Soligenix falls as cancer therapy review by FDA delayed
14/04/2023 13:52
** Shares of drug developer Soligenix Inc SNGX.O down 8.5%
at $1.5 premarket
** SNGX says U.S. FDA requires positive results from second
clinical study, on top of data already submitted, to accept co's
application for its light-based treatment for a rare type of
cancer
** Co says it will work with regulator on protocol and
feasibility of additional trial needed for the therapy, HyBryte
** "While we are very disappointed by this delay, Soligenix
and its clinical investigators remain committed to working with
the FDA and advancing HyBryte to market for patients" - CEO
** FDA in February had declined to review co's application
for HyBryte urn:newsml:reuters.com:*:nL4N34U34Q
** Up to Thursday's close, stock was down ~76% this year
(Reporting by Amna Karimi in Bengaluru)
((Amna.Karimi@thomsonreuters.com; +91 8083261226;))