the Trial of NRX-101 Compared to Lurasidone in Suicidal Bipolar Depression
Both drugs demonstrated > 50% response for treating depression. NRX-101 demonstrated a mean 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size .37; P=0.025), using prespecified analytic methodology memorialized in FDA Special Protocol Agreement. Levels of akathisia with NRX-101 were essentially zero at day 42
This safety advantage was previously reported in the Company's published STABIL-B trial
Akathisia is identified as a life-threatening side effect of nearly all antidepressants, reported in 10-15% of treated patients and is closely linked to suicide in FDA black box warning
Akathisia was seen in 2% of participants treated with NRX-101 vs. 11% treated with lurasidone
Company plans to seek accelerated approval of NRX-101 for use in patients with bipolar depression at risk of akathisia while continuing to broaden the indication to all patients with bipolar depression and perhaps schizophrenia
Study will be presented at the American Society of Clinical Psychopharmacology (ASCP) meeting May 28-31, 2024 (Miami) together with study investigators, accompanied by a broadcast scientific presentation on akathisia and antidepressant safety, and investor Q&A
RADNOR, Pa., May 6, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical stage pharmaceutical company, today announced a statistically significant safety advantage of NRX-101 compared to the standard of care comparator in its recently completed clinical trial in patients with suicidal bipolar depression. Therefore, the Company believes that demonstration of reduced akathisia in the setting of comparable antidepressant efficacy constitutes a basis for Accelerated FDA Approval of NRX-101. The full clinical trial results will be presented at the upcoming meeting to the American Society of Clinical Psychopharmacology held May 28-31, 2024 in Miami. NRx will gather Key Opinion Leaders to educate the public on the importance and potentially life-saving implication of this finding.
Last week, the Company released preliminary top-line data as required by SEC disclosure rules. The Company believes that today's findings based on mixed model regression analysis as specified in the Company's Special Protocol Agreement with the FDA, when combined with the prior STABIL-B trial1, demonstrate a basis for seeking accelerated drug approval of NRX-101 based on improved safety related to akathisia and suicidality in the setting of comparable antidepressant efficacy.
Trial participants had identical mean scores on the Barnes Akathisia Rating Scale (BARS) at baseline with subsequent decrease in the NRX-101 treated group versus an increase in the lurasidone-treated group, yielding a 76% relative mean difference between the groups. The difference was apparent at the first post-randomization visit and continued throughout the trial. (Fig 1) Over the 42 days of observation, an effect size of .37 was identified with a statistically significant P value of 0.025 on the Mixed Model for Repeated Measures (MMRM) methodology agreed to with FDA in the 2018 Special Protocol Agreement. Akathisia as ascertained by a 1 point increase in the BARS was seen in 11% of participants randomized to lurasidone (comparable to previous reports in the literature) and seen in only 2% of those treated with NRX-101, an akathisia level that was previously reported for the placebo arm of the lurasidone registration trial.
Akathisia was a prespecified key safety endpoint of the Company's clinical trial. Hence this finding is not a "post-hoc" observation. As previously noted, this clinical trial of 91 participants with suicidal bipolar depression who were not pre-treated with ketamine demonstrated that NRX-101 and lurasidone were comparable in their antidepressant effect. A 33% but statistically non-significant sustained decrease in suicidality was also seen favoring NRX-101. As noted above, improved antidepressant efficacy is not required to seek drug accelerated drug approval based on a statistically-significant safety benefit.
Based on this safety finding, NRx plans to seek Accelerated Approval of NRX-101 for treatment of bipolar depression in patients at risk for akathisia who are at highest risk of suicide, while continuing to develop evidence to support broader indications both in treatment of depression and schizophrenia. Should these data be confirmed in additional large scale trials, the Company believes that physicians and patients will universally prefer antidepressant and antipsychotic drugs with a reduced akathisia risk. The NRx patent portfolio supports the development of a broad range of combined NMDA/serotonergic drugs for treatment of depression and psychosis.
There is a recent regulatory precedent for the approval of psychiatry drugs that demonstrate comparable efficacy with improved safety. A combination of olanzapine and samidorphan (LYBALVI®) was approved based on comparable effect on schizophrenia symptoms with evidence of less weight gain favoring LYBALVI. Thus, public assertions by journalists and short-sellers that NRx has no path to market based on the finding of comparable efficacy in this trial are utterly baseless and may be designed to mislead investors.
