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Avidity Biosciences Delays Biologics License Application

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Avidity Biosciences Delays Biologics License Application

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The latest announcement is out from Avidity Biosciences ( (RNA) ).

On October 13, 2025, Avidity Biosciences announced a delay in the submission of its Biologics License Application for del-zota to the first quarter of 2026, following a pre-BLA meeting with the FDA. This delay is intended to provide additional non-clinical data to support the chemistry, manufacturing, and controls package, impacting the company’s timeline for regulatory approval.

The most recent analyst rating on (RNA) stock is a Buy with a $75.00 price target. To see the full list of analyst forecasts on Avidity Biosciences stock, see the RNA Stock Forecast page.

Spark’s Take on RNA Stock

According to Spark, TipRanks’ AI Analyst, RNA is a Neutral.

Avidity Biosciences faces significant financial challenges, particularly in profitability and cash flow, which heavily impact its overall score. The technical analysis provides mixed signals, with some bearish momentum. Valuation concerns are evident due to a negative P/E ratio and lack of dividend yield. These factors collectively suggest caution for potential investors.

To see Spark’s full report on RNA stock, click here.

More about Avidity Biosciences

Avidity Biosciences, Inc. operates in the biotechnology industry, focusing on the development of therapies for serious diseases. The company is known for its work on biologics and has a market focus on innovative drug development.

Average Trading Volume: 3,211,806

Technical Sentiment Signal: Buy

Current Market Cap: $7.26B

Find detailed analytics on RNA stock on TipRanks’ Stock Analysis page.

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