BioCentury
ARTICLE | Product Development

Oct. 19 Quick Takes: Tymlos, vonoprazan and Tyvyt meet in Phase III

Plus Orexia, LogicBio, Esperion, MilliporeSigma and Intrivo

October 20, 2021 12:36 AM UTC

A trio of companies disclosed positive Phase III data, setting up two of the biotechs to begin readying regulatory submissions. 

Radius Health Inc. (NASDAQ:RDUS) will submit an sNDA in 1Q22 for Tymlos abaloparatide after the parathyroid hormone-related protein analog met its primary and secondary endpoints in a Phase III study of osteoporosis in men. FDA approved the therapy for high-risk postmenopausal women with osteoporosis in 2017; CHMP recommended against its approval the following year. ...