• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Dashboard
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlerts
    Company
    AboutQuantisnow PlusContactJobs
    Legal
    Terms of usePrivacy policyCookie policy

    Fulcrum Therapeutics Strengthens Leadership Team with the Appointments of Isabel Kalofonos as Chief Commercial Officer and Heather Faulds as Chief Regulatory Affairs & Quality Assurance Officer

    8/19/24 7:00:00 AM ET
    $FULC
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $FULC alert in real time by email

    CAMBRIDGE, Mass., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced the appointment of Isabel Kalofonos as chief commercial officer and Heather Faulds as chief regulatory affairs & quality assurance officer. Together, Ms. Kalofonos and Ms. Faulds will be instrumental in advancing losmapimod towards a New Drug Application (NDA) submission and preparing for commercial launch.

    "I am excited to welcome Isabel to our leadership team as we continue to advance towards the potential approval and launch of losmapimod for the treatment of FSHD," said Alex C. Sapir, Fulcrum's president and chief executive officer. "Isabel has a proven track record of highly successful rare disease drug launches including the launch of ELAHERE® and TAKHZYRO®. With her leadership and experience, we are well positioned to transform Fulcrum Therapeutics into a commercial-stage biotechnology company."

    Mr. Sapir continued, "We are equally excited to have Heather join our leadership team. Heather brings deep knowledge of the neuromuscular landscape and experience in designing and implementing innovative regulatory strategies. During her tenure at Biogen, Heather led the global filing for SPINRAZA® for the treatment of spinal muscular atrophy, which was approved by the FDA under priority review designation in 90 days. Heather's expertise will be invaluable as we continue to prepare for the NDA filing and potential approval of losmapimod."

    Isabel Kalofonos, Chief Commercial Officer

    Ms. Kalofonos joins Fulcrum from ImmunoGen where she served as Senior Vice President and Chief Commercial Officer. While at ImmunoGen, Ms. Kalofonos led commercial efforts globally for the launch of ELAHERE (mirvetuximab soravtansine-gynx) for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Prior to ImmunoGen, she served as Senior Vice President and Global Head of the Prescription Business Unit at Galderma. During her tenure, she led the launch preparation for NEMLUVIO® (nemolizumab), a monoclonal antibody for the treatment of atopic dermatitis and prurigo nodularis, which included marketing, global market access, pricing, and health economics / outcomes research. Ms. Kalofonos also led all commercial franchises of prescription products. Prior to Galderma, Ms. Kalofonos held roles of increasing responsibility at Takeda Pharmaceuticals (formerly Shire), most recently serving as Vice President and Head of the Hereditary Angioedema (HAE) franchise. In this role, she oversaw the global blockbuster launch of TAKHZYRO (lanadelumab-flyo). Prior to the Takeda acquisition, Ms. Kalofonos held roles of increasing responsibility at Shire within corporate strategy, new product planning, and commercial, and gained experience across multiple therapeutic areas including immunology, oncology, neurology, transplant, and gene therapy. Before Shire, she worked in commercial, business strategy, and product launch positions at Forest Labs, Bionevia Pharmaceuticals, and Sunovion Pharmaceuticals.

    "Losmapimod is positioned to be a potential first-to-market oral therapy for the treatment of FSHD, a progressive and debilitating disease for which there are no approved treatments," said Isabel Kalofonos. "This is a pivotal moment, and I am thrilled to join as the company prepares to transition to a commercial-stage organization. With a strong commitment to delivering innovative therapies to patients who currently have no treatment options, I look forward to building on the team's exceptional work and driving the successful launch of losmapimod."

    Heather Faulds, Chief Regulatory Affairs and Quality Assurance Officer

    Ms. Faulds brings over 20 years of experience leading global regulatory strategies across all phases of development, as well as multiple therapeutic areas and modalities. Most recently, Ms. Faulds served as SVP, Regulatory Affairs at Alkermes, where she led the team that achieved FDA approval for LYBALVI® (olanzapine and samidorphan) for the treatment of schizophrenia and bipolar disease. Previously, Heather served as SVP, Regulatory Affairs at Scholar Rock where she led multiple functions spanning regulatory affairs, GxP compliance, pharmacovigilance, and medical writing, and was responsible for regulatory strategies across clinical programs for rare diseases and immuno-oncology. Prior to joining Scholar Rock, Heather spent 12 years at Biogen in roles of increasing responsibility across CMC regulatory and global regulatory strategy. While there, her leadership paved the way for several novel health authority approvals including SPINRAZA (nusinersen), the first treatment for spinal muscular atrophy, which was approved by FDA in 90 days from NDA submission. Ms. Faulds also led regulatory activities for programs in alzheimer's disease and multiple sclerosis.

