Breaks Categories: News

WednesdayOct 22, 2025 2:03 pm

BioMedNewsBreaks — Branded Legacy, Inc. (OTC: BLEG) Advances FDA Pathway for Intranasal Naloxone with Pre-ANDA Briefing Preparation

Branded Legacy (OTC: BLEG), a holding company focused on life sciences and wellness innovation, announced that its subsidiary, BioLegacy Evaluative Group, has begun preparing its FDA Pre-Abbreviated New Drug Application (Pre-ANDA) briefing package for a proprietary intranasal naloxone spray. The milestone follows BioLegacy’s provisional patent filing for its air-driven delivery platform, designed to offer a cost-effective, scalable solution to the opioid overdose crisis. The submission includes a Target Product Profile for 2 mg and 4 mg naloxone HCl nasal sprays, Chemistry, Manufacturing and Controls specifications, a 60-subject bioequivalence study against Narcan(R), and human factors testing to ensure accessibility for non-medical users.…

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WednesdayOct 22, 2025 11:14 am

BioMedNewsBreaks — Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) Featured in NetworkNewsWire Editorial on AI-Driven 3D Imaging for Breast Cancer Detection

Izotropic (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3), developer of the IzoView Breast CT Imaging System, announces its inclusion in a NetworkNewsWire (“NNW”) editorial titled “Investors Eye Next-Gen 3D AI-Imaging Technologies in Growing $9 Billion Market.” The piece highlights how artificial intelligence is transforming medical imaging, particularly in breast cancer diagnostics, where early and accurate detection remains critical. Izotropic’s dedicated 3D imaging platform is designed to enhance detection precision, especially for women with dense breast tissue, positioning the company at the forefront of innovation in a rapidly expanding global market. To view the full press release, visit https://ibn.fm/saP3D About Izotropic Corporation Izotropic…

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WednesdayOct 22, 2025 9:15 am

BioMedNewsBreaks — Soligenix Inc. (NASDAQ: SNGX) Advances HyBryte(TM) as Potential First-Line CTCL Treatment with Promising FLASH Results 

Soligenix (NASDAQ: SNGX) is continuing to build momentum in the treatment of early-stage cutaneous T-cell lymphoma (“CTCL”) through promising results from its pivotal FLASH trial and ongoing FLASH 2 confirmatory study. HyBryte(TM)—a novel, non-UV light-activated therapy using synthetic hypericin—has demonstrated statistically significant efficacy and safety, offering hope in a field where therapeutic innovation has lagged. In the original FLASH study, nearly half of patients showed meaningful response at 18 weeks, and interim results from an independent University of Pennsylvania study reported a 75% response rate. FLASH 2 builds on these findings with improved design while addressing regulatory requirements for confirmatory…

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WednesdayOct 15, 2025 11:33 am

BioMedNewsBreaks — Adageis CEO Discusses AI-Driven Solutions for Value-Based Care in Latest Bell2Bell Podcast 

Adageis, a healthcare technology company revolutionizing patient care through innovative digital solutions, is featured in the latest episode of The Bell2Bell Podcast, produced by IBN, a multifaceted communications organization connecting public companies with the investment community. In the interview, Adageis CEO Shane Speirs explains how the company’s AI-powered platform simplifies the administrative challenges of delivering value-based care by digitizing complex insurance and compliance processes. “We make it easy to see what measures practices need to hit and how to hit them for each individual patient,” Speirs said, noting that Adageis currently supports more than 580,000 patient lives. The conversation explores…

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WednesdayOct 15, 2025 11:05 am

BioMedNewsBreaks — Humacyte, Inc. (NASDAQ: HUMA) Announces $60 Million Registered Direct Offering of Common Stock and Warrants 

Humacyte (NASDAQ: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues, announced it has entered into a securities purchase agreement with fundamental institutional investors for an oversubscribed registered direct offering totaling approximately $60 million. The Company will issue 28,436,018 shares of common stock and accompanying warrants to purchase an equal number of shares at $2.11 per unit. The warrants become exercisable 180 days after issuance, carry an exercise price of $2.11 per share, and expire April 7, 2031. Gross proceeds are expected to total $60 million before fees and expenses, with closing anticipated on or about Oct.…

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TuesdayOct 14, 2025 2:21 pm

BioMedNewsBreaks — Soligenix Inc. (NASDAQ: SNGX) Updates U.S. Medical Advisory Board to Advance Phase 3 Development of HyBryte for CTCL 

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on treatments for rare diseases, announced updates to its U.S. Medical Advisory Board for cutaneous T-cell lymphoma (CTCL) to support the ongoing Phase 3 development of HyBryte(TM) (synthetic hypericin). The board, comprised of leading dermatologic and oncologic experts, will provide strategic guidance as Soligenix advances regulatory and commercialization activities for its photodynamic therapy. President and CEO Christopher J. Schaber, PhD, said the addition of new key opinion leaders reinforces the program’s clinical depth and the company’s commitment to bringing HyBryte to CTCL patients worldwide. To view the full press release, visit https://ibn.fm/6ET3I…

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TuesdayOct 14, 2025 10:15 am

BioMedNewsBreaks – NextPlat Corp (NASDAQ: NXPL, NXPLW) Appoints Amanda L. Ferrio as Chief Financial Officer

NextPlat (NASDAQ: NXPL, NXPLW), a global consumer products and services company providing healthcare and technology solutions through e-commerce and retail channels, announced the promotion of Amanda L. Ferrio to Chief Financial Officer, succeeding Cecile Munnik, CPA/CA, following a transition period through the company’s Q3 2025 filing. Ferrio, who has over 15 years of accounting and finance experience, previously served as Vice President of Accounting & Finance at Progressive Care LLC, where she led financial reporting, budgeting, and SEC compliance. CEO David Phipps said her deep operational insight will support NextPlat’s focus on financial performance and sustainable shareholder value. To view…

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MondayOct 13, 2025 11:14 am

BioMedNewsBreaks — MindWalk Holdings Corp. (NASDAQ: HYFT) Announces 2.3 Million Share Repurchase Program

MindWalk Holdings (NASDAQ: HYFT), a bio-native AI company, announced that its Board of Directors has authorized a share repurchase program allowing the company to buy back up to 2.3 million common shares, or approximately 5% of its 46.15 million shares outstanding, over a 12-month period beginning Oct. 15, 2025. CEO Jennifer Bath said the program reflects confidence in MindWalk’s long-term prospects and provides flexibility to repurchase shares when market prices diverge from intrinsic value, with purchases to be funded through existing cash, investments, or future cash flows. To view the full press release, visit https://ibn.fm/VArOF About MindWalk MindWalk is a Bio-Native…

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FridayOct 10, 2025 9:00 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Partners with Brand Institute to Develop Global Brand Identity for AVERSA FENTANYL

Nutriband (NASDAQ: NTRB), a developer of prescription transdermal pharmaceutical products, announced that its subsidiary 4P Therapeutics has signed an agreement with Brand Institute, Inc., a global leader in pharmaceutical brand name and identity development, to create the worldwide commercial brand name and visual identity for AVERSA FENTANYL, the company’s lead product utilizing its AVERSA(TM) abuse-deterrent transdermal technology. Designed to deter misuse and reduce accidental opioid exposure, AVERSA FENTANYL could become the world’s first abuse-deterrent opioid patch. Brand Institute, with a 75% share of global drug name approvals and 87% of FDA-approved names in 2024, will lead the initiative alongside its…

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ThursdayOct 09, 2025 11:41 am

BioMedNewsBreaks — Fifty 1 Labs, Inc. (OTC: FITY) Appoints Dr. Joel Gagnier as Chief Science Officer to Advance AI-Driven Health Research

Fifty 1 Labs (OTC: FITY), a cutting-edge innovator at the intersection of artificial intelligence, clinical research, and personalized wellness, announced the appointment of Dr. Joel Gagnier, BA, ND, MSc, PhD, as Chief Science Officer. A recognized leader in clinical epidemiology and research methodology, Dr. Gagnier currently serves as Associate Professor in Epidemiology & Biostatistics and Surgery at Western University’s Schulich School of Medicine & Dentistry. His expertise in clinical trial design, bias reduction, and patient-reported outcome measures (PROMs) strengthens Fifty1 AI Labs’ commitment to rigorous, evidence-based research, positioning the company to advance AI-driven solutions in musculoskeletal health, pain management, and…

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