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PTC Therapeutics Receives FDA Complete Response Letter

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PTC Therapeutics Receives FDA Complete Response Letter

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PTC Therapeutics ( (PTCT) ) has issued an update.

On August 19, 2025, PTC Therapeutics announced that the FDA issued a Complete Response Letter regarding their New Drug Application for vatiquinone, a treatment for Friedreich’s ataxia. The FDA indicated that substantial evidence of efficacy was not demonstrated and requested an additional study. PTC plans to meet with the FDA to address these issues, reflecting the potential impact on their operations and market positioning.

The most recent analyst rating on (PTCT) stock is a Hold with a $51.00 price target. To see the full list of analyst forecasts on PTC Therapeutics stock, see the PTCT Stock Forecast page.

Spark’s Take on PTCT Stock

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

PTC Therapeutics’ overall stock score is driven by a strong earnings call that highlights significant future revenue potential from Sephience, coupled with an attractive valuation. However, financial instability due to negative equity and high leverage, along with neutral technical indicators, temper the score. The company’s ability to address balance sheet weaknesses and capitalize on growth opportunities will be crucial for future performance.

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

More about PTC Therapeutics

PTC Therapeutics, Inc. is a global biopharmaceutical company focused on discovering, developing, and commercializing medicines for children and adults with rare disorders. The company aims to provide access to best-in-class treatments for patients with unmet medical needs through its robust and diversified pipeline of transformative medicines.

Average Trading Volume: 1,134,153

Technical Sentiment Signal: Strong Buy

Current Market Cap: $3.88B

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

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