Fulcrum Therapeutics Stock Price, News & Analysis

Fulcrum Therapeutics, Inc. (Nasdaq: FULC) will release its fourth quarter and full year 2022 financial results on March 9, 2023, before U.S. markets open. A conference call and webcast will follow at 8:00 a.m. ET. The company focuses on treatments for genetically defined rare diseases, with two lead clinical programs: losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease. For more details, access the conference call via telephone or the company's website.

Fulcrum Therapeutics, Inc. (Nasdaq: FULC) announced a full clinical hold issued by the FDA on February 23, 2023, for its Investigational New Drug application of FTX-6058, aimed at treating sickle cell disease. The hold, based on preclinical data, requires Fulcrum to suspend dosing in its Phase 1b trial until clarification is provided by the FDA, expected within 30 days. Despite this setback, the interim president expressed optimism about addressing the FDA's queries and maintaining confidence in the drug's potential benefits. FTX-6058 is a small-molecule inhibitor under development to increase fetal hemoglobin levels in patients.

Fulcrum Therapeutics (Nasdaq: FULC) announced the granting of stock options to two new employees as part of its 2022 Inducement Stock Incentive Plan. A total of 113,200 shares were granted at an exercise price of $12.41 each, reflecting the closing price on February 6, 2022. The options have a ten-year term and will vest over four years, beginning with 25% vesting after the first year and 6.25% quarterly thereafter. Fulcrum Therapeutics is focused on developing treatments for genetically defined rare diseases, with lead programs targeting facioscapulohumeral muscular dystrophy and sickle cell disease.

Fulcrum Therapeutics (Nasdaq: FULC) announced management's participation in the virtual SVB Securities Global Biopharma Conference on February 15, 2023, at 10:00 AM ET. The presentation will be accessible via webcast on the company's website, with an archived replay available for 90 days. Fulcrum is dedicated to enhancing the lives of patients with genetically defined rare diseases, focusing on two lead programs: losmapimod for facioscapulohumeral muscular dystrophy and FTX-6058 for sickle cell disease and other hemoglobinopathies. Their proprietary FulcrumSeek™ engine targets gene expression to tackle underlying genetic issues.

Fulcrum Therapeutics (FULC) announced a public offering of 9,615,384 common shares priced at $13.00 each, aiming to raise approximately $125 million before expenses. This offering is conducted under an existing shelf registration statement and is expected to close on or about January 20, 2023. The underwriters have a 30-day option to purchase an additional 1,442,307 shares. Goldman Sachs, SVB Securities, and Piper Sandler are managing the offering. The funds are aimed at advancing Fulcrum’s clinical programs targeting genetic rare diseases, specifically treatments for facioscapulohumeral muscular dystrophy and sickle cell disease.

Fulcrum Therapeutics, Inc. (Nasdaq: FULC) has announced a public offering of $100 million in common stock, with an additional $15 million available to underwriters. The offering, led by Goldman Sachs & Co. LLC, SVB Securities, and Piper Sandler & Co., aims to support the company’s focus on genetically defined rare diseases. The shares will be offered under an effective shelf registration statement previously filed with the SEC. Completion of the offering is contingent on market conditions, with no assurance on final terms.

Fulcrum Therapeutics (Nasdaq: FULC) announced the grant of non-statutory stock options to new employees under its 2022 Inducement Stock Incentive Plan. A total of 29,200 options were awarded to two employees at an exercise price of $10.20 per share, reflecting the closing price on January 9, 2023. The options vest over four years, with 25% vesting after one year and the remaining 75% in quarterly installments over the next three years, contingent on continued employment. Fulcrum focuses on treating genetically defined rare diseases, with clinical programs targeting facioscapulohumeral muscular dystrophy and sickle cell disease.

Fulcrum Therapeutics (Nasdaq: FULC) provided updates on its clinical programs and corporate changes. The FDA granted Fast Track Designation to FTX-6058 for sickle cell disease, with promising Phase 1b trial results showing up to 9.5% increases in fetal hemoglobin (HbF). Enrollment continues in the ongoing trials for both FTX-6058 and losmapimod, targeted for facioscapulohumeral muscular dystrophy. The company also announced a leadership change, appointing Robert J. Gould as interim CEO. Fulcrum expects sufficient cash runway to fund operations into late 2024.

Fulcrum Therapeutics has appointed Robert J. Gould, Ph.D. as interim CEO following the departure of Bryan Stuart to pursue other opportunities. This transition, effective January 3, 2023, comes as the company seeks a permanent CEO. Gould, a founding member and former CEO, brings over 35 years of industry experience and will guide the company through ongoing clinical programs, including FTX-6058 for sickle cell disease and losmapimod for facioscapulohumeral muscular dystrophy. The Board expressed confidence in Gould's leadership during this pivotal time.