Fulcrum Therapeutics Shares Rally Premarket as FDA Lifts Study Hold

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)

Copyright (c) 2023 Dow Jones & Company, Inc.