Fulcrum Therapeutics Inc

Fulcrum Therapeutics, Inc. is a clinical stage biopharmaceutical company. The firm develops new medicines and focuses on unlocking gene control mechanisms to develop small molecule therapies. Its product candidate includes Losmapimod and FTX-HbF. The company was founded by Michael R. Green, Danny Reinberg, Rudolf Jaenisch, Jeannie T. Lee, and Bradley E. Bernstein on August 18, 2015 and is headquartered in Cambridge, MA.

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Fulcrum Therapeutics reports promising data and financial stability in Q4

Fulcrum Therapeutics showcased positive data for FTX-6058 and financial stability in their Q4 2022 earnings call
While facing challenges with the clinical hold, the company's strong cash position and promising programs offer opportunities for growth

Fulcrum Therapeutics reports solid financials, FDA challenges, and leadership change

Fulcrum Therapeutics navigates a mixed landscape with strong financials, promising clinical trial progress, and regulatory challenges that require careful resolution.
New leadership, ongoing FDA collaborations, and a robust cash position position Fulcrum for continued growth and innovation in the biopharmaceutical space.

Fulcrum Therapeutics reports stable finances, regulatory hurdles ahead

Fulcrum Therapeutics maintains a stable financial position with a focus on advancing key pipeline candidates.
Challenges include regulatory uncertainties for FTX-6058 and ongoing R&D investment impacting financials.
Opportunities lie in upcoming data releases, resolving regulatory issues, and strategic growth initiatives.

Fulcrum Therapeutics reports Q3 loss, progresses key clinical trials

Fulcrum Therapeutics reported a mixed performance in Q3 2023, with a net loss driven by significant R&D and administrative expenses.
Despite challenges in cash burn and timeline for commercialization, the company's strong cash position and promising clinical developments highlight its potential.
Opportunities lie in advancing regulatory filings, leveraging positive clinical results, and exploring additional endpoints to showcase therapy efficacy.

Fulcrum Therapeutics advances Phase III trials, secures strong financial position

Fulcrum Therapeutics made significant progress in advancing its pipeline with successful trial enrollments and resolution of clinical holds.
Financially, the company ended 2023 on a strong note with a healthy cash position and reported financials.
Challenges lie in meeting trial endpoints and managing expenses, but opportunities exist in market reception and further data collection.
Overall, Fulcrum's proactive approach to clinical development and stakeholder engagement positions it well for future growth.

Fulcrum Therapeutics secures Sanofi collaboration, advances Phase III trials

Fulcrum Therapeutics' collaboration with Sanofi and strong financial position provide a solid foundation for future growth and development.
The company's focus on advancing Phase III trials, addressing unmet medical needs, and driving innovation through novel endpoints positions it well for success.
While facing challenges in various operational aspects, Fulcrum's strategic planning and emphasis on key appointments and market access strategies indicate a proactive approach to overcoming obstacles.

Fulcrum Therapeutics reports strong Q2 earnings and advances clinical assets

Fulcrum Therapeutics achieved a significant turnaround in financial performance with a notable increase in net income and a strong cash position, supported by collaboration revenue.
Progress in Phase III trials for losmapimod and pociredir, along with positive patient engagement, bodes well for future drug development and market potential.
While facing regulatory and competitive challenges, the company's strategic collaborations, financial stability, and ongoing trials present opportunities for growth and market expansion.

Fulcrum Therapeutics navigates workforce reduction, focuses on sickle cell treatment

Fulcrum Therapeutics faces challenges with workforce reduction and program suspension but remains focused on advancing pociredir for sickle cell disease treatment.
The company's financial position is strong, with a cash balance of $257.2 million and plans to manage cash burn effectively in 2025.
Management changes and analyst inquiries underscore the need for strategic decision-making and operational efficiency to drive future success.

