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Ocugen (OCGN) Selects Coronavirus Vaccine Manufacturer in US
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Ocugen, Inc. (OCGN - Free Report) announced that it has selected Washington-based contract manufacturer, Jubilant HollisterStier as its manufacturing partner for its COVID-19 vaccine candidate, Covaxin, in the United States and Canada. Presently, the vaccine is not authorized/approved in either country.
Shares of Ocugen have skyrocketed 255.7% so far this year against the industry’s decrease of 1.5%.
Image Source: Zacks Investment Research
Please note that Ocugen is looking to submit a biologics license application (“BLA”) for Covaxin in the United States. Last week, the company announced that it will no longer pursue an Emergency Use Authorization (“EUA”) for the vaccine, and instead, will seek more formal approval of the same.
Meanwhile, Ocugen has secured exclusive rights to commercialize Covaxin in Canada and has also initiated discussions with Health Canada for regulatory approval of the same.
We remind investors, that Ocugen has a definitive agreement with India-based Bharat Biotech to co-develop and commercialize the latter’s COVID-19 vaccine, Covaxin, for the United States market.
More than 30 million doses of the vaccine have been administered in India and other countries without any serious side effect being reported so far. The vaccine is currently being administered under EUA in 13 countries, with EUA applications pending in several others.
Notably, 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.
The vaccine is generally well tolerated and has an encouraging safety record so far.
If approved, Ocugen’s Covaxin will be the fourth vaccine to be available in the United States. At present Pfizer/BioNTech’s (BNTX - Free Report) BNT162b2, Moderna’s (MRNA - Free Report) mRNA-1273 and J&J’s (JNJ - Free Report) single-shot COVID-19 vaccine are available in the United States.
Notably, Pfizer/BioNTech and Moderna have already initiated rolling submissions for a BLA with the FDA, seeking approval/licensure of their respective COVID-19 vaccines in the United States.
If you’re looking for big gains, there couldn’t be a better time to get in on a young industry primed to skyrocket from $17.7 billion back in 2019 to an expected $73.6 billion by 2027.
After a clean sweep of 6 election referendums in 5 states, pot is now legal in 36 states plus D.C. Federal legalization is expected soon and that could be a still greater bonanza for investors. Even before the latest wave of legalization, Zacks Investment Research has recommended pot stocks that have shot up as high as +285.9%
You’re invited to check out Zacks’ Marijuana Moneymakers: An Investor’s Guide. It features a timely Watch List of pot stocks and ETFs with exceptional growth potential.
Image: Bigstock
Ocugen (OCGN) Selects Coronavirus Vaccine Manufacturer in US
Ocugen, Inc. (OCGN - Free Report) announced that it has selected Washington-based contract manufacturer, Jubilant HollisterStier as its manufacturing partner for its COVID-19 vaccine candidate, Covaxin, in the United States and Canada. Presently, the vaccine is not authorized/approved in either country.
Shares of Ocugen have skyrocketed 255.7% so far this year against the industry’s decrease of 1.5%.
Please note that Ocugen is looking to submit a biologics license application (“BLA”) for Covaxin in the United States. Last week, the company announced that it will no longer pursue an Emergency Use Authorization (“EUA”) for the vaccine, and instead, will seek more formal approval of the same.
Meanwhile, Ocugen has secured exclusive rights to commercialize Covaxin in Canada and has also initiated discussions with Health Canada for regulatory approval of the same.
We remind investors, that Ocugen has a definitive agreement with India-based Bharat Biotech to co-develop and commercialize the latter’s COVID-19 vaccine, Covaxin, for the United States market.
More than 30 million doses of the vaccine have been administered in India and other countries without any serious side effect being reported so far. The vaccine is currently being administered under EUA in 13 countries, with EUA applications pending in several others.
Notably, 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.
The vaccine is generally well tolerated and has an encouraging safety record so far.
If approved, Ocugen’s Covaxin will be the fourth vaccine to be available in the United States. At present Pfizer/BioNTech’s (BNTX - Free Report) BNT162b2, Moderna’s (MRNA - Free Report) mRNA-1273 and J&J’s (JNJ - Free Report) single-shot COVID-19 vaccine are available in the United States.
Notably, Pfizer/BioNTech and Moderna have already 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.
Time to Invest in Legal Marijuana
If you’re looking for big gains, there couldn’t be a better time to get in on a young industry primed to skyrocket from $17.7 billion back in 2019 to an expected $73.6 billion by 2027.
After a clean sweep of 6 election referendums in 5 states, pot is now legal in 36 states plus D.C. Federal legalization is expected soon and that could be a still greater bonanza for investors. Even before the latest wave of legalization, Zacks Investment Research has recommended pot stocks that have shot up as high as +285.9%
You’re invited to check out Zacks’ Marijuana Moneymakers: An Investor’s Guide. It features a timely Watch List of pot stocks and ETFs with exceptional growth potential.
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