** Shares of drug developer Axcella Health Inc AXLA.O
surge 42% premarket to 85 cents, top gainer across U.S.
exchanges
** Co said late on Wednesday the U.S. FDA cleared the
application to begin mid to late-stage study in the U.S. for
AXA1125 in the treatment of Long COVID Fatigue
** The mid- to late-stage study will enroll participants who
have had fatigue for at least 12 weeks after COVID-19 infection
and measure the main goal of improvements in fatigue
** Study design now accepted by U.S. and U.K. regulatory
authorities - AXLA
** The application was based on a mid-stage study which
found patients who received AXA1125 experienced clinically and
statistically significant improvement in mental and physical
fatigue scores compared to placebo
** Co lost ~84% in 2022
(Reporting by Sriparna Roy)
((Sriparna.Roy@thomsonreuters.com;))