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–

Solstice Oncology has secured $225 million in series A funds to advance a next-gen immunotherapy that the biotech hopes will turn “darkness to light” for cancer care. The company licensed the Fc-enhanced cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, called porustobart, from China's Harbour BioMed back when Boston-based Solstice was founded in February. In return for a $105 million upfront package, Solstice can develop and commercialize the drug outside of China and has already

Sept. 09, 2026 -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today announced the achievement of a milestone in its ongoing collaboration and license agreement with Exelixis, Inc. (“Exelixis”). The milestone achievement is related to a preclinical milestone event for XB404 and resulted in a $2.0 million milestone payment from Exelixis. XB404, built with Adagene’s SA

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

Sept. 9, 2026 -- Insilico Medicine ("Insilico," HKEX: 3696), a clinical-stage biotechnology company powered by generative AI, today announced that it has dosed the first patient with Rentosertib (known as ISM001-055 / INS018_055) in GENESIS-IPF-3, a Phase III clinical trial (NCT07687459, CTR20262475) at Peking Union Medical College Hospital, while Shanghai Pulmonary Hospital has also enrolled its first patient on the same day. The Phase III clinical trial is a prospective, multi-center, randomi

If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated disease) Filing acceptance is based on the Phase III METEOROID study showing that Enspryng reduced the risk of relapses by 68% MOGAD is a rare disease of the central nervous system characterized by unpredictable attacks of the optic nerves, spinal cord or brain Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the