PDUFAconf 0.98

balstilimab — PDUFA

$AGEN · AGENUS INC · second-line cervical cancer

Event date

December 16, 2021

1633 days ago

Sponsor runway

3 mo

$35.0M liquid

Evidence

“The BLA submission for balstilimab received Fast Track and Priority Review designation from the FDA, with a target action date of December 16, 2021.”

Source: Press release · 2021-10-22View press release ↗

Comparable historical pdufas· last 5 years · same event type

75% hit rate (3/4)

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
$BCRX	orladeyo (berotralstat)	2025-09-12	unknown
$ETON	et-400	2025-05-28	unknown
$ALDX	reproxalap	2025-04-02	failure
$IONS	olezarsen	2024-12-19	unknown

Recent insider activity· ±90 days

10 insiders · 1 buys · 1 sells

Grant

2022-02-04

WIINBERG ULF

Director

100,000 @ ——

Grant

2022-02-04

Hirsch Susan B

Director

100,000 @ ——

Grant

2022-02-04

JORDAN WADIH

Director

100,000 @ ——

Grant

2022-02-04

Jeynes-Ellis Allison M

Director

100,000 @ ——

Grant

2022-02-04

Corvese Brian

Director

150,000 @ ——

Grant

2022-02-04

Wright Timothy

Director

150,000 @ ——

Grant

2022-02-02

ARMEN GARO H

See Remarks

237,011 @ $2.51$595K

Grant

2022-02-02

O'Day Steven J

Chief Medical Officer

101,682 @ $2.51$255K

Grant

2022-02-02

KLASKIN CHRISTINE M

PFO & PAO

29,587 @ $2.51$74K

Sell

2022-01-06

O'Day Steven J

Chief Medical Officer

38,679 @ $3.06$118K

Exercise

2022-01-04

O'Day Steven J

Chief Medical Officer

100,000 @ ——

Grant

2022-01-03

Hirsch Susan B

Director

4,677 @ $4.01$19K

Grant

2022-01-03

WIINBERG ULF

Director

6,391.991 @ ——

Grant

2022-01-03

JORDAN WADIH

Director

6,547.893 @ ——

Grant

2022-01-03

Wright Timothy

Director

2,338.533 @ ——

Grant

2022-01-02

O'Day Steven J

Chief Medical Officer

150,000 @ ——

Grant

2022-01-02

ARMEN GARO H

See Remarks

1,900,000 @ ——

Grant

2022-01-02

KLASKIN CHRISTINE M

PFO & PAO

100,000 @ ——

Buy

2021-10-19

AGENUS INC

10%+ Owner

1,400,000 @ $12.00$16.80M

Conv

2021-10-19

AGENUS INC

10%+ Owner

5,451,958 @ ——

Grant

2021-10-01

Hirsch Susan B

Director

3,257 @ $5.76$19K

Grant

2021-10-01

Wright Timothy

Director

1,628.532 @ ——

Grant

2021-10-01

WIINBERG ULF

Director

4,451.32 @ ——

Grant

2021-10-01

JORDAN WADIH

Director

4,559.889 @ ——

Date	Insider	Action	Shares	Price	Value
2022-02-04	WIINBERG ULFDirector	Grant	100,000	—	—
2022-02-04	Hirsch Susan BDirector	Grant	100,000	—	—
2022-02-04	JORDAN WADIHDirector	Grant	100,000	—	—
2022-02-04	Jeynes-Ellis Allison MDirector	Grant	100,000	—	—
2022-02-04	Corvese BrianDirector	Grant	150,000	—	—
2022-02-04	Wright TimothyDirector	Grant	150,000	—	—
2022-02-02	ARMEN GARO HSee Remarks	Grant	237,011	$2.51	$595K
2022-02-02	O'Day Steven JChief Medical Officer	Grant	101,682	$2.51	$255K
2022-02-02	KLASKIN CHRISTINE MPFO & PAO	Grant	29,587	$2.51	$74K
2022-01-06	O'Day Steven JChief Medical Officer	Sell	38,679	$3.06	$118K
2022-01-04	O'Day Steven JChief Medical Officer	Exercise	100,000	—	—
2022-01-03	Hirsch Susan BDirector	Grant	4,677	$4.01	$19K
2022-01-03	WIINBERG ULFDirector	Grant	6,391.991	—	—
2022-01-03	JORDAN WADIHDirector	Grant	6,547.893	—	—
2022-01-03	Wright TimothyDirector	Grant	2,338.533	—	—
2022-01-02	O'Day Steven JChief Medical Officer	Grant	150,000	—	—
2022-01-02	ARMEN GARO HSee Remarks	Grant	1,900,000	—	—
2022-01-02	KLASKIN CHRISTINE MPFO & PAO	Grant	100,000	—	—
2021-10-19	AGENUS INC10%+ Owner	Buy	1,400,000	$12.00	$16.80M
2021-10-19	AGENUS INC10%+ Owner	Conv	5,451,958	—	—
2021-10-01	Hirsch Susan BDirector	Grant	3,257	$5.76	$19K
2021-10-01	Wright TimothyDirector	Grant	1,628.532	—	—
2021-10-01	WIINBERG ULFDirector	Grant	4,451.32	—	—
2021-10-01	JORDAN WADIHDirector	Grant	4,559.889	—	—

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