Ocugen, Inc. (OCGN – Free Report) announced that it will submit a biologics license application (“BLA”) for its COVID-19 vaccine candidate, Covaxin, in the United States following the FDA’s recommendation.
The company will no longer pursue an Emergency Use Authorization (“EUA”) for the vaccine candidate, and instead, will seek more formal approval for Covaxin. This might delay the launch of the vaccine in the United States.
The regulatory body recommended Ocugen to pursue a BLA submission instead of an EUA application for Covaxin and requested additional information and data on the same. The company believes that data from an additional clinical study will likely be necessary to support the BLA.
Shares of Ocugen were down 28.1% on Thursday following the announcement of the news. However, the stock has skyrocketed 265.5% so far this year compared with the industry’s rise of 0.1%.
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Please note that Ocugen has secured exclusive rights to commercialize Covaxin in Canada and has also initiated discussions with Health Canada for the regulatory approval of the same.
We note that, in April 2021, Bharat Biotech announced encouraging data from the second interim analysis of its phase III study of Covaxin, which showed 78% overall efficacy against COVID-19 disease, 100% efficacy against severe COVID-19 disease (including hospitalization), and 70% efficacy against asymptomatic COVID-19 infection.
Covaxin is generally well tolerated and has shown a good safety profile in studies conducted till date. More than 6.7 million doses of the vaccine have been administered in India without any potential thromboembolic event being reported so far.
Ocugen entered into a definitive agreement with India-based Bharat Biotech to co-develop and commercialize the latter’s COVID-19 vaccine, Covaxin, for the U.S. market, in February 2021. Ocugen is also in discussions with BARDA regarding the U.S. government’s support of Covaxin. It is also considering evaluating Covaxin in special populations, such as children, as well as in booster doses.
Other COVID-19 vaccines that have received EUA in the United States are Moderna’s (MRNA – Free Report) mRNA-1273, Pfizer/BioNTech’s (BNTX – Free Report) BNT162b2 and J&J’s (JNJ – Free Report) single-shot COVID-19 vaccine.
Notably, companies like Pfizer/BioNTech and Moderna have already got a head start and initiated rolling submissions for a BLA with the FDA, seeking approval/licensure of their respective COVID-19 vaccines in the United States.
Ocugen currently has a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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