Breaks Categories: News

TuesdayJul 29, 2025 9:00 am

BioMedNewsBreaks – Calidi Biotherapeutics Inc. (NYSE American: CLDI) Receives FDA Fast Track Designation for CLD-201 in Soft Tissue Sarcoma

Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotechnology company developing targeted genetic medicine delivery therapies, announced that the U.S. Food and Drug Administration granted Fast Track designation to CLD-201 (SuperNova), its allogeneic adipose stem-cell loaded oncolytic virus for treating soft tissue sarcoma. The designation provides opportunities for expedited development, including priority review and accelerated approval. CLD-201, which received IND clearance in April, will enter a Phase 1 trial evaluating safety and efficacy in sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma. Chief Medical Officer Guy Travis Clifton, M.D., said the milestone validates CLD-201’s potential to deliver durable,…

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MondayJul 28, 2025 10:58 am

BioMedNewsBreaks — Calidi Biotherapeutics Inc. (NYSE American: CLDI) Announces 1-for-12 Reverse Stock Split Effective August 5

Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotechnology company developing targeted genetic medicine delivery platforms, will implement a 1-for-12 reverse stock split of its common stock effective August 5, 2025. Shares will begin trading on a split-adjusted basis on the NYSE American under the existing ticker “CLDI,” with a new CUSIP of 320703 408. The reverse split, approved by shareholders on July 9 and ratified by the board on July 11, is intended to optimize market dynamics, expand investor appeal and align trading conditions with shareholder interests. Every 12 pre-split shares will convert into one post-split share, with fractional shares…

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MondayJul 28, 2025 10:46 am

BioMedNewsBreaks — Fifty 1 Labs, Inc. (OTC: FITY) to Host July 28 Virtual Shareholder Teleconference Featuring Nobel Laureate Dr. James Orbinski

Fifty 1 Labs (OTC: FITY), a leader in AI-powered health and wellness solutions, announced it will host a virtual shareholder teleconference on Monday, July 28, 2025, at 12:00 PM EST. The event, streamed live on X (formerly Twitter), will feature Senior Scientist Dr. James Orbinski, who accepted the 1999 Nobel Peace Prize on behalf of Médecins Sans Frontières (Doctors Without Borders). The teleconference will highlight the company’s strategic roadmap for subsidiary Fifty 1 AI Labs, including AI-driven drug repurposing for functional medicine, a $1 million R&D investment, and plans for a $5–10 million biotech acquisition by 2027. Management underscored alignment…

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MondayJul 28, 2025 10:35 am

BioMedNewsBreaks — HealthLynked Corp. (OTCQB: HLYK) Launches Enterprise Healthcare Solutions Website and Upgrades Provider Directory

HealthLynked (OTCQB: HLYK), a pioneer in healthcare technology and patient engagement, announced the launch of its newly designed Enterprise Healthcare Solutions Website, www.hlykgroup.com, and significant enhancements to its national provider directory. The new platform serves as a centralized hub for insurance carriers, pharmaceutical companies, marketing firms, ACOs, healthcare networks, and large employers, offering tools for patient engagement, population health, clinical research, coordinated care, and cost management. Upgrades to the consumer-facing provider directory include faster performance and localized provider suggestions, giving patients improved flexibility and transparency in selecting care. CEO Dr. Michael Dent said the developments reflect HealthLynked’s expanding role in…

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MondayJul 28, 2025 9:00 am

BioMedNewsBreaks – Lantern Pharma (NASDAQ: LTRN) Appoints Dr. Lee T. Schalop to Board to Bolster AI-Driven Precision Oncology

Lantern Pharma (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging artificial intelligence and genomic data to accelerate oncology drug discovery, announced the appointment of Lee T. Schalop, MD, to its Board of Directors. Dr. Schalop, co-founder and former CEO of Oncoceutics Inc., brings over 20 years of experience in biotechnology leadership and financial markets, with a track record in developing targeted therapies for solid tumors, including HK327M-mutant gliomas. Oncoceutics was acquired by Chimerix Inc. (NASDAQ: CMRX) for $450 million in 2021 and later by Jazz Pharmaceuticals for $935 million in April 2025. Lantern CEO Panna Sharma said Dr. Schalop’s expertise in…

