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PTCT FDA Decision Approved · 2025-07-28

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 7/28/25$57.17$36.192/10/25
Daily close, T-120 (2/10/25) through T+5. Run-up high $57.17 on 3/21/25, low $36.19 on 5/9/25 (T-120 to T-1). FDA decision 7/28/25. Historical price action, not a forecast.
Positioning before the decision
On Jul 14, 2025, 14 days before the decision date, at-the-money options priced a move of ±14.1% through Aug 15, 2025 (the first listed expiry after the decision; ATM implied volatility 59%). The stock closed -0.9% at the first close across the decision and +16.5% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-07-28
DrugSEPHIENCE (Sepiapterin (PTC923)) - (APHENITY)
IndicationPhenylketonuria (PKU)
Outcome✓ Approvedprimary-sourced
Decision-day move-0.9%
T-120 run-up (low→high)+0.0% ($36.19→$55.31)
Market-cap tierMid
Cohort decision-day move (history)2.1% median (n=234)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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Questions

Was SEPHIENCE (Sepiapterin (PTC923)) - (APHENITY) approved by the FDA?

Yes. The FDA approved the application for SEPHIENCE (Sepiapterin (PTC923)) - (APHENITY) on July 28, 2025. The primary source is linked on this page.

What was SEPHIENCE (Sepiapterin (PTC923)) - (APHENITY) under FDA review for?

The application covered Phenylketonuria (PKU). The FDA approved the application on July 28, 2025.

How did PTCT stock react to the FDA decision?

On the decision day PTCT moved -0.9%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.