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

HCB101 represents the first known U.S. Expanded Access case for a SIRPα Fc fusion protein enabling continued therapy beyond the parent study Sept. 9, 2026 -- HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101- EA-001) as "safe to proceed". The FDA det

Financing led by the Angelini Lumira Biosciences Fund supports development of first-in-class medicines targeting neuronal hyperexcitability and expands Navion’s AI-enabled NaViGATion™ discovery platform Navion Neurosciences, Inc., a preclinical-stage biotechnology company developing next-generation, precision sodium channel therapeutics for neurological diseases, today announced the $10.8M first closing of a Seed financing, led by the Angelini Lumira Biosciences Fund with participation from 3B

Development program will support inhaled formulation development and device assessment for Aceso's ACT-101 candidate, reinforcing Aptar Pharma's upstream services capabilities in inhaled biologic development Aptar Pharma, a global leader in drug delivery, dosing, protection technologies and services, today announced a collaboration with Aceso Therapeutics, a biotech developing novel therapies for cystic fibrosis (CF), a rare genetic disease, to advance the development of ACT-101, an antisense o

The POLARIS-1 study enrolled 147 patients with uncontrolled, moderate-to-severe asthma, and the interim analysis was conducted on the first 98 patients. The analysis demonstrated a half-life of up to 75 days, with clinical effects consistent with twice-yearly dosing. SKB378/WIN378 produced significant and sustained effects on FEV1 (up to 174 mL mean increase, placebo-adjusted mean increases up to +256 mL, p=0.033), FeNO and blood eosinophils, key biomarkers that correlate with asthma exacerbati