The treatment, ersodetug, is currently being tested on participants with congenital hyperinsulinism, a genetic disorder that causes low blood sugar.
Interim data from an early-stage study of its experimental combination treatment for breast cancer showed it meaningfully extended the time patients lived without their disease worsening.
Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.
With the regulator’s traditional green light in IgA nephropathy, Filspari is up against Novartis’ Fabhalta—which won accelerated approval last month—and Calliditas’ Tarpeyo, which was approved in December 2023.
The Waltham, Massachusetts-based company is developing its lead product candidate, obexelimab, for the treatment of several immunology and inflammation diseases including multiple sclerosis and systemic lupus erythematosus (SLE).
The British drugmaker GSK said on Friday that its asthma drug, Nucala, met the main goal of a late-stage study in treating patients with chronic obstructive pulmonary disease.