EPZM, MDVN On Watch, MYGN In Legal Spat With BRLI, ONVO's 3D Story Gets Better

Avanir Pharmaceuticals Inc. (AVNR: Quote) has enrolled the first patient in a phase II study of AVP-923 in the treatment of Levodopa induced dyskinesia in patients with Parkinson's disease. Top line data for this study is expected in the second half of calendar 2014.

AVNR closed Tuesday's trading at $4.50, up 0.67.

Cubist Pharmaceuticals Inc. (CBST: Quote) has submitted a New Drug Application to the FDA for approval of its investigational antibiotic Tedizolid phosphate in the indication of acute bacterial skin and skin structure infections.

Tedizolid phosphate is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

CBST closed Tuesday's trading at $66.19, up 3.84%.

Epizyme Inc. (EPZM: Quote) expects top-line data from its phase I study of EPZ-5676 in the fourth quarter of 2013. EPZ-5676 is being evaluated in patients with advanced hematologic malignancies.

Medivation Inc. (MDVN: Quote) and Astellas Pharma Inc announced that the global phase III trial, dubbed PREVAIL, evaluating the prostate cancer drug XTANDI (enzalutamide) in men with metastatic prostate cancer that has progressed despite androgen deprivation therapy and who have not yet received chemotherapy, will be stopped early as the trial has met both co-primary endpoints of overall survival and radiographic progression-free survival.

XTANDI is already approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel, i.e., post-chemo indication, in the U.S., European Union, Canada and South Korea.

Medivation and Astellas will initiate meetings with and submissions to regulatory agencies for XTANDI for the pre-chemo indication beginning in early 2014.

In Q2, 2013, the U.S. net sales of XTANDI (enzalutamide) were $82.4 million while ex-U.S. net sales were $3.7 million, as reported by Astellas. For the full year 2013, U.S. net sales of XTANDI are expected to be in the range of $345-365 million.

Read the original here:
EPZM, MDVN On Watch, MYGN In Legal Spat With BRLI, ONVO's 3D Story Gets Better