BioMedNewsBreaks

ThursdayMay 01, 2025 10:25 am

BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Granted FDA Waiver for $4.3 Million NDA Filing Fee for NRX-100

NRx Pharmaceuticals (NASDAQ: NRXP) announced it has received a $4.3 million New Drug Application filing fee waiver from the FDA for NRX-100, its preservative-free ketamine therapy for suicidal depression. The waiver, granted to small businesses and drugs deemed essential for public health, enables NRx to complete its NDA by the end of Q2 2025 using existing resources. NRX-100 offers a single-patient ketamine formulation without benzethonium chloride, a preservative associated with neurotoxicity. The company aims to secure FDA approval to provide insurance-covered treatment options beyond current off-label use.  To view the full press release, visit https://ibn.fm/C6SGv  About NRx Pharmaceuticals, Inc.  NRx…

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ThursdayMay 01, 2025 10:08 am

BioMedNewsBreaks — Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) to Host Webinar on PC111 Antibody for Rare Skin Disorders 

Scinai Immunotherapeutics (NASDAQ: SCNI) will host a webinar May 7 at 11:30 a.m. EST to discuss the treatment potential of Pincell’s novel monoclonal antibody, PC111, for rare skin conditions Pemphigus Vulgaris and SJS/TEN. The session will cover unmet medical needs, PC111’s mechanism targeting soluble Fas ligand, and development plans. The event follows Scinai’s March agreement to acquire Pincell and a related €12 million grant application under Poland’s FENG program. Panelists include executives from Scinai and Pincell, with a live Q&A segment.  To view the full press release, visit https://ibn.fm/BunpC  About Scinai Immunotherapeutics Ltd.  Scinai is a biopharmaceutical company with two…

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ThursdayMay 01, 2025 9:40 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) to Report Q1 2025 Results and Provide Business Update on May 13

HeartBeam (NASDAQ: BEAT) will host a conference call on May 13 at 4:30 p.m. Eastern to discuss financial results for the first quarter ended March 31, 2025. CEO Robert Eno and CFO Timothy Cruickshank will lead the call, which will include updates on regulatory progress, commercial-readiness efforts, and upcoming milestones. A corresponding press release and presentation will be available on the company’s investor relations website. To view the full press release, visit https://ibn.fm/HOwza About HeartBeam Inc. HeartBeam is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The company is creating the…

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WednesdayApr 30, 2025 9:48 am

BioMedNewsBreaks — Nutriband Inc. (NASDAQ: NTRB) CEO Issues Shareholder Letter Highlighting 2024 Milestones and 2025 Commercialization Goals 

Nutriband (NASDAQ: NTRB) has released a shareholder letter from CEO Gareth Sheridan outlining key achievements in 2024 and plans for 2025, centered on advancing its AVERSA™ abuse-deterrent transdermal technology. The company is transitioning from feasibility to commercial development of AVERSA Fentanyl in partnership with Kindeva Drug Delivery, targeting a pivotal Human Abuse Liability clinical trial and NDA filing. AVERSA Fentanyl and AVERSA Buprenorphine could reach peak annual sales of up to $200 million and $130 million respectively. Nutriband also expanded its global patent portfolio to 46 countries and raised $8.4 million in a non-brokered placement. The company expects continued revenue…

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TuesdayApr 29, 2025 12:41 pm

BioMedNewsBreaks — Soligenix Inc. (NASDAQ: SNGX) Moves Forward to Strengthen the Case for HyBryte(TM)

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company, is advancing its phase 3 replication study (“FLASH2”) for HyBryte(TM), a novel photodynamic therapy designed to treat early-stage cutaneous T-cell lymphoma (“CTCL”). Building on the success of a prior phase 3 trial, HyBryte(TM)—which uses synthetic hypericin activated by safe visible light—offers a potentially game-changing approach by providing a noninvasive, well-tolerated alternative that targets malignant T-cells with precision. With patient enrollment underway and interim analysis expected in early 2026, the study is designed to potentially meet the stringent requirements of regulatory agencies in order to strengthen the case for HyBryte(TM) as a commercially available…

