Shares of Inovio Pharmaceuticals Inc. (NASDAQ: INO) slid in Monday’s session after the firm received some bad news from the U.S. Food and Drug Administration (FDA). Essentially, the agency placed a clinical hold on Inovio’s proposed Phase 3 clinical program for VGX-3100.
As we have said time and again, clinical trials and FDA decisions have the potential to make or break companies in this industry. For the month of October, a few of these companies have been on the move, and a few more expect results or decisions later this quarter.
A clinical hold is a notification issued by the FDA to a trial sponsor to delay a proposed clinical trial or suspend an ongoing clinical trial. This study has not yet been initiated and has not enrolled or dosed subjects. Additionally, the hold does not pertain to any of Inovio’s other ongoing clinical studies.
The company anticipates receiving a formal letter with complete information from the FDA within 30 days. In its initial communication, the FDA has requested additional data to support the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device.
Inovio is working diligently with the FDA to address its concerns and anticipates that the requested data will be available before the end of 2016. Inovio estimates that the start of the Phase 3 clinical program will be delayed until the first half of 2017, pending resolution of the FDA’s requests.
Excluding Monday’s move, Inovio has outperformed the broad markets with the stock up nearly 25% year to date.
Shares of Inovio were trading down about 17% at $6.96 Monday morning, with a consensus analyst price target of $20.33 and a 52-week trading range of $4.50 to $11.69.