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Following discussions with the FDA, Applied Therapeutics Inc (NASDAQ:APLT) has decided to hold on submitting a marketing application for AT-007 for Galactosemia pending additional talks with the agency.
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- Although the Galactosemia program had previously been discussed for Accelerated Approval based on reduction in galactitol, the FDA has now indicated that clinical outcomes data will likely be required for approval.
- Related: Applied Therapeutics Stock Drops On Delayed NDA Submission For Its Lead Candidate.
- The ongoing ACTION-Galactosemia Kids Phase 3 study is evaluating AT-007 treatment vs. placebo on clinical outcomes over time, including cognition, speech, behavior, and motor skills.
- The first assessment will be completed in Q1 of 2022 and then every six months until the study reaches statistical significance.
- Galactosemia is a rare genetic metabolic disease that cannot metabolize the simple sugar galactose.
- When not appropriately metabolized, galactose is converted to the toxic metabolite, galactitol, which causes neurological complications, including deficiencies in speech, cognition, behavior, and motor skills.
- Also See: Benzinga's Full FDA Calendar.
- Price Action: APLT shares are down 26.6% at $6.57 during the premarket session on the last check Monday.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.