Breaks Categories: News

MondayAug 04, 2025 9:35 am

BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Petitions FDA to Ban Benzethonium Chloride from Ketamine Products

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has filed a Citizen Petition with the FDA requesting the removal of Benzethonium Chloride (BZT) from all ketamine products sold in the U.S. BZT, a quaternary amine preservative, is not Generally Recognized as Safe (GRAS) for parenteral use or Generally Recognized as Safe and Effective (GRASE) for topical use, and has demonstrated toxicity to epithelial cells and nerves. NRx previously submitted an Abbreviated New Drug Application for a preservative-free ketamine formulation with three-year room temperature stability and sterility, supported by a newly filed patent. The company is also pursuing a labeled indication…

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MondayAug 04, 2025 9:30 am

BioMedNewsBreaks – Lantern Pharma (NASDAQ: LTRN) Unveils AI Tool to Predict Blood-Brain Barrier Permeability with 94% Accuracy

Lantern Pharma (NASDAQ: LTRN), an AI-driven oncology drug development company, has launched predictBBB.ai(TM), a public AI module that predicts blood-brain barrier (BBB) permeability of small molecules with 94% accuracy, 95% sensitivity, and 89% specificity. Built on billions of molecular data points from Lantern’s proprietary data lake, the platform addresses the pharmaceutical challenge that only 2–6% of small molecules can cross the BBB. PredictBBB.ai(TM) ranks among the top performers on the Therapeutic Data Commons Leaderboard, leveraging synthetic data augmentation and advanced molecular representation to process compounds in real time. The launch comes as the BBB technologies market is projected to grow…

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ThursdayJul 31, 2025 2:52 pm

BioMedNewsBreaks — Lantern Pharma (NASDAQ: LTRN) Completes Targeted Enrollment for Phase 2 HARMONIC Trial in Japan

Lantern Pharma (NASDAQ: LTRN), an AI-driven developer of targeted cancer therapies using its proprietary RADR(R) platform, has completed targeted enrollment for its Phase 2 HARMONIC(TM) clinical trial in Japan ahead of schedule, enrolling 10 patients across five sites including the National Cancer Center Japan. The trial evaluates LP-300 with carboplatin and pemetrexed in never-smoker non-small cell lung cancer (NSCLC) patients who have progressed after tyrosine kinase inhibitors. CEO Panna Sharma said the milestone validates the company’s international expansion strategy into regions with higher prevalence of never-smoker NSCLC such as Japan and Taiwan, where enrollment continues alongside U.S. sites. The global…

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ThursdayJul 31, 2025 9:10 am

BioMedNewsBreaks – Soligenix Inc. (NASDAQ: SNGX) Achieves Biological Efficacy in Phase 2a SGX945 Study for Behçet’s Disease

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company developing products for rare diseases, has completed its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in Behçet's Disease, meeting the objective of demonstrating biological efficacy. In the open-label trial, SGX945 achieved a 40% improvement in the primary ulcer endpoint versus a historical placebo group from the apremilast (Otezla(R)) Phase 3 study, matching or exceeding apremilast outcomes despite treatment stopping at four weeks. Seven of eight patients reported reduced ulcer duration, number and pain, with benefits persisting through the follow-up period and no treatment-related adverse events reported. CEO Christopher J. Schaber said…

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WednesdayJul 30, 2025 9:00 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Schedules Aug. 13 Call to Discuss Q2 Results and Provide Business Updates

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care with personalized insights, will hold a conference call Aug. 13, 2025, at 4:30 p.m. Eastern to discuss second-quarter results for the period ended June 30, 2025. The company will also provide updates on regulatory initiatives, commercial-readiness activities and anticipated milestones. CEO Robert Eno and CFO Timothy Cruickshank will host the call, followed by a question-and-answer session. To view the full press release, visit https://ibn.fm/9MZKX About HeartBeam Inc. HeartBeam is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The…

