BioMedNewsBreaks

TuesdayMar 17, 2026 11:44 am

BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Feedback On Bioequivalence For Ketamine Product 

NRx Pharmaceuticals (NASDAQ: NRXP) announced it received a letter from the FDA’s Bioequivalence Program stating no bioequivalence deficiencies were identified at this time in its Abbreviated New Drug Application, with a preliminary determination ahead of anticipated approval in Summer 2026. The company highlighted its preservative-free ketamine formulation, which excludes benzethonium chloride, as a potential advancement in safety and stability, while continuing to pursue regulatory pathways for broader therapeutic use. To view the full press release, visit https://ibn.fm/fNDMM 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…

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MondayMar 16, 2026 9:10 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Guidance Supporting NDA Review For NRX-100

NRx Pharmaceuticals (NASDAQ: NRXP) announced that minutes from a Type C meeting with the U.S. Food and Drug Administration support the agency’s willingness to review a New Drug Application for NRX-100, a preservative-free ketamine formulation, based on existing clinical trial data demonstrating substantial evidence of effectiveness without requiring additional clinical trials. The company said the FDA also confirmed openness to reviewing Real World Evidence as confirmatory data and indicated no additional nonclinical or bridging studies would be required, while NRx plans to pursue a primary indication for treating severe depression in patients who may experience suicidal ideation and continues to…

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FridayMar 13, 2026 9:20 am

BioMedNewsBreaks – Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) Reports Q4 and Full-Year 2025 Results, Highlights Launch of TONMYA(TM)

Tonix Pharmaceuticals (NASDAQ: TNXP), a fully integrated commercial biotechnology company, reported financial results for the fourth quarter and full year ended Dec. 31, 2025, highlighting the U.S. launch of TONMYA(TM), the first new medicine approved for fibromyalgia in more than 15 years. The product, approved by the U.S. Food and Drug Administration in August 2025, became commercially available by prescription on Nov. 17, 2025, and early launch metrics indicate growing prescriber uptake, with more than 1,500 healthcare providers prescribing the therapy and approximately 2,500 patients initiating treatment. Tonix also advanced several pipeline programs during the year, including in-licensing TNX-4800 for…

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FridayMar 13, 2026 9:00 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Reports Q4 and Full-Year 2025 Results, Advances Commercialization and Clinical Development

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, reported financial and operational results for the fourth quarter and full year ended Dec. 31, 2025, highlighting progress toward commercialization following U.S. Food and Drug Administration ("FDA") 510(k) clearance of its 12-lead electrocardiogram ("ECG") synthesis software in December 2025. The company has initiated a limited market launch targeting concierge and preventive cardiology groups and secured its first commercial partnership with ClearCardio(TM), while also enrolling initial patients in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. Additional developments include completion…

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WednesdayMar 11, 2026 12:17 pm

BioMedNewsBreaks — Voyager Acquisition Corporation (NASDAQ: “VACHU,” “VACH,” “VACHW”) Reports 99.67% Share Redemptions Ahead Of VERAXA Biotech Merger

Voyager Acquisition (NASDAQ: “VACHU,” “VACH,” “VACHW”) announced that holders of 25,217,315 Class A ordinary shares — representing approximately 99.67% of the shares outstanding — exercised their redemption rights in connection with the company’s planned business combination with VERAXA Biotech AG. Following the redemptions, approximately $885,556 will remain in Voyager’s trust account and 82,685 Class A shares will convert into shares of VERAXA Biotech Holding AG, with the combined company expected to trade on Nasdaq under the ticker “VRXA” upon completion of the transaction. To view the full press release, visit https://ibn.fm/Y6KAF About Voyager Acquisition Corp. Voyager is a special purpose acquisition company with a bold…

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WednesdayMar 11, 2026 9:50 am

BioMedNewsBreaks – Oragenics Inc. (NYSE American: OGEN) Explores CNS Asset Acquisitions To Expand Brain Health Pipeline

