NANJING, China — Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) today announced the successful completion of patient enrollment in the ongoing single-arm, pivotal registrational clinical trial (CTR20213023) for Opamtistomig (LBL-024), a novel PD-L1/4-1BB bispecific antibody. This marks the world’s first registrational clinical trial evaluating an immunotherapy monotherapy for...
treatment News
SOMERSET, N.J. — Legend Biotech Co. (NASDAQ: LEGN), a global leader in cell therapy, announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expansion of the CARVYKTI® label to include adult patients with relapsed and refractory multiple myeloma, who have...
SOMERSET, N.J. – Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of ciltacabtagene...
STOCKHOLM, Sweden — BioArctic AB’s partner Eisai announced today that Leqembi® (brand name in China: “乐意保”, generic name: lecanemab-irmb) has been approved in China as a treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. China is the third country to grant marketing approval,...
NEW YORK, NY — Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced that the U.S. Food and Drug administration (FDA) has granted Breakthrough Therapy designation to LX2006 based on clinical evidence generated on both cardiac and neurologic...
NEW YORK, NY — Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced updates to key components of an Accelerated Approval pathway for LX2006 in Friedreich ataxia (FA) cardiomyopathy, alongside new interim clinical data from ongoing Phase I/II...
NEW YORK, NY — Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced positive interim data across all dose cohorts of LX2006 for the treatment of Friedreich’s ataxia (FA) cardiomyopathy. In both the Lexeo-sponsored SUNRISE-FA Phase 1/2 clinical...
NEW YORK, NY — LEXEO Therapeutics Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to LX2006, the company’s AAVrh.10hFXN-based gene therapy candidate...
THE WOODLANDS, Texas – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney...
TARRYTOWN, N.Y. — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has approved the PD-1 inhibitor Libtayo® (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. This expands the existing European Union (EU) indication for Libtayo in advanced CSCC...