    "I have been fortunate to work on significant advances for the treatment of neurodegenerative and neuromuscular diseases to address the high unmet needs for patients, including SPINRAZA for the treatment of spinal muscular atrophy, and I am eager to bring my regulatory expertise and passion to Fulcrum," said Heather Faulds. "With an opportunity to build on a strong foundation of scientific innovation and clinical execution, I look forward to working closely with the team as we prepare for the next stage of growth. Together, we'll strive to deliver potentially transformative therapies to patients as expeditiously as possible."

    About Fulcrum Therapeutics

    Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's two lead programs in clinical development are losmapimod, a small molecule in development for the treatment of facioscapulohumeral muscular dystrophy (FSHD), and pociredir (formerly known as FTX-6058), a small molecule designed to increase expression of fetal hemoglobin and in development for the treatment of sickle cell disease (SCD). Fulcrum uses proprietary technology to identify drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. For more information, visit www.fulcrumtx.com and follow us on Twitter/X (@FulcrumTx) and LinkedIn.

    About Losmapimod

    Losmapimod is a selective p38α/β mitogen activated protein kinase (MAPK) inhibitor. Fulcrum exclusively in-licensed losmapimod from GSK following Fulcrum's discovery of the role of p38α/β inhibitors in the reduction of DUX4 expression and an extensive review of known compounds. Results reported from the Phase 2b ReDUX4 trial demonstrated slower disease progression and improved function, including positive impacts on upper extremity strength and functional measures supporting losmapimod's potential to be a transformative therapy for the treatment of FSHD. Although losmapimod had never previously been explored in muscular dystrophies, it had been evaluated in more than 3,600 subjects in clinical trials across multiple other indications with no safety signals attributed to losmapimod. Losmapimod has been granted FDA Fast Track designation and Orphan Drug Designation for the treatment of FSHD. Losmapimod is currently being evaluated in a Phase 3 multi-center randomized, double-blind, placebo-controlled, 48-week parallel-group study in people with FSHD (NCT05397470).

    About FSHD

    FSHD is a serious, rare, progressive, and debilitating disease for which there are no approved treatments. It is characterized by fat infiltration of skeletal muscle leading to muscular atrophy involving primarily the face, scapula and shoulders, upper arms, and abdomen. Impact on patients includes relentless and accumulating muscle and functional loss impacting their ability to perform activities of daily living, loss of upper limb function, loss of mobility and independence, and chronic pain. FSHD is one of the most common forms of muscular dystrophy and has an estimated patient population of 30,000 in the United States alone.

    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. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, including express or implied statements regarding advancement of losmapimod towards regulatory submission, approval and commercial launch; the timeline for reporting topline data in the Phase 3 REACH trial of losmapimod in FSHD Fulcrum's ability to deliver an FDA-approved therapy for FSHD patients; and losmapimod's potential as a first-to-market oral therapy; among others. 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. 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. These risks and uncertainties include, but are not limited to, risks associated with Fulcrum's ability to continue to advance its product candidates in clinical trials; initiating and enrolling clinical trials on the timeline expected or at all; obtaining and maintaining necessary approvals from the FDA and other regulatory authorities; replicating in clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials of losmapimod, pociredir and any other product candidates; obtaining, maintaining or protecting intellectual property rights related to its product candidates; managing expenses; managing executive and employee turnover, including integrating new employees; and raising the substantial additional capital needed to achieve its business objectives, among others. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Fulcrum'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 Fulcrum's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Fulcrum's views as of the date hereof and should not be relied upon as representing Fulcrum's views as of any date subsequent to the date hereof. Fulcrum anticipates that subsequent events and developments will cause Fulcrum's views to change. However, while Fulcrum may elect to update these forward-looking statements at some point in the future, Fulcrum specifically disclaims any obligation to do so.

