Yeji
NDA/BLA filedconf 0.95

olezarsen — NDA/BLA filed

$IONS · IONIS PHARMACEUTICALS INC · Familial chylomicronemia syndrome (FCS)
Event date
Date TBD
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 nda/bla fileds· last 5 years · same event type

TickerDrugDateOutcome
$AXSM2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown

Recent insider activity· ±90 days

4 insiders · 0 buys · 7 sells
Exercise10b5-1
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Monia Brett P
Chief Executive Officer
3,220 @ $32.60$105K
Sell10b5-1
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Monia Brett P
Chief Executive Officer
3,220 @ $78.68$253K
Exercise10b5-1
2026-05-13
Monia Brett P
Chief Executive Officer
1,316 @ $32.60$43K
Sell10b5-1
2026-05-13
Monia Brett P
Chief Executive Officer
1,316 @ $78.01$103K
Sell10b5-1
2026-05-04
LOSCALZO JOSEPH
Director
17,781 @ $75.58$1.34M
Exercise10b5-1
2026-05-04
LOSCALZO JOSEPH
Director
12,000 @ $40.05$481K
Exercise10b5-1
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LOSCALZO JOSEPH
Director
10,321 @ $41.08$424K
Exercise10b5-1
2026-05-04
LOSCALZO JOSEPH
Director
16,000 @ $42.88$686K
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LOSCALZO JOSEPH
Director
59,508 @ $74.90$4.46M
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LOSCALZO JOSEPH
Director
10,968 @ $38.06$417K
Sell10b5-1
2026-05-01
KLEIN JOSEPH III
Director
8,680 @ $73.35$637K
Sell10b5-1
2026-05-01
KLEIN JOSEPH III
Director
1,431 @ $74.45$107K
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10,111 @ $47.11$476K
Sell10b5-1
2026-04-28
Baroldi Joseph
EVP, Chief Business Officer
1,626 @ $71.79$117K