Why Is Fulcrum Therapeutics Stock Surging Today?

Fulcrum Therapeutics Inc 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.