BioMedNewsBreaks

FridayJun 13, 2025 2:52 pm

BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Reported Q1 2025 Results, Advanced Toward Commercialization Following VALID-ECG Study Success

HeartBeam (NASDAQ: BEAT) reported financial results and operational highlights for the first quarter of 2025, marking significant progress toward commercialization of its 12-lead ECG synthesis software. The company successfully met clinical endpoints in its VALID-ECG pivotal study, demonstrating a 93.4% diagnostic agreement with standard ECGs, and engaged in productive discussions with the FDA on its 510(k) submission. During the quarter, HeartBeam entered a strategic collaboration with AccurKardia to integrate its FDA-cleared AccurECG(TM) software into HeartBeam’s compact, cable-free cardiac device. The partnership was expected to accelerate product development and improve access to rapid arrhythmia diagnosis. The company also expanded its intellectual…

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ThursdayJun 12, 2025 1:11 pm

BioMedNewsBreaks — Soligenix Inc. (NASDAQ: SNGX) Advances Clinical Programs, Eyes Critical Trial Results in 2025–2026

Soligenix (NASDAQ: SNGX) is a late-stage biopharmaceutical company dedicated to developing and commercializing treatments for rare diseases. The company recently announced its financial results for the first quarter of 2025 as well as accomplishments representative of Soligenix’s continued commitment to advance its pipeline of therapeutic candidates, focusing on areas with significant unmet medical needs. “Our strategic focus remains on advancing our clinical programs, and we anticipate several significant development milestones,” said Soligenix CEO and president Christopher J. Schaber, PhD. “These include top-line results in 2026 from our actively enrolling phase 3 confirmatory study of HyBryte(TM) [synthetic hypericin] for early-stage cutaneous T-cell…

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ThursdayJun 12, 2025 10:36 am

BioMedNewsBreaks — Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Highlights Growth and SEPA Funding Ahead of BIO 2025 CEO Participation

Scinai Immunotherapeutics (NASDAQ: SCNI) announced that CEO Amir Reichman will participate in the BIO International Convention 2025, taking place June 16–19 in Boston. The company will present recent strategic, operational, and financial milestones, including its rapid CDMO business growth and progress on its nanobody pipeline. Scinai recently secured $1.38 million in funding via its Standby Equity Purchase Agreement with Yorkville Advisors, boosting capital without warrants or additional dilution. The company reaffirmed 2025 CDMO revenue guidance of $2 million and targets breakeven in 2026. To view the full press release, visit https://ibn.fm/saChe About Scinai Immunotherapeutics Ltd. Scinai is a biopharmaceutical company…

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ThursdayJun 12, 2025 9:10 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and HOPE Therapeutics to Present at H.C. Wainwright Neuro Perspectives Conference

NRx Pharmaceuticals (NASDAQ: NRXP) and its wholly owned subsidiary HOPE Therapeutics, Inc. announced participation in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference, set for June 16–17, 2025. Dr. Jonathan Javitt, Founder, Chairman and CEO of NRx and Co-CEO of HOPE, will deliver a corporate presentation highlighting recent developments, available on demand to registered attendees starting at 7 a.m. ET on June 16. The company will also conduct one-on-one investor meetings during the event. To view the full press release, visit https://ibn.fm/7jYZu About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA…

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WednesdayJun 11, 2025 9:20 am

BioMedNewsBreaks – Intelligent Bio Solutions Inc. (NASDAQ: INBS) Expands U.S. Forensic Market Presence Through SMARTOX Partnership

Intelligent Bio Solutions (NASDAQ: INBS) reported continued growth in the U.S. Forensic Use Only Market through its strategic alliance with SMARTOX, a Texas-based leader in drug and alcohol screening services. SMARTOX has deployed over 50 INBS Intelligent Fingerprinting Drug Screening Readers and conducted more than 7,000 tests to date—including over 1,500 in 2024—demonstrating rising demand for INBS' rapid, non-invasive testing solution. The technology offers a fingerprint sweat-based alternative to urine and saliva tests, improving efficiency, dignity, and ease of use across corrections, rehabilitation, and drug court environments. INBS is also pursuing FDA clearance for its codeine opiate test, with plans…

