The Food and Drug Administration has lifted a clinical hold on Ocugen's late-stage clinical trials of a Covid-19 vaccine it is attempting to bring to the United States.
The vaccine, called Covaxin, was developed by Bharat Biotech of India. Malvern-based Ocugen (NASDAQ: OCGN) last year formed a partnership with Bharat to co-develop and market Covaxin in North America. The deal, which covers the United States and Canada, was expanded last month to also include Mexico.
In April, according to Ocugen, the FDA issued a clinical hold on Ocugen's planned Phase 2/3 study after the company voluntarily implemented a temporary pause in dosing participants while it evaluates statements made by the World Health Organization following its inspection of Bharat Biotech's manufacturing plant. The WHO said it discovered manufacturing deficiencies at the plant during an inspection in March.
Those issues have been resolved.
“We’re extremely pleased that we can proceed with our clinical trials for Covaxin," said Dr. Shankar Musunuri, CEO and co-founder of Ocugen, in a statement. "The need for delivering an additional, differentiated vaccine option, we believe, remains a priority. … Ocugen will now work with study sites to fully resume this clinical development program immediately.”
Ocugen's stock opened Monday morning up 2% at $2.28 per share. Its stock closed down nearly 2% at $2.19 per share.
During the past year, the company's stock has traded at a high of $17.65 per share and a low of $1.67.
To date, more than 100 million doses of Covaxin having been administered to adults outside the United States. Applications for emergency use authorization of the vaccine are pending in more than 60 other countries.
In March, the FDA rejected Ocugen's request for an emergency use authorization to administer Covaxin in the United States.
In February, the FDA lifted an earlier clinical hold it had on Ocugen's investigational new drug application seeking approval to conduct testing of Covaxin in the United States. The hold was placed because of undisclosed deficiencies with the application that were subsequently addressed by the company.
Ocugen, which has 56 employees, is also developing gene therapies for inherited retinal diseases.
