Gensight Biologics slumps after FDA delays LUMEVOQ roll-out

Gensight Biologics SA

18/01/2022 09:19

** Shares in Gensight Biologics  SIGHT.PA  slump 11.5% to
EUR 4.75 - their lowest since November 2020 - after the
France-based biopharma company gave an update on the regulatory
pathway of its LUMEVOQ treatment
    ** The company says U.S. FDA has recommended an additional
trial to demonstrate the efficacy of LUMEVOQ in treating Leber's
hereditary optic neuropathy  urn:newsml:reuters.com:*:nBw2yfT4ya
    ** "That means that it will require more money (costs for
the trial dedicated) and also a delay in the time-to-market,"
says Invest Securities analyst Jamila Elbougrini
    ** "We initially expected a potential BLA (Biologics License
Application) at the end of this year," the analyst adds, with
the FDA's decision effectively delaying this
    ** Out of four analysts that cover Gensight Biologics, all
rate the stock "strong buy" or "buy" 

 (Reporting by Olivier Sorgho in Gdansk)
 ((Olivier.sorgho@thomsonreuters.com))