Eli Lilly has announced positive results of its Phase 3 study, showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease. Based on these results, Lilly will proceed with global regulatory submissions as quickly as possible and anticipates making a submission to the FDA this quarter. Lilly will work with the FDA and […]

Cambridge-based Convergent Therapeutics has completed a $90 million Series A financing that will support development of a pipeline of novel radioantibodies, including its lead program with CONV01-α for the treatment of advanced prostate cancer. Convergent is a clinical-stage biotech focused on developing next-generation radiopharmaceutical therapies for prostate and other cancers. “While considerable progress has been made in […]

Sarepta Therapeutics has announced that the FDA Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in support of accelerated approval of SRP-9001, a gene transfer therapy for treatment of patients with a form of Duchenne muscular dystrophy (DMD). The committee’s vote, while not binding, will be considered by the FDA when making its decision […]

Cambridge-based Seres Therapeutics and Nestlé Health Science have announced FDA approval of Vowst, an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). Vowst was previously granted Breakthrough Therapy and Orphan Drug Designations by the FDA. Recurrent CDI represents significant unmet need and is a leading cause […]

RNA medicines developer Orbital Therapeutics has announced the successful closing of $270 million Series A financing. Orbital Therapeutics is focused on expanding the applicability of RNA-based medicines across a range of human diseases, including in the areas of next-generation vaccines, immunomodulation, and protein replacement. “Few companies can possess the know-how, technology and biologic insights to […]

The FDA has granted Biogen conditional approval for antisense oligonucleotide Qalsody (tofersen) for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the SOD1 (superoxide dismutase 1) gene, producing a rare, hereditary form of the disease. Qalsody is the first approved treatment to target a genetic cause of ALS. Tofersen was […]