Ocugen shares swing up on Covid-19 vaccine manufacturing deal
Biopharmaceutical play Ocugen is preparing for potential commercial manufacturing of its Covid-19 vaccine for the US and Canadian markets.
- Ocugen, Inc (Nasdaq: OCGN) share price rises to US$6.51 per share on Wednesday (16 June 2021)
- It is working to bring its Covid-19 shot to the US and Canada
- The company is pursuing full US approval for Covaxin, instead of EUA
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Ocugen stock price: What’s the latest?
Shares of drug developer Ocugen, which plans to bring a Covid-19 vaccine to the US, jumped almost 4% to close at US$6.51 on Wednesday. About 26.3 million shares changed hands.
Year-to-date, the stock price has more than doubled, fuelled by positive news about its Covid-19 vaccine candidate, Covaxin, which Ocugen is co-developing with India-based Bharat Biotech for the US market.
Ocugen recently also secured exclusive rights to co-develop, manufacture and commercialise the vaccine in Canada.
On Wednesday, the biotech announced it was preparing for potential commercial manufacturing of Covaxin in the US and Canada, having selected Jubilant HollisterStier as its manufacturing partner.
Sentiment among research teams turned less bullish over the past month, with three in four analysts rating OCGN shares ‘hold’ and only one recommending ‘buy’.
Their average 12-month target price stood at US$6.13 per share as of Wednesday, Bloomberg data showed, implying a potential downside of 5.8% from the last close. That was also nearly half of the US$12.50 average price target last month.
Why is Ocugen no longer seeking emergency use authorisation?
Despite the string of positive developments, Ocugen’s shares had slumped recently when it said it would file for full US approval of Covaxin, instead of emergency use authorisation (EUA).
OCGN shares sank 28.1% last Thursday (10 June 2021), after the drugmaker’s announcement. The Covid-19 shot is already in use in India.
The decision was made because the US Food and Drug Administration (FDA) had recommended Ocugen take the standard path to a full approval, known as a biologics licence application, which takes many additional months, The New York Times (NYT) reported.
The FDA also requested more information and data for the full approval. Ocugen said it expects data from an additional clinical trial will be required to support the marketing application submission for its Covid-19 vaccine candidate.
‘While this will extend our timelines, we are committed to bringing Covaxin to the US,’ Ocugen added.
NYT noted that this is a sign that the FDA is changing its approach to Covid-19 vaccines in general.
Russell 3000 Index to welcome Ocugen as member
On Wednesday, Ocugen announced that it will join the broad-market Russell 3000 Index after the US stock market opens on 28 June 2021. Membership will be in place for one year.
The annual reconstitution of the Russell indices captures the 4,000 largest US stocks as of 07 May 2021, ranking them by total market capitalisation.
Russell indices are used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies.
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