The AI drug discovery company’s reorganization will include laying off around 180 employees and dropping its atopic dermatitis candidate BEN-2293 in an effort to save nearly $56 million.
The investigational kinase inhibitor failed to improve overall survival in the SAPPHIRE study of patients with non-squamous non-small cell lung cancer, causing Mirati to discontinue its development.
The FDA indicated it could potentially grant an accelerated approval for the therapy, called SRP-9001, initially for use in Duchenne patients aged 4 and 5.
The aim of the Lupus Nexus is to transform lupus research and drug development through unprecedented information exchange capabilities. The platform will provide a collaborative solution that is inclusive of diverse patient populations disproportionally affected by lupus.
Ex-FDA Neuroscience Director Billy Dunn was appointed to Prothena’s board of directors last week. Industry representatives and regulatory experts weigh in on the potential ethical implications.
Messenger RNA (mRNA)-based therapeutics have seen a boom in popularity in recent years, a space that has become increasingly competitive as pharma giants entered to produce COVID-19 vaccines and therapies that target a wider range of diseases.
Shares of Intercept Pharmaceuticals fell 16% on Monday over concerns about the prospects of the company’s drug to treat a type of fatty liver disease after the regulator’s advisory panel voted to defer an accelerated approval.
More than $5 billion poured into the longevity space in 2022, and experts say the science is now primed to make a real difference in extending human healthspan.
As part of the deal, Ironwood will acquire VectivBio’s experimental therapy apraglutide, which Ironwood says could reach $1 billion in peak net sales.
The company said it was discussing with major watchdogs across the world whether the trial results are substantial enough to support a regulatory review or whether that will require the results of another ongoing trial.