FDA Places Clinical Hold On Ocugen's Late-Stage COVID-19 Vaccine Trial

The FDA has placed a clinical hold on Ocugen Inc OCGN Phase 2/3 immuno-bridging and broadening study for COVAXIN (BBV152) OCU-002. 

• This results from the Company's decision to implement a temporary pause in dosing participants of OCU-002 voluntarily.
• Ocugen is evaluating World Health Organization statements following their inspection of Bharat Biotech International Limited's (BBIL) manufacturing facility.
• Related: Read Why Did WHO Suspend UN Supply of Bharat Biotech's Covaxin COVID-19 Vaccine.
• The Company said it would work with the FDA to address any questions.
• Also Read: FDA Denies Pediatric EUA To Ocugen For Bharat Biotech's COVID-19 Vaccine Covaxin.
• Price Action: OCGN shares are down 5.52% at $2.74 during the premarket session on the last check Tuesday.