New cases of the coronavirus have slowed down since its peak in January, and restrictions have started to ease as a result. However, shares of Ocugen (NASDAQ:OCGN) are up more than 10% today after the vaccine maker announced that the U.S. Food and Drug Administration (FDA) had lifted its clinical hold on the company’s Investigational New Drug (IND) application. Ocugen had been previously trying to advance clinical studies for Covaxin, its coronavirus drug. Last November, the FDA placed a clinical hold on Covaxin, which caused shares of OCGN to decline sharply.
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Covaxin is a whole-virion inactivated shot that has already received authorization from 20 countries for emergency use. The company also has applications for emergency use authorization in over 60 countries. In addition, Covaxin utilizes the same vero cell manufacturing platform that has been used in the production of polio vaccines.
Commenting on the update, Ocugen CEO Dr. Shankar Musunuri added that:
“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.”
Additionally, Ocugen is developing Covaxin in conjunction with Bharat Biotech, a drug developer based in India.
What Does Covaxin Mean for OCGN Stock?
In January, Ocugen released promising results from its Covaxin study at Emory University. The study showed that participants who received a booster dose of the vaccine demonstrated a strong antibody response to the coronavirus, including the omicron and delta variants. Indeed, 100% of test serum samples showed neutralization against the delta variant, while 90% of test serum samples showed neutralization against the omicron variant. Furthermore, earlier studies with Covaxin showed that the vaccine produced neutralizing potential against the alpha, beta, zeta and kappa variants.
The liquid vaccine carries a shelf life of 12 months at proper temperatures and is different than other vaccines because both adults and children can receive the same dosage.
So, should you buy OCGN stock? InvestorPlace writer David Moadel notes that the $3 level has acted as a level of support thus far this year. However, Moadel also points out that a break above $7.50 could result in a “quick path” to $15. Investors will want to keep a steady gaze on Ocugen as it continues its clinical studies of Covaxin in the US.
On the date of publication, Eddie Pan did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
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