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― Entered into a collaboration and ex-U.S. license agreement with Sanofi for the development and commercialization  of losmapimod ―

Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for First Quarter 2024

― Sanofi receives exclusive rights to commercialize losmapimod in all territories outside the U.S.; Fulcrum retains full U.S. commercialization rights ―

Fulcrum Therapeutics Enters into a Collaboration and License Agreement with Sanofi for the Development and Commercialization of Losmapimod in Facioscapulohumeral Muscular Dystrophy

CAMBRIDGE, Mass., May 06, 2024 (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 2024 financial results will be released on Monday, May 13, 2024 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.

Fulcrum Therapeutics to Host First Quarter 2024 Financial Results Conference Call and Webcast on Monday, May 13, 2024, at 8:00 a.m. ET

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―Industry veteran with late-stage clinical development, medical affairs, and regulatory experience; well-positioned to advance losmapimod towards a potential regulatory submission and approval ―

Fulcrum Therapeutics Appoints Patrick Horn M.D., Ph.D., as Chief Medical Officer

CAMBRIDGE, Mass., March 05, 2024 (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 present a corporate overview at the Leerink Partners Global Biopharma Conference, being held in Miami, FL on Wednesday, March 13, 2024 at 9:20 a.m. ET. Management will also participate in one-on-one investor meetings.

Fulcrum Therapeutics to Participate at the Leerink Partners Global Biopharma Conference

Fulcrum Therapeutics, Inc. (FULC) Q4 2023 Earnings Call Transcript

Fulcrum Therapeutics, Inc. (FULC) came out with a quarterly loss of $0.40 per share versus the Zacks Consensus Estimate of a loss of $0.44. This compares to loss of $0.50 per share a year ago.

Fulcrum Therapeutics, Inc. (FULC) Reports Q4 Loss, Tops Revenue Estimates

― On track to report topline data for Phase 3 REACH trial of losmapimod in facioscapulohumeral m uscular dystrophy (FSHD) in the fourth quarter of 2024 ―

Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Fourth Quarter and Full Year 2023

CAMBRIDGE, Mass., Feb. 20, 2024 (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 fourth quarter and full year 2023 financial results will be released on Tuesday, February 27, 2024 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.

Fulcrum Therapeutics to Host Fourth Quarter and Full Year 2023 Financial Results Conference Call and Webcast on Tuesday, February 27, 2024, at 8:00 a.m. ET

CAMBRIDGE, Mass., Feb. 06, 2024 (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 present a corporate overview at the Oppenheimer 34th Annual Healthcare Life Sciences Conference, being held virtually on Tuesday, February 13, 2024 at 1:20 p.m. ET. Management will also participate in one-on-one investor meetings.

Fulcrum Therapeutics to Participate at the Oppenheimer 34th Annual Healthcare Life Sciences Conference

CAMBRIDGE, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (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 upcoming investor conferences:

Fulcrum Therapeutics to Participate at Upcoming November Investor Conferences

Fulcrum Therapeutics, Inc. (NASDAQ:FULC ) Q3 2023 Earnings Conference Call November 8, 2023 8:00 AM ET Company Participants Chris Calabrese - LifeSci Advisors, LLC Alex Sapir - President and Chief Executive Officer Alan Musso - Chief Financial Officer Iain Fraser - Interim Chief Medical Officer Conference Call Participants Benazir Ali - Stifel Joe Schwartz - Leerink Partners Edward Tenthoff - Piper Sandler Matthew Hagood - Oppenheimer Operator Good morning and welcome to Fulcrum Therapeutics Third Quarter 2023 Financial Results and Business Update Conference Call. Currently, all participants are in a listen-only mode.

Fulcrum Therapeutics, Inc. (FULC) Q3 2023 Earnings Call Transcript

― Completed enrollment in the Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD); expect to report topline data in the fourth quarter of 2024 ―

Fulcrum Therapeutics Announces Recent Business Highlights and Financial Results for Third Quarter 2023

CAMBRIDGE, Mass., Oct. 31, 2023 (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 third quarter 2023 financial results will be released on Tuesday, November 7, 2023 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.

