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Ocugen (OCGN) to File Coronavirus Vaccine BLA in US, Stock Tanks
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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%.
Image Source: Zacks Investment Research
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.
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Image: Bigstock
Ocugen (OCGN) to File Coronavirus Vaccine BLA in US, Stock Tanks
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%.
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.
Zacks Rank
Ocugen currently has a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
+1,500% Growth: One of 2021’s Most Exciting Investment Opportunities
In addition to the stocks you read about above, would you like to see Zacks’ top picks to capitalize on the Internet of Things (IoT)? It is one of the fastest-growing technologies in history, with an estimated 77 billion devices to be connected by 2025. That works out to 127 new devices per second.
Zacks has released a special report to help you capitalize on the Internet of Things’s exponential growth. It reveals 4 under-the-radar stocks that could be some of the most profitable holdings in your portfolio in 2021 and beyond.
Click here to download this report FREE >>