Ocugen Inc (NASDAQ: OCGN) is a US based biopharmaceutical company which has primarily focused its research on developing a cure for blindness disease. However last year, Ocugen shifted their efforts towards distributing Covaxin, a COVID-19 vaccine developed by their Indian partner Bharat Biotech. Ocugen currently have the rights to distribute Covaxin in the US and Canada, assuming the company can receive approval.
Last week, investors rallied behind rumours surrounding a final decision on Covaxin approval by the WHO. However, the World Health Organisation has pushed this date back a further week. Consequentially, as WHO approach their final decision on Covaxin, investors have built strong momentum behind the stock. Ocugen stock is currently trading 8% higher on Tuesday’s open. Here’s what investors need to know about the WHO decision expected this week.
Where does Ocugen currently stand on USA and Canada Covaxin approval?
Ocugen has faced multiple challenges over the past few months in their attempt to bring Covaxin to the USA and Canada. From a company with no strong revenue foundations, the opportunity to distribute a COVID-19 vaccine would have huge implications for the companies future. However, the challenges Ocugen have faced include a rejection from the FDA for Emergency Use. The FDA advised Ocugen to pursue a BLA approach in gaining approval for Covaxin in the United States.
In short, a BLA will take longer to obtain approval for Covaxin distribution in the USA. This is in contrast to an Emergency Use Authorisation, which allows for immediate use and was granted to handful of Bio-Pharma’s including Pfiser and Moderna late last year. Despite this, in August Ocugen expanded their licensing of Covaxin and applied for an EUA in Canada which is yet to be approved.
So what would a WHO approval mean for Ocugen stock?
In May, Bharat Biotech applied for Emergency Use Listing for Covaxin with the World Health Organisation (WHO). Approval from the WHO would enable people who are vaccinated with Covaxin to travel to certain countries who only recognise WHO approved vaccines.
So what are the benefits of a WHO approval for Ocugen stock? Some investors speculate that approval from the WHO would provide Covaxin some legitimacy. This is feeding hopes that an EUL from the WHO may push Covaxin approval over the line in Canada. However, in reality an EUL approval is more of a stamp of approval and it is unclear if this will have any effect on the timeline of Covaxin approval in either the USA or Canada.
Ocugen stock has remained a speculative play as it generally fluctuates sharply on Covaxin data and decisions surrounding the vaccine from regulatory bodies. The World Health Organisation was expected to make their final decision on October 5. However this has been further delayed until sometime this week. The WHO announced they alongside an independent group of experts will meet to carry a risk analysis and decide on EUL approval.
The Bottom Line – Ocugen investors await WHO decision
Overall, the current BLA approach to approving Covaxin in the United States is a long term play. Whether or not the WHO approve Covaxin under an EUL, the company still has multiple hurdles to jump before Covaxin is distributed in the United States. However, an EUL will give Covaxin a stamp of approval that has only been granted to 6 other COVID-19 vaccines. Whether or not this EUL decision will impact Covaxin’s application in Canada remains unknown, however some investors may see this as a step in the right direction.
The information above is general information only and is not financial advice nor does it constitute a recommendation. Youth Investment Group has no liability for personal financial interests or investment decisions. You should make your own investment decisions based upon your own research and what you believe is best for you.
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