"More than 7 million Americans suffer from bipolar depression with a potential market opportunity in excess of $20 billion. No prior drug to treat bipolar depression has demonstrated superiority on side effects most closely linked to suicide. Patients with bipolar depression have a 50% lifetime risk of a suicidal attempt and a 20% lifetime risk of dying from suicide. On this basis of these superiority findings, previously seen in the STABIL-B trial, we plan to seek Accelerated Approval from FDA for treatment of patients with bipolar depression who are at risk for akathisia, as we and our partners continue to broaden the indication to the treatment of all patients with bipolar depression." said Dr. Jonathan Javitt, NRx's Chairman and Chief Scientist. "Patients and key opinion leaders alike have told us clearly that an antidepressant with comparable antidepressant effect and reduced risk of akathisia and other risk factors for suicidality would be unambiguously preferred in the marketplace."
Background on Akathisia
Akathisia is a known extrapyramidal side effect of all serotonin-targeted antidepressants and antipsychotic drugs. It can be demonstrated in laboratory models, using rodent behavioral data.2 Prof. Daniel Javitt, the inventor of NRX-101 first discovered the ability of NMDA antagonist drugs to reduce akathisia in 2009, which forms the basis of the Company's composition of matter patent portfolio. In his 2012 patent application Javitt stated 3
A major limitation in use of antipsychotic and antidepressant medications is the liability to produce behavioral side effects, especially anxiety, agitation, and akathisia, all of which are associated with generating or exacerbating suicidality in psychotic or depressed patients. These behavioral side effects can be differentiated from symptoms of the illness by consideration of both time course and specific patterns of symptoms.
The side effect is clearly recognized in an FDA-mandated black box warning applied to lurasidone and all medications in its class of drugs, with a specific warning about suicidality as follows:
"The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality"4.
In most clinical trials, safety endpoints are not a basis for drug approval, although adverse safety findings may prevent drug approval. Typically, new drugs are compared to placebo in order to prove a difference in efficacy. In this case, the trial was conducted against the standard of care drug, not against placebo and, therefore, safety differences are highly important. Akathisia is a labeled negative side-effect of lurasidone and all similar drugs, and is closely linked to suicidal behavior.56 It is a side effect about which patients must be warned[7] and has figured prominently in class action lawsuits brought against manufacturers of serotonin-targeted antidepressants and antipsychotics. Currently, there is no FDA-approved treatment for akathisia and it is considered a medical emergency by many treating psychiatrists. Akathisia causes extreme anxiety to patients, inability to control motor movement, and impulsive acts, all to often leading to suicide and may be the key driver of the observed increase in suicidal ideation and behavior associated with all serotonin-targeted antidepressants and antipsychotic drugs.
"These studies support our original observation that D-cycloserine reverses the akathisia-like behaviors induced by lurasidone in rodent models. It is exciting to see those findings demonstrated in a second trial with unequivocal statistical significance," said Prof. Daniel Javitt, co-founder of NRx Pharmaceuticals. "Hopefully, this opens a path to bringing a lifesaving drug to millions of patients with suicidal depression whose only approved long-term treatment is electroconvulsive therapy."
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.
1 Nierenberg A, Lavin P, Javitt DC, et. al. NRX-101 vs lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior; a randomized prospective phase 2 trial. Int J Bipolar Dis 2023;11:28-38, doi.org/10.1186/s40345-023-00308-5
2 Walf, A. A., & Frye, C. A. (2007). The use of the elevated plus maze as an assay of anxiety-related behavior in rodents. Nature Protocols, 2(2), 322-328. https://doi.org/10.1038/nprot.2007.44
3 Javitt DC. Composition and method for treatment of depression and psychosis in humans. US Patent 10583138B2. Granted March 10, 2020.
4 Trivedi et al., J Clin Psychiatry, 72:765-774, 2011
5 Chow LC, Kahouh NK, Bostwick JR, et. al., Akathisia and newer second-generation antipsychotic drugs: A review of current evidence. Pharmacotherapy 202;40(6):565-574 doi: 10.1002/phar.2404
6 Uwai Y, Nabekura T. Risk factors for suicidal behavior/ideation and hostility/aggression in patients with bipolar disorders: An analysis using the Japanese adverse drug event report database. J Psychiatric Res 2022;153:99-103. https://doi.org/10.1016/j.jpsychires.2022.07.005
7 https://www.webmd.com/schizophrenia/side-effects-of-lurasidon
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SOURCE NRx Pharmaceuticals, Inc.
$RDAR Under heavy accumulation... Big updates coming this week!
https://twitter.com/raadr_
1. The companies and individuals holding restricted stock have no intentions of liquidating those positions.
2. No Reverse Split (R/S) is planned for $RDAR
$RDAR - Raadr, Inc. would like to address several recent Shareholder concerns:
— RAADR.com (@raadr_) May 2, 2024
1. The companies and individuals holding restricted stock have no intentions of liquidating those positions.
2. No Reverse Split (R/S) is planned for $RDAR
Have a wonderful Thursday!!
