Breaks Categories: News

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 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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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 10:24 am

BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Reports Q4 and Full-Year 2024 Financial Results, Highlights FDA Clearance and Commercial Progress 

HeartBeam (NASDAQ: BEAT), a medical technology company focused on advanced cardiac care, announced its financial and operational results for the fourth quarter and full-year 2024. The company achieved key milestones, including FDA 510(k) clearance for the HeartBeam System, the launch of an Early Access Program to refine its clinical workflow, and the submission of an FDA application for its 12-lead ECG synthesis software. HeartBeam also raised $11.5 million in gross proceeds from a public offering to support commercialization efforts. Financially, research and development expenses rose to $11.1 million in 2024 from $6.8 million in 2023, while net loss widened to…

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WednesdayMar 12, 2025 9:40 am

BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Reports CNM-Au8 Significantly Improves Survival in ALS Patients 

Clene (NASDAQ: CLNN) Clene Inc. (NASDAQ: CLNN) announced new long-term survival data from the HEALEY ALS Platform Trial, showing that treatment with CNM-Au8® 30 mg significantly extended survival for patients with ALS. The analysis compared patients receiving CNM-Au8 (Regimen C) to a large concurrent control group (Regimen A) and demonstrated a median survival increase of 6.5 months. The strongest survival benefit was observed in a subset meeting the planned Phase 3 RESTORE-ALS trial criteria, where CNM-Au8 extended median survival by 14.8 months. These findings reinforce CNM-Au8’s potential to enhance ALS patient outcomes as Clene prepares for its confirmatory Phase 3 trial…

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TuesdayMar 11, 2025 10:45 am

BioMedNewsBreaks — Annovis Bio Inc. (NYSE: ANVS) to Present at Alzheimer’s & Parkinson’s Drug Development Summit 

Annovis Bio (NYSE: ANVS), a late-stage clinical drug platform company focused on neurodegenerative diseases, will participate in the 13th Alzheimer’s & Parkinson’s Drug Development Summit from March 18-20 in Boston. CEO Maria Maccecchini, Ph.D., will present Phase III data on buntanetap and discuss a holistic approach to targeting neurotoxic proteins on March 19. Annovis will also join a panel on advancing Parkinson’s therapies, emphasizing the need for broader treatment strategies beyond single-target approaches.   To view the full press release, visit https://ibn.fm/nyW4N  About Annovis Bio Inc.  Annovis Bio, headquartered in Malvern, Pennsylvania, is committed to addressing neurodegeneration in diseases such as…

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MondayMar 10, 2025 9:59 am

BioMedNewsBreaks — Calidi Biotherapeutics Inc. (NYSE American: CLDI) Reports Promising Preclinical Results for RTNova Virotherapy Platform 

Calidi Biotherapeutics (NYSE American: CLDI) announced positive preclinical results for its systemic RTNova platform, demonstrating effective delivery of transient gene therapy payloads to targeted tumors. The tumor-specific virotherapy has shown efficacy across more than 60 tumor cell lines, with a unique vaccinia virus strain enveloped in a human cell membrane providing protection in the bloodstream while targeting distant tumors. In preclinical models, a single dose of the tumor-selective triple knockout (“3KO”) RT virus with an undisclosed immunotherapeutic payload significantly altered the tumor microenvironment, leading to complete tumor eradication in some cases. The findings support the platform’s potential to revolutionize cancer…

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ThursdayMar 06, 2025 10:10 am

BioMedNewsBreaks – NextPlat Corp (NASDAQ: NXPL) to Release Full-Year 2024 Financial Results on March 17 

NextPlat (NASDAQ: NXPL, NXPLW), a global e-commerce provider, announced it will release its financial results for the full-year ended Dec. 31, 2024, before market open on March 17, 2025. Executive Chairman and CEO Charles M. Fernandez, CFO Cecile Munnik, and President and CEO of Global Operations David Phipps will host a conference call at 8:30 a.m. Eastern to discuss the results and recent developments.  To view the full press release, visit: https://ibn.fm/xsszX About NextPlat Corp  NextPlat is a global e-commerce platform company created to capitalize on multiple high-growth sectors and markets including technology and healthcare. Through acquisitions, joint ventures and…

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