Fulcrum Therapeutics Inc. (NASDAQ:FULC) stock is surging on Monday, after the company released initial results from the ongoing 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease.
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“We are highly encouraged by these initial data from the 20 mg cohort, which show clear evidence of a dose-response and build on the strong profile established with the 12 mg cohort,” said Alex Sapir, Fulcrum’s President and CEO.
Mean absolute fetal hemoglobin (HbF) increased by 9.9% at six weeks of treatment with pociredir (vs. 5.6% at week six and 8.6% at week 12 in the 12 mg cohort), increasing from a baseline of 7.1% to 16.9%.
As of the Nov. 11, 2025 data cutoff, seven of 12 patients (58%) achieved absolute HbF levels ≥20% at week six, and all patients demonstrated a robust HbF increase.
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HbF levels of 20% are associated with ~90% of patients experiencing zero vaso-occlusive crisis (VOCs) per year, based on real-world data presented by Fulcrum at the 20th Annual Sickle Cell & Thalassemia Conference (ASCAT) in October 2025.
A clear dose-response was observed, with a >3.75-fold mean induction of HbF at week 12 among patients who reached the week 12 visit as of the Nov. 11, 2025 data cutoff (n=6), compared to a 2.4-fold mean induction at week 12 in the 12 mg cohort.
The average baseline for these six patients is 5% as compared to 7.1% for the full cohort. Fold induction accounts for differences in baseline HbF levels and enables a normalized comparison of dose-response.
The proportion of F-cells (HbF-containing red blood cells) increased from a mean of 31% at baseline to 58% at week six (n=9), indicating early progression toward pan-cellular HbF induction (evenly distributed across red blood cells).
The safety profile observed in the 20 mg dose cohort, together with follow-up data from the 12 mg dose cohort, remained consistent with previously reported safety data.
Analyst Views
HC Wainwright maintains a Buy rating and raises the price forecast from $18 to $25.
Piper Sandler reiterates the Overweight rating and raises the price forecast from $16 to $23.
Cantor Fitzgerald maintains the Overweight rating and raises the price forecast from $15 to $24.
RBC Capital maintains Fulcrum with a Sector Perform and raises the price forecast from $7 to $10.
FULC Price Action: Fulcrum Therapeutics stock is up 9.66% at $14.21 at publication on Monday.
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