|Clinical and Regulatory|
This event is set for a specific date and makes planning easier. However, specific dates may change.
|Disease and Treatment|
|Indication:||Metastatic Castration-Resistant Prostate Cancer|
|Treatment Name:||XTANDI(R) (enzalutamide)|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
Detailed Event Description from Company Announcement
FDA Accepts for Review Supplemental New Drug Application for XTANDI(R) (enzalutamide) Capsules in Metastatic Castration-Resistant Prostate Cancer With Data From Head-to-Head Studies of Enzalutamide Versus Bicalutamide
SAN FRANCISCO, CA and TOKYO, JAPAN -- (Marketwired) -- 02/22/16 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI® (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.