Breaks Categories: News

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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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…

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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.…

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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…

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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,…

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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…

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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…

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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…

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