Avidity Biosciences Announces FDA Partial Clinical Hold on New Participant Enrollment in Phase 1/2 MARINA™ Trial

Participants currently enrolled in MARINA and MARINA-OLE™ trials may continue to
be treated with AOC 1001

Avidity received Investigational New Drug (IND) clearance for FSHD and DMD
studies from FDA; programs now advancing into the clinic

SAN DIEGO, Sept. 27, 2022 /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 U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on new participant enrollment in the Phase 1/2 MARINA™ clinical trial of AOC 1001 in adults with myotonic dystrophy type 1 (DM1). Close to 40 participants are currently enrolled in the MARINA and MARINA open label extension (MARINA-OLE™) trials.

See the full PR attached.

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