Vera Therapeutics is on course to gain full approval of Trutakna (atacicept-vymj) after announcing Tuesday that the drug met all prespecified endpoints at the final efficacy analysis of the Phase III ORIGIN 3 trial in adults with primary IgA nephropathy (IgAN) at risk for disease progression. The news sent company shares up nearly 15% in premarket trading. Trutakna, designed to simultaneously block BAFF and APRIL, gained accelerated FDA approval in July to reduce proteinuria in adults with prim

Ivonescimab Reduced the Risk of Death by 27% Compared to Pembrolizumab HARMONi-2 Demonstrated an Improvement in Median Overall Survival of 8.2 Months PD-L1 High Expression Subgroup: Hazard Ratio = 0.58 Summit is Conducting Global Phase III HARMONi-7 Study in Patients with PD-L1 High-Expressing NSCLC Summit Therapeutics Inc. (NASDAQ: SMMT) today noted that its partner Akeso Inc. announced that updated data, including overall survival (OS), from the randomized, double-blind Phase III HARMONi-2 tr

Sept. 14, 2026 -- Sapience Therapeutics, Inc., a clinical-stage biotechnology company dedicated to developing first-in-class peptide therapeutics targeting the underlying oncogenic and immune mechanisms driving cancer and pre-cancerous disease, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company an Investigational New Drug (IND) application for ST316 (IND 184073) for the treatment of familial adenomatous polyposis (FAP), a rare inherited disorder associated w

The ink was barely dry on the FDA approval letter for AstraZeneca’s Etcamah before the oral SERD suffered a key clinical setback. Etcamah failed to significantly improve patients’ time before tumor progression or death compared with the aromatase inhibitor anastrozole for the first-line treatment of ER-positive, HER2-negative breast cancer, AZ said Friday. The readout comes from the Serena-4 phase 3 trial, in which all patients also received Pfizer’s CDK4/6 inhibitor Ibrance. AZ noted a numeri

IND clearance further expands development of C-CAR168 across chronic autoimmune diseases with significant unmet medical need Sept. 14, 2026 -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to initiate a P

Designation is driven by compelling Phase 2 clinical data in patients with complicated Staphylococcus aureus bacteremia showing AP-SA02 may offer substantial improvement over available therapies Potentially accelerating the path to market for this innovative antibacterial treatment AP-SA02 now holds Breakthrough Therapy, Fast Track and QIDP designations, providing strong regulatory validation Sept. 14, 2026 -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a lat

FDA approval expands Joenja indication to include children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) ages 4 to 11 who weigh at least 27kg Newly approved Joenja doses are expected to be available in October September 11, 2026: Pharming (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune and genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (

Sept. 11, 2026 -- PerZeption Inc. has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Eye Institute (NEI) for the project "Efficient Achromatic and Chromatic Photostress Recovery Assessment for Age-related Macular Degeneration." The study will be performed in collaboration with researchers at the Brunson Center for Translational Vision Research at the University of California, Irvine. How quickly vision recovers after bright light exposure is a sensitive

The U.S. FDA has granted Orphan Drug Designation for asedebart (Lu AG13909), Lundbeck's novel investigational anti-ACTH monoclonal antibody, for the treatment of endogenous Cushing's syndrome Endogenous Cushing's Syndrome is a rare endocrine disorder driven in most cases by excess adrenocorticotropic hormone, or ACTH, leading to chronic cortisol excess and substantial disease burden, with current treatment options often limited by suboptimal disease control and treatment-related complications 1–

First two patients dosed in the EXACT study Topline data from the initial 16-week placebo-controlled portion of the study expected mid-2027; final readout expected by the end of 2027 Sept. 11, 2026 -- Eloxx Pharmaceuticals, Inc. (Nasdaq: ELOX), a clinical-stage biopharmaceutical company developing exaluren for the treatment of rare kidney diseases, today announced that the first two patients have been dosed in the EXACT Study, a Phase 2b clinical trial evaluating exaluren in patients with nonse