Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis PERSEUS phase 3 study in primary progressive multiple sclerosis did not meet its primary endpoint in delaying time to onset of 6-month composite confirmed disability progression compared to placebo The safety profile of tolebrutinib was consistent with previous studies December 15, 2025. Results from the PERSEUS phase 3 study (clinical study identifier: NCT04458051) showed that tolebrutinib did not meet its primary

Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds. Orphan Drug and Fast Track designations from the FDA Dec. 11, 2025 -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today

Financing led by 5AM Ventures, OrbiMed, and Monograph Capital to drive development of a broad portfolio of proprietary obesity programs with potential for monthly and quarterly dosing; Founder Daniel Santi, M.D., Ph.D., transitions to Chief Technical and Scientific Officer role Dec. 11, 2025 -- Prolynx, a biotechnology company developing a next-generation portfolio of ultra-long-acting medicines for obesity and related metabolic conditions, today announced the closing of a $70 million Series A

Final Decision from European Commission Expected in Q1 2026 Dec. 12, 2025 -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardi

Efficacy data remain consistent with previous disclosures, showing 10.3-month median PFS in all patients and 11.4-month median PFS in 2L patients Subset analyses show broad activity in patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer, regardless of prior fulvestrant or other SERD exposure, or ESR1 mutation status Phase 3 ReDiscover-2 trial in CDK4/6-experienced breast cancer ongoing Dec. 12, 2025 -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precis

Key milestone achieved as Company advances clinical program to full approval trial of ateganosine sequenced with a checkpoint inhibitor in comparison to chemotherapy Dec. 11, 2025 -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the first patient has been dosed in the Company’s THIO-104 Phase 3 pivotal trial evaluating the efficacy of ateganosine

Phase 1 Clinical Trial Met All Primary and Secondary Endpoints and Demonstrated Positive Safety, Pharmacokinetics, and Mechanistic Validation Clinical Data Build Upon Robust Preclinical Activity Seen in Multiple Models of Inflammatory Disease Novel Approach Addresses Inflammation Driven by Monocytes and Neutrophils, Key Drivers in Many Auto-Inflammatory and Auto-Immune Diseases Phase 2 Study in Behçet's Disease, an Orphan Inflammatory Indication Selected for Initial Proof-Of-Concept, to Start in

Dec. 11, 2025 -- Autobahn Labs (“Autobahn”), a venture studio focused on transforming high-potential academic science into investable drug discovery and development programs, announced today a strategic partnership with global life sciences company Astellas Pharma Inc. (“Astellas”). The collaboration seeks to advance academic research and discoveries into novel therapeutics, providing Astellas’ Innovation Lab and Oncology Research units with integrated visibility into promising platforms, techn

Study did not meet the primary or key secondary endpoint 45% reduction in hypoglycemia events observed at top ersodetug dose (10 mg/kg) compared to 40% improvement in placebo arm Management to host conference call today at 8:30am ET Dec. 11, 2025 -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced topline results from its Phase 3 sunRIZE study evaluating ersodetug in patien

Dec. 11, 2025 -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of the planned discussion with the FDA leading to the confirmation to file a New Drug Application (NDA) for relutrigine in early 2026. “We are very pleased with the collaborative dis