$CBIA HAS BIG NEWS COMING SOON -- LOAD UP NOW!! https://twitter.com/BlueHeavenCafe
$CBDW https://cbdw.ai/ is dedicated to transforming the IR industry through cutting-edge AI centric solutions, ensuring a seamless and efficient customer experience.
https://finance.yahoo.com/news/1606-corp-unveils-ai-vertical-130000881.html
$IFUS has all the right stuff folks. Last call for sub dollar shares...
Just in case you all missed this $IFUS updates:
I just used the 500,000 India dairy cattle in the recent JV LOI PR, and the cost savings listed in the 34 page study guide this year and I got $164,630,000 the IFUS SGP+ can save the India group PER YEAR.
That is one hell of an incentive for India folks to close the deal
$IFUS Trash to cash story of how an ag fiber waste is now converted into the best cattle and dairy cow feed on the planet. https://t.co/UptozmQMld
— NotTheMoma (@NotTheMoma2) February 22, 2024
$RDAR Corporate Update Next Week ⬇️
$RDAR We want to let all our shareholders and investors/ supporters know we will be putting out a corporate update next week ! We will address the share structure, future partners and the future of our app !
— RAADR.com (@raadr_) May 3, 2024
$RDAR .001 - .00673 1-Yr Forecast by WalletInvestor - News next week and #ArtificialInteligence coming to the #app here. Things are looking up from the bottom here!
https://twitter.com/raadr_
FREY......CHPT.......BLNK......MULN.......https://stockcharts.com/h-sc/ui?s=FREY&p=W&yr=1&mn=3&dy=0&id=p96837884856
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$MULN
— TGS Trades (@TGS_Trades) May 4, 2024
05.04.24 Saturday update for #MULN:
- Up 32% net over past 5 trading days. $3.16 to $4.16.
- Approved for $45K HVIP rebate in CA for Mullen 3 trucks, plus $7.5K federal rebate.
- Adds large commercial electric dealer to network (Pritchard Electric)
- Short interest… pic.twitter.com/i0XjVBXMIu
$CBDW Embracing a New Era in Investor Communications
Commenting on the launch, Greg Lambrecht, CEO of 1606 Corp., expressed unwavering enthusiasm about the potential of IR Chat to transform investor relations. “Our Chat IR solution heralds a new era in investor communications, offering a dynamic and interactive platform for public companies to engage with their shareholders and potential investors effectively,” said Lambrecht. “We believe this innovative technology will drive greater transparency, trust, and engagement within the investor community.” https://cbdw.ai/news/1606-corp-unveils-new-ai-vertical-ir-chat-a-bot-for-public-companies-and-investors/
ALYI getting run up right now .0017
$CBIA Leads Retail Revolution with Introduction of Innovative Customer Loyalty Program https://finance.yahoo.com/news/canopus-biopharma-inc-cbia-dba-120000564.html
JAGX it’s time hit the ask. .29
$EARI Large volume. New marketing campaign and recent acquisition of Reef cannabis infused drinks: https://otcmarkets.com/stock/EARI/news/EARI-Beverage-Group-OTC-EARI-Acquires-Exclusive-Licensing-Rights-for-Reef-Drinks?id=433037
$CBDW 1606's unique sales strategy
Our focus is not just on expanding our technology but also on securing strategic partnerships across industries. We aim to integrate our conversational AI solutions with major independent sales organizations (ISOs), enhancing our market reach and operational efficiency. This strategy positions CBDW as a crucial player in a market poised for significant growth, reflecting our commitment to our investors and partners alike. The Company has fielded significant interest already from independent sales organizations in the public sector as well public companies. Relationships have been established with ISO's allowing access to the tens of thousands of publicly-traded companies, providing what we believe is a massive opportunity.
https://www.newswire.com/news/1606-corp-unveils-new-ai-vertical-ir-chat-a-bot-for-public-companies-22315336
$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
Guess who $IDGR hired as a Director?:
David Weintraub
David Weintraub is the former CEO of Swifty Car Wash, a company that he successfully took public and then returned to private holding. During his over 30 years of investment banking experience, Mr. Weintraub has personally raised hundreds of millions of dollars in capital, primarily for public companies.
David Weintraub is the President of Ideal Group's wholly owned subsidiary Portfolio Partners Inc. Portfolio Partners, Inc. is the parent company of Travel Zen, Inc., which acquires deeds to fractional timeshares in a portfolio of premium resorts concentrated during spring break at the most popular ski resorts in the USA
Z
#BreakingNews: $CBDW 1606 Corp. Unveils New AI Vertical: IR Chat, a Bot for Public Companies and Investors https://www.accesswire.com/857819/1606-corp-unveils-new-ai-vertical-ir-chat-a-bot-for-public-companies-and-investors
AGBA...............MULN........................https://stockcharts.com/h-sc/ui?s=AGBA&p=D&yr=0&mn=2&dy=12&id=p84071410134
https://stockcharts.com/h-sc/ui?s=MULN&p=D&yr=0&mn=2&dy=12&id=p84071410134
New Director of $IDGR Robert Egeland has done over 28,000 Mortgages.
