FDA lifts partial clinical hold on Medivation's pidilizumab

10 March 2016

Shares of US biotech firm Medivation (Nasdaq: MDVN) fell 2.48% to $38.16 yesterday, despite the company reporting positive news on the development of its blood cancer drug candidate.

The company announced that the US Food and Drug Administration 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.

Medivation acquired rights to pidiluzumab from CureTech under a $355 million deal in 2014, after Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) pulled out of a collaboration with the company (The Pharma Letter February 1, 2013).

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