Ocugen, Inc. OCGN shares were advancing strongly Thursday after the biopharma issued a regulatory update.
Pennsylvania-based Ocugen said it has initiated a rolling submission of its regulatory application for its COVID-19 vaccine candidate Covaxin in Canada.
Ocugen is co-developing the vaccine along with India's Bharat Biotech in the U.S. and Canada.
The rolling submission process was recommended and accepted under the Minister of Health's "Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19." It will be transitioned to a new drug submission for COVID-19.
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The rolling submission allows submission of safety and efficacy data and information as it becomes available, and Health Canada can start its review right away as information continues to come in to accelerate the overall review process.
Ocugen initiated the rolling submission through its affiliate, Vaccigen, Ltd.
Health Canada will make a decision upon review of the evidence submitted that supports its safety, efficacy and quality.
With the U.S. Food and Drug Administration deciding not to accommodate any further emergency use authorizations, Ocugen has opted to follow the full-approval filing process in the U.S.
Ocugen is a biopharma focused on discovering, developing and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19.
In premarket trading, Ocugen shares were surging 4.5% to $6.73.
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