Company Update (NASDAQ:MDVN): U.S. FDA Lifts Partial Clinical Hold on Medivation Inc’s Pidilizumab

Medivation Inc (NASDAQ:MDVN) announced that the U.S. Food and Drug Administration(FDA) has lifted the partial clinical hold on the Investigational New Drug (IND) application for pidilizumab (MDV9300) in hematological malignancies and confirmed that the Phase II clinical trial in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), as well as other studies that cross reference the IND, may now proceed. The partial clinical hold was not related to any safety concerns.

The investigator brochure, protocols, and informed consent documents related to the Phase II trial have satisfactorily been revised to reflect the Company’s understanding that PD-1 (Programmed Death-1) is not the target of pidilizumab. No patients had yet been enrolled in the trial, which commenced in late 2015. Patients who were receiving pidilizumab through investigator-sponsored trials have continued to receive treatment and those investigators have been informed to update their protocols and informed consent documents to state that pidilizumab is not an anti-PD-1 antibody.

“We are delighted that the FDA has lifted the partial clinical hold and that we may proceed with our potentially pivotal trial in this area of high unmet medical need,” said David Hung, M.D., Founder, President & Chief Executive Officer of Medivation. “As we move forward, we also are working to determine the compound’s exact binding mechanism which, we believe, modulates the body’s innate immune response and differentiates it from the heavily crowded immuno-oncology space that targets the adaptive side of immunity.”

The Company also intends to submit an amendment to the Chemistry, Manufacturing and Controls (CMC) section of the IND in the second quarter to provide for larger manufacturing lot sizes to better support the current and planned clinical activities for pidilizumab, which is intended for development in other hematologic malignancies, such as multiple myeloma. As such, the DLBCL trial is targeted to resume in the second half of this year. (Original Source)

Shares of Medivation closed yesterday at $39.13, down $-1.62 or -3.98%. MDVN has a 1-year high of $70.79 and a 1-year low of $26.41. The stock’s 50-day moving average is $33.73 and its 200-day moving average is $41.05.

On the ratings front, Medivation has been the subject of a number of recent research reports. In a report issued on March 4, Maxim Group analyst Jason Kolbert reiterated a Buy rating on MDVN, with a price target of $47, which implies an upside of 20.1% from current levels. Separately, on February 26, Brean Murray Carret’s Jonathan Aschoff maintained a Buy rating on the stock and has a price target of $61.

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Jonathan Aschoff have a total average return of -15.4% and -11.2% respectively. Kolbert has a success rate of 30.8% and is ranked #3707 out of 3712 analysts, while Aschoff has a success rate of 33.0% and is ranked #3680.

The street is mostly Bullish on MDVN stock. Out of 7 analysts who cover the stock, 5 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $52.00, which implies an upside of 32.9% from current levels.

Medivation Inc is a biopharmaceutical company engaged in the development of novel small molecule drugs to treat diseases like Alzheimer’s disease and Huntington disease.

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