Uncategorized Archives - PsychedelicNewsWire (PNW)

TuesdayJul 08, 2025 9:00 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Subsidiary to Acquire 49% Stake in Prominent Florida Neuropsychiatry Clinic

The acquisition of Cohen and Associates, a respected interventional psychiatry practice, by NRx subsidiary HOPE Therapeutics, is expected to be immediately accretive to revenue and EBITDA. Cohen, serving the Sarasota-Bradenton area in Florida, specializes in treatments, including ketamine and TMS, for mood disorders, PTSD, and suicidal depression. HOPE Therapeutics is expanding toward a target of 30 clinics with a $100 million run rate by the end of 2025. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, and its wholly-owned subsidiary HOPE Therapeutics, Inc., a multi-site clinical care delivery organization, recently signed a binding letter of intent to acquire a 49%…

FridayJun 27, 2025 9:45 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Applies for FDA Commissioner’s National Priority Voucher for IV Ketamine NRX-100

The new FDA voucher program aims to speed approval of drugs aligned with national health priorities. NRX-100, a preservative-free ketamine, is also under an Abbreviated New Drug Application (“ANDA”) with a priority review request. NRx has submitted full CMC data and draft labeling for NRX-100, meeting key Commissioner’s National Priority Voucher pre-qualification criteria. The company’s U.S.-based manufacturing aims to reduce foreign supply chain dependence and address diversion concerns. A patent on the preservative-free process and a citizen petition to withdraw preserved ketamine could bolster NRx’s market position. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and…

ThursdayJun 12, 2025 9:00 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Files Abbreviated New Drug Application for Preservative-Free IV Ketamine NRX-100 Amid Ongoing Shortage

The company targets all current ketamine indications, including anesthesia and pain management. The U.S. is facing a severe ketamine shortage, prompting NRx to seek priority FDA review. NRX-100 eliminates benzethonium chloride, aligning with U.S. health initiatives to remove toxic preservatives. The company plans to petition the FDA to remove benzethonium chloride from all intravenous ketamine products. The filing complements the company’s NDA for NRX-100 for suicidal depression, with a PDUFA date expected in late 2025. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for NRX-100, a preservative-free formulation…

ThursdayJun 05, 2025 11:15 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Signs Agreement to Acquire Kadima to Launch $100M Psychiatry Clinic Network

The Kadima Neuropsychiatry Institute acquisition is part of NRx subsidiary HOPE Therapeutics’ model for a planned national clinic network, and is expected to immediately improve revenue and EBITDA for NRx and HOPE Therapeutics. HOPE aims to develop a network of up to 30 interventional psychiatry clinics by the end of 2025, with a $100 million pro forma run rate by YE 25. Kadima specializes in interventional psychiatry, and Kadima’s founder Dr. David Feifel, will join HOPE as Chief Medical Innovation Officer. NRx’s broader pipeline includes FDA-designated treatments for bipolar depression and acute suicidality. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical…

WednesdayMay 28, 2025 9:45 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Announces $10.3 Million Financing to Expand HOPE Clinic Network, Advances FDA Drug Approval

Subsidiary HOPE Therapeutics signed a $7.8 million debt financing term sheet with Universal Capital. Combined with a prior strategic investment, for which a financing term sheet has also been signed, the total financing investment, assuming both are closed, represents an expected $10.3 million for HOPE acquisition funding, supporting initial acquisitions of Dura Medical, Kadima, and NeuroSpa clinics. The expanding HOPE clinic network will deliver neuroplastic therapies for depression and PTSD, including ketamine and TMS. NRx continues regulatory progress for NRX-100 (IV ketamine) and NRX-101 (oral bipolar depression therapy). The FDA waived NRx’s $4.3 million drug application fee, and patents could…

FridayMay 23, 2025 10:30 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Subsidiary, HOPE Therapeutics, to Expand Interventional Psychiatry Treatment with Kadima Institute Acquisition

Kadima Neuropsychiatry Institute is expected to become the clinical model for HOPE Therapeutics’ nationwide network of psychiatric clinics. The acquisition brings profitability and is expected to be accretive to both revenue and EBITDA. Kadima’s founder and medical director, Dr. David Feifel, a leader in interventional psychiatry, will join HOPE as Chief Medical Innovation Officer. NRx’s pipeline includes investigational drugs for suicidal bipolar depression and chronic pain. HOPE is targeting 30 clinic acquisitions by the end of 2025, projecting $100M in annual revenue. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, and its wholly owned subsidiary HOPE Therapeutics, Inc., a medical…

TuesdayMay 20, 2025 9:00 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Is ‘One to Watch’

NRx Pharmaceuticals is advancing a pipeline of innovative therapies targeting multibillion-dollar unmet needs in central nervous system disorders. The company’s lead candidate, NRX-100 (preservative free IV ketamine), NDA in process with the FDA, has been granted Fast Track designation by the FDA for acute suicidal depression, and a patent for this novel formulation has been filed with the U.S. Patent and Trademark Office. NRX-101 (oral D-cycloserine/lurasidone), has received FDA Breakthrough Therapy designation, expediting its development. HOPE Therapeutics, NRx’s interventional psychiatry subsidiary, is targeting $100M in forward looking revenue by year-end 2025, through development of a national clinic network treating suicidal depression,…

TuesdayJul 09, 2024 10:00 am

Study Highlights How Psilocybin Impacts Auditory Cortex, Causing Perception Changes

New research has generated new insights into how psilocybin influences the auditory cortex in mice models. Psilocybin is a natural psychedelic compound that is found in more than 200 species of fungi. The compound is known to induce altered states of consciousness when ingested, including changes in cognition, mood and perception. Various studies have investigated the compound’s effectiveness in treating mental-health disorders, including anxiety and depression. While its therapeutic potential is evident, the exact mechanisms via which this psychedelic alters perception and brain function aren’t well understood. Prior studies have shown that psilocybin alters activity patterns in the brain and…

TuesdayJun 25, 2024 10:00 am

Analyzing Possible Industry Implications of FDA Advisory Panel Decision on MDMA

About a week ago, an advisory committee to the U.S. Food and Drug Administration (FDA) rejected evidence supporting the approval of MDMA as an alternative treatment for post-traumatic stress disorder (PTSD). This is a deflating moment for many in psychedelic research who have, for years, conducted trials on the drug in an effort to gain approval for commercial distribution. The application reviewed by the advisory committee was presented by Lykos Therapeutics, which concluded phase 2 and 3 trials investigating the effectiveness of MDMA-assisted therapy in managing post-traumatic stress disorder. In their report, the advisors revealed that they went through the…

ThursdayMay 23, 2024 11:15 am

4th Annual Psychedelic Therapeutics and Drug Development Conference Comes to Boston, MA

Researchers and leaders in academia, industry, the non-profit sector, and government organizations are invited to attend the 4th Annual Psychedelic Therapeutics and Drug Development Conference being held May 23-24, 2024, in Boston, MA. The conference focuses on discussing the hurdles as well as challenges in the research and development of psychedelics for various health conditions. Join the experts for this two-day conference that involves exploration, learning, discussion, and networking. Specific areas of discussion will include: Targets for novel drug development Toxicology studies and considerations The dosage debate and new evidence Second generation psychedelic drug design FDA regulatory guidance The speaker…

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