Avidity Biosciences price target raised to $54 from $48 at BofA

BofA raised the firm’s price target on Avidity Biosciences (RNA) to $54 from $48 and keeps a Buy rating on the shares. The firm notes Avidity Biosciences announced alignment with the FDA on a path to an accelerated approval for del-brax in FSHD based on the novel biomarker, circulating DUX4 — cDUX, and the phase 3 confirmatory trial design. Management commented they have received detailed regulatory feedback on the necessary steps required to validate cDUX and pursue accelerated approval. The registrational biomarker cohort in the phase 1/2 FORTITUDE trial completed enrollment in March with topline data expected in Q2 2026 followed by a BLA submission for accelerated approval in the second half of 2026. This is in-line with BofA’s assumptions for a 2027 launch. The firm is encouraged by this regulatory update indicating a path to accelerated approval but await additional updates from the program to further de-risk the regulatory path.