Breaks Categories: News

TuesdaySep 09, 2025 11:32 am

BioMedNewsBreaks — Gyre Therapeutics (NASDAQ: GYRE) Advances Toward China Approval and Expands Clinical Pipeline With Hydronidone

Gyre Therapeutics (NASDAQ: GYRE) has made strong progress through the first three quarters of FY2025, according to a report by Noble Capital Markets Senior Vice President and Equity Research Analyst Robert LeBoyer. The company posted continued sales growth from two recently launched products, submitted an application for Hydronidone approval in China, and initiated a U.S. Phase 2 trial for the drug. Gyre also named Dr. Han Ying, a board member since January 2025, as CEO. Phase 3 data for Hydronidone in chronic hepatitis B-associated fibrosis met its primary endpoint of fibrosis regression, supporting an NMPA filing in 3Q25. With Breakthrough…

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MondaySep 08, 2025 11:41 am

BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Reports Study Showing Comparable Accuracy Between HeartBeam System and Standard 12-Lead ECG in Detecting Arrhythmias

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care with personalized insights, announced study results showing no significant differences in detecting atrial fibrillation, atrial flutter and sinus rhythm when its deep learning algorithms were applied to the HeartBeam System versus standard 12-lead ECGs. Data from 201 patients, presented at HRX Live 2025 in Atlanta by Dr. Joshua Lampert of Mount Sinai Heart, demonstrated high accuracy rates in both groups (94.5% HeartBeam vs. 95.5% standard 12-lead). CEO Rob Eno said the findings highlight the potential of HeartBeam’s compact, 3D device to expand advanced cardiac monitoring to settings where…

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MondaySep 08, 2025 9:45 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Subsidiary HOPE Therapeutics Closes Acquisition of Dura Medical

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that its wholly owned subsidiary HOPE Therapeutics Inc. has closed the acquisition of Dura Medical, a revenue-generating and EBITDA-positive provider of interventional psychiatry services in Naples and Ft. Myers, Florida. Dura, founded in 2018, delivers treatments for depression, PTSD, suicidality, anxiety, and chronic pain through Ketamine Infusion Therapy, Transcranial Magnetic Stimulation, Spravato(R), Stellate Ganglion Blocks, and traditional psychiatry. The acquisition, along with pending deals for Neurospa TMS and Cohen and Associates, expands HOPE’s planned network to more than eight locations across Florida. Stephen Durand, Dura’s founder and a U.S. Army veteran,…

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FridaySep 05, 2025 9:53 am

BioMedNewsBreaks — HealthLynked Corp. (OTCQB: HLYK) Completes Reverse Stock Split to Support Growth Plans

HealthLynked (OTCQB: HLYK) has completed a reverse stock split as part of its strategy to strengthen its capital structure, improve market positioning, and align with the expectations of institutional investors and national trading platforms. The non-dilutive move reduces outstanding shares, raises the per-share price, and supports potential uplisting opportunities while preserving existing shareholder ownership. The company recently launched its patented AI healthcare guide, ARi, and continues to expand its nationwide telemedicine platform and digital services. HealthLynked is also in discussions with major insurance carriers to integrate its technology into care management workflows, positioning the company for scalable recurring revenue growth.…

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ThursdaySep 04, 2025 12:54 pm

BioMedNewsBreaks — Soligenix Inc. (NASDAQ: SNGX) Publishes Data Demonstrating Two-Year Stability of ThermoVax Ebolavirus Vaccines

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on rare diseases, announced the publication of new data showing extended stability of its ebolavirus vaccines developed with the ThermoVax(R) platform. Bivalent and trivalent vaccines formulated from Zaire ebolavirus, Sudan ebolavirus, and Marburg marburgvirus antigens retained full potency after two years of storage at up to 40°C (104°F), according to a manuscript accepted by Vaccine. Developed in collaboration with Dr. Axel Lehrer at the University of Hawaiʻi at Mānoa, the thermostable vaccines have demonstrated robust immune responses in animal models, with up to 100% protection in non-human primates. Soligenix noted that ThermoVax…

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ThursdaySep 04, 2025 12:39 pm

BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Presents Preclinical Data Showing CNM-Au8 Improves Cellular Health in Parkinson’s Disease Model 

Clene (NASDAQ: CLNN), through its wholly owned subsidiary Clene Nanomedicine Inc., announced new preclinical data demonstrating that CNM-Au8(R) improved mitochondrial function, reduced inflammation, and restored cellular metabolism in a novel dopaminergic neuron model of Parkinson’s disease (PD). The findings, presented at the Michael J. Fox Foundation H2 Therapeutics Stewardship Meeting in New York City, showed CNM-Au8 corrected metabolic imbalances, normalized dysregulated gene expression, and exhibited a favorable safety profile with no toxicity observed in PD neurons. Conducted in collaboration with the Salk Institute and supported by MJFF funding, the study underscores CNM-Au8’s potential as a neuroprotective therapy for both familial…

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ThursdaySep 04, 2025 10:58 am

BioMedNewsBreaks — Oncotelic Therapeutics, Inc. (OTCQB: OTLC) Highlights CEO Dr. Vuong Trieu’s Impact and Clinical Pipeline Progress

Oncotelic Therapeutics (OTCQB: OTLC), a clinical-stage biopharmaceutical company developing oncology and immunotherapy treatments, provided an update on its pipeline while recognizing the contributions of Chairman and CEO Dr. Vuong Trieu. Dr. Trieu has filed more than 500 patents and holds 75 issued patents spanning biologics, small molecules, nanoparticles and diagnostics. He co-invented and developed Abraxane (nab-paclitaxel), acquired by Celgene in a $2.9 billion transaction, and later sold Cynviloq (nanoparticle paclitaxel) to NantPharma in a $1.3 billion deal. His career achievements extend across multiple therapeutic areas with a focus on advancing first-in-class treatments for high unmet medical needs. To view the…

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ThursdaySep 04, 2025 10:18 am

BioMedNewsBreaks — Fifty 1 Labs, Inc. (OTC: FITY) Subsidiary Publishes Landmark Primer on Oncology Real-World Evidence

Fifty 1 Labs (OTC: FITY) through its subsidiary Fifty1 AI Labs, announced the publication of a landmark technical primer on transportability methods in oncology real-world evidence (RWE) in the Journal of Comparative Effectiveness Research. Co-authored by CTO Alind Gupta and CEO Paul Arora, the paper showcases how advanced statistical and AI-driven frameworks can bridge data gaps, accelerate health technology assessments, and improve global access to life-saving therapies. With the oncology RWE market projected to expand from $789 million in 2024 to $3.51 billion by 2035 at a CAGR of 14.7%, the publication underscores Fifty1 Labs’ leadership in advancing drug repurposing…

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ThursdaySep 04, 2025 9:50 am

BioMedNewsBreaks – Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) CEO Featured on IBN’s BioMedWire Podcast

Izotropic (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3), a medical device company developing the IzoView Breast CT Imaging System, was featured in the latest episode of IBN’s BioMedWire Podcast. CEO Robert Thast discussed the company’s mission to improve early breast cancer detection, noting IzoView’s ability to identify cancers as small as 2 millimeters compared to the 11-millimeter average under current standards of care. Thast also outlined Izotropic’s intellectual property portfolio, AI-driven advancements, competitive outlook, and commercialization strategy in Europe and the U.S., adding that the company could be a takeover target as demand for innovative breast imaging solutions grows. To view…

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ThursdaySep 04, 2025 9:20 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Secures $5.3 Million from Warrant Exercises to Advance AVERSA Fentanyl NDA

Nutriband (NASDAQ: NTRB), a company developing abuse deterrent pharmaceutical products, announced the exercise of warrants at a strike price of $6.43, generating $5,306,000 in proceeds. The funds will support the remaining clinical development of AVERSA Fentanyl and submission of its New Drug Application (NDA) with the U.S. Food and Drug Administration. AVERSA Fentanyl, which could become the world’s first opioid patch with abuse deterrent properties, is estimated to reach peak annual U.S. sales of $80 million to $200 million, according to a 2022 Health Advances market analysis report. To view the full press release, visit https://ibn.fm/7olqo About Nutriband Inc. We…

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