Business
Avidity Biosciences Reports First Quarter 2025 Financial Results and Recent Highlights
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
About this update from Atrium Therapeutics, Inc.
[{"type":"text","content":"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 \nPositive 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\n Executing on global commercial infrastructure development and on track with preparations for first potential commercial launch in U.S. in 2026\nStrong balance sheet supports execution across three late-stage clinical programs and commercial launch preparations with cash runway into mid-2027\nSAN DIEGO, May 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™) to profoundly improve people's lives, today reported financial results for the first quarter ended March 31, 2025, highlighting recent progress.\n\n \n \n \n \n \n \n\n \n\"We continue to build on the consistent and reproducible data readouts from our platform across all three of our clinical programs for DMD44, DM1 and FSHD, and are executing on our transition to become a global commercial organization. In March 2025, we shared positive topline EXPLORE44® Phase 1/2 del-zota data demonstrating remarkable and consistent improvements across multiple measures including a substantial increase in dystrophin production and reduction in creatine kinase levels to near normal, which will support our planned BLA submission at year end 2025 and reinforces del-zota's potential to become a groundbreaking treatment for people living with DMD44,\" said Sarah Boyce, president and chief executive officer at Avidity. \"We look forward to delivering on multiple milestones this year and remain on track to share several key regulatory updates for del-brax in the second quarter that include a potential accelerated approval path in U.S., alignment on the design of the global Phase 3 trial and initiation of the trial. We are also planning to share topline del-brax data from the FORTITUDE™ dose escalation cohorts in the second quarter.\"\n\"2025 is a pivotal year for Avidity as we build out our global commercial infrastructure to support three potential product launches for del-zota, del-desiran and del...