New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 1, 2014
17:03 EDTMDVN, ALPMYNew England Journal of Medicine publishes results from Phase 3 PREVAIL trial
Astellas Pharma US , a U.S. subsidiary of Tokyo-based Astellas Pharma (ALPMY) and Medivation (MDVN) announced the online publication in the New England Journal of Medicine of the results from the Phase 3 PREVAIL trial, an international, randomized, double-blind, placebo-controlled clinical study of enzalutamide. The study evaluated the benefit and safety of enzalutamide in men with metastatic prostate cancer, who had few or no symptoms, that had progressed on luteinizing hormone-releasing hormone, LHRH, therapy or after bilateral orchiectomy. The paper, "Enzalutamide in Men with Metastatic Prostate Cancer Before Chemotherapy," appears in the June 1 online issue and the companies anticipate publication in a future print issue of the Journal. "The PREVAIL study results demonstrate that treatment with enzalutamide in men with metastatic castration resistant prostate cancer can decrease the risk of death, delay the growth or spread of metastatic prostate cancer, and delay the time to initiation of chemotherapy," said Tomasz M. Beer, M.D., F.A.C.P., professor of medicine and deputy director of the Knight Cancer Institute at Oregon Health & Science University, and co-principal investigator of the PREVAIL study. "We are delighted that the New England Journal of Medicine has chosen to publish these important results." A supplemental New Drug Application, sNDA, based on the PREVAIL results received a priority review designation from the U.S. Food and Drug Administration. The Prescription Drug User Fee Act, PDUFA, goal date is September 18. A variation application to amend the European Marketing Authorization Application based on the results of PREVAIL was validated for review by the European Medicines Agency on April 24.
News For ALPMY;MDVN From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
August 27, 2015
08:35 EDTMDVNMedivation price target raised to $166 at William Blair after talazoparib deal
Subscribe for More Information
August 24, 2015
07:02 EDTMDVNMedivation to acquire worldwide rights to Talazoparib from BioMarin
Medivation (MDVN) and BioMarin Pharmaceutical (BMRN) have entered into an asset purchase agreement under which Medivation will acquire all worldwide rights to talazoparib, a highly-potent, orally-available poly ADP ribose polymerase inhibitor currently in a Phase 3 study for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer. Under the agreement, Medivation will be responsible for all research, development, regulatory and commercialization activities for all indications on a global basis. Under the terms of the agreement, Medivation will pay BioMarin $410 million upfront, up to an additional $160 million upon the achievement of regulatory and sales-based milestones and mid-single digit royalties for talazoparib. At the closing of the transaction, Medivation will assume all financial obligations associated with the development and commercialization of talazoparib. The closing of the transaction is conditioned on the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is anticipated to close in 2015.

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use