Oct. 27, 2025 -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the U.S. Food and Drug Administration (FDA) has granted rare pediatric drug designation (RPDD) for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG). Iopofosine I 131 is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid

Oct. 27, 2025 -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that the first patient has been dosed in a Phase I clinical trial of BMF-650, the Company’s investigational, next-generation oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”). BMF-650 is an orally administered, next-generation small molecule GLP-1 RA being developed by Biomea for the treatment of o

- Obexelimab met primary endpoint with a 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions compared with placebo, p=0.0009 Oct. 27, 2025 -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced positive results from the Phase 2 MoonStone tri

Results from pre-clinical studies demonstrate immunomodulatory activity of QEL-005 across multiple immune cell lineages involved in complex autoimmune inflammation, including B cells, T cells and inflammatory macrophages Broad mechanism of action of QEL-005 provides clear product differentiation compared to CAR-T and other B-cell depletion approaches, offering a potentially safer and better tolerated therapeutic option Data being presented supports CTA filings in Q4 ahead of initiating the CHILL

The formal safety review of Cohort 3 (5ug/kg/day) has been successfully completed with no safety or tolerability issues observed, allowing advancement into Cohort 4 with a dose of 10 ug/kg/day Actively screening patients for Cohort 4; anticipate initiation of dosing in the coming weeks Cohort 4 dose is potentially more reflective of the clinical efficacy threshold given positive trend in observations on multiple immunological biomarkers from the previous six patients in Cohorts 1 through 3, the

Achieves significant expansion of NeurAxis’ total addressable market Clearance now includes patients aged “8 years and older” Expanded age indication will utilize the upcoming January 1st, 2026, Category I CPT code to report PENFS procedures Oct. 24, 2025 -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced that it has

Anti-tumor activity was observed in heavily pretreated mCRPC patients across all dose cohorts; in 22 patients who completed at least 2 cycles of therapy, 59% achieved PSA50 response and 32% achieved PSA90 response All 5 patients (5/5) with measurable disease according to RECIST criteria achieved a partial response (PR), all by the first response assessment Results to date exhibit a favorable safety profile with low rates of treatment-related adverse events Oct. 24, 2025 -- Halda Therapeutics a

KYV-101 resulted in a profound reduction in disease-associated autoantibodies and impact on disease activity in patients with difficult-to-treat rheumatoid arthritis (RA) KYV-101 continues to demonstrate a well-tolerated profile, consistent with observations from 100 patients treated with KYV-101 to date1 Emerging IIT data in RA reinforce broad potential for KYV-101 in rheumatology indications Oct. 25, 2025 -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical compan

Sanofi’s efdoralprin alfa met all primary and key secondary endpoints in alpha-1 antitrypsin deficiency emphysema phase 2 study Efdoralprin alfa demonstrated superiority in a head-to-head study versus a standard of care plasma-derived therapy Results reinforce the potential of efdoralprin alfa to be the first restorative recombinant therapy that normalizes and maintains functional AAT levels Phase 2 data support both three-week and four-week dosing regimens for efdoralprin alfa - a potentially s

Cosentyx® (secukinumab) achieved statistically significant and clinically meaningful sustained remission vs placebo at Week 521 Trial showed reduction in annual cumulative steroid dose vs placebo through Week 52; safety profile consistent with known profile of Cosentyx1 Data highlight potential of Cosentyx as novel targeted PMR treatment, second most common inflammatory disease in adults ≥502, with limited options available October 22, 2025 – Novartis today announced that Cosentyx® (secukinumab