-- FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD) -- -- Jeffrey M. Statland, M.D.
-- Unprecedented data from FORTITUDE™ dose escalation cohorts for del-brax treated participants, compared to placebo, demonstrate improvement in function, strength and PROs as well as rapid and significant reduction in biomarkers -- -- Data support planned accelerated approval BLA submission in H2 2026 -- -- Data being presented at the 32nd Annual FSHD Society International Research Congress (I...
-- Planning accelerated approval BLA submission in H2 2026, following topline data fromFORTITUDE™ biomarker cohort in Q2 2026 -- -- Initiated global, confirmatory Phase 3 FORWARD ™ study of del-brax 2mg/kg every six weeks -- -- Investor and analyst webcast event today, Monday, June 9, 2025 at 8 a.m. ET -- SAN DIEGO , June 9, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopha...
SAN DIEGO , May 21, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that on May 20, 2025, the Human Capital Management Committee of Avidity's Board of Directors granted non-qualified stock option awards to purchase an aggregate of ...
On track to deliver key regulatory updates for del-brax and topline data from dose escalation cohorts in the FORTITUDE™ trial in the second quarter Positive topline del-zota data further supports first BLA submission at year end 2025 – continues to highlight reproducibility and consistency across three late-stage clinical trials for DMD44, DM1 and FSHD Executing on global commercial infrastruc...
SAN DIEGO , May 6, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that Avidity management will participate in a fireside chat during the following investor conference: Bank of America Securities 2025 Health Care Conference on Tues...
SAN DIEGO , April 21, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that on April 20, 2025, the Human Capital Management Committee of Avidity's Board of Directors granted non-qualified stock option awards to purchase an aggregate...
Del-desiran first-ever investigational treatment for DM1 to receive Orphan Drug designation in Japan SAN DIEGO , April 8, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that the Japan Ministry of Health, Labour and Welfare (MHLW)...
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