Inovio's potential COVID-19 vaccine trial on partial clinical hold

Marco Green
October 1, 2020

Crucially, the hold isn't related to an adverse effect, and Inovio's phase-one trial is still moving forward. Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold.

Inovio's shares, the second best performing stock on the Nasdaq biotechnology index this year through Friday's close, plunged 33% before the opening bell.

Inovio Pharmaceuticals Inc., based in Plymouth Meeting, announced Monday that the Phase 2/3 trial of its COVID-19 vaccine candidate is on "partial clinical hold" because the FDA has "additional questions" about the company's CELLECTRA 2000 delivery device. The agency raised questions about the trial and the delivery device slated for use in the study. It said the FDA's concerns were more in relation to the details about administering the shot in its upcoming trial.

Inovio said the FDA's questions were only about Phases 2 and 3 of their clinical trials, which the company was slated to move into this month, and not Phase 1, which can continue. As it turns out, talks with the FDA have bogged the process down, with Inovio having no other option than to indefinitely delay its phase 3 trials until it can make some headway with the regulator.

The news caused a 39 percent dip in Inovio's stock on Monday, Business Insider reported. In response to this, shares of the company soared as investors jumped on the opportunity to trade this hot stock.

Crucially, the trial hold isn't related to an adverse event.

INOVIO has 15 DNA medicine clinical programs now in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. The patient has since been released from the hospital and the vaccine trial resumed in the U.K., however it remains paused in the United States. With shares up almost 268% year-to-date, the average price target of $15.71 implies further upside potential of 29.4% from current levels. The company has six "buy" ratings, one "hold" rating, and no "sell" ratings, with a median price target of $22.

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