PsychedelicNewsBreaks Archive - PsychedelicNewsWire (PNW)

WednesdayDec 03, 2025 9:15 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Amends IND to Advance NRX-101 With TMS for Depression Treatment

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said it amended its Investigational New Drug filing for NRX-101 to include use of the drug in combination with Transcranial Magnetic Stimulation for depression, including suicidal depression. The update follows evidence suggesting NRX-101 may significantly enhance TMS outcomes, with published studies showing more than two-fold improvements in symptom reduction and clinical response rates exceeding 80%. The Company noted NRX-101’s D-cycloserine component appears to augment neuroplasticity associated with TMS, while its low-dose lurasidone is intended to mitigate D-cycloserine’s known risk of low-grade hallucinations. NRx said it aims to validate the findings in a…

TuesdayDec 02, 2025 9:20 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Announces FDA Receipt of ANDA for KETAFREE With July 2026 Review Goal Date

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said the FDA has received its Abbreviated New Drug Application for KETAFREE(TM), a preservative-free intravenous ketamine formulation, deeming the submission “substantially complete” and assigning a July 29, 2026 review goal date. CEO Jonathan Javitt said KETAFREE is designed to provide a single-patient, preservative-free alternative to current multidose ketamine vials that contain Benzethonium Chloride, a compound no longer recognized as safe by the FDA. The Company said KETAFREE aligns with MAHA initiatives to remove toxic substances from medicines and supports domestic supply-chain priorities, with potential 2026 approved drug sales if approved on schedule.…

TuesdayDec 02, 2025 9:10 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Schedules Corporate Update Call for Dec. 2

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said it will host a corporate update conference call on Dec. 2, 2025, at 9 a.m. Eastern to review recent clinical, regulatory and operational developments. To view the full press release, visit https://ibn.fm/W51Qg 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 awarded Fast Track Designation for the treatment of Suicidal…

MondayDec 01, 2025 9:50 am

PsychedelicNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Present at NobleCon21

NRx Pharmaceuticals (NASDAQ: NRXP) said Founder, Chairman and CEO Jonathan Javitt, M.D., M.P.H., will present at NobleCon21 on Dec. 3 at 4:30 p.m. EST, offering an update on the company’s expanded focus in investigational drugs, medical devices, and interventional psychiatric therapies for suicidal depression, PTSD, and related conditions, as well as progress in generating clinical revenue since NobleCon 2024. To view the full press release, visit https://ibn.fm/JeaP1 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,…

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…

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