On Thursday, Avidity Biosciences Inc. (NASDAQ:RNA) shares received an updated price target from BofA Securities, with the firm raising its expectation from $40.00 to $45.00 while maintaining a Buy rating on the stock. The adjustment follows Avidity's announcement of positive early-stage results from its FSHD treatment study.
Avidity reported significant biomarker reduction and improvements in muscle strength in patients with Facioscapulohumeral Muscular Dystrophy (FSHD) treated with their drug candidate, del-brax.
The data, which showed more than a 50% reduction in DUX4 related gene panels, exceeded BofA Securities' initial expectations, particularly as the improvements were observed with a limited follow-up period of approximately four months.
The company's phase 1/2 FORTITUDE study, which is fully enrolled with 39 patients, did not reveal any safety concerns, as the adverse events noted were consistent across both the treatment and placebo groups. These results have led BofA Securities to anticipate a potential accelerated approval pathway for del-brax, citing the promising initial data.
Avidity plans to continue its research with dose selection expected in the third quarter of 2024, and the initiation of a biomarker cohort in the second half of 2024 aimed at securing accelerated approval.
Additionally, a functional cohort is slated to begin in the first half of 2025 as part of the process towards full approval. According to BofA Securities, these developments could significantly expedite the timeline for del-brax's commercial launch, potentially bringing it to market as early as 2025, two years earlier than initially projected. The firm reiterated its Buy rating on Avidity Biosciences' stock due to these promising developments.
In other recent news, Avidity Biosciences announced plans for a $300 million public offering of its common stock, aiming to raise funds for the further development of its clinical programs and research.
The biopharmaceutical company also received Breakthrough Therapy designation from the U.S. Food and Drug Administration for its lead investigational drug, delpacibart etedesiran, for the treatment of myotonic dystrophy type 1.
In the realm of financial analysis, Wells Fargo (NYSE:WFC) reaffirmed its Overweight rating on Avidity Biosciences, maintaining a steady price target of $50.00. Similarly, Cantor Fitzgerald initiated coverage on Avidity Biosciences with an Overweight rating, indicating potential for outperformance.
Moreover, the company expanded its board of directors with the appointment of Simona Skerjanec, a pharmaceutical industry veteran. These are among the recent developments in Avidity Biosciences.
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