Fulcrum Therapeutics Inc (NASDAQ:FULC) shares are trading higher after the FDA lifted the clinical hold on the Investigational New Drug (IND) application for FTX-6058 for the potential treatment of sickle-cell disease (SCD).
"Based on the initial data from the Phase 1b trial, which showed increasing levels of HbF with each dose escalation, we believe in the potential of FTX-6058 to not only shift the current standard of care but importantly, offer these patients a differentiated oral option. We look forward to building on these results with plans to resume enrollment for patients with SCD," said Alex Sapir, Fulcrum's president & CEO.
In February, the FDA placed the IND for FTX-6058 on clinical hold.
In its communication, the agency noted preclinical data previously submitted in April, October, and December 2022 and non-clinical and clinical evidence of hematological malignancies observed with other inhibitors of polycomb repressive complex 2 (PRC2).
In connection with the clinical hold, Fulcrum suspended dosing in the Phase 1b trial of FTX-6058.
Price Action: FULC shares are up 52% at $5.96 on the last check Tuesday.
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