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Investing.com - Truist Securities stated Monday that uniQure’s recent regulatory setback for its Huntington’s disease treatment has minimal implications for PTC Therapeutics and Wave Life Sciences. PTC Therapeutics (NASDAQ:PTCT), which is trading near its 52-week high at $66.58, has demonstrated impressive momentum with a 68.79% return over the past year.
The research firm noted that uniQure (NASDAQ:QURE) announced the FDA is unlikely to approve its AMT-130 therapy with the current data package, potentially due to issues with using the ENROLL-HD natural history study as a matched control.
According to Truist, this setback appears specific to uniQure’s approach, as the ENROLL-HD study lacked MRI assessments that could serve as matching criteria with AMT-130’s Phase 1/2 study, unlike other natural history studies such as PREDICT-HT and TRACK-HD.
The firm highlighted that AMT-130’s procedure requires 12 total injections into the caudate region of the brain, suggesting uniQure may have selected patients with caudate regions large enough for these injections, potentially creating selection bias compared to natural history controls.
Truist maintained that this issue does not affect PTC Therapeutics (NASDAQ:PTCT) or Wave Life Sciences (NASDAQ:WVE), as PTC’s PIVOT-HD trial for votoplam includes a placebo control, while Wave has proposed using MRI of caudate as a surrogate biomarker for its upcoming Phase 2/3 registration study, with updates from both programs expected in Q4 2025.PTC Therapeutics has shown robust financial performance with 96% revenue growth and a P/E ratio of 8.61. InvestingPro data shows the company is expected to report earnings on November 4, just one day away. According to InvestingPro Tips, analysts anticipate continued sales growth this year, with three analysts recently revising earnings estimates upward. Discover 10+ additional exclusive insights with InvestingPro, including comprehensive Pro Research Reports available for 1,400+ top US stocks.
In other recent news, PTC Therapeutics has been in the spotlight due to several significant developments. BofA Securities raised its price target for the company to $87 from $76, maintaining a Buy rating, following strong early adoption trends for PTC’s newly approved drug, Sephience. This drug, aimed at treating phenylketonuria (PKU), has seen promising uptake since it began shipping in mid-August. However, the company faced a setback when it received a Complete Response Letter (CRL) from the FDA regarding its vatiquinone application for Friedreich’s ataxia (FA), citing insufficient evidence of efficacy. This regulatory hurdle resulted in Jefferies lowering its price target for PTC Therapeutics to $63 from $64, though it maintained a Buy rating. Meanwhile, Goldman Sachs reiterated a Sell rating with a $44 target, following the FDA’s CRL. Despite the challenges with vatiquinone, BofA continues to see strong potential in Sephience, naming PTC Therapeutics a top pick for 2025. These developments highlight the mixed outlook for the company as it navigates both regulatory challenges and promising product launches.
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