FULC Fulcrum Therapeutics Inc.

13.99
+0.92  (+7%)
Previous Close 13.07
Open 13.92
52 Week Low 7.01
52 Week High 22.39
Market Cap $447,005,514
Shares 31,951,788
Float 22,764,502
Enterprise Value $275,917,046
Volume 118,090
Av. Daily Volume 162,111
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Upcoming Catalysts

Drug Stage Catalyst Date
Losmapimod
COVID-19
Phase 3
Phase 3
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Losmapimod
Facioscapulohumeral muscular dystrophy (FSHD)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
Losmapimod
Facioscapulohumeral muscular dystrophy (FSHD)
Phase 2
Phase 2
Phase 2 open-label trial has completed enrolment - noted March 5, 2020.
FTX-6058
Sickle Cell Disease
Phase 1
Phase 1
Phase 1 trial initiation announced October 5, 2020.

Latest News

  1. CAMBRIDGE, Mass., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced the company's recognition of Rare Disease Day 2021.

    "While COVID-19 has had an impact on most people around the world, it has put a new spotlight on the importance of connectivity and community for people affected by rare diseases who are at a higher risk of feelings of isolation and can face significant challenges in accessing information and healthcare services," said Robert J. Gould, Ph.D., Fulcrum's president and chief executive officer. "We have been privileged to work with many patients and caregivers…

    CAMBRIDGE, Mass., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced the company's recognition of Rare Disease Day 2021.

    "While COVID-19 has had an impact on most people around the world, it has put a new spotlight on the importance of connectivity and community for people affected by rare diseases who are at a higher risk of feelings of isolation and can face significant challenges in accessing information and healthcare services," said Robert J. Gould, Ph.D., Fulcrum's president and chief executive officer. "We have been privileged to work with many patients and caregivers affected by genetically defined diseases including facioscapulohumeral muscular dystrophy and sickle cell disease. They have bravely shared their stories in efforts to help others better understand these diseases and access information and support that can help."

    Rare Disease Day (www.rarediseaseday.org) was established by EURODIS in 2008 and is held on the last day of February each year in an effort to build awareness of rare diseases and the impact they have on patients and their families. The theme for Rare Disease Day 2021 highlights the need to provide members of the rare disease community around the world with new opportunities to meet, share insights and support and join together in efforts in education and advocacy. This year will mark the first all-digital Rare Disease Day involving interactive online events planned by hundreds of international advocacy, research and patient care organizations.

    During February, Fulcrum Therapeutics supported a range of efforts to help build broader awareness of facioscapulohumeral muscular dystrophy (FSHD) and sickle cell disease (SCD) by presenting information from patients and caregivers about the challenges they face. The company will also invite employees to join a virtual meeting and Q&A session where members of the FSHD and SCD communities will talk about how they have addressed different challenges and the opportunities for collaboration between patients and companies working to develop new treatments. Company team members will also take part in the virtual 5k race sponsored by the National Organization for Rare Disorders (NORD). And Fulcrum is launching a new corporate Facebook page that will present perspectives from patients and caregivers about their experiences and hopes for the future.

    About FSHD

    FSHD is characterized by progressive skeletal muscle loss that initially causes weakness in muscles in the face, shoulders, arms and trunk, and progresses to weakness throughout the lower body. Skeletal muscle weakness results in significant physical limitations, including an inability to smile and difficulty using arms for activities, with many patients ultimately becoming dependent upon the use of a wheelchair for daily mobility.

    FSHD is caused by mis-expression of DUX4 in skeletal muscle, resulting in the presence of DUX4 proteins that are toxic to muscle tissue. Normally, DUX4-driven gene expression is limited to early embryonic development, after which time the DUX4 gene is silenced. In people with FSHD, the DUX4 gene is turned "on" as a result of a genetic mutation. The result is death of muscle and its replacement by fat, leading to skeletal muscle weakness and progressive disability. There are no approved therapies for FSHD, one of the most common forms of muscular dystrophy, with an estimated patient population of 16,000 to 38,000 in the United States alone.

    About Sickle Cell Disease

    Sickle cell disease (SCD) is a genetic disorder of the red blood cells caused by a mutation in the HBB gene. This gene encodes a protein that is a key component of hemoglobin, a protein complex whose function is to transport oxygen in the body. The result of the mutation is less efficient oxygen transport and the formation of red blood cells that have a sickle shape. These sickle shaped cells are much less flexible than healthy cells and can block blood vessels or rupture cells. SCD patients typically suffer from serious clinical consequences, which may include anemia, pain, infections, stroke, heart disease, pulmonary hypertension, kidney failure, liver disease and reduced life expectancy.

    About Fulcrum Therapeutics

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta-thalassemia, into Phase 1 clinical development.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties, and other important factors, in the Company's most recent filings with the Securities and Exchange Commission.

    Contacts:

    Investors:

    Christi Waarich

    Director, Corporate Communications and Investor Relations



    617-651-8664

    Stephanie Ascher

    Stern Investor Relations, Inc.



    212-362-1200

    Media:

    Kaitlin Gallagher

    Berry & Company Public Relations



    212-253-8881



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  2. CAMBRIDGE, Mass., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that its fourth quarter and full year 2020 financial results will be released on Thursday, March 4, 2021 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.

