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On Wednesday, TD Cowen demonstrated confidence in PTC (NASDAQ:PTC) Therapeutics (NASDAQ:PTCT) by increasing the stock’s price target from $50.00 to $60.00 and maintaining a Buy rating. The decision came after the New Drug Application (NDA) for vatiquinone, aimed at treating Friedreich’s ataxia, was officially accepted for review, with a Prescription Drug User Fee Act (PDUFA) date set for August 19. According to InvestingPro data, analyst targets for PTCT range from $41 to $113, with the stock showing remarkable momentum, gaining over 90% in the past year. Based on InvestingPro’s Fair Value analysis, the stock appears to be trading above its intrinsic value.
The acceptance of the NDA marks a significant milestone for PTC Therapeutics as it progresses towards potentially bringing a new treatment to market for Friedreich’s ataxia, a condition that currently has a high unmet medical need, especially in the pediatric population.
According to TD Cowen’s analysis, the optimism is partly due to encouraging longer-term analyses when compared to a natural history comparator, which indicated that vatiquinone showed benefits on the modified Friedreich’s Ataxia Rating Scale (mFARS). This positive data has led to a more constructive outlook from key opinion leaders (KOLs) in the field.
The KOL consulted by TD Cowen anticipates that vatiquinone, if approved, would experience rapid uptake among pediatric patients due to the lack of existing treatment options. This potential has been factored into the Sum of The Parts (SOTP) valuation, resulting in the revised price target.
PTC Therapeutics’ focus on developing therapies for rare disorders could potentially be bolstered by this development. The company’s commitment to addressing the needs of patients with Friedreich’s ataxia is reflected in the progression of vatiquinone through the regulatory review process. With the PDUFA date approaching, stakeholders may keep a close eye on further updates from the company and regulatory authorities.
In other recent news, PTC Therapeutics reported that its revenue for 2024 reached approximately $814 million, surpassing its guidance. The company’s strong financial performance was driven by sales from its Duchenne Muscular Dystrophy franchise. PTC Therapeutics also submitted four regulatory applications to the FDA in 2024, including one for the gene therapy Kebilidi, which received approval in November. Additionally, the company entered a significant agreement with Novartis (SIX:NOVN) for the PTC518 program, securing $1.0 billion upfront and potential additional milestones. In regulatory news, the FDA accepted PTC Therapeutics’ New Drug Application for vatiquinone, granting it Priority Review status. This drug aims to treat Friedreich’s ataxia, a rare neuromuscular disorder. Analyst activity includes Cantor Fitzgerald raising its price target for PTC Therapeutics to $113, maintaining an Overweight rating, while Cowen increased its target to $50, keeping a Hold rating. These developments reflect ongoing interest in PTC Therapeutics’ financial health and product pipeline.
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