By Michael Dabaie
Ocugen Inc. said the U.S. Food and Drug Administration has issued a clinical hold on the company’s investigational application for a new drug to begin a Phase 3 trial for Covid-19 vaccine candidate BBV152, known as Covaxin outside the U.S. shares in presale decline.
Shares of Ocugen fell 14% to $6.11 in premarket trading.
The FDA plans to identify the specific shortcomings behind the clinical hold and information on how to address them, the company said.
Ocugen said it expects to receive formal written communications with the additional information from the FDA, and plans to work with the agency to resolve its questions as soon as possible.
Ocugen is co-developer of Bharat Biotech’s Covaxin Covid-19 vaccine candidate in the US and Canadian markets.
Write to Michael Dabaie at [email protected]