BioMedNewsBreaks

WednesdayDec 03, 2025 12:26 pm

BioMedNewsBreaks — Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% JV Reports IV Sapu003 Cuts GI Exposure to Everolimus by Up to 67-Fold 

Oncotelic Therapeutics (OTCQB: OTLC), 45% owner of the Sapu Nano joint venture, announced new pharmacokinetic and tissue-distribution data showing that Sapu003, its intravenous Deciparticle (TM) formulation of everolimus, dramatically reduces gastrointestinal drug accumulation compared with oral everolimus. Oral dosing drives extreme gut exposure—up to 2,448× plasma levels in the stomach—while IV Sapu003 limits GI tissue levels to just 36–48× plasma, representing reductions of up to 67-fold. The company stated that this shift may improve tolerability, maintain the drug’s intrinsic metabolic profile, and provide more consistent systemic exposure. To view the full press release, visit https://ibn.fm/dVPuX About Oncotelic Therapeutics Inc. Oncotelic Therapeutics…

Continue Reading

WednesdayDec 03, 2025 11:45 am

BioMedNewsBreaks – Lantern Pharma (NASDAQ: LTRN) Details Encouraging LP-184 Phase 1a Results Showing Durable Disease Control in Advanced Solid Tumors

Lantern Pharma (NASDAQ: LTRN), a clinical-stage biotechnology company using artificial intelligence and genomics to transform oncology drug development, reported additional details and clinical insights from its completed Phase 1a dose-escalation study of LP-184 along with highlights from a recent webinar. The study in 63 heavily pre-treated patients with advanced solid tumors met all primary endpoints for safety and tolerability and established a clear recommended Phase 2 dose. Encouraging signals of durable disease control were observed, particularly in tumors with DNA damage repair pathway deficiencies. Building on these results, Lantern is advancing multiple biomarker-guided Phase 1b/2 trials across triple-negative breast cancer,…

Continue Reading

WednesdayDec 03, 2025 10:10 am

BioMedNewsBreaks – Soligenix Inc. (NASDAQ: SNGX) Featured in BioMedWire Editorial Highlighting HyBryte(TM) and Rare Disease Policy

Soligenix (NASDAQ: SNGX) was featured in a BioMedWire editorial titled “Chronic Rare Diseases in an Aging America: Why HyBryte and Federal Policy Matter Now,” which examines the growing burden of rare diseases affecting more than 30 million Americans and the urgent need for new therapies. The article spotlights Soligenix’s late-stage development of HyBryte(TM) (synthetic hypericin) for cutaneous T-cell lymphoma, now in its final confirmatory study before worldwide marketing submissions, and places the Company’s efforts at the intersection of advancing treatment options and emerging national health policy initiatives. To view the full press release, visit https://ibn.fm/P6erx About Soligenix Soligenix is a…

Continue Reading

WednesdayDec 03, 2025 9:15 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Amends IND to Advance NRX-101 With TMS for Depression Treatment

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said it amended its Investigational New Drug filing for NRX-101 to include use of the drug in combination with Transcranial Magnetic Stimulation for depression, including suicidal depression. The update follows evidence suggesting NRX-101 may significantly enhance TMS outcomes, with published studies showing more than two-fold improvements in symptom reduction and clinical response rates exceeding 80%. The Company noted NRX-101’s D-cycloserine component appears to augment neuroplasticity associated with TMS, while its low-dose lurasidone is intended to mitigate D-cycloserine’s known risk of low-grade hallucinations. NRx said it aims to validate the findings in a…

Continue Reading

TuesdayDec 02, 2025 9:50 am

BioMedNewsBreaks – HealthLynked Corp. (OTCQB: HLYK) Adds Insurance and Employer-Benefits Leaders Chris Pulos and Jason Bishara to Board

