Shares of Inovio Pharmaceuticals (INO) were crushed.
All on news the US FDA just placed its Phase 2/3 clinical trials of INO on partial clinical hold.
The good news is the FDA’s decision was “not due to the occurrence of any adverse events” in its Phase 1 study. While it’s not entirely clear why the FDA acted, Inovio has said the agency “has additional questions” about the Phase 2/3 study.
According to Inovio, “The company is actively working to address the FDA’s questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed.”
“This partial clinical hold is not due to the occurrence of any adverse events related to INOVIO’s ongoing expanded Phase 1 study of INO-4800, the conduct of which may continue and is not impacted by the FDA’s notification. In addition, this partial clinical hold does not impact the advancement of INOVIO’s other product candidates in development. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA’s partial clinical hold and subject to the receipt of external funding to conduct the trial.”