Why Agios Pharmaceuticals Stock Is Up More Than 21% Today

Drugmaker Agios Pharmaceuticals (NASDAQ: AGIO) is positioning to win the FDA's approval of its mitapivat as a treatment for sickle cell disease sooner than investors may have been expecting.That's the overarching takeaway from this morning's press release anyway. As it explains, Agios' recent meeting with the U.S. Food and Drug Administration laid the groundwork for the "submission of a proposal for a confirmatory clinical trial to support U.S. accelerated approval of mitapivat." The company's already submitted the proposal for this abbreviated trial, in fact, and expects to submit its request for accelerated full approval to the FDA within the next few months.Agios Pharmaceuticals' oral pyruvate kinase (PK) activator mitapivat is proving to be a capable multipurpose therapy. Already approved to treat several forms of anemia, the drug has also performed well in the company's so-called RISE UP trials as a treatment for sickle cell disease ... a relatively rare disease with a limited number of effective treatment options. The drug performed so well, in fact, that the company's looking for somewhat special regulatory treatment of mitapivat when used for this particular purpose.Continue readingWeiter zum vollständigen Artikel bei MotleyFool Weiter zum vollständigen Artikel bei MotleyFool