Applied Therapeutics Stock Skyrockets Over 120% on FDA Trial News
A new 'confirmatory' Phase 3 study for its lead drug govorestat and the settlement of a key lawsuit fuel investor optimism.
Shares of Applied Therapeutics (NASDAQ: APLT) soared more than 120% in a dramatic trading session, fueled by a pivotal update on its lead drug candidate and the resolution of a lingering legal issue. The clinical-stage biopharmaceutical company's stock experienced exceptionally high trading volume, running more than 45 times its daily average.
The primary catalyst for the surge was the company's announcement of a new 'confirmatory' Phase 3 study for its lead drug, govorestat. The trial is designed to further evaluate the drug's effectiveness in treating Charcot-Marie-Tooth (CMT) disease associated with SORD deficiency, a rare degenerative neuromuscular disorder. The designation of the trial as 'confirmatory' is significant, as it suggests the company may have a clearer and potentially accelerated path toward regulatory approval from the U.S. Food and Drug Administration (FDA).
Investor confidence was further bolstered by the simultaneous news of a . The suit was tied to a previous Complete Response Letter from the FDA regarding govorestat's application for a different condition, Classic Galactosemia. Resolving this legal overhang removes a significant uncertainty for the company and its shareholders, allowing focus to return to the drug's clinical progress.
The has renewed hope in govorestat's potential. According to recent company reports, earlier phases of the CMT trial have already demonstrated that the drug can slow disease progression. For investors, the initiation of a confirmatory study signals that the company is moving confidently towards a potential commercial launch.
The combination of positive clinical developments and legal resolution has created a powerful narrative for Applied Therapeutics. With a clearer regulatory pathway and diminished legal risk, the company is positioned to capitalize on its lead drug candidate. Market watchers will now be closely monitoring the progress of the new Phase 3 trial as the company advances toward a potential FDA submission.