Inovio Pharmaceuticals (NASDAQ:INO) stock was really taking it on the chin Monday, following a very discouraging revelation from the company.
The biotech announced that morning that the clinical trials for its INO-4800 COVID-19 vaccine candidate have been halted. This was because the Food and Drug Administration (FDA) served notice that it has additional questions about the phase 2/3 trial of INO-4800, in particular, the company’s proprietary CELLECTRA 2000 injection device that will be used in the testing.
Inovio said it is laboring to answer the regulator’s questions; the company plans to respond in October. After its responses are submitted, the FDA will have up to 30 days to render a decision about whether the clinical trials can proceed.
The company stressed that the FDA’s decision was not based upon, and does not impact, the expanded phase 1 trial of the vaccine candidate, which is ongoing. It also does not affect