Shares of the biopharmaceutical company Fulcrum Therapeutics (NASDAQ:FULC) have surged by nearly 35% at the time of writing, driven by the announcement that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its investigational new drug application for FTX-6058, intended for the treatment of sickle-cell disease (SCD).
Earlier this year, in February, the healthcare regulator placed a clinical hold, leading to a pause in the Phase 1b study of the drug. The recent action from the FDA comes on the back of previous preclinical data submitted in April, October, and December 2022, and non-clinical and clinical observations of hematological malignancies associated with other PRC2 inhibitors.
Next, the company plans to advance the clinical development of FTX-6058, which has shown an increase in HbF (fetal hemoglobin) levels with each dose escalation in the Phase 1b trial.
Importantly, FTX-6058 has bagged fast track as well as orphan drug designations for the treatment of SCD. SCD, a genetic disorder of the red blood cells, can lead to serious consequences, including stroke, kidney failure, liver disease, and lower life expectancy in patients.
Today’s price gains come after a nearly 69% correction in Fulcrum shares over the past six months. Notably, Stifel Nicolaus analyst Dae Gon Ha has upped the rating on the stock to a Buy from a Hold alongside an $11 price target today.
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