Earnings summaries and quarterly performance for Fulcrum Therapeutics.
Executive leadership at Fulcrum Therapeutics.
Board of directors at Fulcrum Therapeutics.
Research analysts who have asked questions during Fulcrum Therapeutics earnings calls.
Matthew Biegler
Oppenheimer & Co. Inc.
4 questions for FULC
Edward Tenthoff
Piper Sandler Companies
3 questions for FULC
Joseph Schwartz
Oppenheimer
3 questions for FULC
Anish Nikhanj
RBC Capital Markets
2 questions for FULC
Corinne Jenkins
Goldman Sachs
2 questions for FULC
Dae Gon Ha
Stifel
2 questions for FULC
Gregory Renza
RBC Capital Markets
2 questions for FULC
Kristen Kluska
Cantor Fitzgerald
2 questions for FULC
Rick Miller
C.L. King & Associates
2 questions for FULC
Drewry Park
Leerink Partners
1 question for FULC
Jeremiah Lorentz
BofA Securities
1 question for FULC
Recent press releases and 8-K filings for FULC.
- Fulcrum Therapeutics' lead asset, pociredir, a fetal hemoglobin inducer for sickle cell disease, holds Fast Track and Orphan designation, with patents extending until 2040.
- Data from the Phase Ib study's 20 mg cohort showed a robust increase in fetal hemoglobin (HbF) from approximately 7% to 16.9% after six weeks, with seven of 12 patients achieving HbF levels above 20%. The drug also demonstrated reductions in hemolysis markers and an increase in total hemoglobin.
- The company plans to report full 20 mg cohort data in Q1 2026, conduct an end-of-phase meeting with the FDA in H1 2026, and potentially initiate a global registrational study in H2 2026.
- Fulcrum Therapeutics ended 2025 with a strong cash runway of $352 million, projected to last into at least 2029, fully funding anticipated regulatory milestones.
- Fulcrum Therapeutics' lead asset, pociredir, for sickle cell disease, demonstrated a robust and rapid increase in fetal hemoglobin (HbF), with the 20mg cohort achieving 16.9% HbF after 6 weeks and seven of 12 patients exceeding 20% HbF.
- The Phase Ib study also showed a meaningful reduction in vaso-occlusive crises (VOCs) and that pociredir was well tolerated.
- Key milestones for 2026 include reporting full 20mg cohort data in Q1, an end-of-phase meeting with the agency in H1, and potential enrollment in a global registrational study in H2.
- The company reported a strong cash runway of $352 million at the end of last year, which is expected to fund operations into at least 2029 and through the anticipated registrational study.
- Fulcrum Therapeutics' lead asset, pociredir, a fetal hemoglobin inducer for sickle cell disease, is completing its Phase Ib study, with data presented in July and December 2025.
- Recent data from the 20 mg cohort demonstrated a robust and rapid increase in fetal hemoglobin (HbF), with seven of 12 patients achieving over 20% HbF after 6-12 weeks, and all patients showing at least a 6.5% increase.
- The study also indicated a meaningful reduction in vaso-occlusive crises (VOCs), observing five VOCs across four patients compared to an expected 16 VOCs over 12 weeks, and the drug was well-tolerated.
- For 2026, key milestones include an end-of-phase meeting with the agency in the first half and the potential initiation of a registrational study in the second half.
- The company maintains a strong cash runway of $352 million at the end of last year, which is expected to fund operations until at least 2029.
- Fulcrum Therapeutics, Inc. expects to report approximately $352.3 million in cash, cash equivalents, and marketable securities as of December 31, 2025, which is projected to provide a cash runway into 2029.
- The company updated its corporate presentation on January 12, 2026, for upcoming investor meetings, including a presentation at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026.
- For its lead product candidate, pociredir, updated results for the 20 mg cohort of the Phase 1b PIONEER study are expected in Q1 2026, with an End-of-Phase meeting with the FDA planned for 1H 2026, and initiation of a global registrational trial anticipated in H2 2026.
- Initial 20 mg cohort data for pociredir as of November 11, 2025, showed a 9.9% mean absolute increase in HbF at Week 6 and >3.75-fold induction of HbF at 12 weeks in patients, with 58% (7/12) achieving ≥20% HbF at their latest study visit, and the drug was generally well-tolerated.
