PDUFAoutcome: unknownconf 0.98

exagamglogene autotemcel — PDUFA

$CRSP · CRISPR Therapeutics AG · severe sickle cell disease (SCD)

Event date

December 8, 2023

911 days ago

Sponsor runway

6+ yrs

$2.44B liquid

Evidence

“The FDA has granted Priority Review for SCD and Standard Review for TDT and assigned Prescription Drug User Fee Act target action dates of December 8, 2023 and March 30, 2024, respectively.”

Source: 8-K filed 2023-06-09View on EDGAR ↗0000950170-23-027129

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

5 insiders · 0 buys · 8 sells

Grant

2024-02-27

George Simeon

Director

216,578 @ $71.50$15.49M

Grant

2024-02-27

George Simeon

Director

63,177 @ $71.50$4.52M

Grant

2024-02-27

George Simeon

Director

769,196 @ $71.50$55.00M

Sell

2024-02-20

KASINGER JAMES R.

General Counsel and Secretary

1,913 @ $79.67$152K

Sell

2024-02-20

Kulkarni Samarth

Chief Executive Officer

6,370 @ $79.67$507K

Exercise

2024-02-18

Kulkarni Samarth

Chief Executive Officer

13,250 @ ——

Exercise

2024-02-18

KASINGER JAMES R.

General Counsel and Secretary

3,825 @ ——

Sell10b5-1

2024-02-15

Kulkarni Samarth

Chief Executive Officer

5,951 @ $81.04$482K

Sell10b5-1

2024-02-15

Kulkarni Samarth

Chief Executive Officer

1,100 @ $81.66$90K

Sell10b5-1

2024-02-15

Kulkarni Samarth

Chief Executive Officer

12,949 @ $79.94$1.04M

Exercise10b5-1

2024-02-15

Kulkarni Samarth

Chief Executive Officer

20,000 @ $19.12$382K

Exercise10b5-1

2024-01-29

Kulkarni Samarth

Chief Executive Officer

50,000 @ $19.12$956K

Sell10b5-1

2024-01-29

Kulkarni Samarth

Chief Executive Officer

700 @ $61.10$43K

Sell10b5-1

2024-01-29

Kulkarni Samarth

Chief Executive Officer

49,300 @ $60.50$2.98M

Exercise10b5-1

2024-01-16

Kulkarni Samarth

Chief Executive Officer

20,000 @ $19.12$382K

Sell10b5-1

2024-01-16

Kulkarni Samarth

Chief Executive Officer

20,000 @ $62.50$1.25M

Grant

2023-10-13

Kulkarni Samarth

Chief Executive Officer

25,000 @ ——

Grant

2023-10-13

Prasad Raju

Chief Financial Officer

13,832 @ ——

Grant

2023-10-13

KASINGER JAMES R.

General Counsel and Secretary

16,667 @ ——

Grant

2023-10-13

KASINGER JAMES R.

General Counsel and Secretary

6,340 @ ——

Grant

2023-10-13

Kulkarni Samarth

Chief Executive Officer

52,500 @ ——

Grant

2023-10-13

Morrow Phuong Khanh

Chief Medical Officer

16,667 @ ——

Date	Insider	Action	Shares	Price	Value
2024-02-27	George SimeonDirector	Grant	216,578	$71.50	$15.49M
2024-02-27	George SimeonDirector	Grant	63,177	$71.50	$4.52M
2024-02-27	George SimeonDirector	Grant	769,196	$71.50	$55.00M
2024-02-20	KASINGER JAMES R.General Counsel and Secretary	Sell	1,913	$79.67	$152K
2024-02-20	Kulkarni SamarthChief Executive Officer	Sell	6,370	$79.67	$507K
2024-02-18	Kulkarni SamarthChief Executive Officer	Exercise	13,250	—	—
2024-02-18	KASINGER JAMES R.General Counsel and Secretary	Exercise	3,825	—	—
2024-02-15	Kulkarni SamarthChief Executive Officer	Sell10b5-1	5,951	$81.04	$482K
2024-02-15	Kulkarni SamarthChief Executive Officer	Sell10b5-1	1,100	$81.66	$90K
2024-02-15	Kulkarni SamarthChief Executive Officer	Sell10b5-1	12,949	$79.94	$1.04M
2024-02-15	Kulkarni SamarthChief Executive Officer	Exercise10b5-1	20,000	$19.12	$382K
2024-01-29	Kulkarni SamarthChief Executive Officer	Exercise10b5-1	50,000	$19.12	$956K
2024-01-29	Kulkarni SamarthChief Executive Officer	Sell10b5-1	700	$61.10	$43K
2024-01-29	Kulkarni SamarthChief Executive Officer	Sell10b5-1	49,300	$60.50	$2.98M
2024-01-16	Kulkarni SamarthChief Executive Officer	Exercise10b5-1	20,000	$19.12	$382K
2024-01-16	Kulkarni SamarthChief Executive Officer	Sell10b5-1	20,000	$62.50	$1.25M
2023-10-13	Kulkarni SamarthChief Executive Officer	Grant	25,000	—	—
2023-10-13	Prasad RajuChief Financial Officer	Grant	13,832	—	—
2023-10-13	KASINGER JAMES R.General Counsel and Secretary	Grant	16,667	—	—
2023-10-13	KASINGER JAMES R.General Counsel and Secretary	Grant	6,340	—	—
2023-10-13	Kulkarni SamarthChief Executive Officer	Grant	52,500	—	—
2023-10-13	Morrow Phuong KhanhChief Medical Officer	Grant	16,667	—	—

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