Inovio Pharmaceuticals Inc. (INO) - Get Free Report shares plunged Monday after the drugmaker said the U.S. Food & Drug Administration put its late-state coronavirus vaccine trial on 'partial clinical hold'.
Inovio said the FDA raised questions about its Cellectra 2000 delivery device, which is being used in the trial, while adding that the request was "not due to the occurrence of any adverse events" related to the group's expanded Phase 1 study of INO-4800, a coronavirus vaccine candidate being explored with Thermo Fisher Scientific (TMO) - Get Free Report.
"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," the company said. "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. "
Inovio shares, which were briefly halted in pre-market trading by the Nasdaq prior to publication of the FDA hold, were marked 28.8% lower in early Monday deal at $12.08 each, a move that would lope more than half of its six month gains.
Inovio said earlier this month that Thermo Fisher will manufacture drug substance and perform fill-and-finish work for the vaccine candidate and that, at peak capacity, Inovio Thermo Fisher project they could produce at least 100 million doses of INO-4800 annually, once its approved.
Inovio said it was working with a consortium of manufacturing partners to help it meet its target of making 100 million doses of INO-4800 in 2021.
The World Health Organization says that around 150 potential vaccines are currently under some form of study, with 34 active human trials taking place from Russian to Bahrain.
Several U.S. firms are also in the hunt, including Moderna (MRNA) - Get Free Report, Novavax (NVAX) - Get Free Report, Johnson & Johnson (JNJ) - Get Free Report and Pfizer (PFE) - Get Free Report, which said earlier this month that it's eyeing regulatory approval for it mRNA-based vaccine as early as October.
Eli Lilly & Co LLY , meanwhile, reached an agreement with Amgen AMGN last week to manufacture its potential coronavirus antibody treatment as global cases look set to pass the 30 million mark.