Ocugen Inc. (NASDAQ: OCGN) stock plunged by 3.65% at last close whereas the OCGN stock price soars by 5.48% in the pre-market trading session. Ocugen, Inc. is a biopharmaceutical firm specializing on the discovery, development, and commercialization of gene therapies to treat blindness and the development of a COVID-19 vaccine.
What is happening?
OCGN has today announced that COVAXIN’s Emergency Use Authorization (EUA) application will be submitted to the US Food and Drug Administration (FDA) in June.
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Dr. Shankar Musunuri, Chairman of the Board, CEO, and Co-founder of Ocugen said that OCGN do not think that the FDA’s recently changed advice on EUAs poses any worries about their ability to submit the EUA for COVAXIN as planned, which is presently in progress and expected to be submitted to the FDA in June. OCGN thinks that k the FDA’s recent guideline indicates that Ocugen remains to fulfill all of the requirements for an EUA submission. Ocugen plans to begin pre-biologics license application (BLA) negotiations with the FDA after the EUA application is filed.
Dr. Bruce Forrest who is Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen said that The FDA’s recommendation focuses on vaccinations based on the spike protein. He further educated people about COVAXIN that, COVAXIN is a revolutionary but conventional vaccine that combines an inactivated form of the complete virus with a new adjuvant that induces a broadly protective immune response beyond the spike protein, potentially protecting against a wide range of existing and developing variations and minimizing the risk of mutant viral escape.
COVAXIN has been demonstrated to create memory T cell responses for its various epitopes, indicating longevity and a quick antibody response to subsequent infections, in addition to creating powerful immune responses against various antigens.