Ocugen sinks after FDA asks for more data on Covid vaccine - InvestingChannel

Ocugen sinks after FDA asks for more data on Covid vaccine

Shares of Ocugen are sinking are the company announced that upon recommendation from the Food and Drug Administration, it will no longer pursue an Emergency Use Authorization for Covaxin, its Covid-19 vaccine candidate. The company will pursue submission of a biologics license application for Covaxin.

The FDA provided feedback to Ocugen regarding the master file the company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application and requested additional information and data. Ocugen said it is in discussions with the FDA to understand the additional information required to support a BLA submission. The company anticipates that data from an additional clinical trial will be required to support the submission. “While this will extend our timelines, we are committed to bringing COVAXIN to the US,” said Dr. Shankar Musunuri, CEO of Ocugen.
Shares of Ocugen are down 29%, or $2.74, to $6.57 in premarket trading.

Related posts

Carl Icahn Increases His Stake In Take-Two Interactive To 10.68%

ValueWalk

iPad Mini Display Outperformed By Kindle Fire HD & Nexus 7

ValueWalk

Foxconn Might Open Manufacturing Plants In The U.S. [REPORT]

ValueWalk

Peter Cundill Protégé Tim McElvaine on Investing in Japan [VIDEO]

ValueWalk

Set Bing Home Page Image As Lock Screen In Windows 8

ValueWalk

Morning Market News: JCP, APO, MCHP, ZIP, ENR, LGF, EA, ATVI, COV, LNT

ValueWalk