Eli Lilly and Cambridge-based Sigilon Therapeutics have announced that Lilly will acquire Sigilon in a transaction worth up to $310 million. The transaction is expected to close in the third quarter of 2023, subject to customary closing conditions. Since 2018, Lilly and Sigilon have worked together to develop encapsulated cell therapies, including SIG-002, for the treatment of […]

The FDA has granted full approval to Leqembi, the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD). According to Eisai, which developed the drug with Biogen, Leqembi could generate $7 billion in annual sales globally by 2030. […]

Sarepta Therapeutics has announced FDA accelerated approval of its Elevidys gene therapy for the treatment of children aged 4 through 5 years with Duchenne muscular dystrophy (DMD) and a confirmed mutation in the dystrophin gene. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Elevidys is intended to treat […]

Bluebird Bio has announced that the FDA has accepted the Biologics License Application (BLA) for lovo-cel for priority review. Lovo-cel is a one-time gene therapy for individuals living with sickle cell disease (SCD). It is specifically designed to treat the underlying cause of SCD through the addition of a functional gene that enables production of […]

RNA medicines biotech ReNAgade Therapeutics has raised $300 million in a Series A financing round led by MPM BioImpact and F2 Ventures. ReNAgade has built a comprehensive and complementary platform that combines its proprietary delivery technologies, including novel lipid nanoparticles (LNPs), with a broad array of coding, editing, and gene insertion tools, in an all-RNA […]

Biogen and partner Eisai have announced that the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that the data from Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease (AD). Additionally, the committee members confirmed the overall benefit-risk profile of Leqembi, the […]