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Ocugen Says No Longer Pursue EUA For COVAXIN; Expects Addl. Trial Needed To Support BLA Submission

Ocugen Inc. (OCGN) said that it will no longer pursue an Emergency Use Authorization or EUA for its COVID-19 vaccine candidate COVAXIN. The company noted that it will pursue submission of a biologics license application or BLA for COVAXIN.

In Thursday pre-market trade, OCGN was trading at $5.69 down $3.62 or 38.88%.

Ocugen said it is in discussions with the FDA to understand the additional information required to support a BLA submission. The company anticipates that data from an additional clinical trial will be required to support the submission.

The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data.

Recently, Ocugen said that it secured exclusive rights to commercialize COVAXIN in Canada and has initiated discussions with Health Canada for regulatory approval.

The company stated that it will pursue expedited authorization for COVAXIN under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.

COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

COVAXIN is currently being administered under emergency use authorizations in 13 countries, and applications for emergency use authorization are pending in more than 60 additional countries.

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