FDA places FTX-6058 on clinical hold; Fulcrum reports Q4/FY2022 results

Fulcrum Therapeutics, Inc.

FDA placed full clinical hold on FTX-6058 IND for sickle cell disease; enrollment paused and dosing suspended.
Phase 1b 12 mg cohort showed up to 10% absolute HbF increase; company working to address FDA concerns.
Losmapimod Phase 3 REACH trial enrollment on track to complete in second half of 2023.
Completed $117.3M public offering in January 2023; cash runway extends into mid-2025.
CMO Santiago Arroyo resigned; Iain Fraser appointed Interim CMO, effective March 9, 2023.

item 2.02 item 9.01

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Fulcrum Therapeutics, Inc. reported financial results for the quarter and year ended December 31, 2022.

Period: the quarter and year ended December 31, 2022
Result: reported results

Exact text from the filing

On March 9, 2023, Fulcrum Therapeutics, Inc., or Fulcrum, announced its financial results for the quarter and year ended December 31, 2022.

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Source: SEC EDGAR

accession 0000950170-23-006834

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