Breaks Categories: News

ThursdayAug 14, 2025 10:15 am

BioMedNewsBreaks – Clene Inc. (NASDAQ: CLNN) Reports Q2 2025 Results, Targets Year-End NDA Submission for ALS Therapy

Clene (NASDAQ: CLNN), a late clinical-stage biopharma company developing treatments for neurodegenerative diseases, reported Q2 2025 results and said it has sufficient cash runway into Q1 2026. The company plans to meet with the FDA this quarter to review survival data for lead candidate CNM-Au8 in amyotrophic lateral sclerosis (ALS) and is preparing analyses of NIH-sponsored Expanded Access Program neurofilament light biomarker data, expected in Q4. These steps are intended to support a potential New Drug Application submission under the FDA’s accelerated approval pathway for ALS by year-end 2025. Management said its focus remains on delivering an impactful therapy to the…

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ThursdayAug 14, 2025 10:11 am

BioMedNewsBreaks — Lantern Pharma (NASDAQ: LTRN) Reports Q2 2025 Results, Achieves Complete Responses in Multiple Trials, Expands AI Platform

Lantern Pharma (NASDAQ: LTRN), a clinical-stage biopharma company leveraging its RADR(R) AI/ML platform for oncology drug discovery and development, announced Q2 2025 results and portfolio updates. The company reported complete responses in patients across two trials — LP-300 in advanced NSCLC and LP-284 in refractory diffuse large B-cell lymphoma — along with completion of LP-184 Phase 1a enrollment, positioning it for Phase 1b/2 studies in high-value indications. LP-184 has FDA Fast Track and multiple Rare Pediatric Disease designations and showed significant survival gains in ATRT models. Lantern strengthened its IP with a European patent allowance for LP-284 and publication of…

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ThursdayAug 14, 2025 9:25 am

BioMedNewsBreaks – Soligenix Inc. (NASDAQ: SNGX) Q2 2025 Results Highlight Progress in Late-Stage Rare Disease Pipeline

Soligenix (NASDAQ: SNGX), a late-stage biopharma company developing treatments for rare diseases, reported Q2 2025 results and recent milestones. The company expects top-line Phase 2a results for SGX302 in mild-to-moderate psoriasis before year-end, along with continued updates from its investigator-initiated study of HyBryte(TM) for early-stage cutaneous T-cell lymphoma (CTCL). A confirmatory Phase 3 trial of HyBryte(TM) in early-stage CTCL is actively enrolling, with results anticipated in 2026. Soligenix also completed a Phase 2a proof-of-concept study of SGX945 for Behçet’s Disease, achieving its primary objective of demonstrating biological efficacy, and transferred manufacturing of synthetic hypericin to the U.S. under its Sterling…

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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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