Applied Therapeutics (APLT) is expected to have its first FDA approval before the end of the year, with another approval for a different indication in 20251. The company's updated analysis indicates that they are on track for these approvals, with the first approval related to their lead drug candidate, govorestat, for the treatment of Classic Galactosemia12 The company has recently completed a late-cycle review meeting with the FDA and has announced that an Advisory Committee meeting, which was previously scheduled, will no longer be necessary4. This is a positive sign, as it suggests that the FDA is moving forward with the approval process without requiring additional input from an advisory panel. The Prescription Drug User Fee Act (PDUFA) target action date for the first approval is November 28, 202414. Therefore, the expected timeline for APLT's product approval is as follows:
- First FDA Approval: Before end of year 2024 (November 28, 2024)
- Second FDA Approval: 2025 (for a different indication)
These approvals will be significant milestones for APLT, representing the culmination of their efforts in developing and bringing their drug candidates to market.
9/21/2024 08:14am
