Ocugen (NASDAQ: OCGN) long term investors are celebrating today after an announcement directly from the World Health Organization that the drug Covaxin is approved for an emergency use authorization. OCGN has been building since mid October but a sharp dip on the 26th shook some shareholders. But those that held out have enjoyed an over 85% increase ahead of the run expected today.

OCGN Stock News

The biopharmaceutical company, Ocugen, is the co-developer of the Covid-19 drug Covaxin whose EUA approval was delayed after the WHO requested additional information from Bharat Biotech International Ltd. – the drug’s developer. According to the agreement between Ocugen and Bharat Biotech, the former is allowed to market Covaxin in the U.S. and Canada while the latter has the rest of the global market. Although the drug was developed in India, the approval process in the US and Canada has been treacherous for Ocugen. 

OCGN started the rolling review process, or New Drug Submission for COVID-19, with Health Canada in July. This allows companies to test Covaxin and submit safety and efficacy information to Health Canada along the way. In theory this will speed up Health Canada’s review process which is beneficial for OCGN, but till then the company will be unable to market Covaxin in Canada. Even with the WHO’s EUA, Covaxin will not be approved in Canada or the US without the standard review process. 

Ocugen has also begun the review process for Covaxin in the US and submitted its IND application to the FDA on October 27th. With the FDA’s approval, OCGN will begin its Phase 3 clinical trial which is intended to provide a comparison to the results of a similar trial conducted in India. Already, 30 million doses have been supplied in India as well as other countries which has given Covaxin a promising track record so far. However, OCGN’s trial study will need time for not only approval but application as well. With that in mind, the company intends to complete its study during H1 2022.

Meanwhile, OCGN stock could give shorts a run for their money as the WHO’s announcement dove the stock into pre-market action. Of the company’s 198.76 million outstanding shares, roughly 56.3 million are held by the OCGN’s 143 institutional holders. This means about 28.32% of its shares are owned by institutions. Groups like Cambridge Investment Research Advisors, Inc. and SG Americas Securities, LLC have opened new positions on the company based on the announcement as well.

OCGN Stock Forecast

Clearly, OCGN has the potential to capture two very lucrative markets with Covaxin’s approval but it will require a great deal of patience from its shareholders. The WHO’s approval will likely permit Covaxin’s use in 60 countries or those participating in the COVID-19 Vaccines Global Access initiative in addition to the 17 countries which had previously approved its use. It is also a very bullish sign that – with time – the FDA and Health Canada will both approve Covaxin. 

Media Sentiment

As investors take profits OCGN stock has shown a lot of volatility but OCGN stock price will eventually come out as @BMoeKnows.

OCGN Stock: Technical Analysis

OSCN stock chart

Despite the pre-market run up, OCGN stock has fallen back to $13.88 as many investors take profits. It may rebound off of its weak support near 13.61 or continue to its secondary support near 12.06. OCGN stock has a resistance point at 17.38 from market open. The MACD had a bearish crossover and accumulation has mimicked the stock’s action so far. The RSI is currently at 44 after becoming overbought earlier today.

Should you Buy?

OCGN stock appears to be a case of “paytience” for most long term investors. As the stock fluctuates today fresh off of the announcement, it will likely cool off and provide a new entry point for investors willing to wait for FDA and Health Canada’s approval. Analysts are projecting $408 million in revenue for OCGN by 2023 which is a very bullish outlook for the stock’s future. At OCGN stock price of only $13.88, this could be a major ROI for shareholders.


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