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TuesdayJun 10, 2025 1:02 pm

BioMedNewsBreaks — Calidi Biotherapeutics Inc. (NYSE American: CLDI) Taps Biotech Veteran to Lead Next Phase of Growth

Calidi Biotherapeutics (NYSE American: CLDI) recently announced the appointment of Eric Poma, PhD, as its new chief executive officer and member of the board of directors. The company was featured in an article that reads, “As Calidi Biotherapeutics continues to pioneer targeted antitumor virotherapies, the appointment of Dr. Poma as CEO represents a strategic move to harness experienced leadership for the company’s next phase of growth. His extensive background in oncology, successful track record in fundraising and strategic partnerships, and comprehensive understanding of the biotech landscape position him to effectively steer Calidi’s innovative therapies through clinical development and toward commercialization.” To…

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MondayJun 09, 2025 1:32 pm

BioMedNewsBreaks — Panna Sharma, Lantern Pharma CEO, Says FDA’s Elsa AI Rollout Underscores Urgency to Modernize

Panna Sharma, CEO of Lantern Pharma, commented on the U.S. Food and Drug Administration’s launch of its new AI tool in PharmaVoice, stating: “The timeline is aggressive, especially given that the scope and rigor of the initial pilot testing wasn’t fully showcased, but this reflects the urgency FDA feels.” His remarks highlight the rapid pace at which the agency is moving to integrate artificial intelligence into its regulatory infrastructure. The FDA officially announced the agency-wide deployment of Elsa, a generative AI tool designed to assist staff in reviewing clinical protocols, summarizing adverse events, comparing drug labels, and identifying inspection targets.…

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MondayJun 09, 2025 9:00 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Secures U.S. Patent for Abuse-Deterrent Transdermal Technology

Nutriband (NASDAQ: NTRB) has been granted U.S. patent No. 12,318,492 for its "Abuse and Misuse Deterrent Transdermal Systems," further strengthening domestic protection for its Aversa(TM) technology. The patent, issued June 3, 2025, enhances the company’s intellectual property portfolio for abuse-deterrent transdermal products designed to curb misuse, diversion, and accidental exposure. Aversa(TM) is currently in development as part of Nutriband’s lead product, Aversa Fentanyl, which aims to be the first abuse-deterrent fentanyl patch on the market, with peak U.S. sales potential projected between $80 million and $200 million. To view the full article, visit https://ibn.fm/9bBiW About Nutriband Inc. Nutriband is primarily…

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FridayJun 06, 2025 2:00 pm

BioMedNewsBreaks — Why Intelligent Bio Solutions Inc. (NASDAQ: INBS) Is ‘One to Watch’

Intelligent Bio Solutions (NASDAQ: INBS) is a medical technology company pioneering rapid, non-invasive diagnostics through its proprietary Intelligent Fingerprinting Drug Screening System. INBS was featured in a recent article that reads, “By utilizing fingerprint sweat analysis, the company offers a cost-effective, hygienic solution to detect recent drug use — targeting substances commonly found in workplace settings… The company’s vision is to redefine drug screening by removing the pain points of traditional testing methods, including biohazardous waste, privacy concerns, and long result turnaround times. With results in under 10 minutes and no need for gender-specific collectors or laboratory facilities, the system empowers…

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FridayJun 06, 2025 11:34 am

BioMedNewsBreaks — FDA Accelerates Launch of AI Tool Elsa, Raising Questions on Transparency and Oversight 

The U.S. Food and Drug Administration (“FDA”) has fast-tracked the rollout of its AI tool, Elsa, originally planned for June 30, with Commissioner Dr. Marty Makary touting the launch as both “ahead of schedule and under budget.” Elsa is already streamlining workflows across the agency, reducing multiday review tasks to minutes, and handling administrative functions such as safety profile assessments, label comparisons, and protocol reviews. The tool is housed in a secure GovCloud environment and was not trained on industry-submitted data, according to Makary. Still, the launch has raised questions about transparency, validation, and long-term oversight. Some FDA staff reportedly…

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