Biotech Values

[pcrutch]

ARIA and MRK get a standard (10-month) review for ridaforolimus in sarcoma. Not great news for Rida, IMO. 2 reasons: FDA gave it both fast-track and orphan drug designation. HR for OS must still be underwhelming

Merck (NYSE:MRK - News), known outside the United States and Canada as MSD, and ARIAD Pharmaceuticals, Inc., (NASDAQ:ARIA - News), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the New Drug Application (NDA) for ridaforolimus, an investigational oral mTOR inhibitor under development for the treatment of metastatic soft-tissue or bone sarcomas in patients who had a favorable response to chemotherapy. The FDA assigned a Standard review classification to this application.

Merck and ARIAD previously announced that the European Medicines Agency had accepted the marketing authorization application for ridaforolimus. As part of an exclusive license agreement with ARIAD, Merck is responsible for the development and worldwide commercialization of ridaforolimus in oncology. ARIAD intends to co-promote ridaforolimus in the United States.

http://finance.yahoo.com/news/FDA-Accepts-New-Drug-bw-2267542902.html?x=0&.v=1