Yeji
FDA approvalconf 0.99

orladeyo — FDA approval

$BCRX · BIOCRYST PHARMACEUTICALS INC
Event date
December 12, 2025
176 days ago
Sponsor runway
12 mo
$238.4M liquid

Evidence

“the U.S. Food and Drug Administration has approved the Company\'s new drug application for the use of an oral pellet formulation of once-daily ORLADEYO ® (berotralstat) for prophylactic therapy in pediatric patients with hereditary angioedema aged 2 to <12 years”
Source: 8-K filed 2025-12-12View on EDGAR ↗0001171843-25-007909

Comparable historical fda approvals· last 5 years · same event type

100% hit rate (10/10)
TickerDrugDateOutcome
$INCYzynyz2026-05-18success
$INCYjakafi xr2026-05-01success
$AXSMauvelity2026-04-30success
$INCYzynyz2026-03-30success
$BIIBspinraza2026-03-27success
$CORTlifyorli2026-03-25success
$RYTMimcivree2026-03-19success
$ASNDyuviwel2026-02-27success
$BMRNpalynziq2026-02-27success
$ETONdesmoda2026-02-25success

Recent insider activity· ±90 days

9 insiders · 0 buys · 6 sells
Exercise10b5-1
2026-03-02
Stonehouse Jon P
Director
305,995 @ $3.22$985K
Disp10b5-1
2026-03-02
Stonehouse Jon P
Director
305,995 @ $8.64$2.64M
Grant
2026-02-27
Frank Steven
Director
1,285 @ $8.75$11K
Grant
2026-02-27
MILANO VINCENT
Director
848 @ $8.75$7K
Grant
2026-02-27
McKee Amy E
Director
642 @ $8.75$6K
Grant
2026-02-27
Milne Jill C.
Director
528 @ $8.75$5K
Grant10b5-1
2026-02-27
Stonehouse Jon P
Director
421 @ $8.75$4K
Grant
2026-01-23
Milne Jill C.
Director
12,272 @ ——
Grant
2026-01-23
Milne Jill C.
Director
26,684 @ ——
Grant
2026-01-23
Milne Jill C.
Director
2,582 @ ——
Exercise
2025-12-22
Gayer Charles K
President and CCO
50,000 @ $5.51$276K
Exercise
2025-12-22
Gayer Charles K
President and CCO
10,091 @ $5.04$51K
Sell10b5-1
2025-12-22
Barnes Alane P
Chief Legal Officer
21,773 @ $7.65$167K
Exercise
2025-12-22
Gayer Charles K
President and CCO
14,142 @ $3.22$46K
Tax10b5-1
2025-12-19
Barnes Alane P
Chief Legal Officer
16,902 @ $7.41$125K
Tax
2025-12-19
Stonehouse Jon P
Director
61,793 @ $7.41$458K
Tax
2025-12-19
Gayer Charles K
President and CCO
11,477 @ $7.41$85K
Gift
2025-12-18
Stonehouse Jon P
Director
10,000 @ ——
Gift
2025-12-18
Stonehouse Jon P
Director
20,000 @ ——
Grant
2025-12-17
Gayer Charles K
President and CCO
986,950 @ ——
Grant
2025-12-17
Gayer Charles K
President and CCO
471,000 @ ——
Grant
2025-12-17
Ghias Babar
Chief Financial Officer
355,050 @ ——
Grant
2025-12-17
Barnes Alane P
Chief Legal Officer
121,700 @ ——
Grant
2025-12-17
Barnes Alane P
Chief Legal Officer
255,050 @ ——
Grant
2025-12-17
Ghias Babar
Chief Financial Officer
121,700 @ ——
Sell10b5-1
2025-12-15
Barnes Alane P
Chief Legal Officer
21,210 @ $7.65$162K
Tax10b5-1
2025-12-12
Barnes Alane P
Chief Legal Officer
8,540 @ $7.57$65K
Tax
2025-12-12
Stonehouse Jon P
Director
27,368 @ $7.57$207K
Tax
2025-12-12
Gayer Charles K
President and CCO
8,181 @ $7.57$62K
Sell10b5-1
2025-12-03
Barnes Alane P
Chief Legal Officer
19,770 @ $7.65$151K
Sell10b5-1
2025-12-02
Barnes Alane P
Chief Legal Officer
50,906 @ $7.21$367K
Exercise10b5-1
2025-12-01
Barnes Alane P
Chief Legal Officer
91,004 @ $3.22$293K
Sell10b5-1
2025-12-01
Barnes Alane P
Chief Legal Officer
91,004 @ $7.10$647K
Grant
2025-11-28
Frank Steven
Director
1,566 @ $7.18$11K
Grant
2025-11-28
McKee Amy E
Director
783 @ $7.18$6K
Grant
2025-11-28
MILANO VINCENT
Director
783 @ $7.18$6K
Sell10b5-1
2025-11-13
SANDERS MACHELLE
Director
9,600 @ $7.14$69K
← All catalysts for $BCRX