By Fulcrum Therapeutics experienced a significant boost in stock value as the U.S. Food and Drug Administration (FDA) lifted the clinical hold on their investigational-new-drug application for FTX-6058. This development is particularly significant for the treatment of sickle-cell disease.
The clinical-stage biopharmaceutical company, based in Cambridge, Massachusetts, worked closely with the FDA to address concerns related to the hold, which was originally implemented in February. With the hold now lifted, Fulcrum is preparing to resume enrollment for patients with inherited red blood cell disorders.
Earlier this year, Fulcrum temporarily halted dosing in a Phase 1b study of FTX-6058 due to preclinical data concerns raised by the FDA. The company committed to collaborating with the agency to address questions regarding the modulation of the PRC2 complex and the preclinical data.
Following the news of the FDA’s decision, Fulcrum Therapeutics’ shares experienced a surge in premarket trading. As of now, the stock has increased by almost 29%, reaching $5.04. This is a significant improvement compared to the closing price of $3.92 on Monday. It is worth noting that on February 23, before the disclosure of the clinical hold, the stock closed at $12.89.
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