- Ocugen (NASDAQ:OCGN) stock is down despite news that the FDA is allowing it to proceed with clinical trials of its Covid-19 vaccine candidate
- This news lifts a significant hurdle that had been holding the company back in recent months
- However, Ocugen’s share price remains down sharply on the year
Shares of Ocugen (NASDAQ:OCGN) are in focus today on news that the U.S. Food and Drug Administration (FDA) has lifted its clinical hold on the company’s Covid-19 vaccine candidate. India’s Bharat Biotech produced the vaccine.
OCGN stock is down 2% despite the news that clears the biotechnology company to proceed with the necessary clearances for its Covid-19 vaccine. In April, the agency paused trials of Ocugen’s vaccine candidate, called Covaxin, after a World Health Organization inspection of a Bharat Biotech facility.
It appears Bharat has resolved those issues, which is a positive development for Ocugen and its shareholders.
What Happened With OCGN Stock
In a news release, Dr. Shankar Musunuri, chairman and co-founder of Ocugen said:
“We’re extremely pleased that we can proceed with our clinical trials for Covaxin … The need for delivering an additional, differentiated vaccine option, we believe, remains a priority.”
Ocugen is responsible for conducting clinical trials and commercializing the Covid-19 vaccine in the U.S. under its partnership with Bharat Biotech. Covaxin already has full approval in India. Globally, Ocugen says 350 million doses of Covaxin have been administered.
Covaxin also has emergency-use authorization in 25 other countries. The vaccine is not yet approved in the United States or Canada.
Why It Matters
Today’s news that the FDA has cleared Ocugen to once again proceed with clinical trials for its Covid-19 vaccine is a positive development. The Malvern, Pennsylvania-based company’s vaccine candidate has suffered from repeated delays and is late to come to market.
Prior to Covid-19, Ocugen was primarily focused on developing treatments for eye disease. It pivoted to developing a vaccine against Covid-19 in partnership with Bharat Biotech in an effort to capitalize on offering a solution to the global health crisis. However, the delay in bringing the Covid-19 vaccine to market has hurt Ocugen’s share price.
Year to date, OCGN stock is down 50% and currently trading at just $2.16 a share. At various times, Ocugen has been treated as a meme stock and its share price has jumped as high as $18 before collapsing again.
What’s Next for Ocugen
OCGN stock gets a bounce today on news that it can again resume its clinical trials. However, until the company’s Covid-19 vaccine receives full approval in the U.S. and Canada, it is likely to remain a penny stock and could fall further should there be any further delays or setbacks.
Investors should proceed with caution.
On the date of publication, Joel Baglole did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.