Fulcrum Therapeutics to Host Third Quarter 2023 Financial Results Conference Call and Webcast on Tuesday, November 7, 2023, at 8:00 a.m. ET

Fulcrum Therapeutics, Inc. has had some key potential catalysts resolved positively recently. These included the FDA lifted the clinical hold on Fulcrum's sickle-cell disease candidate, allowing the company's Phase 1b trial to move forward. The company has also made progress in filling management positions and has initiated a Phase 3 study for its late-stage candidate, Losmapimod.

An Updated View On Fulcrum Therapeutics

CAMBRIDGE, Mass., Sept. 22, 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 that management will participate in a fireside chat at the Cantor Fitzgerald Global Healthcare Conference, being held in New York, NY on Thursday, September 28, 2023 at 8:35 a.m. ET.

Fulcrum Therapeutics to Participate at the Cantor Fitzgerald Global Healthcare Conference

Fulcrum's (FULC) shares surge as the FDA lifts the clinical hold it had earlier placed on its pipeline candidate FTX-6058, to treat patients with sickle cell disease.

Fulcrum (FULC) Up as FDA Lifts Clinical Hold on SCD Candidate

Fulcrum Therapeutics Inc (NASDAQ:FULC) is up 49.7% to trade at $5.87 at last glance -- its highest levels since March -- after the U.S. Food and Drug Administration (FDA) lifted its clinical hold on the biotech name's application for its sickle cell disease treatment.

Options Traders Blast Biotech Stock on FDA Buzz

Fulcrum Therapeutics (NASDAQ: FULC ) stock is on the rise Tuesday as investors react to positive news from the FDA. The big news here is the FDA lifted its clinical hold on the Investigational New Drug (IND) application for FTX-6058.

Why Is Fulcrum Therapeutics (FULC) Stock Up 43% Today?

Fulcrum Therapeutics announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for its sickle cell disease therapeutic FTX-6058, sending its shares almost 40% higher in pre-market trading.

Fulcrum Therapeutics shares skyrocket as FDA lifts clinical hold on sickle cell disease trial

CAMBRIDGE, Mass., Aug. 22, 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 that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Investigational New Drug (IND) application for FTX-6058 for the potential treatment of sickle-cell disease (SCD).

FDA Lifts Clinical Hold on Fulcrum Therapeutics' FTX-6058 for Sickle Cell Disease

Fulcrum Utility Services Ltd (AIM:FCRM), the energy infrastructure group, shed more than two-thirds of its value on Monday after it announced it would be cancelling its AIM listing subject to shareholder approval. Arguing there are limited prospects of raising additional equity on AIM, the group said trading volumes on the exchange have been too weak to justify the significant costs and regulatory burden associated with being a quoted company.

Fulcrum Utility Services to cancel listing as shares plummet

Fulcrum Therapeutics, Inc. (NASDAQ:FULC ) Q2 2023 Earnings Conference Call August 3, 2023 8:00 AM ET Company Participants Chris Calabrese - LifeSci Advisors, LLC Alexander Sapir - President and Chief Executive Officer Iain Fraser - Interim Chief Medical Officer Gregory Tourangeau - Principal Accounting Officer Conference Call Participants Benazir Ali - Stifel Joseph Schwartz - Leerink Partners Edward Tenthoff - Piper Sandler Matthew Hagood - Oppenheimer Judah Frommer - Credit Suisse Operator Good morning and welcome to the Fulcrum Therapeutics Second Quarter 2023 Financial Results and Business Update Conference Call. Currently all participants are in a listen-only mode.

Fulcrum Therapeutics, Inc. (FULC) Q2 2023 Earnings Call Transcript

Fulcrum Therapeutics, Inc. (FULC) came out with a quarterly loss of $0.38 per share versus the Zacks Consensus Estimate of a loss of $0.44. This compares to loss of $0.83 per share a year ago.

News for Fulcrum Therapeutics Inc Stock (FULC)