PDUFAconf 0.75

olezarsen — PDUFA

$IONS · IONIS PHARMACEUTICALS INC · Familial chylomicronemia syndrome (FCS)

Event date

Date TBD

Sponsor runway

7 mo

$1.92B liquid

Evidence

“We are on track to submit a supplemental new drug application for both the 50 mg and 80 mg doses to the U.S. Food and Drug Administration ("FDA") by the end of the year and expect a Prescription Drug User Fee Act ("PDUFA") target action date in 2026.”

Source: 8-K filed 2025-11-10View on EDGAR ↗0001140361-25-041225

Comparable historical pdufas· last 5 years · same indication

Ticker	Drug	Date	Outcome
$IONS	olezarsen	2024-12-19	unknown

Recent insider activity· ±90 days

4 insiders · 0 buys · 7 sells

Exercise10b5-1

2026-05-14

Monia Brett P

Chief Executive Officer

3,220 @ $32.60$105K

Sell10b5-1

2026-05-14

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

2026-05-04

LOSCALZO JOSEPH

Director

10,321 @ $41.08$424K

Exercise10b5-1

2026-05-04

LOSCALZO JOSEPH

Director

16,000 @ $42.88$686K

Sell10b5-1

2026-05-04

LOSCALZO JOSEPH

Director

59,508 @ $74.90$4.46M

Exercise10b5-1

2026-05-04

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

Exercise10b5-1

2026-05-01

KLEIN JOSEPH III

Director

10,111 @ $47.11$476K

Sell10b5-1

2026-04-28

Baroldi Joseph

EVP, Chief Business Officer

1,626 @ $71.79$117K

Date	Insider	Action	Shares	Price	Value
2026-05-14	Monia Brett PChief Executive Officer	Exercise10b5-1	3,220	$32.60	$105K
2026-05-14	Monia Brett PChief Executive Officer	Sell10b5-1	3,220	$78.68	$253K
2026-05-13	Monia Brett PChief Executive Officer	Exercise10b5-1	1,316	$32.60	$43K
2026-05-13	Monia Brett PChief Executive Officer	Sell10b5-1	1,316	$78.01	$103K
2026-05-04	LOSCALZO JOSEPHDirector	Sell10b5-1	17,781	$75.58	$1.34M
2026-05-04	LOSCALZO JOSEPHDirector	Exercise10b5-1	12,000	$40.05	$481K
2026-05-04	LOSCALZO JOSEPHDirector	Exercise10b5-1	10,321	$41.08	$424K
2026-05-04	LOSCALZO JOSEPHDirector	Exercise10b5-1	16,000	$42.88	$686K
2026-05-04	LOSCALZO JOSEPHDirector	Sell10b5-1	59,508	$74.90	$4.46M
2026-05-04	LOSCALZO JOSEPHDirector	Exercise10b5-1	10,968	$38.06	$417K
2026-05-01	KLEIN JOSEPH IIIDirector	Sell10b5-1	8,680	$73.35	$637K
2026-05-01	KLEIN JOSEPH IIIDirector	Sell10b5-1	1,431	$74.45	$107K
2026-05-01	KLEIN JOSEPH IIIDirector	Exercise10b5-1	10,111	$47.11	$476K
2026-04-28	Baroldi JosephEVP, Chief Business Officer	Sell10b5-1	1,626	$71.79	$117K

← All catalysts for $IONS