    Contact:

    Chris Calabrese

    LifeSci Advisors, LLC

    [email protected]

    917-680-5608



    Primary Logo

    Get the next $FULC alert in real time by email

    Chat with this insight

    Save time and jump to the most important pieces.

    Recent Analyst Ratings for
    $FULC

    DatePrice TargetRatingAnalyst
    9/13/2024$17.00 → $4.00Buy → Neutral
    H.C. Wainwright
    9/12/2024$15.00 → $4.00Outperform → Sector Perform
    RBC Capital Mkts
    9/12/2024$4.00Outperform → Market Perform
    Leerink Partners
    9/12/2024$10.00 → $2.00Neutral → Underperform
    BofA Securities
    9/12/2024Buy → Hold
    Stifel
    9/12/2024Overweight → Neutral
    Cantor Fitzgerald
    9/9/2024$5.00 → $10.00Underperform → Neutral
    BofA Securities
    5/20/2024$23.00Overweight
    Cantor Fitzgerald
    More analyst ratings

    $FULC
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • Fulcrum Therapeutics to Participate in Upcoming May Conferences

      CAMBRIDGE, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (the "Company") (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced that management will participate in the following conferences: H.C. Wainwright BioConnect Investor Conference at NASDAQMay 20, 2025New York, New York RBC Capital Markets Global Healthcare ConferenceMay 21, 2025Fireside Chat at 3:35 pm ET, Participation link: HERENew York, New York The webcast of the fireside chat will be accessible by visiting the "Events and Presentations" section of Fulcrum Therapeutics' websi

      5/8/25 4:05:00 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for First Quarter 2025

      ― Enrollment complete in the 12 mg dose cohort (n=16) of the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD); initiated the 20 mg dose cohort ― ― On track to provide clinical data from the 12 mg dose cohort in early Q3 2025 and the 20 mg dose cohort by the end of 2025 ― ― Ended Q1 2025 with $226.6 million in cash, cash equivalents, and marketable securities; cash runway into at least 2027 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., May 01, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improv

      5/1/25 7:00:00 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Fulcrum Therapeutics to Host First Quarter 2025 Financial Results Conference Call and Webcast on Thursday, May 1, 2025, at 8:00 a.m. ET

      CAMBRIDGE, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (the "Company") (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced that its first quarter 2025 financial results will be released on Thursday, May 1, 2025, 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. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and u

      4/24/25 8:00:00 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $FULC
    Insider Purchases

    Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • Sapir Alex bought $492,028 worth of shares (43,360 units at $11.35) (SEC Form 4)

      4 - Fulcrum Therapeutics, Inc. (0001680581) (Issuer)

      3/5/24 4:15:17 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $FULC
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • SEC Form 4 filed by Chief Financial Officer Musso Alan A

      4 - Fulcrum Therapeutics, Inc. (0001680581) (Issuer)

      1/28/25 4:15:14 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 4 filed by Chief Legal Officer Oltmans Curtis Gale

      4 - Fulcrum Therapeutics, Inc. (0001680581) (Issuer)

      1/28/25 4:15:06 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 4 filed by Officer Sapir Alex

      4 - Fulcrum Therapeutics, Inc. (0001680581) (Issuer)

      1/28/25 4:15:11 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $FULC
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • Amendment: SEC Form SC 13G/A filed by Fulcrum Therapeutics Inc.

      SC 13G/A - Fulcrum Therapeutics, Inc. (0001680581) (Subject)

      11/14/24 4:25:46 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Amendment: SEC Form SC 13G/A filed by Fulcrum Therapeutics Inc.

      SC 13G/A - Fulcrum Therapeutics, Inc. (0001680581) (Subject)

      11/14/24 6:15:07 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Amendment: SEC Form SC 13G/A filed by Fulcrum Therapeutics Inc.

      SC 13G/A - Fulcrum Therapeutics, Inc. (0001680581) (Subject)

      11/12/24 3:51:00 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $FULC
    SEC Filings

    See more
    • SEC Form DEFR14A filed by Fulcrum Therapeutics Inc.

      DEFR14A - Fulcrum Therapeutics, Inc. (0001680581) (Filer)

      5/7/25 4:37:59 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Amendment: SEC Form SCHEDULE 13G/A filed by Fulcrum Therapeutics Inc.