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TuesdayJul 29, 2025 12:58 pm

BioMedNewsBreaks — Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Publishes Peer-Reviewed Data Supporting PC111 as Potential Disease Modifier 

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company developing inflammation and immunology biological products and providing boutique CDMO services, announced the publication of a peer-reviewed article in the Journal of Dermatological Treatment confirming the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody. The study demonstrated PC111’s ability to prevent blister formation in humanized models of pemphigus by targeting soluble Fas Ligand, offering a differentiated, non-immunosuppressive approach. Data also highlighted potential use in SJS/TEN, a life-threatening dermatological condition. CEO Amir Reichman said the findings reinforce PC111’s potential to transform treatment for these high unmet-need indications and deliver meaningful value…

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TuesdayJul 29, 2025 12:51 pm

BioMedNewsBreaks — Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) Highlights IzoView Breast CT Advantages Over Existing Imaging Technologies

Izotropic (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3), a medical device company developing imaging-based products for breast cancer detection and treatment, released an educational overview comparing its IzoView Breast CT Imaging System to current breast imaging technologies. IzoView offers true 3D, ultra-high-resolution imaging without breast compression and is designed to bridge the gap between digital breast tomosynthesis and MRI. Developed under a global license from UC Davis, IzoView delivers 100x greater spatial resolution than MRI at a lower cost and with shorter scan times, aiming to improve screening, diagnosis, and treatment planning, particularly in women with dense breast tissue. To view…

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TuesdayJul 29, 2025 11:54 am

BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) CEO to Join Fireside Chat at BTIG Virtual Biotechnology Conference

NRx Pharmaceuticals (NASDAQ: NRXP), announced that CEO and Chairman Prof. Jonathan Javitt, MD, MPH will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on July 29–30, 2025. The discussion, scheduled for 8:00 a.m. EDT on July 30, will feature Prof. Samuel Wilkinson, MD, of Yale School of Medicine, and BTIG Research Analyst Dr. Thomas Shrader. The session will focus on neuroplasticity in treating CNS disorders, including the use of ketamine and other neuroplastic and psychedelic drugs for depression, suicidality, and PTSD. To view the full press release, visit https://ibn.fm/a8ahp About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a…

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TuesdayJul 29, 2025 10:10 am

BioMedNewsBreaks — Fifty 1 Labs, Inc. (OTC: FITY) Reports Strong Shareholder Engagement in Virtual Teleconference Highlighting AI-Driven Growth Strategy 

Fifty 1 Labs (OTC: FITY), a pioneer in AI-powered health and wellness solutions, successfully hosted its July 28 virtual shareholder teleconference via X (formerly Twitter), outlining its transformative strategy through subsidiary Fifty 1 AI Labs. CEO Paul Arora detailed the company’s AI-driven drug repurposing platform targeting the $320.6 billion functional medicine market and $5.68 trillion biotech sector, supported by a $350,000 personal investment and salary deferrals from management until reaching a $50 million valuation. Key initiatives include a $1 million R&D investment, a targeted $5–10 million biotech acquisition by 2027, and planned uplisting to OTCQB in 2026 and NASDAQ thereafter.…

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TuesdayJul 29, 2025 9:00 am

BioMedNewsBreaks – Calidi Biotherapeutics Inc. (NYSE American: CLDI) Receives FDA Fast Track Designation for CLD-201 in Soft Tissue Sarcoma

Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotechnology company developing targeted genetic medicine delivery therapies, announced that the U.S. Food and Drug Administration granted Fast Track designation to CLD-201 (SuperNova), its allogeneic adipose stem-cell loaded oncolytic virus for treating soft tissue sarcoma. The designation provides opportunities for expedited development, including priority review and accelerated approval. CLD-201, which received IND clearance in April, will enter a Phase 1 trial evaluating safety and efficacy in sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma. Chief Medical Officer Guy Travis Clifton, M.D., said the milestone validates CLD-201’s potential to deliver durable,…

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