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

Phase 1 study of PRT13722 in patients with HR+ breast cancer anticipated to begin enrolling patients in the fourth quarter of 2026. Sept. 10, 2026 -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company to proceed with a Phase 1 study under its Investigational New Drug Application (IND) for PRT13722, an oral KAT6A selective degrader being developed for the treatment of patients with H

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

Porustobart, a second-generation Fc-enhanced CTLA-4 antibody, is being advanced across two clinical indications in the neoadjuvant setting, beginning with MSS clinical stage II-III colon cancer Phase 2 trial of porustobart for colon cancer will be open for enrollment early in the fourth quarter of 2026 Financing led by RA Capital Management, joined by Canaan Partners, Forbion, and other investors Sept. 09, 2026 -- Solstice Oncology, a clinical-stage immuno-oncology company focused on treating c

First presentation of pivotal Phase 3 CAPLYTA ® data in adults with bipolar mania underscores the asset's potential across mood disorders New SPRAVATO ® analyses and schizophrenia research emphasize a focus on complex, high-burden neuropsychiatric conditions Sept. 8, 2026 -- Johnson & Johnson (NYSE: JNJ) today announced that 24 abstracts featuring clinical data and real-world evidence across the neuropsychiatry portfolio will be presented at the 2026 Psych Congress Annual Meeting (September 15-

Collaboration combines Rose Pharma investigational rapid-acting GLP-1 receptor agonist with MannKind’s Technosphere ® inhalation technology MannKind to receive an equity interest and potential royalties while providing pharmaceutical development and manufacturing support through completion of a Phase 1b clinical study Sept. 09, 2026 -- MannKind Corporation (Nasdaq: MNKD), a biopharmaceutical company focused on developing innovative, patient-centric therapies for chronic diseases, and Rose Pharm