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

(RTTNews) - Avanir Pharmaceuticals Inc. (AVNR) 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) 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) 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) 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.

Medivation has a global agreement in place with Astellas Pharma that was signed in October 2009 to develop and commercialize XTANDI.

MDVN closed Tuesday's trading at $53.89, up 8.17%.

Myriad Genetics Inc. (MYGN) has sued BioReference Laboratories Inc. (BRLI) alleging that OncoGeneDx, a comprehensive suite of genetic tests for inherited cancer, including testing for BRCA1/2, offered by Bio-Reference Labs' subsidiary GeneDx infringes on its intellectual property.

BioReference indicated that it is not surprised by the action and that it is confident in its position.

BRLI touched a new high of $33.45 on Tuesday before closing at $33.35, up 3.51% from the previous day's close.

Organovo Holdings Inc. (ONVO) said that its 3D liver tissues demonstrated retention of key liver functions for up to 40 days, longer than one month. The 3D liver tissues also exhibited dose-dependent responses to acetaminophen, a known liver toxicant, with the toxic effects being able to be assessed using both standard screening assays and histopathological assessment of the treated tissue, according to the company.

ONVO closed Tuesday's trading 10.13% higher at $6.85.

Pain Therapeutics Inc. (PTIE) rose 16 percent to $3.77 on Tuesday following news that Pfizer Inc. (PFE) will continue the development program for REMOXY (oxycodone) Extended-Release Capsules CII.

REMOXY received a Complete Response Letter in December 2008 and in June 2011. In order to address the questions raised by the FDA in the June 2011 Complete Response Letter, Pfizer has decided to proceed with the additional clinical studies and other actions.

The complete response submission is not expected to occur prior to mid-2015.

RedHill Biopharma Ltd. (RDHL) is all set to commence a phase III study of RHB-105 for the treatment of Helicobacter pylori (H. pylori) bacterial infection in the U.S. by the end of this month, subject to final preparations.

The company noted that a phase II study conducted in Australia with the RHB-105 active agents demonstrated an eradication rate greater than 90% in patients who had previously failed at least one course of standard of care therapy for H. pylori infection.

RDHL closed Tuesday's trading at $10.92, up 3.51%.

Repros Therapeutics Inc. (RPRX) now expects to submit a New Drug Application for Androxal for the treatment of men with secondary hypogonadism during the fourth quarter of 2014. A pre-NDA meeting will be requested before the end of this year, and it is anticipated that the meeting will be held during the first quarter of 2014.

RPRX closed Tuesday's trading at $23.69, up 0.08%. In after-hours, the stock was up 0.13% to $23.72.

ZIOPHARM Oncology Inc. (ZIOP) dropped 3.45% to $4.76 in extended trading on Tuesday after the company announced that it intends to commence an underwritten public offering of $50 million of shares of its common stock.

The company's lead drug candidate is Ad-RTS IL-12, which is currently being tested in two phase II studies, the first for the treatment of advanced melanoma, and the second in combination with other therapies for the treatment of advanced breast cancer.