Healthcare Business

Is the FDA's Hold on Inovio's COVID-19 Vaccine Study Too Much?

Things aren’t looking up for Inovio Pharmaceuticals Inc. (NASDAQ: INO), after the U.S. Food and Drug Administration (FDA) notified the company that it was placing a partial hold on its COVID-19 vaccine study. The company has about a month to address the FDA’s questions before the trial can continue.

Specifically, the FDA noted that it has additional questions about Inovio’s planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800. This includes the firm’s Cellectra 2000 delivery device that will be used in the trial.

Until the FDA gets the answers it wants from Inovio, the firm’s Investigational New Drug Application (IND) for the trial is on partial clinical hold. The company plans to respond in October, after which the FDA will have up to 30 days to decide whether Inovio can proceed with its trial.

Note that this partial clinical hold is not due to any adverse events related to Inovio’s ongoing expanded Phase 1 study of INO-4800. Additionally, this partial clinical hold has no impact on the advancement of other product candidates in development.

Again, Inovio will have to wait it out until they can answer the FDA. All the while, other companies are moving forward with their clinical trials. Investors hope that Inovio does not get left in the dust, although they have to be happy with the stock’s performance, all things considered.

Excluding Monday’s move, Inovio Pharmaceuticals stock had outperformed the broad markets, with a gain of about 413% year to date. In the past 52 weeks, the share price was up closer to 710%.

The stock closed Friday at $16.94 a share, in a 52-week range of $1.92 to $33.79. The consensus price target is $19.00. Following the announcement, the stock was down about 32% at $11.63 in early trading indications Monday.