COVAXIN Pediatric EUA Declined, But Majority of Expected Market Unaffected
Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.
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FDA Has Denied The Pediatric Emergency Use Application (EUA). Ocugen has announced that the FDA has declined its EUA for pediatric use in the ages 2 through 18 group. Although its approval would have been positive sign for full product BLA approval, we do not believe its denial will have any impact on the BLA for adult use.
BLA Application for Adult Use Is Unaffected. Ocugen did not give details about the reasons for the denial, only saying that it will “continue working with the FDA to evaluate the the regulatory pathway for COVAXIN.” We believe the FDA is highly unlikely to approve additional COVID-19 products under Emergency Use guidelines, and that the COVAXIN pediatric indication submission will be reviewed …
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
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