Breaks Categories: News

TuesdayApr 07, 2026 9:10 am

PsychedelicNewsBreaks – Silo Pharma Inc. (NASDAQ: SILO) Advances IP Portfolio With EPO Notice of Intent to Grant Patent

Silo Pharma (NASDAQ: SILO), a developmental stage biopharmaceutical company focused on novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, announced that the European Patent Office has issued a Rule 71(3) communication indicating its intent to grant a patent covering methods of preventing stress-induced fear and depressive-like behavior using serotonin 4 (5-HT4) receptor agonists. The patent, exclusively licensed from Columbia University, is expected to strengthen the company’s intellectual property position across major European markets as Silo advances its pipeline targeting stress-related and central nervous system disorders. To view the full press release, visit https://ibn.fm/k9Vu8 About Silo Pharma,…

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MondayApr 06, 2026 9:20 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Labeling Feedback for Preservative-Free Ketamine Application

NRx Pharmaceuticals (NASDAQ: NRXP) announced it has received a letter from the FDA Office of Generic Drugs indicating only minor formatting comments on the proposed label for its preservative-free ketamine product, with a final label submission expected this month and potential approval of its Abbreviated New Drug Application anticipated in Summer 2026 pending final review. The company noted the product could help expand U.S. ketamine supply amid reported shortages and aligns with federal efforts to re-shore critical drug manufacturing, while NRx also continues advancing a Fast Track-designated New Drug Application to evaluate intravenous ketamine for severe depression with suicidal ideation. To…

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MondayMar 16, 2026 9:10 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Guidance Supporting NDA Review For NRX-100

NRx Pharmaceuticals (NASDAQ: NRXP) announced that minutes from a Type C meeting with the U.S. Food and Drug Administration support the agency’s willingness to review a New Drug Application for NRX-100, a preservative-free ketamine formulation, based on existing clinical trial data demonstrating substantial evidence of effectiveness without requiring additional clinical trials. The company said the FDA also confirmed openness to reviewing Real World Evidence as confirmatory data and indicated no additional nonclinical or bridging studies would be required, while NRx plans to pursue a primary indication for treating severe depression in patients who may experience suicidal ideation and continues to…

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ThursdayMar 12, 2026 9:20 am

PsychedelicNewsBreaks – Helus Pharma(TM) (NASDAQ: HELP) (Cboe CA: HELP) Appoints Jill Conwell as Chief People Officer

This NewsBreak has been disseminated on behalf of Helus Pharma and may include paid advertising. Helus Pharma(TM) (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (“NSAs”) to address mental health conditions, announced the appointment of Jill Conwell as chief people officer, effective immediately. Conwell brings more than 20 years of leadership experience in the life sciences industry, with expertise in organizational strategy, talent development, corporate communications and investor relations. She has previously held senior leadership roles at Aclaris Therapeutics, Idera Pharmaceuticals and Shire Pharmaceuticals, where she helped build and scale organizations during periods of growth…

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MondayMar 09, 2026 9:10 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Subsidiary HOPE Therapeutics Opens Palm Beach Clinic for Depression and PTSD Treatment

NRx Pharmaceuticals (NASDAQ: NRXP) announced that its subsidiary HOPE Therapeutics has opened a new clinic in Palm Beach, Florida, focused on treating depression and post-traumatic stress disorder through an interventional psychiatry approach that includes ketamine and other neuroplastic drugs, transcranial magnetic stimulation (TMS), hyperbaric oxygen therapy and physician-led psychotherapy. The facility expands HOPE’s growing network of clinics and builds on a nationwide partnership with neurocare AG to bring non-invasive neuroplastic therapies to patients. Peer-reviewed publications cited by the company report an 87% clinical response rate in treatment-resistant depression using short-term treatment protocols, while pilot programs incorporating hyperbaric oxygen therapy have…

