Larimar set to open at record low as FDA maintains clinical hold on trial

Hanall Biopharma

15/02/2022 11:06

** Shares of biopharma co  LRMR.O  fall ~58% premarket and
are set to open at an all-time low of $3.50 after co says U.S.
FDA is maintaining its clinical hold on an early-stage trial of
CTI-1601, to treat Friedreich's ataxia (FA) 
    ** Stock is the biggest pct loser across all U.S. exchanges 
    ** Patients with FA, a rare inherited disease causing
progressive nervous system damage and movement problems, are
unable to produce enough of an essential protein called frataxin
    ** The trial was put on clinical hold in May following 
Larimar's notification of mortalities, which occurred at the
highest dose levels in a non-human primate toxicology study
 urn:newsml:reuters.com:*:nL3N2ND2HO
    ** In its feedback, FDA stated additional data is needed to
resolve the clinical hold  urn:newsml:reuters.com:*:nFWN2UP1G5
    ** LRMR is analyzing previously completed studies, and is
evaluating if additional studies are warranted; co intends to
engage with FDA to provide requested data
    ** Co says the continued clinical hold will impact timing of
planned open-label extension and pediatric clinical trials 
    ** Stock lost ~22.4% this year, as of last close

 (Reporting by Mrinalika Roy in Bengaluru)
 ((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325;))