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Limb-Girdle Muscular Dystrophy Leaders Advance Collaborative Dialogue to Accelerate Drug Development to Address the Urgent Unmet Need in Limb-Girdle Muscular Dystrophy

/PRNewswire/ On February 8, 2024, The Speak Foundation, a patient-led 501(c)(3) organization for Limb-Girdle Muscular Dystrophy (LGMD), convened a.

United statesDouglas sprouleMichelle campbellMatthew wicklundJannie kennedyKatherine mathewsKathryn bryant knudsonNicholas johnsonPeter marksLouise rodino klapacNicole verdunLindsay alfanoPeter kangPeter steinJames signorovitchJerryr mendell

Limb-Girdle Muscular Dystrophy Scientific Leaders - Together With the FDA - Will Come Together for a Drug Development Workshop on February 8, 2024

/PRNewswire/ On February 8, 2024, The Speak Foundation, a patient-led 501(c)(3) organization for Limb-Girdle Muscular Dystrophy (LGMD), will be convening a.

United statesMatthew wicklundKathryn bryantLouise rodino klapacPeter steinPeter marksRachel decontiNicholas johnsonKatherine mathewsDouglas sprouleJerryr mendellPeter kangLindsay alfanoSpeak foundationVirginia commonwealth universityOffice of new drugs

BridgeBio Pharma Shares Positive Long-Term Data from an Ongoing Phase 2 Study, which Support the Potential Use of Glycosylated Alpha-dystroglycan (⍺DG) Levels as a Surrogate Endpoint in Limb-girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9)

- Early assessment of increased glycosylated ⍺DG levels at 3 months predicted subsequent ambulatory improvements at 9 months, supporting the use of glycosylated ⍺DG levels as a potential surrogate.

United kingdomSouth carolinaUnited statesTamy harperDouglas sprouleVikram baliVirginia commonwealth universityMl bio solutionsWorld muscle societyDrug administrationBridgebio pharma incBio pharma incSecurities exchangeNorth star assessmentAccelerated approvalBio pharma

BridgeBio Pharma Announces Opportunity for Accelerated Approval Pathway in Limb-girdle Muscular Dystrophy Type 2I (LGMD2I/R9) Based on Glycosylated Alpha-dystroglycan (⍺DG) Levels and Announces First Patient Dosed in FORTIFY Phase 3 Study

- BridgeBio met with the U.S. Food and Drug Administration to discuss the use of glycosylated αDG levels as a surrogate endpoint; based on this meeting, the Company believes there is potential to.

United statesTahseen mozaffarDouglas sprouleKathryn bryant knudsonVikram baliUniversity of californiaDrug administrationSpeak foundationMl bio solutionsBio pharma incBridgebio pharma incSecurities exchangeWorld muscle societyAccelerated approvalBio pharmaNorth star assessment

BridgeBio explores path forward for muscular disease drug

BioPharma

Douglas sprouleBridgebio pharmaMl bio solutionsDrug administration

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