Shares of Medivation (MDVN) were halted at 2:48 p.m. today while up 2.7% at $96.89. The reason for the halt: Medivation’s Xtandi was approved for use in “pre-chemo metastatic castration-resistant prostate cancer” by the FDA.
Citigroup’s Yaron Werber explains the significance:
Overall the updated Xtandi label is in-line with expectations and is now better than the Zytiga label. The new indication is for the treatment of patients with metastatic castration-resistant prostate cancer which is the same as the Zytiga indication and encompasses the pre-chemo and post-chemo segments. In the clinical section of the label the statistically significant improvement in overall survival from PREVAIL is included, compared to the Zytiga label which states the analysis of overall survival did not meet statistical significance.
We Continue To Like Stock Into TERRAIN and Breast Cancer Data─ The risk/reward is positive for TERRAIN with data at YE:14 or early '15. Recall, there was no interim analysis and the study enrolled M1 patients so PFS should be roughly similar to the 16 months that was in PREVAIL (also an M1 population). In addition, breast cancer is upside to expectations in our view and we expect ph2a Xtandi data in AR+ TNBC at SABCS in December.
Shares of Medivation have gained 1.6% to $98.46 at 5:07 p.m. in after-hours trading.
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