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MondayMar 02, 2026 9:10 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Appoints Prof. Joshua C. Brown As Chief Medical Innovation Officer

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has appointed Prof. Joshua C. Brown, MD, PhD, as Chief Medical Innovation Officer. Prof. Brown is a psychiatrist, neurologist and neuroscientist who studies the mechanisms of Transcranial Magnetic Stimulation (TMS) and their translation into clinical optimization. He serves as Medical Director of the McLean Hospital TMS Service, Director of TMS research and founding director of the Brain Stimulation Mechanisms Laboratory, with more than $20 million in federal funding from the National Institute of Mental Health and the Defense Advanced Research Projects Agency. At NRx, he will support development of mechanistically informed neuropsychiatric…

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TuesdayFeb 17, 2026 2:41 pm

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Completes FDA Type C Meeting for NRX-100 NDA Pathway 

NRx Pharmaceuticals (NASDAQ: NRXP) announced completion of an in-person Type C guidance meeting with the U.S. Food and Drug Administration, attended by leadership from the Division of Psychiatry Products, Office of Neuroscience and Center for Drug Evaluation and Research. Based on oral guidance, the company believes it has a path to file a New Drug Application for NRX-100, a preservative-free ketamine formulation, supported by existing adequate and well-controlled trials and confirmatory evidence from more than 65,000 patients in a Real World Evidence dataset, while also seeking a broader indication for treatment-resistant depression with suicidality. The FDA advised that no additional nonclinical or bridging studies would be required, and…

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TuesdayFeb 17, 2026 9:50 am

PsychedelicNewsBreaks – Helus Pharma(TM) (NASDAQ: HELP) (Cboe CA: HELP) Reports Positive Phase 2a SPL026 Data Published in Nature Medicine

This NewsBreak has been disseminated on behalf of Helus Pharma and may include paid advertising. Helus Pharma(TM) (NASDAQ: HELP) (Cboe CA: HELP) announced publication in Nature Medicine of Phase 2a trial results showing that a single 21.5 mg dose of SPL026 achieved statistically significant and clinically meaningful reductions in depressive symptoms versus placebo in patients with moderate-to-severe major depressive disorder, meeting the primary endpoint at two weeks with a mean MADRS difference of -7.35 (p=0.023) and demonstrating effects as early as one week. The treatment was generally well tolerated with no treatment-related serious adverse events, and benefits were sustained for…

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WednesdayJan 14, 2026 9:40 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Licenses Real-World Evidence From 70,000 Patients to Support FDA Accelerated Approval of NRX-100

NRx Pharmaceuticals (NASDAQ: NRXP) announced it has licensed regulatory-grade real-world evidence drawn from more than 70,000 U.S. patients treated with intravenous ketamine or nasal S-ketamine for depression and suicidal ideation to support its application for Accelerated Approval of NRX-100, a preservative-free ketamine, under Fast Track Designation. The dataset, provided by Osmind, includes nearly one million treatment sessions and extensive longitudinal safety and effectiveness data and will be submitted to the U.S. Food and Drug Administration following a 2025 policy update allowing de-identified real-world evidence. NRx is seeking approval of NRX-100 for the treatment of suicidal ideation in depression, including bipolar…

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ThursdayDec 18, 2025 9:20 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Eliminates Balance Sheet Debt Through Anson Equity Conversion

NRx Pharmaceuticals (NASDAQ: NRXP) announced it has repaid the remaining $5.4 million of balance sheet debt owed to Anson Funds LLC through an equity conversion into common stock with no warrants or repricing mechanisms, fully retiring the original $16.2 million loan used for prior debt repayment and operating expenses. With the transaction completed, the clinical-stage biopharmaceutical company expects to end calendar year 2025 debt free, positioning its capital structure to support anticipated drug approvals and clinic expansions, with Chairman and CEO Dr. Jonathan Javitt thanking Anson for its support during a challenging biotech market and citing progress toward potential 2026…

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