Bullish indicating open at $55-$60, IPO prices at $37
On Monday, BofA Securities analyst Tazeen Ahmad raised the price target on Avidity Biosciences (NASDAQ:RNA) shares to $54.00, up from the previous $48.00, while maintaining a Buy rating on the stock. The company, currently valued at $3.93 billion, has shown strong momentum with a 9.26% return over the past week. According to InvestingPro data, analyst targets for the stock range from $48 to $96, with seven analysts recently revising their earnings expectations upward. The adjustment follows Avidity Biosciences’ recent announcement regarding their alignment with the FDA on a pathway to accelerated approval for their drug candidate, del-brax, in treating Facioscapulohumeral Muscular Dystrophy (FSHD).
The company has reported detailed regulatory feedback from the FDA on the necessary steps to validate circulating DUX4 (cDUX), a novel biomarker, and to pursue an accelerated approval. The phase 3 confirmatory trial design has also been agreed upon. This development is considered a significant step forward for Avidity Biosciences, as it could potentially expedite the availability of del-brax to patients.
Avidity Biosciences completed enrollment for the registrational biomarker cohort in the phase 1/2 FORTITUDE trial in March. The company anticipates releasing topline data in the second quarter of 2026, with a Biologics License Application (BLA) submission for accelerated approval expected in the second half of 2026. These timelines align with BofA Securities’ projections for a market launch in 2027.
The analyst expressed optimism about the regulatory update, which suggests a clear route towards accelerated approval for the drug. The firm also looks forward to additional updates from the program to further assess the regulatory path and reduce potential risks. InvestingPro analysis shows the company maintains a strong financial position with more cash than debt on its balance sheet and a healthy current ratio of 16.91, indicating robust liquidity to support its development programs.
Avidity Biosciences’ approach to treating FSHD, a rare and currently untreatable muscle disease, represents a considerable commercial opportunity. Should Avidity Biosciences succeed in bringing del-brax to market, it would be the first company to offer a therapy for this condition, potentially securing a significant market position. While the company’s overall financial health score is rated as "FAIR" by InvestingPro, with particularly strong momentum metrics, investors should note that comprehensive analysis of this and 1,400+ other stocks is available through InvestingPro’s detailed Research Reports.
In other recent news, Avidity Biosciences has released positive topline data from its Phase 1/2 FORTITUDE program, showing that their investigational therapy, del-brax, improves function and strength in patients with Facioscapulohumeral Muscular Dystrophy (FSHD). The company plans to submit a Biologics License Application in the second half of 2026 and has initiated a global Phase 3 study to confirm these findings. In related developments, the Japan Ministry of Health, Labour and Welfare granted Orphan Drug designation to Avidity’s treatment for myotonic dystrophy type 1 (DM1), known as del-desiran. This designation includes benefits such as tax incentives and priority review, marking the first such recognition for a DM1 treatment in Japan.
Avidity Biosciences also announced a change in its independent auditor, appointing Deloitte & Touche LLP for the fiscal year ending December 31, 2025, following a competitive selection process. Meanwhile, H.C. Wainwright adjusted its price target for Avidity Biosciences to $68, maintaining a Buy rating as the company nears the release of significant trial data. Cantor Fitzgerald reiterated its Overweight rating on Avidity Biosciences, maintaining a price target of $96, as the company progresses with its Phase 3 trial for del-brax. These developments underscore Avidity Biosciences’ ongoing efforts in advancing RNA therapeutics for rare neuromuscular diseases.
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