Ocugen forced to pursue a BLA path in the US for COVID-19 candidate

11 June 2021

USA-based biotech firm Ocugen (Nasdaq: OCGN) suffered a setback yesterday when it revealed that, on the recommendation of the US Food and Drug Administration (FDA), it will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN.

The company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN, which would have been a much faster route to potential approval, as has been the case with all the COVID-19 vaccines that have been cleared for use. As a result, the company’s shares fell as much as 40% yesterday, closing down 28% at $6.69.

Ocugen acquired rights to develop the vaccine in the USA and Canada from India’s Bharat Biotech.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK