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Home » Fulcrum Therapeutics Inc.

Articles Tagged with ''Fulcrum Therapeutics Inc.''

Rare disease failure batters Fulcrum shares

Sep. 12, 2024
By Lee Landenberger
After missing the primary and secondary endpoints in its phase III study of losmapimod in treating the rare disease facioscapulohumeral muscular dystrophy (FHSD), Fulcrum Therapeutics Inc. is yanking the program’s plug. The selective p38α/β mitogen activated protein kinase inhibitor had a lot of money behind it. It was originally in-licensed from GSK plc and then, in May, Sanofi SA signed on to help Fulcrum develop and commercialize losmapimod for FHSD worldwide, excluding the U.S., in a deal worth $1.06 billion.
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Sanofi lever hoists Fulcrum in $1B-plus FSHD pact

May 13, 2024
By Randy Osborne
Fulcrum Therapeutics Inc.’s deal with Sanofi SA to develop and commercialize oral losmapimod shone more light on facioscapulohumeral muscular dystrophy (FSHD), a rare genetic disease where Avidity Biosciences Inc. also has an earlier-stage but high-profile program.
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Sickle cells

With hold lifted, Fulcrum restarts phase Ib of FTX-6058 in sickle cell disease

Aug. 22, 2023
By Karen Carey
Shares of Fulcrum Therapeutics Inc. shot up 38.5% on Aug. 22 following news that the U.S. FDA had lifted the clinical hold on the company’s phase Ib sickle cell disease candidate, FTX-6058.
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Red blood cells, DNA
Hematologic

Fulcrum Therapeutics licenses rights from Camp4 to advance novel therapies for Diamond-Blackfan anemia

July 11, 2023
Fulcrum Therapeutics Inc. has entered into a worldwide, exclusive license agreement with Camp4 Therapeutics Corp. to advance the discovery, development and commercialization of new therapeutic agents against an undisclosed target for the potential treatment of Diamond-Blackfan anemia (DBA).
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Sickle cells

EHA 2022 presentations describe sickle cell disease headway and headwinds

June 14, 2022
By Anette Breindl and Patrick Cole
At the European Hematology Association's annual meeting in Vienna last week, companies reported impressive progress for the treatment of sickle cell disease.
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Sickle cell disease

At EHA 2022, sickle cell disease headway and headwinds

June 13, 2022
By Anette Breindl
At the European Hematology Association’s annual meeting in Vienna last week, companies reported impressive progress for the treatment of sickle cell disease.
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Mast cell releasing histamine during allergic response

EHA 2022: Best in class? Cogent soars on early data in mastocytosis

June 10, 2022
By Jennifer Boggs
Analysts have already started tagging Cogent Biosciences Inc.’s bezuclastinib as potentially best in class, after the company presented impressive, though early stage, data at the European Hematology Association Congress in Vienna demonstrating promising efficacy and a possibly differentiating safety profile for the selective KIT D816V inhibitor in advanced systemic mastocytosis.
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Wall Street MAD about Fulcrum’s interim phase I data in sickle cell

Aug. 10, 2021
By Randy Osborne
Fulcrum Therapeutics Inc. shares (NASDAQ:FULC) closed at $18.77, up $10.44 or 125%, on word of positive interim results from a phase I trial in healthy adult volunteers with oral FTX-6058 for sickle cell disease (SCD). The firm has “already achieved maximal target engagement [MTE] at all three doses,” said Christopher Morabito, the company’s chief medical officer. “I don’t think we’ll exceed that.”
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Pills and bottle

Fulcrum set to pivot in FSHD? No DUX4 score but secondary goals extolled

June 25, 2021
By Randy Osborne
Fulcrum Therapeutics Inc.’s phase IIb data with losmapimod in facioscapulohumeral muscular dystrophy (FSHD) brought renewed hope for patients in what historically has proved a challenging therapeutic space. Though the firm’s oral p38 mitogen-activated protein kinase inhibitor missed its primary biomarker endpoint – changes in DUX4-driven gene expression – other indicators of benefit in the study called ReDUX4 painted a bright picture.
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Boy in wheelchair, scenic overlook

Fulcrum looks for balance in its phase II FSHD study

Aug. 11, 2020
By Lee Landenberger
An interim analysis from Fulcrum Therapeutics Inc.’s phase II study of losmapimod for treating facioscapulohumeral muscular dystrophy (FSHD) produced data that pleased the CEO and displeased investors.
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