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Investing.com - BofA Securities has lowered its price target on PTC Therapeutics (NASDAQ:PTCT) to $76.00 from $82.00 while maintaining a Buy rating following a regulatory setback for the company’s vatiquinone treatment. The company, currently trading at a P/E ratio of 6.46 and showing impressive revenue growth of 96% over the last twelve months, remains well-positioned financially according to InvestingPro data.
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for PTC (NASDAQ:PTC)’s New Drug Application (NDA) for vatiquinone in Friedreich’s ataxia, requesting the company conduct another "adequate and well-controlled study" before resubmitting the application.
The rejection was not entirely unexpected, as BofA noted management had previously indicated during second-quarter earnings that labeling discussions with the FDA had not yet begun, often a sign of potential regulatory issues.
The original phase 3 trial for vatiquinone failed to demonstrate statistically significant benefits on its primary endpoint, with PTC’s application based instead on positive trends in subscales and open-label extension data.
Despite this setback, BofA maintains its Buy rating on PTC Therapeutics, citing a positive outlook for the company’s recently approved Sephience treatment for phenylketonuria (PKU), which received FDA approval in late July. The company has demonstrated strong momentum with a 10% return over the past week. For deeper insights into PTC Therapeutics’ financial health and growth prospects, including exclusive ProTips and comprehensive analysis, visit InvestingPro.
In other recent news, PTC Therapeutics reported its financial results for the second quarter of 2025, surpassing analyst expectations. The company achieved an earnings per share (EPS) of -0.83, which was better than the forecasted -1.06. Additionally, PTC Therapeutics’ revenue reached $179 million, exceeding the anticipated $171.74 million. In a separate development, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter rejecting the company’s New Drug Application for vatiquinone, a treatment for Friedreich’s ataxia. The FDA stated that PTC failed to provide substantial evidence of efficacy and required an additional well-controlled study before resubmission. On the analyst front, RBC Capital raised its price target for PTC Therapeutics to $63, maintaining an Outperform rating. The firm highlighted the resilience of PTC’s Translarna drug and the anticipated strong launch of Sephience. Similarly, TD Cowen increased its price target to $56, citing the successful launch of Sephience in the U.S. and European markets as a key factor.
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