Following hot on the heels of FDA approval for the Biogen/Eisai Alzheimer’s drug Leqembi, Eli Lilly presented results from its Phase 3 study of donanemab which showed that the drug significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s. The data were shared at the 2023 Alzheimer’s Association International Conference as a featured […]

Cambridge-based Korro Bio and Lexington’s Frequency Therapeutics have agreed to combine the companies in an all-stock transaction. The combined company will focus on the advancement of Korro Bio’s portfolio of RNA editing programs under the name Korro Bio, Inc. and will apply to trade on Nasdaq. In addition, Korro Bio has secured commitments from a […]

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 […]