He is the head of Oxygen Commercial, the newest subsidiary of $IDGR.
https://www.otcmarkets.com/stock/IDGR/news/Ideal-Group-of-Companies-Inc-Appoints-Robert-Egeland-as-Vice-Chairman-and-Begins-Trading-Under-New-Symbol-IDGR?id=429571
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$AGBA Majority shareholder support already obtained from both AGBA and Triller. Estimating 3-4 weeks now for merger combination to complete.
FREY......CHPT......BLNK........MULN..........................https://stockcharts.com/h-sc/ui?s=FREY&p=D&yr=0&mn=2&dy=12&id=p84071410134
https://stockcharts.com/h-sc/ui?s=CHPT&p=D&yr=0&mn=2&dy=12&id=p84071410134
https://stockcharts.com/h-sc/ui?s=BLNK&p=D&yr=0&mn=2&dy=12&id=p84071410134
https://stockcharts.com/h-sc/ui?s=MULN&p=D&yr=0&mn=2&dy=12&id=p84071410134
..........................https://www.mullenusa.com/battery
$CBDW 1606 Corp. CEO Greg Lambrecht in a recent interview with the team at Redchip mentioned multiple vertical expansion plans for 1606 Corps AI Chatbot.
cbdw.ai
redchip.com
AGBA..................MULN.........................https://chartexchange.com/symbol/nasdaq-muln/
https://chartexchange.com/symbol/nasdaq-AGBA/
$RONN reports the hydrogen market continues to grow and after several months of talks expects to sign a mou regarding a VERY significant capital equity infusion.
$RONN reports the hydrogen market continues to grow and after several months of talks expects to sign a mou regarding a VERY significant capital equity infusion.#Hydrogen #HFCEV #EV #HydrogenEnergy
— Ronn Motor Group (Formerly $LPHM) (@leepharma) April 26, 2024
GOEV..................MULN......................................https://stockcharts.com/h-sc/ui?s=GOEVV&p=D&yr=0&mn=2&dy=12&id=p84071410134
https://stockcharts.com/h-sc/ui?s=MULN&p=D&yr=0&mn=2&dy=12&id=p84071410134
$AGBA Triller going to see ‘biggest influx’ of users after new TikTok law!!!
https://www.foxbusiness.com/video/6351757905112
Triller CEO Bobby Sarnevesht reacts to recently signed TikTok legislation and shares why his product is a viable alternative!
GROY...................................https://stockcharts.com/h-sc/ui?s=GROY&p=D&yr=0&mn=2&dy=12&id=p84071410134
TPET...................MULN.................................https://stockcharts.com/h-sc/ui?s=TPET&p=D&yr=0&mn=3&dy=0&id=p11960084343
https://stockcharts.com/h-sc/ui?s=MULN&p=D&yr=0&mn=3&dy=0&id=p11960084343
IGPK..... HUGE MOVE.... check out >>>>>>> merge with a billion in Revs just about completed..
TheStockGuru
@Austria_9999
$IGPK : JFHE
Phase - 1 second part will be fill soon. EXPECTING otc 2023 annual and first quarter 2024 report will upload in disclosure, Attorney letter will updated, Business description and insiders name Changes and yield sign will remove Today end of the day or Tomorrow!!!!!
12:17 PM · Apr 23, 2024
876 Views
KULR...................MULN...................................https://stockcharts.com/h-sc/ui?s=KULR&p=D&yr=0&mn=3&dy=0&id=p11960084343
https://stockcharts.com/h-sc/ui?s=MULN&p=D&yr=0&mn=3&dy=0&id=p11960084343
$LBRG Expansion to Meet Rising E-Commerce Demand - Exploding Rev's here way undervalued pps!
https://finance.yahoo.com/news/enhanced-inventory-management-solutions-meet-120500771.html
Best Growth Stock's full report breaks through the noise and offers a comprehensive analysis of the $AGBA Group Holding Limited merger with Triller.
https://bestgrowthstocks.com/access-agba-analysis/
$PDGO is thrilled to announce the successful acquisition of a 100% interest in 58 oil and gas wells along with 600 acres of land in Oklahoma. https://www.otcmarkets.com/otcapi/company/dns/news/document/73893/content
AKBA..........................MULN.......................................https://stockcharts.com/h-sc/ui?s=AKBA&p=D&yr=0&mn=2&dy=12&id=p84071410134
https://stockcharts.com/h-sc/ui?s=MULN&p=D&yr=0&mn=2&dy=12&id=p84071410134
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