PsychedelicNewsBreaks Archive - PsychedelicNewsWire (PNW)

MondayNov 17, 2025 10:49 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Reports Q3 Results and Advances NRX-100 and NRX-101 Regulatory Programs

NRx Pharmaceuticals (NASDAQ: NRXP) reported third-quarter 2025 results and outlined progress across its clinical programs, noting its first revenue-generating activities and key regulatory milestones for NRX-100 and NRX-101. The Company highlighted expanded Fast Track status and an active Expanded Access program for NRX-100 in suicidal depression, continued advancement of its NDA supported by large-scale real-world ketamine data, and an ANDA pathway for its preservative-free ketamine KETAFREE that remains on track for a Q2 2026 GDUFA date. NRx also noted FDA communication with no major deficiencies in its revised ANDA filing and ongoing efforts to remove benzethonium chloride from commercial ketamine…

ThursdayNov 13, 2025 1:09 pm

PsychedelicNewsBreaks – NextPlat Corp. (NASDAQ: NXPL, NXPLW) Reports Q3 2025 Results Highlighted by Cost Reductions and Improving Healthcare Trends

NextPlat (NASDAQ: NXPL, NXPLW) reported third-quarter 2025 results showing consolidated revenue of about $13.8 million compared with $15.4 million in the prior year, primarily reflecting lower 340B pharmacy contract revenue before late-quarter customer re-engagement efforts drove improving prescription volumes expected to continue into Q4. Gross margin declined to 19.9% from 23.2% on lower Healthcare and e-commerce margins tied to reduced 340B revenue, new airtime costs and temporary customer rate adjustments. Operating expenses fell to roughly $4.7 million from $7.8 million as stock-based compensation, executive compensation and headcount decreased under companywide efficiency measures, contributing to a reduced net loss of about…

WednesdayNov 12, 2025 11:55 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Report Q3 2025 Financial Results and Host Conference Call on Nov. 17

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced it will release its third quarter 2025 financial results before market open on Monday, Nov. 17, 2025, followed by a conference call at 8:30 a.m. ET to discuss corporate, financial, and operational updates. To view the full press release, visit https://ibn.fm/EaOsB About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been…

MondayNov 03, 2025 2:31 pm

PsychedelicNewsBreaks – From San Francisco to Serbia: Global Psychedelic Week Sparks Worldwide Connection

Global Psychedelic Week (GPW) 2025, taking place Nov. 3–9, 2025, marks the world’s first distributed psychedelic conference, connecting over 5,000 participants across 100 countries through a hybrid model of online and in-person gatherings. Featuring more than 100 leading voices—including Rick Doblin, Robin Carhart-Harris, and Dr. Pamela Kryskow—GPW’s powerful vision is to create a global dialogue on psychedelic science, therapy, and culture. Nearly 60 local events in countries such as India, Serbia, Jamaica, Colombia, and Argentina will foster community-based connection. “During Global Psychedelic Week, over 100 in-person events will take place around the world. We’re decentralizing the conversation and meeting people…

ThursdayOct 16, 2025 2:40 pm

PsychedelicNewsBreaks – NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Advances KETAFREE(TM), Expands Pipeline Targeting Urgent Needs

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, recently secured approval from the U.S. Food and Drug Administration (“FDA”) for its Suitability Petition to advance KETAFREE(TM), a preservative-free version of ketamine. “The ruling allows the company to re-file its Abbreviated New Drug Application (‘ANDA’) for the product, which it has now done, a key step in bringing it to market,” reads a recent article. “Currently, ketamine is sold in multidose vials that require preservatives to maintain sterility after repeated use. The most common additive, Benzethonium Chloride, is known to be toxic. NRx’s proposed alternative eliminates preservatives by using single-patient dosing,…

MondayOct 06, 2025 10:38 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Present at Noble Capital Markets Emerging Growth Virtual Equity Conference

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, and its wholly owned subsidiary HOPE Therapeutics Inc., announced that Founder, Chairman, and CEO Dr. Jonathan Javitt will present at the Noble Capital Markets Emerging Growth Virtual Equity Conference on Oct. 8, 2025, at 9:30 a.m. ET. Dr. Javitt will discuss the upcoming launch of a low-dose D-Cycloserine (DCS) product shown to enhance the effectiveness of Transcranial Magnetic Stimulation (TMS) for depression, as well as the Company’s expanded clinical operations in Florida and collaborations with the U.S. Department of Veterans Affairs to treat veterans with suicidal depression and PTSD. To view the…

MondaySep 29, 2025 10:10 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Re-files ANDA for Preservative-Free IV Ketamine KETAFREE(TM)

NRx Pharmaceuticals (NASDAQ: NRXP) announced it has re-filed its Abbreviated New Drug Application with the U.S. FDA for KETAFREE(TM), a preservative-free IV ketamine formulation, covering all existing approved indications, following FDA approval of its Suitability Petition. Targeting a ketamine market estimated at $750 million annually in the U.S. and projected to reach $3.35 billion globally by 2034, NRx is seeking priority review amid an ongoing drug shortage, citing its patented formulation manufactured with Nephron Pharmaceuticals in South Carolina as a safer alternative free of benzethonium chloride, a preservative linked to neurotoxicity. To view the full press release, visit https://ibn.fm/O5lcF About…

WednesdaySep 24, 2025 11:15 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Approval of Suitability Petition for Preservative-Free Ketamine Product

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted its Suitability Petition for KETAFREE(TM), a planned single-patient, preservative-free ketamine product. Unlike current ketamine offerings in multi-dose vials containing the toxic preservative Benzethonium Chloride, KETAFREE(TM) is designed to eliminate such additives. The approval enables immediate re-filing of the Company’s Abbreviated New Drug Application. NRx noted the product supports federal priorities of re-shoring sterile drug manufacturing and removing harmful preservatives, with the ketamine market estimated at $750 million. The Company is also advancing NRX-100, a non-generic ketamine formulation under development for suicidal depression…

MondaySep 08, 2025 9:45 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Subsidiary HOPE Therapeutics Closes Acquisition of Dura Medical

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that its wholly owned subsidiary HOPE Therapeutics Inc. has closed the acquisition of Dura Medical, a revenue-generating and EBITDA-positive provider of interventional psychiatry services in Naples and Ft. Myers, Florida. Dura, founded in 2018, delivers treatments for depression, PTSD, suicidality, anxiety, and chronic pain through Ketamine Infusion Therapy, Transcranial Magnetic Stimulation, Spravato(R), Stellate Ganglion Blocks, and traditional psychiatry. The acquisition, along with pending deals for Neurospa TMS and Cohen and Associates, expands HOPE’s planned network to more than eight locations across Florida. Stephen Durand, Dura’s founder and a U.S. Army veteran,…

WednesdaySep 03, 2025 1:10 pm

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Join H.C. Wainwright’s 27th Annual Global Investment Conference; CEO Fireside Chat Set for Sept. 8, 2025, 4:30 to 5 p.m. ET

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, and HOPE Therapeutics, Inc. (“HOPE”), an interventional psychiatry network wholly owned by NRx Pharmaceuticals, announced that Chairman and CEO Jonathan Javitt, M.D., M.P.H., will participate in a fireside chat at H.C. Wainwright’s 27th Annual Global Investment Conference on Monday, Sept. 8, 2025, from 4:30 to 5 p.m. ET. A webcast will be available on the Events page of the Investors section of the Company’s website, with a replay posted two hours after the event for 30 days. To view the full press release, visit https://ibn.fm/8fef5 About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc.…

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