Phase 2 EMBRAZE proof-of-concept trial designed to assess apitegromab's ability to safely preserve lean muscle mass in individuals on GLP-1 receptor agonist therapy for obesity New preclinical head-to-head comparison shows that SRK-439 is more potent than an anti-ActRII antibody in maintaining lean mass in diet-induced obesity (DIO) mice; lean mass loss with SRK-439, 1mg/kg dose was equivalent to anti-ActRII antibody, 20mg/kg dose Company hosting Investor Event today in New York City focusing on its selective latent myostatin inhibition programs in Spinal Muscular Atrophy and obesity with pr ..read more

This is the first compound in Zai’s portfolio of internally developed drugs to advance into Phase 2, demonstrating Zai’s global capabilities Based on a proof-of-concept study, ZL-1102 is the first topical biologic to show penetration of psoriatic skin resulting in a clinical response SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the first patient has been dosed in a global Phase 2 clinical trial (NCT06380907) evaluating the efficacy and safety of the company’s internally developed anti-IL-17 investigational therapy, ZL-1102 ..read more

NILEMDO®▼ (bempedoic acid), a first-in-class, oral treatment and NUSTENDI®▼ (bempedoic acid / ezetimibe fixed-dose combination) receive label update approval from the European Commission as treatments to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels1,2 This makes bempedoic acid the first and only LDL-C-lowering treatment indicated for primary and secondary prevention of cardiovascular events Up to 80% of patients do not reach guideline-recommended LDL-C goals despite receiving treatments such as statins and remain at an increased risk of a heart at ..read more

CAMBRIDGE, Mass.--(BUSINESS WIRE)--VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation at ASCO will provide an update to the encouraging data previously sha ..read more

SAN FRANCISCO--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (“Tivic Health”, Nasdaq: TIVC), a health tech company that develops and commercializes bioelectronic medicine, announced today it has initiated the second phase of its clinical work to advance its novel non-invasive cervical vagus nerve stimulation (“ncVNS”). The company has entered into a collaboration agreement with The Feinstein Institutes for Medical Research at Northwell Health to optimize its ncVNS device therapy for use in specific clinical indications. Tivic Health will conduct a second 20-person clinical trial in collabor ..read more

Updated Prescription Drug User Fee Act (PDUFA) goal date of December 29, 2024 PRINCETON, N.J.--(BUSINESS WIRE)--$BMY #CheckMate--Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as “subcutaneous nivolumab”) across all previously approved adult, solid tumor O ..read more

Persons with Lived Experience Session Expanded to Include Michaela & Kyle Devins Clinical Session Expanded to Include Neuralink Preclinical Session Expanded to Include Axonis, Novoron, Sania & Rewire Medical   CARLSBAD, Calif.--(BUSINESS WIRE)--$LCTX #LineageCellTherapeutics--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced updates to its 2nd Annual Spinal Cord Injury Investor Symposium ("2nd SCIIS"). The 2nd SCIIS aims to accelerate development ..read more

Highly differentiated Cell Therapy in Phase 1 Trial for Lymphoma and Multiple Myeloma HOUSTON & SEATTLE--(BUSINESS WIRE)--Indapta Therapeutics, Inc., a privately held biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and autoimmune diseases, today announced that Cancer Prevention and Research Institute of Texas (CPRIT) has granted the company a competitive product development research award. The $4.5 million grant will support Indapta’s ongoing clinical development of its lead product, IDP-023, for patients with advanced non-Hodgkin ..read more

The Accelerating Medicines Partnership® in Amyotrophic Lateral Sclerosis (AMP® ALS) will create the largest open data platform for ALS research Partnership will enable discovery and development of diagnostic tools, biomarkers, and better treatments NORTH BETHESDA, Md.--(BUSINESS WIRE)--The Foundation for the National Institutes of Health (FNIH) announces the launch of a public-private partnership to build the largest data source for amyotrophic lateral sclerosis (ALS) and expedite the identification of biomarkers and clinical outcome assessments that would allow earlier diagnosis and accele ..read more

– Enrollment completed within planned timeframe of 14 months – – IGV-001 granted Fast Track designation by U.S. FDA – – $35 million financing completed in 2024 to fund operations beyond expected Phase 2b data readout in mid-2025 – PHILADELPHIA--(BUSINESS WIRE)--Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, today announced the completion of enrollment in its randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM). IGV-001 is derived from ..read more