BioMedNewsBreaks

MondayMar 24, 2025 10:44 am

BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Plans 2025 NDA Submission Following Positive ALS Trial Data 

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company, reported a full-year 2024 net loss of $39.4 million, or $5.67 per share, compared to a loss of $49.5 million in 2023. Revenue remained limited, but Clene highlighted regulatory progress and survival data supporting CNM-Au8, its gold nanocrystal suspension for ALS. The company expects to meet with the FDA in Q2 2025 to finalize analysis plans for biomarker data, with a potential accelerated NDA submission in the second half of 2025. Clene ended the year with $12.2 million in cash and expects to begin enrollment for its confirmatory Phase 3 RESTORE-ALS trial in…

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MondayMar 24, 2025 9:42 am

BioMedNewsBreaks — Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) Secures Actinium-225 Supply Agreement with Eckert & Ziegler to Support Expanding Pipeline 

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM), a leader in targeted radiotherapies, announced a supply agreement with Eckert & Ziegler for Actinium-225 (Ac-225) to support development of its lead candidate Actimab-A and other radiotherapy programs. The agreement ensures access to high-quality Ac-225 for both U.S. and international clinical trials. Actimab-A, an Ac-225-based agent targeting CD33, is being advanced into pivotal Phase 2/3 trials for relapsed/refractory acute myeloid leukemia and early-stage studies in combination with checkpoint inhibitors for solid tumors including head and neck and non-small cell lung cancers. The partnership strengthens Actinium’s ability to scale development and meet global demand for targeted…

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FridayMar 21, 2025 2:31 pm

BioMedNewsBreaks — Calidi Biotherapeutics Inc. (NYSE American: CLDI): Poised in the Future of Oncology with Cutting-Edge Treatments

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage biotechnology company at the forefront of research and development of innovative treatments in the field of immuno-oncology. With cancer being the second leading cause of death globally, the company focuses on harnessing antitumor virotherapies and patented technologies designed to protect and potentiate the virotherapy during administration to combat cancer more effectively and with fewer side effects. The company’s approach includes a systemic platform using extracellular enveloped viruses and an intratumoral platform utilizing stem cells to protect the therapy from the body’s immune system during administration. Calidi’s pipeline includes promising therapies such as RTNova,…

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FridayMar 21, 2025 12:34 pm

BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Unveils Progress on CNM-Au8(R), Eyes Potential Fast-Track FDA Approval

Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), is actively advancing its lead drug candidate, CNM-Au8®. The company presented its progress at two key investor events this month, including the Q1 Virtual Investor Summit and the 37th Annual Roth Conference. At both events, Clene’s management discussed the latest achievements with CNM-Au8, a gold nanocrystal-based oral suspension that targets mitochondrial dysfunction and promotes neuronal health. The drug has shown promising results in…

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FridayMar 21, 2025 11:50 am

BioMedNewsBreaks – Soligenix Inc. (NASDAQ: SNGX) Announces Key Milestones and 2024 Financial Results

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, today announced its recent accomplishments and financial results for the year ended Dec. 31, 2024. “We remain highly focused on advancing our multiple clinical programs as we work towards achieving a number of important and potentially transformational development milestones, including top-line results in 2026 for our actively enrolling confirmatory Phase 3 placebo-controlled study evaluating HyBryte(TM) (synthetic hypericin) in the treatment of early-stage cutaneous T-cell lymphoma (‘CTCL’),” stated Christopher J. Schaber, PhD, president and chief executive officer…

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WednesdayMar 19, 2025 2:14 pm

BioMedNewsBreaks — Adageis Navigates Complexities of Value-Based Care with Tailored Solution

Adageis was featured in a recent article that discussed the company’s positioning as healthcare shifts toward value-based care, where providers are reimbursed for patient outcomes rather than the number of procedures performed. “While the model promises higher-quality care at lower costs, it also introduces complex reimbursement structures that can be difficult to navigate,” the article reads. “One of the major challenges in the marketplace is the sheer complexity… Adageis has a solution that integrates with nearly 100 electronic health record systems, overlaying existing platforms to provide easy-to-read measures tailored to each patient’s insurance,” Adageis CEO Shane Speirs was quoted as saying.…

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TuesdayMar 18, 2025 12:51 pm

BioMedNewsBreaks — Why Soligenix Inc. (NASDAQ: SNGX) Is ‘One to Watch’

Soligenix (NASDAQ: SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for rare diseases with high unmet medical needs. “Operating through two key segments, the company’s Specialized BioTherapeutics division is dedicated to oncology and inflammation therapies, while its Public Health Solutions segment advances vaccines and therapeutics targeting biothreats and infectious diseases,” reads a recent article. “With a diversified pipeline, multiple orphan and fast-track designations, and collaborations with government agencies, Soligenix is uniquely positioned for potential regulatory approvals and commercialization.” To view the full article, visit https://ibn.fm/AUjKv About Soligenix Inc. Soligenix is a late-stage biopharmaceutical company focused on developing…

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MondayMar 17, 2025 11:46 am

BioMedNewsBreaks — Aditxt Inc. (NASDAQ: ADTX) Provides Corporate Update, Announces Weekly Investor Series 

Aditxt (NASDAQ: ADTX), a health innovation platform, provided a corporate update highlighting progress across its subsidiaries and acquisition initiatives. The company remains focused on advancing its autoimmune treatment subsidiary Adimune™, precision diagnostics unit Pearsanta™, and neurological monitoring subsidiary Adivue™, while also pursuing strategic acquisitions, including Appili Therapeutics and Evofem Biosciences. Additionally, Aditxt will launch its Aditxt Weekly Update series on March 21, 2025, featuring CEO Amro Albanna and Evofem CEO Saundra Pelletier, aiming to enhance transparency and investor engagement.  To view the full press release, visit https://ibn.fm/hL9Qa  About Aditxt Inc.  Aditxt is an innovation platform dedicated to accelerating promising health…

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MondayMar 17, 2025 9:05 am

BioMedNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) to Present at BIO-Europe Spring 2025

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company specializing in inflammation and immunology (I&I) biological products and contract development and manufacturing (CDMO) services, announced its participation in the BIO-Europe Spring 2025 conference from March 17-19 in Milan, Italy. The company’s leadership will meet with potential pharmaceutical partners, prospective CDMO clients, and institutional investors to showcase its innovative NanoAb pipeline and biologics manufacturing capabilities. Scinai will also exhibit its CDMO services at booth #22. To view the full press release, visit https://ibn.fm/hyqU6 About Scinai Immunotherapeutics Ltd. Scinai is a biopharmaceutical company with two complementary business units. One is focused on in-house development…

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FridayMar 14, 2025 3:45 pm

BioMedNewsBreaks — Adageis’ AI-Driven Approach: A Game-Changer in Efficient, Patient-Centered Healthcare

Adageis was featured in a recent article that discussed how its ProActive Care approach shifts healthcare from reactive to preventive, patient-centered care by leveraging AI-driven analytics to identify high-risk patients and address care gaps. This model enhances patient outcomes by focusing on early intervention, care coordination, more time with doctors to focus on patient needs, and better overall health management. For healthcare providers, it boosts operational efficiency and revenue potential through optimizing workflows, meeting value-based care metrics, and minimizing administrative burdens. With the ability to integrate seamlessly with major electronic health record (“EHR”) systems, Adageis’ platform supports providers in delivering more…

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