Applying Multimodal AI Analytics to Inform Patient Selection and Therapeutic Strategy in BRCA1/2-Mutated Breast Cancers BostonGene, developer of the leading AI model for tumor and immune biology, today announced an expansion of its scientific collaboration with Dana-Farber Cancer Institute to deepen the understanding of the complex biological mechanisms driving BRCA1- and BRCA2-associated breast cancers. The collaboration applies BostonGene’s foundation model of tumor and immune biology and mul

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

Payment follows approximately $5 million received in January 2026, bringing total cash proceeds received to approximately $11 million Company remains eligible for up to approximately $10 million in additional proceeds through future revenue earnouts Monetization of a strategic holding provides additional capital to advance Orchestra BioMed’s pivotal programs and reflects its approach to creating value through partnerships Sept. 15, 2026 -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchest

Novo’s attempted rebrand got off to a shaky start this week with the news that the pharma had walked away from a $285 million biobucks pact to develop a monthly weight loss drug after less than two years. The multi-pronged partnership , which was signed in November 2024, centered on using Ascendis’ TransCon platform to develop candidates in metabolic diseases like obesity and diabetes. The lead program was meant to be a once-monthly GLP-1 receptor agonist that was initially focused on both of t

Company's Cognitive Network Restoration Therapy (CNRT) technology aims to make meaningful cognitive recovery possible years after initial injury Targeting a brain hub involved in executive function, CNRT activates underperforming networks to reverse deficits and restore independence Groundbreaking therapeutic approach has the potential to transform chronic cognitive impairment care from rehabilitation to restoration Sept. 15, 2026 -- ReEmerge, Inc. (ReEmerge), a private MedTech company innovati

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