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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 States , Douglas Sproule , Michelle Campbell , Matthew Wicklund , Jannie Kennedy , Katherine Mathews , Kathryn Bryant Knudson , Nicholas Johnson , Peter Marks , Louise Rodino Klapac , Nicole Verdun , Lindsay Alfano , Peter Kang , Peter Stein , James Signorovitch , Jerryr Mendell , Drug Administration , Office Of New Drugs , Everylife Foundation For Rare Diseases , University Of Minnesota Medical School , University Of Texas San Antonio , Analysis Group , Virginia Commonwealth University , Drug Developers , Speak Foundation , University Of Iowa Health Care ,

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 States , Matthew Wicklund , Kathryn Bryant , Louise Rodino Klapac , Peter Stein , Peter Marks , Rachel Deconti , Nicholas Johnson , Katherine Mathews , Douglas Sproule , Jerryr Mendell , Peter Kang , Lindsay Alfano , Speak Foundation , Virginia Commonwealth University , Office Of New Drugs , Scientific Drug Development Workshop In Rockville , University Of Minnesota Medical School , Led Patient Focused Drug Development Meeting , University Of Iowa Health Care , University Of Texas San Antonio , Ml Bio Solutions , Drug Administration , Limb Girdle Muscular Dystrophy , Drug Development Workshop , Drug Evaluation ,

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 Kingdom , South Carolina , United States , Tamy Harper , Douglas Sproule , Vikram Bali , Virginia Commonwealth University , Ml Bio Solutions , World Muscle Society , Drug Administration , Bridgebio Pharma Inc , Bio Pharma Inc , Securities Exchange , North Star Assessment , Accelerated Approval , Bio Pharma , Annual Congress , Limb Girdle Muscular Dystrophy Type , Bridgebio Pharma , Securities Act , Securities Exchange Act , Accelerated Approval Pathway , Risk Factors , Annual Report , Bio Media Contact ,

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 States , Tahseen Mozaffar , Douglas Sproule , Kathryn Bryant Knudson , Vikram Bali , University Of California , Drug Administration , Speak Foundation , Ml Bio Solutions , Bio Pharma Inc , Bridgebio Pharma Inc , Securities Exchange , World Muscle Society , Accelerated Approval , Bio Pharma , North Star Assessment , Annual Congress , South Carolina , Limb Girdle Muscular Dystrophy Type , Bridgebio Pharma , Securities Act , Securities Exchange Act , Accelerated Approval Pathway , Risk Factors , Annual Report , Bio Contact ,

BridgeBio explores path forward for muscular disease drug

BioPharma ....

Douglas Sproule , Bridgebio Pharma , Ml Bio Solutions , Drug Administration ,