NRx Pharmaceuticals Inc. NRXP Archives - Page 3 of 5

TuesdaySep 02, 2025 9:00 am

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Secures FDA Fast Track for IV Ketamine Formulation NRX-100 in Suicidal Depression

The FDA designation expands the drug’s potential patient pool tenfold, to an estimated 13 million Americans who consider suicide annually. Clinical trials demonstrated rapid and statistically significant reductions in suicidal ideation with IV ketamine versus placebo and comparators. Fast Track status makes NRX-100 eligible for Accelerated Approval and the Commissioner's National Priority Voucher program. NRx is preparing an expanded access policy and seeking meetings with FDA leadership to align on data submission. The U.S. suicidal depression market is estimated at more than $3 billion annually. NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug…

FridayAug 22, 2025 12:00 pm

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Seeks FDA Ban on Toxic Ketamine Preservative

NRx Pharmaceuticals has filed a Citizen Petition with the FDA to remove benzethonium chloride from ketamine products. The preservative has known toxicity and is no longer allowed in hand sanitizers or topical antiseptics. Ketamine is increasingly used off-label for treating suicidal depression and PTSD. The company argues repeated exposure to benzethonium chloride through IV use poses unnecessary health risks. NRx has submitted data showing its preservative-free ketamine maintains sterility and stability for three years. The company is pursuing FDA approval for both its preservative-free ketamine (“NRX-100”) and oral NMDA-targeting drug (“NRX-101”). NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has…

MondayAug 18, 2025 10:40 am

QualityStocksNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Reports Q2 2025 Results, Highlights Progress Across Lead Programs and Strategic Investment

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, reported financial results for the quarter ended June 30, 2025, and provided a corporate update. The Company highlighted progress in all three lead programs, including expanded FDA Fast Track designation for NRX-100 in treating suicidal depression, filing of multiple regulatory documents, and advancement of the NRX-101 NDA. A strategic investor group led by B Group Capital has committed capital through a purchase of restricted common stock with a one-year lockup and no dilutive mechanisms. The capital is expected to support the Company through key regulatory milestones and help scale HOPE Therapeutics and…

FridayAug 08, 2025 10:55 am

QualityStocksNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Subsidiary HOPE Therapeutics(TM) Secures Florida Regulatory Clearance to Close Dura Medical Acquisition

NRx Pharmaceuticals (NASDAQ: NRXP), through its wholly owned subsidiary HOPE Therapeutics(TM), Inc., announced it has received final clearance from the Florida Agency for Health Care Administration to proceed with closing its acquisition of revenue-generating, EBITDA-positive Dura Medical LLC, pending customary conditions. Founded in 2018, Dura operates clinics on Florida’s west coast specializing in mental health and chronic pain treatment, offering Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), Spravato(R), Stellate Ganglion Blocks, and Traumatic Incident Reduction Therapy. The company also serves veterans through the Veterans Affairs Community Cares Network. HOPE leaders said the acquisition will expand its Florida network and integrate…

FridayJul 18, 2025 3:00 pm

QualityStocksNewsBreaks – NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Charts Dual-Path for NRX-100

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and PTSD, is accelerating its push toward regulatory approval of NRX-100, a preservative-free intravenous ketamine formulation. “The company recently filed an application under the newly created FDA Commissioner’s National Priority Voucher (‘CNPV’) program, which promises significantly shortened review timelines for drugs that meet urgent U.S. health priorities,” reads an article discussing NRx. “In parallel, the company has filed an Abbreviated New Drug Application (‘ANDA’) for NRX-100 with a request for priority review. The two pathways, CNPV and ANDA, are expected to complement one another. Should the…

WednesdayJul 16, 2025 11:33 am

QualityStocksNewsBreaks – NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Positioning at the Forefront of Next-Gen Treatment

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, is executing a dual growth strategy focused on expanding its national network of mental health clinics through its subsidiary, HOPE Therapeutics, and advancing its proprietary NMDA-based therapies toward FDA approval. HOPE recently announced plans to deploy $10.3 million in total acquisition capital to purchase clinics that provide interventional psychiatric care focused on neuroplastic therapies like transcranial magnetic stimulation (“TMS”) and ketamine. The clinics are projected to generate $15 million in 2025 revenue, with additional acquisitions in discussion that could add another $20 million. At the same time, NRx is progressing NRX-100, a…

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…

TuesdayJun 24, 2025 9:10 am

QualityStocksNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Taps IBN to Lead Corporate Communications Amid Drug Advancements and Subsidiary Launch

NRx Pharmaceuticals (NASDAQ: NRXP) a clinical-stage biopharmaceutical company developing innovative treatments for suicidal depression and PTSD, has engaged IBN to manage its corporate communications strategy. NRx is advancing two FDA-designated therapies—NRX-100 and NRX-101—with an NDA underway for NRX-100 and additional regulatory filings in progress. The company also launched HOPE Therapeutics, a subsidiary focused on building a national psychiatric care network, with plans for a public spin-out. IBN will leverage its extensive media portfolio to expand investor awareness and outreach. To view the full press release, visit https://ibn.fm/L8kUd About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics…

MondayJun 23, 2025 9:20 am

QualityStocksNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Applies for FDA Commissioner’s Priority Voucher for NRX-100 Ketamine Formulation

NRx Pharmaceuticals (NASDAQ: NRXP) has filed for the newly launched FDA Commissioner’s National Priority Voucher (CNPV) program, seeking accelerated review for NRX-100, its preservative-free intravenous ketamine formulation. The company believes NRX-100 meets all criteria outlined by FDA Commissioner Marty Makary, who announced the voucher program on June 17, 2025, to prioritize treatments aligned with urgent U.S. health needs—including suicidal depression and PTSD. NRx has already submitted the chemistry, manufacturing, and controls (CMC) portion of its application and received FDA feedback, placing it on track for potential accelerated review of its full New Drug Application (NDA) by late 2025. If granted,…

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