Ocugen Submits IND Application for COVAXIN

Ocugen, Inc. (OCGN) shares closed 5% higher on Wednesday but fell 2.91% at the time of writing, during early trading hours on Thursday. The stock price surged after the biopharmaceutical company announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for COVAXIN.

The COVID-19 vaccine candidate, COVAXIN (BBV152), will be evaluated for use outside the U.S.

According to OCGN, it is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform, which has been used in the production of polio vaccines for decades.

Notably, COVAXIN had been developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

The Phase 3 trial has been proposed in the IND application. The trial is designed to evaluate whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in the adult population in the U.S.

Notably, adults who have not been vaccinated for COVID-19 or have already received two doses of an mRNA vaccine at least six months earlier will be observed under the trial. (See Ocugen stock charts on TipRanks)

Ocugen’s Phase 3 immuno-bridging study, OCU-002, has plans to enroll several hundred healthy adults in the U.S., if the study gets the regulator’s approval. The safety and tolerability profile will also be evaluated. Ocugen expects to complete the study during the first half of 2022.

The CEO of Ocugen, Dr. Shankar Musunuri, said, “We are very excited to take this next step in the development of COVAXIN, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public. We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”

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Wall Street’s Take

Noble Financial analyst Robert LeBoyer reiterated a Buy rating on the stock with the price target of $15 (56.09% upside potential).

Meanwhile, the Street is cautiously optimistic about the stock and has a Moderate Buy consensus rating based on 2 Buys. The average Ocugen price target of $12.50 implies 30.07% upside potential. However, the company shares have lost 14.3% over the past six months.

Risk Analysis

According to the new TipRanks’ Risk Factors tool, Ocugen is at risk mainly from three factors: Tech and Innovation, Finance and Corporate, and Legal and Regulatory, which contribute 30%, 23%, and 23%, respectively, to the total 77 risks identified for the stock.