HealthLynked (OTCQB: HLYK), an AI-driven global healthcare network focused on improving care coordination and reducing costs, appointed Chris G. Pulos of Marsh McLennan Agency and Jason Bishara of NSI Insurance Group to its Board. The Company said the additions bring decades of experience in employer benefits, payer strategy, insurance and risk management as HealthLynked expands collaborations with insurers, employer groups and healthcare organizations. Founder and CEO Dr. Michael Dent said their expertise will support national scaling of the HealthLynked Network and its AI platform, ARI, while strengthening governance ahead of a planned Nasdaq Capital Market listing. To view the full…

Continue Reading

TuesdayDec 02, 2025 9:30 am

BioMedNewsBreaks – Oncotelic Therapeutics, Inc. (OTCQB: OTLC) JV Sapu Nano Presents Data Showing Deciparticle Platform Supports Broad Hydrophobic Drug Formulation

Oncotelic Therapeutics (OTCQB: OTLC) said its 45%-owned joint venture, Sapu Nano, reported new data at the 2025 San Antonio Breast Cancer Symposium showing that its Deciparticle(TM) nanomedicine platform can consistently formulate structurally diverse hydrophobic therapeutics—including macrolide mTOR inhibitors, cyclic and linear peptides, ascomycin macrolactams and polyketides—into sub-20 nm nanoparticles suitable for IV delivery. The Company said the findings confirm Deciparticle as a versatile, cGMP-ready delivery platform backed by ISO-5 manufacturing capabilities that support rapid translation to Phase 1 supply. CEO Dr. Vuong Trieu said the results position Deciparticle as a modular engine for multiple oncology, immunology and peptide drug candidates,…

Continue Reading

TuesdayDec 02, 2025 9:20 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Announces FDA Receipt of ANDA for KETAFREE With July 2026 Review Goal Date

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said the FDA has received its Abbreviated New Drug Application for KETAFREE(TM), a preservative-free intravenous ketamine formulation, deeming the submission “substantially complete” and assigning a July 29, 2026 review goal date. CEO Jonathan Javitt said KETAFREE is designed to provide a single-patient, preservative-free alternative to current multidose ketamine vials that contain Benzethonium Chloride, a compound no longer recognized as safe by the FDA. The Company said KETAFREE aligns with MAHA initiatives to remove toxic substances from medicines and supports domestic supply-chain priorities, with potential 2026 approved drug sales if approved on schedule.…

Continue Reading

TuesdayDec 02, 2025 9:10 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Schedules Corporate Update Call for Dec. 2

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said it will host a corporate update conference call on Dec. 2, 2025, at 9 a.m. Eastern to review recent clinical, regulatory and operational developments. To view the full press release, visit https://ibn.fm/ZSIqm About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal…

Continue Reading

MondayDec 01, 2025 9:50 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Present at NobleCon21

NRx Pharmaceuticals (NASDAQ: NRXP) said Founder, Chairman and CEO Jonathan Javitt, M.D., M.P.H., will present at NobleCon21 on Dec. 3 at 4:30 p.m. EST, offering an update on the company’s expanded focus in investigational drugs, medical devices, and interventional psychiatric therapies for suicidal depression, PTSD, and related conditions, as well as progress in generating clinical revenue since NobleCon 2024. To view the full press release, visit https://ibn.fm/4Gi6M About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain,…

Continue Reading

MondayDec 01, 2025 9:15 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Outlines Regulatory Strategy After NSE Decision on ECG Synthesis Software

HeartBeam (NASDAQ: BEAT), a medical technology company developing personalized cardiac-care insights, detailed its strategy following receipt of a Not Substantially Equivalent decision for its 510(k) submission covering its 12-lead ECG Synthesis Software. The Company has been in active discussions with FDA review staff, which have signaled willingness to work toward a constructive resolution. HeartBeam said its VALID-ECG clinical study met endpoints and that remaining FDA concerns may be resolved through revised labeling. To advance the process, the Company plans to pursue multiple parallel paths—including a formal appeal or a 510(k) resubmission—and believes recent interactions indicate a viable path forward under…

Continue Reading