Applied Therapeutics, Inc. (APLT) experienced a significant stock price increase on Wednesday, with trading volume exceeding 31.75 million shares compared to its average volume of 1.26 million. This surge was fueled by positive news regarding the company’s ongoing New Drug Application (NDA) review for govorestat, a potential treatment for Classic Galactosemia.
Galactosemia is a rare genetic disorder that prevents the body from processing galactose, a type of sugar. Applied Therapeutics recently concluded its late-cycle review meeting with the FDA, receiving encouraging news. The agency has decided that an advisory committee meeting, initially scheduled for October 9th, is no longer necessary. This positive development indicates the FDA’s confidence in the drug’s potential and its alignment with the company’s strategy.
The FDA confirmed that the Priority Review of the NDA is progressing as planned, with a target action date of November 28th. The agency expects to finalize post-marketing requirements in October 2024.
In April, the FDA extended the review period for Applied Therapeutics’ marketing application by three months. However, despite this extension, analysts remain optimistic about the future of govorestat. William Blair, an investment firm, predicts that Applied Therapeutics will successfully launch govorestat in the galactosemia market in 2025, citing the high unmet medical need, absence of other approved therapies, and a well-defined patient population. They project that govorestat sales will exceed $1 billion by 2030, achieving a peak market penetration of 70%.
At the end of Wednesday’s trading session, APLT stock closed at $7.97, representing a 71.40% increase. This positive news and the continued progress of the NDA review highlight the promising future of govorestat as a potential treatment for Classic Galactosemia and a significant growth driver for Applied Therapeutics.