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FridayJul 25, 2025 3:19 pm

BioMedNewsBreaks — Nutriband Inc. (NASDAQ: NTRB): Innovation Meets Science Through Scalable Platform  

Nutriband (NASDAQ: NTRB) is positioning at the forefront of abuse-deterrent drug delivery in advancing its flagship fentanyl patch and buprenorphine candidates. The company combines transdermal innovation with abuse-deterrent science to meet critical public health needs. According to Nurtiband, AVERSA Fentanyl, with the possibility to reach peak annual U.S. sales of $80 to $200 million, holds the potential to be the world’s first opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. In addition, Nutriband is advancing AVERSA Buprenorphine, which upon approval is projected to achieve peak U.S. sales between…

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FridayJul 25, 2025 3:11 pm

BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Builds Momentum to Bring New Hope to Neuro Patients

Clene (NASDAQ: CLNN), together with its subsidiary Clene Nanomedicine Inc., is preparing to initiate neurofilament biomarker analyses for its lead drug candidate CNM-Au8(R) in ALS, following feedback from the FDA during a recent Type C meeting. Slated for early Q4 2025, the analyses will assess changes in neurofilament light chain (“NfL”)—a recognized marker for neurodegeneration—among nearly 200 patients treated through the Expanded Access Program for CNM-Au8. “We are encouraged by the FDA’s collaborative approach and their constructive feedback on our NfL biomarker analysis plan from the ongoing NIH-sponsored EAP program,” said Benjamin Greenberg, MD, Head of Medical at Clene. “With…

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WednesdayJul 23, 2025 10:49 am

BioMedNewsBreaks — Lantern Pharma (NASDAQ: LTRN) Reports First Complete Response in Phase 1 LP-284 Trial for Aggressive DLBCL 

Lantern Pharma (NASDAQ: LTRN) announced a complete metabolic response in a heavily pretreated patient with aggressive Grade 3 non-germinal center B-cell DLBCL during its ongoing Phase 1 trial of LP-284—the first such response observed with the candidate. The patient had failed three prior regimens, including CAR-T and bispecific antibody therapy, before responding after just two cycles of LP-284, a next-generation acylfulvene developed using Lantern’s RADR(R) AI platform. This outcome highlights LP-284’s synthetic lethal mechanism and potential as a paradigm-shifting therapy for refractory lymphomas, supporting accelerated development and strategic expansion in the $4 billion global B-cell cancer market. To view the…

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TuesdayJul 22, 2025 3:45 pm

BioMedNewsBreaks — Calidi Biotherapeutics Inc. (NYSE American: CLDI) to Host Investor Webinar Highlighting RedTail Platform and Oncology Advancements

Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotech company developing targeted genetic medicine therapies, will host an investor webinar on July 24, 2025, at 4:15 p.m. ET. Led by CEO Eric Poma, Ph.D., the event will showcase Calidi’s RedTail(TM) platform, a systemically delivered viral therapy designed to treat metastatic tumors by evading immune detection. Preclinical data on lead candidate CLD-401 showed tumor elimination and immune memory activation. The company is progressing toward an IND filing and pursuing strategic pharma partnerships to support commercialization. A Q&A session will follow the presentation. To view the full press release, visit https://ibn.fm/hQKmP About Calidi…

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TuesdayJul 22, 2025 11:15 am

BioMedNewsBreaks — CNS Pharmaceuticals Inc. (NASDAQ: CNSP) CEO Featured in Virtual Investor Summer Spotlight Conference 

CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company developing treatments for cancers of the brain and central nervous system, announced that CEO John Climaco participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference. Climaco shared his personal journey, leadership vision and enthusiasm for the company’s development programs. The webcast is available on virtualinvestorco.com and the Events section of the CNS Pharmaceuticals website. To view the full press release, visit https://ibn.fm/SigT8 About CNS Pharmaceuticals Inc. CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the…

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