    Dial-in Number
    U.S./Canada Dial-in Number: 800-527-6973
    International Dial-in Number: 470-495-9162
    Conference ID: 6376419

    Replay Dial-in Number: 855-859-2056
    Replay International Dial-in Number: 404-537-3406
    Conference ID…

    CAMBRIDGE, Mass., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that its fourth quarter and full year 2020 financial results will be released on Thursday, March 4, 2021 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments.

    Dial-in Number

    U.S./Canada Dial-in Number: 800-527-6973

    International Dial-in Number: 470-495-9162

    Conference ID: 6376419

    Replay Dial-in Number: 855-859-2056

    Replay International Dial-in Number: 404-537-3406

    Conference ID: 6376419

    An audio webcast will be accessible through the Investor Relations section of the company's website https://ir.fulcrumtx.com/events-and-presentations. Following the live webcast, an archived replay will also be available.

    About Fulcrum Therapeutics 

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia into Phase 1 clinical development.

    Please visit www.fulcrumtx.com.

    Contact:

    Christi Waarich

    Director, Investor Relations and

    Corporate Communications

    617-651-8664



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  3. CAMBRIDGE, Mass., Feb. 19, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that management will participate in the following virtual investor conferences:

    • Virtual SVB Leerink 10th Annual Global Healthcare Conference
      Presentation on Thursday, February 25, 2021 at 10:40 a.m. ET.
    • Virtual H.C. Wainwright Global Life Sciences Conference
      Prerecorded Fireside Chat Available on Tuesday, March 9, 2021 at 7:00 a.m. ET.

    Audio webcasts of the presentations will be available through the Investor Relations section of the Fulcrum website at https://ir.fulcrumtx.com/events-and-presentations. Archived…

    CAMBRIDGE, Mass., Feb. 19, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that management will participate in the following virtual investor conferences:

    • Virtual SVB Leerink 10th Annual Global Healthcare Conference

      Presentation on Thursday, February 25, 2021 at 10:40 a.m. ET.
    • Virtual H.C. Wainwright Global Life Sciences Conference

      Prerecorded Fireside Chat Available on Tuesday, March 9, 2021 at 7:00 a.m. ET.

    Audio webcasts of the presentations will be available through the Investor Relations section of the Fulcrum website at https://ir.fulcrumtx.com/events-and-presentations. Archived replays will be available on the Company's website for 90 days after each conference.

    About Fulcrum Therapeutics

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta thalassemia into Phase 1 clinical development.

    Please visit www.fulcrumtx.com.

    Contact:

    Christi Waarich

    Director, Investor Relations

    and Corporate Communications

    617-651-8664

     



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  4. CAMBRIDGE, Mass., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced closing of its previously announced underwritten public offering of 4,600,000 shares of its common stock at a public offering price of $11.00 per share, which includes 600,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less underwriting discounts and commissions. The total gross proceeds of the offering were $50.6 million, before deducting underwriting discounts and commissions and offering expenses payable by Fulcrum…

    CAMBRIDGE, Mass., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced closing of its previously announced underwritten public offering of 4,600,000 shares of its common stock at a public offering price of $11.00 per share, which includes 600,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares at the public offering price, less underwriting discounts and commissions. The total gross proceeds of the offering were $50.6 million, before deducting underwriting discounts and commissions and offering expenses payable by Fulcrum. All of the shares in the offering were sold by Fulcrum.

    SVB Leerink, Piper Sandler & Co. and Credit Suisse acted as joint book-running managers for the offering. H.C. Wainwright & Co. acted as lead manager for the offering.

    The shares were offered by Fulcrum pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission ("SEC").

    This offering was made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at ; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at ; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by e-mail at .

    This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Fulcrum Therapeutics

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta-thalassemia, into Phase 1 clinical development.

    Contact:

    Christi Waarich

    Director, Investor Relations

    and Corporate Communications

    617-651-8664



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  5. CAMBRIDGE, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that it has priced an underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $11.00 per share, for total gross proceeds of $44.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Fulcrum. All of the shares in the offering are being sold by Fulcrum. In addition, Fulcrum has granted the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock at the public offering price, less the underwriting…

    CAMBRIDGE, Mass., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc. (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that it has priced an underwritten public offering of 4,000,000 shares of its common stock at a public offering price of $11.00 per share, for total gross proceeds of $44.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Fulcrum. All of the shares in the offering are being sold by Fulcrum. In addition, Fulcrum has granted the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock at the public offering price, less the underwriting discount and commissions. The offering is expected to close on January 22, 2021, subject to customary closing conditions.

    SVB Leerink, Piper Sandler & Co. and Credit Suisse are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

    The shares are being offered by Fulcrum pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the Securities and Exchange Commission ("SEC").

    This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at ; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at ; or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by e-mail at .

    This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Fulcrum Therapeutics

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The company has advanced losmapimod to Phase 2 clinical development for the treatment of facioscapulohumeral muscular dystrophy (FSHD) and Phase 3 for the treatment of COVID-19. Fulcrum has also advanced FTX-6058, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and beta-thalassemia, into Phase 1 clinical development.  

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, such as those, among others, relating to the Company's plans to consummate the public offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to the satisfaction of customary closing conditions related to the public offering and the impact of general economic, industry or political conditions in the United States or internationally. There can be no assurance that the Company will be able to complete the public offering on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the offering, Fulcrum and its business can be found under the caption "Risk Factors" included in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, the Company's preliminary prospectus supplement filed with the SEC on January 19, 2021, and other filings that the Company may make with the SEC in the future. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Contact:

    Christi Waarich

    Director, Investor Relations

    and Corporate Communications

    617-651-8664

     



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