Tuesday turned out to be a good day for Ocugen (OCGN) investors. Shares took off after the company disclosed that the FDA had removed the clinical hold placed on the investigational new drug (IND) application for Covaxin. This is the Covid-19 vaccine the company has acquired the US rights for from India-based Bharat.
Recall, shares sunk in November after the FDA put a clinical hold on the IND. Lifting the halt will give Ocugen the opportunity to move forward with a Phase 3 immuno-bridging study, OCU-002, in which participants will be administered two doses of either the vaccine or placebo 28 days apart.
The main aim of the study is to evaluate the data against the results achieved in the Phase 3 trial overseen by Bharat. 26,000 Indian patients were involved in that study in which the vaccine displayed a 93.4% efficacy rate against severe COVID-19 disease and showed it was effective 77.8% of the time against symptomatic disease and 63.6% against asymptomatic disease. 20 countries have already provided the vaccine with emergency use authorization, with the company awaiting EUA decisions in more than 60 other countries.
It all sets the scene for Ocugen to try and add its offering to the currently recommended Covid-19 vaccines and H.C. Wainwright’s Swayampakula Ramakanth believes the covid-shaped opportunity for Ocugen is still at play.
“While management could provide additional details regarding the upcoming Phase 3 study during their year-end earnings call on February 25, we expect the study to start in 2Q22,” said the analyst. “Given that this study is evaluating a 30-day immunogenic profile post the second dose, the study could complete by end of 2022 and management could file the biologics license application with the regulatory agency by mid-2023.”
To this end, Ramakanth maintained a Buy rating backed by a $10 price target. Investors stand to pocket ~134% gain, should all go according to plan over the next 12 months. (To watch Ramakanth’s track record, click here)
The Street’s average target is almost identical, coming in at $10.33. Two other analysts have recently chimed in with Ocugen reviews with one saying Buy and the other Hold, all adding up to a Moderate Buy consensus rating. (See Ocugen stock analysis on TipRanks)
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Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
Source: https://finance.yahoo.com/news/ocugen-stock-10-analyst-thinks-195318342.html