Not very long ago, Ocugen Inc. (OCGN) stock (previously known as HSGX) was an unpopular biotech stock trading on the NASDAQ that not many investors were aware of. After the merger with Histogenics in 2019, the company made a reverse stock split at the ratio of 1:60. Since then, the stock continued to have a poor run in the market through December 2020 due to many challenges the company faced in getting the approval of the FDA for any of its products.
Ocugen Is Bringing a Vaccine Candidate to the FDA
Last year in December, the company announced its partnership with the Indian company, Bharat Biotech, to co-develop COVAXIN. The manufactured vaccine has been demonstrated to have an 81% efficacy which recently received approval for use in India. Since the announcement that their vaccine was granted emergency use authorization by the government of India, Ocugen stock has soared, so the stock is already up over 1900% over the last 12 months.
The covid-19 vaccine named COVAXIN is said to be given the same licensure status as other vaccines that are currently in use in India. One of the driving reasons that have been bullish for this stock is that in the phase 2 study the vaccine has supposedly shown high levels of antibody response and no serious side effects, which makes a strong case for Ocugen’s vaccine candidate to be used widely in the future.
If the company receives emergency use authorization from the U.S. FDA, the company is expected to receive a 45% share of the profits from the U.S. sales, and this could turn out to be a catalyst helping the stock reach new highs.
Insight to What’s Keeping Ocugen’s Momentum Going
Ocugen is a company focused on developing gene therapies to cure eye diseases. In addition to the Covid-19 vaccine, the company’s pipeline focuses on three gene therapy products named OCU400 (for the treatment of Inherited Retinal Disorders), OCU410 (for the treatment of Dry Age-Related Macular Degeneration), and OCU200 (for the treatment of Neovascular Disorders). Last year in July, the FDA granted the third Orphan Drug Designation for OCU400, the first gene therapy candidate, to conduct treatment in RHO mutation-associated retinal degeneration. Although all three products are still in the pre-clinical stage, if the pipeline succeeds, we might be able to see positive growth in the company and its stock as a result of these developments.
On the contrary, some critics say it will be difficult for Ocugen to compete with other vaccines as there is a lot of competition in the U.S., and the U.S. has already ordered other vaccines, and COVAXIN is late to the vaccine race. If the vaccine produces the said broad immune response compared to other vaccines and could handle strains in phase 3 trials, then Ocugen’s stock will stand a great chance of finding a tailwind. The fact that the company has shown no revenue for the last 5 years can make investors dubious as well. Ocugen doesn’t have any products in the market as of now but will be providing updates on its pipeline developments in the Q4 2020 earnings report.
Takeaway
Investing in young biotech companies can be quite tricky as the FDA’s decisions on pharmaceutical products can often reward and impoverish investors in the market. For now, investors should watch this stock and keep tabs on what’s happening with COVAXIN and the company’s other products.
Disclosure: The author does not have any shares mentioned in this article.
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