Spero Therapeutics: Falls after FDA puts clinical hold on antimicrobial therapy study
05/02/2021 14:30
** Biopharmaceutical co's shares SPRO.O fall 15% to $16.20
premarket
** SPRO says U.S. FDA has placed a clinical hold on its
mid-stage clinical trial of SPR720, its oral antimicrobial
therapy being tested in patients with a type of lung disease
caused by certain types of mycobacteria urn:newsml:reuters.com:*:nL4N2G52XF
** Co says it had notified the FDA of its decision to pause
dosing in the trial as a precautionary measure following deaths,
in adult non-human primates, in the drug's ongoing animal
toxicology study
** Says deaths observed had inconclusive causality to the
drug; adds that no serious adverse events have been observed in
any human study participants
** Says it received verbal notification of the clinical hold
but has not yet received a written notice from the regulator
** Co says it is in discussion with the FDA to determine
further development pathway for the SPR720 clinical program
** Stock down 1.8% YTD as of last close
(Reporting by Amruta Khandekar)
((Amruta.Khandekar@thomsonreuters.com;))