New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 1, 2014
17:03 EDTALPMY, MDVNNew 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.
June 23, 2015
08:03 EDTMDVNMedivation lowered expectations skews risk/reward to upside, says UBS
UBS noted Medivation shares have been weak since ASCO but believes the risk reward has been skewed to the upside. The firm said its thesis is different from consensus as they believe the company's pipeline advancement this year could drive multiple expansion if Xtandi sales can at least remain flat. UBS reiterated its Buy rating and $142 price target on Medivation shares.
June 17, 2015
07:08 EDTALPMY, MDVNMedivation, Astellas Pharma announce enrollment of first patients in TRUMPET
Subscribe for More Information
07:07 EDTALPMY, MDVNMedivation and Astellas Pharma enroll first patients in prostate cancer registry
Astellas (ALPMY) and Medivation (MDVN) have enrolled the first patients in TRUMPET - Treatment Registry for Outcomes in CRPC Patients -, a prospective observational patient registry designed to better understand the unique needs and treatment patterns for patients with castration-resistant prostate cancer. The registry will enroll and evaluate 2,000 patients diagnosed with CRPC from urology and oncology sites across the U.S. TRUMPET is currently enrolling eligible patients and their caregivers; the study will be completed in 2020.

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