- Fulcrum Therapeutics announced the pricing of an underwritten public offering, including 11,851,853 shares of common stock at $13.50 per share and pre-funded warrants for up to 1,111,193 shares at $13.499 per pre-funded warrant.
- The offering is expected to generate $175.0 million in gross proceeds for Fulcrum.
- The net proceeds are intended for general corporate purposes, which may include working capital, research and development expenses (including clinical trials), regulatory submissions, commercialization, and potential acquisitions.
- The offering is anticipated to close on or about December 11, 2025.
- Fulcrum Therapeutics has commenced an underwritten public offering to sell $150.0 million of its common stock.
- The company intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares.
- The net proceeds from the offering are primarily intended for general corporate purposes, including working capital, capital expenditures, research and development expenses (such as funding clinical trials), and potential acquisitions or investments.
- Fulcrum Therapeutics announced positive initial results from the 20 mg dose cohort of the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD), presented at the 67th American Society of Hematology Annual Meeting.
- The trial demonstrated a clear dose-response with robust fetal hemoglobin (HbF) induction, showing a mean absolute HbF increase of 9.9% at Week 6 (from a baseline of 7.1% to 16.9%).
- As of the November 11, 2025 data cutoff, 7 of 12 patients (58%) in the 20 mg cohort achieved absolute HbF levels ≥20% at Week 6, and a >3.75-fold mean induction of HbF was observed at Week 12 among patients who reached that visit.
- Pociredir continued to be generally well-tolerated, with no treatment-related serious adverse events (SAEs) reported.
- Fulcrum Therapeutics reported positive data from the 20 milligram cohort of pociredir for sickle cell disease, showing a 9.9% mean absolute increase in HbF at week six and 58% of patients (7 out of 12) achieving ≥20% fetal hemoglobin at their last study visit.
- The drug demonstrated a greater than 3.75-fold HbF induction and was generally well tolerated with no discontinuations due to adverse events.
- Encouraging trends were observed in the reduction of vaso-occlusive crises (VOCs), with only 5 VOCs reported in 4 patients at the November 11 data cut, compared to an expected 16 VOCs over 12 weeks, and 67% of patients reporting no VOCs during the treatment period.
- The company plans to complete the 20 mg cohort and share updated data in Q1 2026, submit an end-of-phase meeting request to the FDA in Q1 2026, and potentially kick off a registrational study in H2 2026.
- Fulcrum Therapeutics announced updated data from the 20 mg cohort of its PIONEER Study for pociredir in Sickle Cell Disease (SCD), with data cut as of November 11, 2025.
- The 20 mg cohort demonstrated a 9.9% mean absolute increase in HbF at Week 6 for the full cohort (n=12), with 58% of patients (7/12) reaching ≥20% HbF at their latest study visit.
- Patients completing the 12-week treatment period in the 20 mg cohort (n=6) achieved >3.75-fold induction of HbF, demonstrating a clear dose-response compared to the 12 mg cohort's 2.4-fold induction.
- Pociredir at 20 mg was generally well-tolerated, with no serious treatment-related adverse events reported , and showed continued progression towards pan-cellularity, improvements in anemia and hemolysis, and encouraging trends in vaso-occlusive crises (VOC) reduction.
- Fulcrum Therapeutics announced positive data from the 20 mg cohort of its Pociredir study for sickle cell disease, showing a 9.9% mean absolute increase in fetal hemoglobin (HbF) at week six. This result exceeds the 8.6% increase observed with the 12 mg dose at week 12.
- The 20 mg dose demonstrated strong efficacy, with 58% of patients (7 out of 12) achieving greater than or equal to 20% HbF at their last study visit, and a greater than 3.75-fold induction in HbF. All patients showed a response, with at least a 6.5% increase in HbF.
- Pociredir at 20 mg was generally well tolerated, with no dose-limiting toxicities or discontinuations due to adverse events, and showed encouraging trends in vaso-occlusive crisis (VOC) reduction.
- The company plans to discuss the 20 mg dose with regulators in the first half of next year for registrational trials, prioritizing speed to market for this oral fetal hemoglobin inducer.
Quarterly earnings call transcripts for Fulcrum Therapeutics.
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