ROCKET🚀🚀🚀Ocugen says EU backs a U.S. trial for gene therapy

$Ocugen(OCGN.US)$
Ocugen (NASDAQ:OCGN) shares traded higher on Wednesday after the company said that EU regulators agreed to a U.S.-based trial to support a marketing authorization application for the company’s gene therapy candidate, OCU400.

The decision comes after an expert panel of the EU drug regulator, the European Medicines Agency (EMA), reviewed the critical components of the company's Phase 3 liMeliGhT clinical trial for OCU400 in retinitis pigmentosa, a group of rare eye disorders.

“The EMA opinion is an extremely favorable outcome, as it will potentially reduce the time and cost to gain marketing authorization in the EU,” the company noted.

Early this week, Ocugen (OCGN) said that the U.S. FDA cleared an amendment to its OCU400 Phase 3 clinical trial.

The pivotal liMeliGhT study, expected to enroll 150 participants mainly in the U.S., marks a significant milestone for Ocugen (OCGN), as it looks to obtain regulatory approval for OCU400 in 2026.