Dec. 15, 2025 -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class 1 resubmission and as a result, the new Prescription Drug User Fee Act (PDUFA) target

- Orelabrutinib is the first BTK inhibitor to demonstrate significant clinical activity in a Phase 2 clinical trial for SLE - - Zenas acquired the exclusive right to develop, manufacture and commercialize orelabrutinib in the field of Multiple Sclerosis globally, and non-oncology fields in all territories outside Greater China and Southeast Asia, in October 2025 license agreement with InnoCare - Dec. 15, 2025 -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO

IND submitted for ABP-102/CT-P72, a HER2 × CD3 T cell engager, with preclinical studies demonstrating enhanced HER2-high tumor selectivity and a favorable safety profile ABP-102/CT-P72 represents Abpro’s first IND submission for a phase 1 trial in a solid tumor indication, and is being co-developed by Abpro and Celltrion, Inc. Dec. 15, 2025 -- Abpro Holdings, Inc. (Nasdaq: ABP, “Abpro”), a biotechnology company developing novel breakthrough therapeutics for solid tumors, together with its co-

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