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Ocugen: FDA Issues Clinical Hold on Covid-19 Trial; Shares Down

By Michael Dabaie

 

Ocugen Inc. said the U.S. Food and Drug Administration issued a clinical hold on the company's investigational new-drug application to initiate a Phase 3 trial for Covid-19 vaccine candidate BBV152, known as Covaxin outside the U.S., sending shares lower premarket.

Shares of Ocugen were down 14% to $6.11 in premarket trading.

The FDA plans to identify the specific deficiencies behind the clinical hold and information on how to address them, the company said.

Ocugen said it expects to receive formal written communication with the additional information from the FDA, and plans to work with the agency to resolve its questions as promptly as possible.

Ocugen is co-developing Bharat Biotech's Covaxin Covid-19 vaccine candidate in the U.S. and Canadian markets.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

November 26, 2021 07:40 ET (12:40 GMT)

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