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Investing.com - Goldman Sachs has reiterated its Sell rating and $44.00 price target on PTC Therapeutics (NASDAQ:PTCT), currently trading at $51.56 with a market capitalization of $4.1 billion, following the company’s receipt of a Complete Response Letter (CRL) from the FDA. According to InvestingPro data, the company maintains an EXCELLENT financial health score and trades at a P/E ratio of 6.4.
The FDA issued the CRL for PTC (NASDAQ:PTC)’s vatiquinone New Drug Application for treating children and adults with Friedreich’s ataxia (FA), indicating that substantial evidence of efficacy was not demonstrated.
Goldman Sachs noted that this outcome was "generally expected" based on management’s commentary during second-quarter 2025 earnings, when the company had not yet entered into labeling discussions with regulators.
The investment bank’s analysis suggests PTC Therapeutics’ return to growth remains primarily tied to the Sephience launch, with upcoming third and fourth quarter earnings expected to provide more color on the early performance of this product.
Goldman Sachs indicated it would take a more constructive view on PTC shares if the company were to deploy its strong cash position toward "high quality mid-to-late stage assets" to diversify beyond its current PKU opportunity.
In other recent news, PTC Therapeutics faced a significant setback as the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for vatiquinone, a treatment for Friedreich’s ataxia. The FDA stated that PTC Therapeutics did not provide substantial evidence of efficacy and requested an additional well-controlled study before the application could be resubmitted. This decision aligns with earlier feedback from both the FDA and the European Medicines Agency, which had expressed concerns about the sufficiency of existing data. Following this development, Jefferies lowered its price target for PTC Therapeutics to $63, maintaining a Buy rating. Similarly, BofA Securities reduced its price target to $76, also retaining a Buy rating. Despite the regulatory hurdle, Truist Securities maintained its Buy rating and $86 price target, viewing the CRL as a "clearing event" for future developments. The market had already anticipated challenges in gaining approval for vatiquinone, according to analysts.
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