Fulcrum Therapeutics Shares Rally Premarket as FDA Lifts Study Hold
August 22 2023 - 7:48AM
Dow Jones News
By Colin Kellaher
Fulcrum Therapeutics shares surged in premarket trading Tuesday
after the U.S. Food and Drug Administration lifted a full clinical
hold on an investigational-new-drug application for FTX-6058 for
the treatment of sickle-cell disease.
The Cambridge, Mass., clinical-stage biopharmaceutical company
said it worked diligently with the FDA to resolve the hold, which
was implemented in February, and that it plans to resume enrollment
for patients with the inherited red blood cell disorders.
Fulcrum earlier this year suspended dosing in a Phase 1b study
of FTX-6058 after the FDA initiated the hold due to previously
reported preclinical data. At the time, Fulcrum said it would work
with the agency to address questions related to modulation of the
PRC2 complex and the preclinical data.
Fulcrum shares, which closed Monday at $3.92, were recently up
nearly 29% to $5.04 in premarket trading. The stock closed at
$12.89 on Feb. 23, the day before Fulcrum disclosed the clinical
hold.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 22, 2023 07:33 ET (11:33 GMT)
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