Applied Therapeutics (APLT) saw its stock price jump over 68% on September 18th, 2024, following a positive update on the regulatory pathway for its lead drug candidate, govorestat, which is being developed to treat Classic Galactosemia.
The company announced that the FDA has decided to waive the previously scheduled Advisory Committee meeting, signaling confidence in the drug’s safety and efficacy profile. Moreover, the FDA reaffirmed the Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2024, keeping the potential approval timeline on track.
Implications for Investors
This news is a significant positive development for Applied Therapeutics. The removal of the Advisory Committee meeting streamlines the approval process and reduces uncertainty for investors. Additionally, the company’s CEO, Shoshana Shendelman, expressed confidence in the ongoing dialogue with the FDA, further bolstering investor sentiment.
The potential approval of govorestat would be a game-changer for Applied Therapeutics. Galactosemia is a rare and debilitating disease with no currently approved treatments. Govorestat, if approved, would address a significant unmet medical need and could generate substantial revenue for the company.
Market Potential
While Galactosemia is a rare disease, the market potential for govorestat is significant. With approximately 3,000 patients in the US and 4,000 patients in the EU, and mandatory newborn screening in place, the drug could reach a substantial portion of the affected population.
Moreover, the absence of approved therapies means that govorestat could command a premium price, further enhancing its revenue potential.
Cautious Optimism
While the recent FDA update is undoubtedly positive, investors should maintain a degree of cautious optimism. The drug approval process is inherently uncertain, and unexpected setbacks can occur.
However, the current trajectory for govorestat appears promising. If approved, the drug could transform Applied Therapeutics into a commercial-stage biopharmaceutical company with a significant revenue stream.
Conclusion
Applied Therapeutics’ recent stock price surge reflects the market’s optimism about the potential approval of govorestat. The company’s strong position in addressing a significant unmet medical need and the positive regulatory developments make it an attractive investment opportunity. However, investors should remain mindful of the inherent risks associated with the drug development process and maintain a balanced perspective.
Disclaimer: This blog post is for informational purposes only and should not be considered financial advice. Always conduct your own research and consult with a qualified financial advisor before making any investment decisions.
