FDA Lifts Clinical Hold on Ocugen’s New Drug Application for COVAXIN; Shares Gain 15.6%

Ocugen, Inc. (OCGN) revealed that the U.S. Food and Drug Administration has lifted the clinical hold on the company’s application to evaluate its COVID-19 vaccine candidate, popularly known as COVAXIN, outside the United States.

Following the news, shares of the company rallied 15.6% in the pre-market trading session on Tuesday.

The vaccine uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades. COVAXIN has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

Notably, it has already been authorized under emergency use in 20 countries, and applications for the same are pending in more than 60 other countries. Further, it has recently been added by the WHO to the list of vaccines authorized for emergency use.

With the hold being uplifted, the vaccine will be evaluated as a candidate in the United States.

The CEO and Co-Founder of Ocugen, Dr. Shankar Musunuri, said, “We are pleased to be able to move our clinical program for COVAXIN forward, which we hope will bring us closer to offering an alternative COVID-19 vaccine. We firmly believe that managing this pandemic requires more than one approach to vaccines, so we are heartened to be able to continue developing our vaccine candidate.”

Ocugen Earnings

The company is estimated to report a loss of $0.07 for Q4 2021. Ocugen stock earnings history is unimpressive, as it lagged estimates in the last few quarters. OCGN is expected to release earnings on February 25, 2022.

Overall, the analysts are cautiously optimistic about the stock with a Moderate Buy consensus rating based on 2 Buys and 1 Hold.

Negative Sentiment

TipRanks’ Stock Investors tool shows that investors currently have a Very Negative stance on Ocugen, with 13.5% of investors on TipRanks decreasing their exposure to OCGN stock over the past 30 days.

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