Ocugen Inc (NASDAQ:OCGN) shares are trading lower by 5.86% to $2.73 during Tuesday's pre-market session after the company announced that it was informed by the FDA that the agency placed its Phase 2/3 immuno-bridging and broadening study for COVAXIN, OCU-002, on clinical hold.
Ocugen says this is a result of the company’s decision to voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility. Ocugen will work with the FDA to address any questions.
