Applied Therapeutics (NASDAQ:APLT) stock is on the rise Wednesday after the clinical-stage biopharmaceutical company got an update from the Food and Drug Administration (FDA).
The FDA has accepted the company’s New Drug Application (NDA) for govorestat as a treatment for Classic Galactosemia. It was also granted Priority Review status with a target action date of Aug. 28, 2024.
To go along with this, the FDA is planning an advisory committee meeting to review the NDA for govorestat. Investors will note that the drug was also previously granted Pediatric Rare Disease designation. If approved, it will be eligible for a Priority Review Voucher.
Nicole Casale, President of the Galactosemia Foundation, said this about the news.
“We are excited to see that the FDA has accepted the govorestat NDA for priority review. The Galactosemia community is in urgent need of a safe and effective treatment, and the potential approval of govorestat provides hope for many families. Acceptance of the govorestat NDA brings us one step closer to availability of a first-ever treatment.”
How This Affects APLT Stock
APLT stock is seeing heavy trading on Wednesday following the FDA update. That has more than 5.3 million shares of the company’s stock changing hands as of this writing. To put that in perspective, the daily average trading volume for Applied Therapeutics’ shares is about 2 million units.
APLT stock is up 58.7% as of Wednesday morning. The stock is also up 143% year-to-date.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
