Form 8-K for MEDIVATION, INC.
Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01. Regulation FD Disclosure.
On March 9, 2016, Medivation, Inc. (Company) 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. As previously disclosed, 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. A copy of the Company’s press release announcing the lifting of the partial clinical hold is furnished as Exhibit 99.1 hereto.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise stated in such filing.
Item 9.01. Financial Statements and Exhibits.
99.1 U.S. FDA Lifts Partial Clinical Hold on Medivation’s Pidilizumab