Oragenics (NYSE American: OGEN) announced it is exploring potential acquisitions of additional central nervous system assets focused on brain health and brain recovery indications that align with its proprietary intranasal drug delivery platform and lead candidate ONP-002. The company said the initiative complements its existing AI-enabled drug discovery collaboration with Receptor.AI and is intended to build a diversified CNS pipeline, while ONP-002 continues advancing through Phase IIa clinical trials in Australia targeting concussion and mild traumatic brain injury with plans for U.S. Phase IIb studies following a future IND submission. To view the full press release, visit https://ibn.fm/S8Srs About Oragenics,…

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WednesdayMar 11, 2026 9:40 am

BioMedNewsBreaks – NanoViricides (NYSE American: NNVC) to Present at NIBA Investment Conference As NV-387 Oral Gummies Drug Supply Completed

NanoViricides, Inc. (NYSE American: NNVC) announced that it will present at NIBA’s 152nd Investment Conference in Fort Lauderdale on March 12, where President and Executive Chairman Anil R. Diwan will outline progress on the company’s broad-spectrum antiviral platform. The company also reported that manufacturing of its NV-387 Oral Gummies drug product has been completed in preparation for patient dosing once clinical sites are ready, as the therapy advances toward a Phase II trial for monkeypox in the Democratic Republic of Congo following a successful Phase I safety study in healthy volunteers. To view the full press release, visit https://ibn.fm/AILOV ABOUT…

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WednesdayMar 11, 2026 9:30 am

BioMedNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Launches New Growth Strategy Focused On Neurology And Oncology Pipeline Expansion

CNS Pharmaceuticals (NASDAQ: CNSP) announced a new corporate growth strategy aimed at building a high-value pipeline in neurology and oncology through the acquisition or in-licensing of preclinical and clinical-stage therapeutic assets. Following a comprehensive strategic review incorporating clinical probability-of-success modeling, regulatory pathway analysis and market assessments, the company said it will prioritize programs with differentiated mechanisms, clear development pathways and strong commercial potential, while preparing legacy assets TPI 287 and berubicin for potential out-licensing to focus resources on advancing a new acquisition-driven pipeline. To view the full press release, visit https://ibn.fm/MutVR About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is a clinical-stage…

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TuesdayMar 10, 2026 10:39 am

BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Collaborates With Mount Sinai to Advance AI-ECG Algorithm Development

HeartBeam (NASDAQ: BEAT) announced a strategic collaboration with the Icahn School of Medicine at Mount Sinai in New York to accelerate the joint development and validation of next-generation AI-ECG algorithms. The partnership will combine HeartBeam’s patented ECG platform, which captures the heart’s electrical activity from three non-coplanar dimensions, with Mount Sinai’s clinically annotated 12-lead ECG datasets and artificial intelligence expertise to advance AI-driven cardiac monitoring. By leveraging longitudinal, high-fidelity synthesized 12-lead ECG data collected from patients in home settings alongside Mount Sinai’s clinical data resources, the collaboration aims to accelerate the training and validation of AI models designed to support personalized cardiac insights, expand potential clinical…

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TuesdayMar 10, 2026 9:00 am

BioMedNewsBreaks – Soligenix Inc. (NASDAQ: SNGX) SGX945 Granted Promising Innovative Medicine Designation in UK for Behçet Disease

Soligenix (NASDAQ: SNGX) announced that SGX945 (dusquetide) has received Promising Innovative Medicine (“PIM”) designation from the U.K. Medicines and Healthcare Products Regulatory Agency for the treatment of Behçet’s Disease. The designation represents the first step toward potential inclusion in the U.K.’s Early Access to Medicines Scheme, which allows patients with life-threatening or seriously debilitating conditions to access promising therapies earlier. The PIM designation was granted based on Phase 2 clinical data indicating that dusquetide may provide a significant advantage over existing treatments while demonstrating a favorable potential benefit-risk profile for patients with this rare inflammatory disorder. To view the full…

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