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TuesdayApr 29, 2025 11:25 am

BioMedNewsBreaks — Adageis Is Reshaping Patient Care Through Smart Tech

Adageis is revolutionizing healthcare with its flexible, AI-centric software solutions and ProActive Care Platform, built to eliminate administrative burdens and enable providers to focus on patients. With simplicity core to its design, the platform empowers healthcare organizations by identifying missed revenue opportunities from insurers and guiding providers to secure rightful payments. Using predictive analytics through its Patented Risk Engine (“PRE”), Adageis enhances steady cash flow by forecasting incentive payments and factoring receivables. The platform seamlessly integrates with over 90 electronic health record systems, minimizing disruption and easing the shift to value-based care. As the healthcare sector continues in this trend, Adageis…

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TuesdayApr 29, 2025 9:40 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Reports Positive VALID-ECG Study Results Supporting 12-Lead ECG Technology

HeartBeam (NASDAQ: BEAT) announced that its synthesized 12-lead ECG technology met clinical endpoints in the VALID-ECG pivotal study, achieving a 93.4% diagnostic agreement with standard 12-lead ECGs for arrhythmia assessment. Results were presented by Dr. Thomas Deering of Piedmont Heart Institute during the Heart Rhythm Society’s annual conference. HeartBeam’s 3D ECG technology, designed to fit into a credit card-sized device, aims to bring hospital-grade cardiac insights to patients anywhere, with commercialization planned following anticipated FDA clearance. To view the full press release, visit https://ibn.fm/i8Q5n About HeartBeam Inc. HeartBeam is a medical technology company dedicated to transforming cardiac care by providing powerful…

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TuesdayApr 29, 2025 9:10 am

BioMedNewsBreaks – NextPlat Corp (NASDAQ: NXPL) Receives Nasdaq Notice for Minimum Bid Price Noncompliance

NextPlat (NASDAQ: NXPL, NXPLW) announced it has received a written notice from Nasdaq Stock Market LLC stating that the company is not in compliance with Nasdaq Listing Rule 5550(a)(2), as its closing bid price has remained below $1.00 per share for 30 consecutive business days. NextPlat has been granted a 180-calendar day period, until Oct. 27, 2025, to regain compliance by maintaining a minimum $1.00 closing bid price for at least 10 consecutive business days. The company may qualify for an additional 180-day extension if it meets other listing requirements. NextPlat stated it is actively pursuing strategies to improve business efficiency…

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MondayApr 28, 2025 9:32 am

BioMedNewsBreaks — Calidi Biotherapeutics Inc. (NYSE American: CLDI) Advances RTNova Platform with IL15 Superagonist Payload

Calidi Biotherapeutics (NYSE American: CLDI) announced the selection of IL15 superagonist (IL15-IL15Ra) as the first therapeutic payload for its systemic antitumor virotherapy platform, RTNova. Preclinical data presented at the AACR Annual Meeting show that Calidi's engineered vaccinia virus can deliver IL15 superagonist directly into the tumor microenvironment, significantly boosting immune response and tumor elimination while minimizing systemic toxicity. The RTNova platform aims to treat metastatic cancers by enabling systemic delivery of tumor-targeted virotherapies.  To view the full press release, visit: https://ibn.fm/4TR7U  About Calidi Biotherapeutics  Calidi Biotherapeutics specializes in proprietary technology that empowers the immune system to combat cancer. The company’s…

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FridayApr 25, 2025 4:00 pm

BioMedNewsBreaks — Why Nutriband Inc. (NASDAQ: NTRB) Is ‘One to Watch’ 

Nutriband (NASDAQ: NTRB), a company focused on the development of a portfolio of transdermal pharmaceutical products, was featured in a recent article that discussed its innovative AVERSA(TM) abuse-deterrent technology and business model. “AVERSA technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to patients who need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, Australia, and China, with recent extensions into Macao,” the article reads.  “The company’s…

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