Yeji
PDUFAoutcome: unknownconf 0.98

olezarsen — PDUFA

$IONS · IONIS PHARMACEUTICALS INC · Familial chylomicronemia syndrome (FCS)
Event date
December 19, 2024
534 days ago
Sponsor runway
7 mo
$1.92B liquid

Evidence

“In June 2024, the FDA accepted our NDA for patients with FCS for Priority Review with a Prescription Drug User Fee Act, or PDUFA, date of December nbsp;19, 2024.”
Source: 8-K filed 2024-09-09View on EDGAR ↗0001193125-24-215939

Comparable historical pdufas· last 5 years · same event type

60% hit rate (3/5)
TickerDrugDateOutcome
$RCKTkresladi2026-03-28success
$RYTMimcivree2026-03-20success
$CYTKaficamten2025-12-26unknown
$ALDXreproxalap2025-12-16unknown
$BCRXorladeyo2025-12-12success
$OMERnarsoplimab2025-09-25unknown
$BCRXorladeyo (berotralstat)2025-09-12unknown
$ETONet-4002025-05-28unknown
$ALDXreproxalap2025-04-02failure
$RCKTkresladi2024-06-30failure

Recent insider activity· ±90 days

14 insiders · 1 buys · 27 sells
Sell10b5-1
2025-03-11
Monia Brett P
Chief Executive Officer
140 @ $32.32$5K
Other
2025-02-28
O'NEIL PATRICK R.
EVP CLO & General Counsel
554 @ $28.21$16K
Other
2025-02-28
Swayze Eric
EVP Research
415 @ $28.21$12K
Other
2025-02-28
Monia Brett P
Chief Executive Officer
437 @ $28.21$12K
Other
2025-02-28
BENNETT C FRANK
EVP, Chief Scientific Officer
320 @ $28.21$9K
Other
2025-02-28
Birchler Brian
EVP, Corp and Development Ops
414 @ $28.21$12K
Other
2025-02-28
Geary Richard S
EVP, Chief Development Officer
415 @ $28.21$12K
Sell10b5-1
2025-02-20
O'NEIL PATRICK R.
EVP CLO & General Counsel
1,207 @ $32.35$39K
Sell10b5-1
2025-02-04
Monia Brett P
Chief Executive Officer
38,843 @ $31.65$1.23M
Sell10b5-1
2025-02-04
O'NEIL PATRICK R.
EVP CLO & General Counsel
6,165 @ $31.62$195K
Sell
2025-01-31
HOUGEN ELIZABETH L
EVP, Finance & CFO
1,523 @ $32.44$49K
Sell
2025-01-31
Swayze Eric
EVP Research
1,367 @ $32.31$44K
Sell
2025-01-31
Schneider Eugene
EVP, Chf Clinical Develop Ofcr
1,484 @ $32.20$48K
Sell
2025-01-31
O'NEIL PATRICK R.
EVP CLO & General Counsel
1,406 @ $32.49$46K
Sell
2025-01-31
Monia Brett P
Chief Executive Officer
13,242 @ $32.45$430K
Sell
2025-01-31
Geary Richard S
EVP, Chief Development Officer
1,406 @ $32.40$46K
Sell
2025-01-31
BENNETT C FRANK
EVP, Chief Scientific Officer
1,327 @ $32.46$43K
Grant
2025-01-30
Monia Brett P
Chief Executive Officer
25,372 @ ——
Grant
2025-01-30
O'NEIL PATRICK R.
EVP CLO & General Counsel
3,820 @ ——
Grant
2025-01-30
Swayze Eric
EVP Research
3,714 @ ——
Grant
2025-01-30
Schneider Eugene
EVP, Chf Clinical Develop Ofcr
4,032 @ ——
Grant
2025-01-30
Geary Richard S
EVP, Chief Development Officer
3,820 @ ——
Grant
2025-01-30
BENNETT C FRANK
EVP, Chief Scientific Officer
3,607 @ ——
Grant
2025-01-30
HOUGEN ELIZABETH L
EVP, Finance & CFO
4,138 @ ——
Sell
2025-01-16
O'NEIL PATRICK R.
EVP CLO & General Counsel
7,360 @ $32.83$242K
Sell
2025-01-16
Baroldi Joseph
EVP, Chief Business Officer
1,029 @ $32.70$34K
Sell
2025-01-16
BENNETT C FRANK
EVP, Chief Scientific Officer
6,752 @ $32.90$222K
Sell
2025-01-16
HOUGEN ELIZABETH L
EVP, Finance & CFO
8,870 @ $32.81$291K
Sell
2025-01-16
Swayze Eric
EVP Research
7,154 @ $32.84$235K
Sell
2025-01-16
Baroldi Joseph
EVP, Chief Business Officer
3,401 @ $32.70$111K
Sell
2025-01-16
Monia Brett P
Chief Executive Officer
33,445 @ $32.63$1.09M
Sell
2025-01-16
Devers Shannon L.
EVP, Chief Human Resources Ofc
4,267 @ $32.78$140K
Sell
2025-01-16
Schneider Eugene
EVP, Chf Clinical Develop Ofcr
6,523 @ $32.79$214K
Sell
2025-01-16
Geary Richard S
EVP, Chief Development Officer
7,072 @ $32.86$232K
Sell
2025-01-16
Birchler Brian
EVP, Corp and Development Ops
5,400 @ $32.70$177K
Sell
2025-01-16
Swayze Eric
EVP Research
22 @ $32.70$719
Exercise
2025-01-15
Devers Shannon L.
EVP, Chief Human Resources Ofc
12,295 @ ——
Exercise
2025-01-15
YANG MICHAEL J.
Director
1,931 @ ——
Grant
2025-01-15
Swayze Eric
EVP Research
245 @ ——
Exercise
2025-01-15
O'NEIL PATRICK R.
EVP CLO & General Counsel
19,690 @ ——
Grant
2025-01-15
O'NEIL PATRICK R.
EVP CLO & General Counsel
22,000 @ ——
Grant
2025-01-15
O'NEIL PATRICK R.
EVP CLO & General Counsel
33,000 @ ——
Grant
2025-01-15
Jenne Kyle
EVP, Chf GL Pdt Str Ofcr
18,700 @ ——
Grant
2025-01-15
Jenne Kyle
EVP, Chf GL Pdt Str Ofcr
28,050 @ ——
Exercise
2025-01-15
HOUGEN ELIZABETH L
EVP, Finance & CFO
23,887 @ ——
Grant
2025-01-15
HOUGEN ELIZABETH L
EVP, Finance & CFO
31,000 @ ——
Grant
2025-01-15
HOUGEN ELIZABETH L
EVP, Finance & CFO
46,500 @ ——
Grant
2025-01-15
Devers Shannon L.
EVP, Chief Human Resources Ofc
22,000 @ ——
Grant
2025-01-15
Devers Shannon L.
EVP, Chief Human Resources Ofc
33,000 @ ——
Exercise
2025-01-15
BENNETT C FRANK
EVP, Chief Scientific Officer
18,011 @ ——
+ 44 more
← All catalysts for $IONS