Travere Therapeutics Inc. submitted a New Drug Application to the U.S. Food and Drug Administration under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy (IgAN).
Shares of Calliditas Therapeutics soared in trading after the company announced positive Phase III data from a study of Nefecon in IgA nephropatjhy (IgAN), an autoimmune renal disease.
As Rigel Pharmaceuticals awaits a regulatory decision for Tavalisse (fostamatinib) for a platelet disorder, the company reported a developmental setback for the therapy in another clinical trial.