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Fulcrum Therapeutics Inc
NASDAQ:FULC

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Fulcrum Therapeutics Inc
NASDAQ:FULC
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Price: 6.73 USD -3.03% Market Closed
Market Cap: $448.2m

Fulcrum Therapeutics Inc
Investor Relations

Fulcrum Therapeutics, Inc. is a clinical stage biopharmaceutical company. The company is headquartered in Cambridge, Massachusetts and currently employs 104 full-time employees. The company went IPO on 2019-07-18. The firm focuses on improving the lives of patients with genetically defined rare diseases. The firm has developed a product engine which identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The firm is also engaged in developing drugs for the treatment for the root cause of muscle disorders, central nervous system disorders and blood disorders. The firm uses its proprietary product engine to identify and validate drug targets and develop product candidates to address diseases caused by the mis-expression of certain genes. Its product candidate includes losmapimod, is a small molecule that is developed for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and FTX-6058, is a small molecule designed to bind embryonic ectoderm development (EED).

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Last Earnings Call
Fiscal Period
Q4 2025
Call Date
Feb 24, 2026
AI Summary
Q4 2025

Robust HbF Induction: Pociredir 20 mg showed a mean increase in fetal hemoglobin (HbF) from 7.1% to 19.3% at 12 weeks, with 58% of patients achieving at least 20% HbF—levels linked to meaningful clinical benefit.

Encouraging Hematologic Effects: The trial saw a 1.1 g/dL mean rise in total hemoglobin and significant reductions in hemolysis markers (LDH down 34%, indirect bilirubin down 40%) and reticulocytes (down 42%), reflecting improved red blood cell health.

VOC Reduction Trend: Seven of twelve patients reported no vaso-occlusive crises (VOCs) during treatment, with observed VOCs (6 in 5 patients) well below the 16 events expected from baseline rates.

Favorable Safety Profile: Pociredir was generally well tolerated at 20 mg, with no treatment-related serious adverse events or dose-limiting toxicities, and all observed adverse events resolved with continued dosing.

Regulatory and Phase III Plans: Fulcrum plans to initiate a registration-enabling trial in the second half of 2026 and is engaging with US and European regulators, supported by data viewed as strong enough to move forward.

Competitive Positioning: Management believes pociredir has a two-year head start over other oral HbF inducers in development, with a focus on maximizing global access.

Key Financials
Baseline HbF
7.1%
Mean HbF at Week 12
19.3%
Patients Achieving ≥20% HbF
58%
F cells
63%
Patients with No VOCs During Treatment
7 of 12
Observed VOC Events During Treatment
6 in 5 patients
Expected VOC Events (from Baseline Rate)
16 events over 12 weeks
Patients Dosed in Fulcrum Trials (all doses)
almost 150
Earnings Call Recording
Other Earnings Calls

Management

Mr. Alexander C. Sapir
CEO, President & Director
No Bio Available
Mr. Alan A. Musso C.M.A., CPA
Chief Financial Officer
No Bio Available
Mr. Curtis G. Oltmans J.D.
Senior VP, Chief Legal Officer & Corporate Secretary
No Bio Available
Mr. Mel Hayes
Executive Vice President of Patient Experience
No Bio Available
Dr. Danny Reinberg
Founder
No Bio Available
Mr. Gregory Tourangeau
Controller & Principal Accounting Officer
No Bio Available

Contacts

Address
MASSACHUSETTS
Cambridge
26 Landsdowne St
Contacts
+16176518851.0
www.fulcrumtx.com
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