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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Earnings data Q4 2024

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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Reduction in DUX4-driven gene expression observed in biopsies with highest baseline levels of DUX4-driven gene expression

Fulcrum Therapeutics Announces Interim Analysis Data from its ReDUX4 Trial in Facioscapulohumeral Muscular Dystrophy (FSHD)

Fulcrum Therapeutics (FULC) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Why Earnings Season Could Be Great for Fulcrum Therapeutics (FULC)

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Fulcrum Therapeutics has been struggling lately, but the selling pressure may be coming to an end soon.

Fulcrum Therapeutics Sees Hammer Chart Pattern: Time to Buy?

Collaboration will Combine MyoKardia’s Leading Precision Cardiovascular R&D Platform with Fulcrum’s Proprietary Product Engine to Identify Targets that Modulate Gene Expression Collaboration will Combine MyoKardia’s Leading Precision Cardiovascular R&D Platform with Fulcrum’s Proprietary Product Engine to Identify Targets that Modulate Gene Expression

MyoKardia and Fulcrum Therapeutics Announce Multi-Target Collaboration to Discover Novel Targeted Therapies for Genetic Cardiomyopathies

Fulcrum stock gapped up Wednesday after the Food and Drug Administration gave it the go-ahead to begin a coronavirus treatment study. The drug is also in testing for muscular dystrophy.

This Biotech Stock Gapped Up On FDA Go-Ahead For Coronavirus Drug Study

The U.S. Food and Drug Administration (FDA) has notified Fulcrum Therapeutics Inc.

Why This FDA Update Is Crucial for Fulcrum Therapeutics and COVID-19

Fulcrum Therapeutics (FULC) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

Is Fulcrum Therapeutics (FULC) Stock a Solid Choice Right Now?

Fulcrum receives early notification from U.S. Food and Drug Administration (FDA) that study may proceed Fulcrum receives early notification from U.S. Food and Drug Administration (FDA) that study may proceed

Fulcrum Therapeutics Announces Initiation of Multi-Center Phase 3 (LOSVID) Trial with Losmapimod for Hospitalized COVID-19 Patients

CAMBRIDGE, Mass., June  10, 2020  (GLOBE NEWSWIRE) --   Fulcrum Therapeutics, Inc.   (Nasdaq: FULC) today announced the closing of a $68.5 million private placement pursuant to a securities purchase agreement with a group of institutional investors and accredited investors.

Fulcrum Therapeutics Completes $68.5 Million Private Placement

Investigational New Drug (IND) application submitted; Company preparing to initiate Phase 3 trial

Fulcrum Therapeutics to Evaluate Losmapimod as Potential Treatment for COVID-19

As of late, it has definitely been a great time to be an investor in Fulcrum Therapeutics, Inc. (FULC).

Fulcrum Therapeutics, Inc. (FULC) Shares March Higher, Can It Continue?

Fulcrum Therapeutics, Inc. (FULC) CEO Robert Gould on Q1 2020 Results - Earnings Call Transcript

Conference call scheduled for 8:00 a.m. ET today Conference call scheduled for 8:00 a.m. ET today

Fulcrum Therapeutics Reports Recent Business Highlights and First Quarter 2020 Financial Results

CAMBRIDGE, Mass., April  13, 2020  (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 it is on track for submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the second half of 2020 for FTX-6058 following the completion of preclinical safety studies and Good Laboratory Practices (GLP) toxicology work.

Fulcrum Therapeutics Announces Completion of IND-enabling Safety Studies for FTX-6058 in Sickle Cell Disease

CAMBRIDGE, Mass., April  02, 2020  (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 provided a business update in the context of the developing situation with the COVID-19 (coronavirus) pandemic.

Fulcrum Therapeutics Provides Business Update on Impact of COVID-19

– Losmapimod achieves target engagement in muscle –

Fulcrum Therapeutics Announces Complete Data from Phase 1 Trial with Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD)

Fulcrum Therapeutics, Inc. (FULC) CEO Robert Gould on Q4 2019 Results - Earnings Call Transcript

CAMBRIDGE, Mass., Jan.  29, 2020  (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 United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to losmapimod, a selective p38α/β mitogen activated protein kinase (MAPK) inhibitor for the treatment of facioscapulohumeral muscular dystrophy (FSHD). Fulcrum also announced the issuance of U.S. patent 10,537,560 with claims covering the use of other p38 kinase inhibitors for the treatment of FSHD.

Fulcrum Therapeutics Receives Orphan Drug Designation for Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD) and Announces Expanded Patent Portfolio

CAMBRIDGE, Mass., Jan.  06, 2020  (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 Katina Dorton to the Company’s board of directors and as chair of the audit committee.

Fulcrum Therapeutics Appoints Katina Dorton to its Board of Directors

Acceleron (XLRN) signs a collaboration/license pact with Fulcrum Therapeutics aimed at identifying small molecules designed to modulate specific pathways targeting a pulmonary disease indication.

Acceleron, Fulcrum Therapeutics Ink Deal for Pulmonary Disease

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Fulcrum Therapeutics' (FULC) CEO Robert Gould on Q3 2019 Results - Earnings Call Transcript

Data presented in an oral presentation at World Muscle Society meeting highlighted safety, tolerability, pharmacokinetics and target engagement of losmapimod in patients with facioscapulohumeral dystrophy. Data presented in an oral presentation at World Muscle Society meeting highlighted safety, tolerability, pharmacokinetics and target engagement of losmapimod in patients with facioscapulohumeral dystrophy.

Fulcrum Therapeutics Announced Results of Phase 1 Clinical Trial of Losmapimod in FSHD

CAMBRIDGE, Mass., Oct.  01, 2019  (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 announces that the company will present data from multiple studies of losmapimod in facioscapulohumeral dystrophy (FSHD) patients during the International Annual Congress of the World Muscle Society being held from October 1-5 in Copenhagen, Denmark. 

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