BioMedNewsBreaks

ThursdayAug 14, 2025 9:00 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Reports Q2 2025 Results, Advances Toward FDA Clearance and Commercial Launch

HeartBeam (NASDAQ: BEAT), a medical technology company developing personalized cardiac care solutions, reported financial and operational results for the quarter ended June 30, 2025. The company said it remains on track to receive FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment by year-end, following positive pivotal study results showing 93.4% diagnostic agreement with standard 12-lead ECGs. HeartBeam is executing commercial readiness plans, including establishing manufacturing, logistics, and cardiologist review services, with launch expected after clearance. Additional highlights include an accepted AI algorithm abstract for HRX Live 2025, issuance of a new international patent bringing the total…

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WednesdayAug 13, 2025 11:37 am

BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) to Present Corporate Update at Emerging Growth Conference on Aug. 20

Clene (NASDAQ: CLNN), a clinical-stage biopharmaceutical company developing treatments for neurodegenerative diseases such as ALS and MS, will present at the Emerging Growth Conference on Aug. 20, 2025, at 2:20 p.m. ET. The virtual session will feature a corporate update followed by a Q&A, with a live webcast available through the Events section of Clene’s website and via the conference registration link and replays accessible through the conference portal and YouTube channel. To view the full press release, visit https://ibn.fm/Z46nC About Clene Inc. Clene Inc., (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is…

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TuesdayAug 12, 2025 11:14 am

BioMedNewsBreaks — Fifty 1 Labs, Inc. (OTC: FITY) and BioSpark AI Achieve Major Milestone in AI-Driven Drug Repurposing

Fifty 1 Labs (OTC: FITY), through its subsidiary Fifty1 AI Labs and in partnership with BioSpark AI Technologies Inc., has transformed more than 10,000 unstructured case reports into a structured, queryable database of over 2,000 real-world patient treatment-outcome pathways. Built using BioSpark’s patented natural language processing system and Fifty1’s proprietary AI modeling, the dataset provides a high-fidelity foundation for therapeutic discovery in complex conditions such as chronic fatigue, neuroinflammation and post-viral syndromes. The collaboration, which aligns with Fifty1 Labs’ intent to acquire BioSpark, has prioritized off-patent drug candidates with market opportunities ranging from $1 billion to over $160 billion. The…

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TuesdayAug 12, 2025 10:30 am

BioMedNewsBreaks — Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) Launches New Corporate Website and Brand Identity

Izotropic (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3), a medical device company focused on innovative imaging technologies for improved breast cancer screening, diagnosis and treatment, has unveiled a redesigned corporate website at izocorp.com along with a refreshed brand identity. The updated site offers streamlined navigation, expanded content and multimedia resources that communicate the Company’s value proposition and commercialization strategy. The rebrand introduces the corporate tagline “Advanced Imaging. Accessible Care.” and a dedicated product tagline for its flagship IzoView Breast CT Imaging System, “Engineered for Today’s Challenges and Tomorrow’s Care Models.” To view the full press release, visit https://ibn.fm/WtJQg About Izotropic More information…

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MondayAug 11, 2025 10:58 am

BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Fast Track Designation for NRX-100 in Treating Suicidal Ideation in Depression 

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for treating suicidal ideation in patients with depression, including bipolar depression—a 10-fold expansion from its prior 2017 designation for use with NRX-101 in suicidal bipolar depression. The FDA’s determination, based on preliminary data, also supports potential eligibility for the Commissioner’s National Priority Voucher Program and the Accelerated Approval Program. Controlled trials licensed by NRx showed NRX-100 (IV ketamine) reduced suicidal ideation significantly, with one Columbia University study reporting a 55% response rate versus 30% for active comparator…

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MondayAug 11, 2025 9:50 am

BioMedNewsBreaks – Alliance Global Partners Maintains Buy Rating, Increases Price Target as Soligenix Inc. (NASDAQ: SNGX) Advances Proprietary Clinical Programs

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company targeting rare diseases, was spotlighted last week in a report from Alliance Global Partners (“AGP”), which maintained its Buy rating for Soligenix and raised SNGX’s price target to $10 per share. According to the report, the increase was based on the increasing valuation of HyBryte(TM) for the treatment of early-stage cutaneous T cell lymphoma (“CTCL”) and new estimated valuation for Soligenix’s SGX945, a treatment for Behçet's disease. According to the report, SNGX’s phase 3 FLASH2 trial is on track to have topline results announced next year. AGP noted that in December 2024, Soligenix…

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MondayAug 11, 2025 9:20 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) CEO Steps Aside Temporarily to Run for Irish Presidency

Nutriband (NASDAQ: NTRB) announced that CEO Gareth Sheridan will step aside for three months to pursue candidacy in the Irish Presidential election, with nomination hearings and voting taking place in September and October. Co-Founder and Chairman Serguei Melnik, a corporate strategy expert with over 20 years in capital markets, will assume CEO duties during this period, guiding the company toward its 2026 NDA filing target. Sheridan emphasized confidence in the leadership team, noting continued progress on AVERSA Fentanyl, which the FDA recently granted a meeting request for. AVERSA Fentanyl is positioned to be the first abuse-deterrent opioid patch, designed to…

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MondayAug 11, 2025 9:10 am

BioMedNewsBreaks – Calidi Biotherapeutics Inc. (NYSE American: CLDI) Reports Q2 2025 Results and Business Highlights

Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotechnology company developing targeted therapies to deliver genetic medicines to metastatic disease sites, reported a Q2 2025 net loss of $5.7 million, or $1.99 per share, compared to a net loss of $7.4 million, or $16.75 per share, in Q2 2024. R&D expenses were $2.6 million versus $2.2 million last year, while G&A expenses were $3.1 million compared to $3.6 million. Calidi ended the quarter with $5.3 million in cash and $0.1 million in restricted cash. Recent highlights include new preclinical data on CLD-401 from the proprietary RedTail platform, showing enhanced efficacy through…

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FridayAug 08, 2025 10:55 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Subsidiary HOPE Therapeutics(TM) Secures Florida Regulatory Clearance to Close Dura Medical Acquisition

NRx Pharmaceuticals (NASDAQ: NRXP), through its wholly owned subsidiary HOPE Therapeutics(TM), Inc., announced it has received final clearance from the Florida Agency for Health Care Administration to proceed with closing its acquisition of revenue-generating, EBITDA-positive Dura Medical LLC, pending customary conditions. Founded in 2018, Dura operates clinics on Florida’s west coast specializing in mental health and chronic pain treatment, offering Ketamine Infusion Therapy, Transcranial Magnetic Stimulation (TMS), Spravato(R), Stellate Ganglion Blocks, and Traumatic Incident Reduction Therapy. The company also serves veterans through the Veterans Affairs Community Cares Network. HOPE leaders said the acquisition will expand its Florida network and integrate…

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FridayAug 08, 2025 9:30 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Secures FDA Type C Meeting for AVERSA(TM) Fentanyl Abuse-Deterrent Patch

Nutriband (NASDAQ: NTRB), a developer of prescription transdermal pharmaceutical products, announced the U.S. Food and Drug Administration has granted a Type C Meeting on Sept. 18, 2025, to review Chemistry, Manufacturing, and Controls plans for its lead product, AVERSA(TM) Fentanyl. Developed in partnership with Kindeva, the patch integrates Nutriband’s abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch to help prevent abuse, diversion, misuse, and accidental exposure while maintaining access for patients in need. Positioned to be the world’s first abuse-deterrent opioid patch, AVERSA Fentanyl targets peak annual U.S. sales potential of $80 million to $200 million, with future global market expansion…

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