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Ocugen (OCGN) Covaxin Studies Clinical Hold Lifted by FDA

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Shares of Ocugen, Inc. (OCGN - Free Report) gained in pre-market on May 23 after the company announced that the FDA  has lifted the clinical hold on its phase II/III study, OCU-002, for Covaxin (BBV152) for COVID-19.

The gains were mostly offset, and the stock ended in negative. However, it was up in pre-market trading.

Covaxin is an investigational vaccine candidate product in the United States. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research’s National Institute of Virology.

It is currently approved for adults in India and authorized for emergency use in 25 countries.

Last month, the stock tanked after the FDA placed a clinical hold on the study. Ocugen had voluntarily paused dosing in the phase II/III OCU-002 study temporarily after inspection of its India-based partner Bharat Biotech’s manufacturing facility by World Health Organization (“WHO”). WHO identified some deficiencies in good manufacturing practices (GMP) at the facility. As a result, Bharat Biotech suspended the production of Covaxin for export.

Ocugen is conducting the OCU-002 study to support its biologics license application for the approval of Covaxin in the United States.

The stock has declined 54.1% this year so far compared with the industry’s decrease of 23.5%.


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Ocugen has faced several roadblocks in bringing Covaxin to the U.S. markets. In February, the FDA lifted a clinical hold that it had earlier placed on the Covaxin investigational new drug application (IND), clearing the way to begin the OCU-002 study. Earlier, the FDA declined to issue an emergency use authorization (EUA) to Covaxin for allowing its use in the pediatric population aged two to 18 years.

Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report)   led the race for successfully developing mRNA-based COVID-19 vaccines.

The FDA expanded EUA to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 vaccine in children five to 11 years of age. The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine.

Moderna submitted a EUA request to the FDA for a 25 μg two-dose primary series of mRNA-1273 in children six months to under six years of age.

Ocugen currently has a Zacks Rank #5 (Strong Sell). 

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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