The top line results showed that the ELPIS II trial did not meet its primary endpoint of improvement in right ventricular ejection fraction (RVEF) at month 12, but there were exploratory clinical endpoints that the Company is continuing to analyze and plans to discuss with the FDA to determine a potential path forward in HLHS Laromestrocel has maintained what Longeveron believes is a favorable safety and tolerability pro with prior clinical trials, now with 644 patients treated across Longeveron

Sept. 17, 2026 -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that AK158D1, its investigational next-generation bispecific antibody-drug conjugate (ADC) targeting EGFR and TROP2, has secured Phase I clinical trial clearance from the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA). The trial will assess the candidate in patients with advanced malignant solid tumors. AK158D1 is Akeso's fourth ADC to enter clinical development and joins

Sept. 16, 2026 -- Prescription-only treatment gives clinicians a new way to treat eligible adults with moderate to severe major depressive disorder at home, either as a standalone treatment or alongside medication Flow Neuroscience today announced that FL-100 is now available by prescription across the United States, introducing the first FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for depression to the US market. FL-100 is intended for the treatment of modera

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