      SCHEDULE 13G/A - Fulcrum Therapeutics, Inc. (0001680581) (Subject)

      5/2/25 5:33:17 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 10-Q filed by Fulcrum Therapeutics Inc.

      10-Q - Fulcrum Therapeutics, Inc. (0001680581) (Filer)

      5/1/25 7:10:20 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $FULC
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • Fulcrum Therapeutics downgraded by H.C. Wainwright with a new price target

      H.C. Wainwright downgraded Fulcrum Therapeutics from Buy to Neutral and set a new price target of $4.00 from $17.00 previously

      9/13/24 7:32:27 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Fulcrum Therapeutics downgraded by RBC Capital Mkts with a new price target

      RBC Capital Mkts downgraded Fulcrum Therapeutics from Outperform to Sector Perform and set a new price target of $4.00 from $15.00 previously

      9/12/24 3:56:30 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Fulcrum Therapeutics downgraded by Leerink Partners with a new price target

      Leerink Partners downgraded Fulcrum Therapeutics from Outperform to Market Perform and set a new price target of $4.00

      9/12/24 12:22:27 PM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $FULC
    Leadership Updates

    Live Leadership Updates

    See more
    • Fulcrum Therapeutics Strengthens Leadership Team with the Appointments of Isabel Kalofonos as Chief Commercial Officer and Heather Faulds as Chief Regulatory Affairs & Quality Assurance Officer

      CAMBRIDGE, Mass., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced the appointment of Isabel Kalofonos as chief commercial officer and Heather Faulds as chief regulatory affairs & quality assurance officer. Together, Ms. Kalofonos and Ms. Faulds will be instrumental in advancing losmapimod towards a New Drug Application (NDA) submission and preparing for commercial launch. "I am excited to welcome Isabel to our leadership team as we continue to advance towards the potential approval a

      8/19/24 7:00:00 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Fulcrum Therapeutics Appoints Patrick Horn M.D., Ph.D., as Chief Medical Officer

      ―Industry veteran with late-stage clinical development, medical affairs, and regulatory experience; well-positioned to advance losmapimod towards a potential regulatory submission and approval ― ― Interim Chief Medical Officer, Iain Fraser, MBChB, DPhil, will continue to serve on Fulcrum's executive leadership team as senior vice president (SVP) of early development ― CAMBRIDGE, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced the appointment of Patrick Horn, M.D., Ph.D., as

      3/18/24 7:00:00 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Fulcrum Therapeutics Appoints Chief Financial Officer

      CAMBRIDGE, Mass., Aug. 03, 2023 (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 appointment of Alan A. Musso as chief financial officer, effective August 7, 2023. A 30-year veteran in the life sciences industry, Mr. Musso has held numerous financial and operational leadership positions over the course of his career. "We are delighted to welcome Alan to our executive leadership team," said Alex C. Sapir, president and chief executive officer at Fulcrum Therapeutics. "Alan's wealth of industry experience and impressive track record

      8/3/23 6:55:00 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $FULC
    Financials

    Live finance-specific insights

    See more
    • Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for First Quarter 2025

      ― Enrollment complete in the 12 mg dose cohort (n=16) of the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD); initiated the 20 mg dose cohort ― ― On track to provide clinical data from the 12 mg dose cohort in early Q3 2025 and the 20 mg dose cohort by the end of 2025 ― ― Ended Q1 2025 with $226.6 million in cash, cash equivalents, and marketable securities; cash runway into at least 2027 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., May 01, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improv

      5/1/25 7:00:00 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Fulcrum Therapeutics to Host First Quarter 2025 Financial Results Conference Call and Webcast on Thursday, May 1, 2025, at 8:00 a.m. ET

      CAMBRIDGE, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (the "Company") (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced that its first quarter 2025 financial results will be released on Thursday, May 1, 2025, 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. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and u

      4/24/25 8:00:00 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Fourth Quarter and Full Year 2024

      ― On track to provide clinical data from the 12 mg dose cohort from the Phase 1b PIONEER trial of pociredir in SCD in mid-2025 and the 20 mg dose cohort by the end of 2025 ― ― Ended 2024 with $241.0 million in cash, cash equivalents, and marketable securities; cash runway into at least 2027 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today reported financial results for the fourth quart

      2/25/25 7:00:00 AM ET
      $FULC
      Biotechnology: Pharmaceutical Preparations
      Health Care