Cesalatamig is Currently Being Evaluated in Phase 1/2 Studies in the United States (NCT06635785) and in China (CTR20253261) Fast Track Designation Supports Expedited Development of Cesalatamig for Non-small Cell Lung Cancer (NSCLC) that Progressed after Concurrent or Sequential PD-(L)1-targeted Immunotherapy and Platinum-based Chemotherapy Sept. 16, 2026 -- OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, today an

— IASO208 is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance — Supported by early clinical data from an investigator-initiated trial in China, IASO208 is expected to advance directly into a Phase 1b clinical study in the United States for relapsed/refractory B-cell non-Hodgkin lymphoma Sept. 16, 2026 -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and comm

NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM PDUFA target action date set for June 29, 2027 Sept. 15, 2026 --- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bezuclasti

Sept. 15, 2026 -- Xylo Bio, a clinical-stage biotechnology company developing novel neurotherapeutics for psychiatric and neurological disorders, today announced the first participants dosed in its Phase 1 clinical study of XYL-1001, a novel, selective 5-HT2A agonist being developed for major depressive disorder (MDD). The randomized, double-blind, placebo-controlled Phase 1 study is being conducted in Australia and is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmac

ENA Respiratory Begins Part B Dosing in INNA-051 Phase IIa Community Study Designed to Protect Against Symptomatic Viral Respiratory Infections Sept. 15, 2026 -- ENA Respiratory, a clinical-stage pharmaceutical company developing host defence enhancers for the prevention of complications associated with respiratory viral infections in at-risk populations, today announces it has dosed the first participants in Part B of its Phase IIa community study of INNA-051. INNA-051 is a virus-agnostic, o

Study informed by encouraging exploratory efficacy findings and a favorable safety profile in the prior Phase 3 trial Approximately 120 participants with severe postpartum depression (PPD) planned; first participant dosing expected in early Q4 2026 Company expects existing resources to support BLOOM Sept. 14, 2026 -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of novel oral therapeutics, today announced the initiation of BLOOM, a Phase 3 study eva

Sept. 14, 2026 -- Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) , a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, today announced that a preclinical research paper evaluating the combination of ATG-037 (CD73 Small Molecule Inhibitor) and selinexor for the treatment of multiple myeloma

Long-term pooled data from the pivotal TRUST-I and TRUST-II studies showed similar efficacy, including duration of response and progression-free survival, between CD74 and non-CD74 ROS1 fusion-partner subgroups Among patients who received IBTROZI after prior chemotherapy, response rates remained consistent, offering reassurance for patients who begin chemotherapy before a ROS1 fusion is identified Sept. 15, 2026 -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling so

RYBREVANT plus chemotherapy demonstrates durable benefit with a differentiated approach that dual-targets EGFR and MET Results mark significant progress for a patient population with poor outcomes and a historical five-year survival rate of just 8% Sept. 13, 2026 -- Johnson & Johnson (NYSE: JNJ) today announced results from the final overall survival (OS) analysis of the Phase 3 PAPILLON study evaluating first-line intravenous (IV) RYBREVANT (amivantamab-vmjw) plus carboplatin-pemetrexed chemot

The fifteen-month dataset represents the final analysis from the Phase 1/2 study At the Month 15 primary timepoint, SKY-0515-treated patients showed a +1.59-point difference in Composite Unified Huntington's Disease Rating Scale (cUHDRS) change from baseline versus overlap-weighted external natural history control Differences favoring SKY-0515 were statistically significant across all four cUHDRS components – Total Functional Capacity, Total Motor Score, Symbol Digit Modalities Test and Stroop W