PDUFAoutcome: unknownconf 0.99
orladeyo (berotralstat) — PDUFA
$BCRX · BIOCRYST PHARMACEUTICALS INC · Hereditary angioedema (HAE) in pediatric patients aged 2 to 11 years
Event date
September 12, 2025
267 days ago
Sponsor runway
12 mo
$238.4M liquid
Evidence
Comparable historical pdufas· last 5 years · same event type
60% hit rate (3/5)
| Ticker | Drug | Date | Outcome |
|---|---|---|---|
| $RCKT | kresladi | 2026-03-28 | success |
| $RYTM | imcivree | 2026-03-20 | success |
| $CYTK | aficamten | 2025-12-26 | unknown |
| $ALDX | reproxalap | 2025-12-16 | unknown |
| $BCRX | orladeyo | 2025-12-12 | success |
| $OMER | narsoplimab | 2025-09-25 | unknown |
| $ETON | et-400 | 2025-05-28 | unknown |
| $ALDX | reproxalap | 2025-04-02 | failure |
| $IONS | olezarsen | 2024-12-19 | unknown |
| $RCKT | kresladi | 2024-06-30 | failure |
Recent insider activity· ±90 days
7 insiders · 0 buys · 5 sells
Sell10b5-1
2025-12-03Barnes Alane P
Chief Legal Officer
19,770 @ $7.65$151K
Sell10b5-1
2025-12-02Barnes Alane P
Chief Legal Officer
50,906 @ $7.21$367K
Sell10b5-1
2025-12-01Barnes Alane P
Chief Legal Officer
91,004 @ $7.10$647K
Exercise10b5-1
2025-12-01Barnes Alane P
Chief Legal Officer
91,004 @ $3.22$293K
Grant
2025-11-28McKee Amy E
Director
783 @ $7.18$6K
Grant
2025-11-28Frank Steven
Director
1,566 @ $7.18$11K
Grant
2025-11-28MILANO VINCENT
Director
783 @ $7.18$6K
Sell10b5-1
2025-11-13SANDERS MACHELLE
Director
9,600 @ $7.14$69K
Grant
2025-08-29Frank Steven
Director
1,353 @ $8.31$11K
Grant
2025-08-29McKee Amy E
Director
676 @ $8.31$6K
Grant
2025-08-29MILANO VINCENT
Director
676 @ $8.31$6K
Exercise
2025-08-13HEGGIE THERESA
Director
30,000 @ $2.91$87K
Exercise
2025-08-13HEGGIE THERESA
Director
40,000 @ $5.41$216K
Sell
2025-08-13HEGGIE THERESA
Director
70,000 @ $8.51$596K
Grant
2025-07-24Ghias Babar
Chief Financial Officer
147,000 @ ——
Grant
2025-07-24Ghias Babar
Chief Financial Officer
305,000 @ ——