BioMedNewsBreaks

MondayAug 18, 2025 9:24 am

BioMedNewsBreaks — Soligenix Inc. (NASDAQ: SNGX) Awarded FDA Orphan Drug Designation for Dusquetide in Behçet’s Disease

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on rare diseases, announced the U.S. FDA has granted orphan drug designation to dusquetide, the active ingredient in SGX945, for treatment of Behçet's Disease. The designation follows a review of recent Phase 2a clinical results demonstrating biological efficacy and safety in patients. To view the full press release, visit https://ibn.fm/Up5sU About Soligenix Inc. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) (SGX301 or…

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FridayAug 15, 2025 10:35 am

BioMedNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Reports Q2 2025 Results, Advances TPI 287 Toward Phase 2 GBM Trial

CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company developing treatments for cancers in the brain and central nervous system, reported a Q2 2025 net loss of $2.4 million, slightly improved from $2.5 million in Q2 2024, driven by reduced Berubicin trial costs. R&D expenses rose to $1.2 million from $1.1 million on preparation for a TPI 287 trial, while G&A fell to $1.2 million from $1.4 million on lower legal, travel and stock-based compensation costs. The Company ended the quarter with $12.1 million in cash, sufficient to fund operations into the second half of 2026. CEO John Climaco said CNS is…

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ThursdayAug 14, 2025 3:38 pm

BioMedNewsBreaks — NextPlat Corp (NASDAQ: NXPL) Narrows Q2 Loss 66% as E-Commerce Growth Offsets Healthcare Headwinds

NextPlat (NASDAQ: NXPL, NXPLW), a global consumer products and services company in healthcare and technology, reported Q2 2025 revenue of $13.2 million versus $17.0 million a year ago, reflecting strong e-commerce growth offset by declines in healthcare operations from lower prescription volumes and reduced 340B contract revenue. Gross margin fell to 21.8% from 34.5% on mix shifts and industry drug price pressures. Operating expenses dropped to $4.7 million from $16.8 million on the absence of prior-year non-recurring charges and cost-cutting measures, producing a net loss of $1.8 million, or ($0.07) per share, compared to a $5.3 million loss last year.…

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ThursdayAug 14, 2025 11:00 am

BioMedNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) to Present at Webull Financial Biotech/MedTech Webinar Series

CNS Pharmaceuticals (NASDAQ: CNSP), a biopharma company developing novel treatments for primary and metastatic cancers in the brain and central nervous system, announced it will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech, taking place virtually Aug. 19–21, 2025. To view the full press release, visit https://ibn.fm/ctTvf About CNS Pharmaceuticals, Inc. CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's drug candidate TPI 287 is an abeotaxane, which stabilizes microtubules and inhibits cell division, causing apoptosis…

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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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