NDA/BLA filedoutcome: unknownconf 0.95

exagamglogene autotemcel — NDA/BLA filed

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

Event date

June 8, 2023

1094 days ago

Sponsor runway

6+ yrs

$2.44B liquid

Evidence

“On June 8, 2023, the Company and Vertex announced that the FDA has accepted the BLAs for the product candidate, exa-cel, being investigated for the treatment of SCD and TDT in patients ages 12 to 35.”

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

Comparable historical nda/bla fileds· last 5 years · same event type

Ticker	Drug	Date	Outcome
$AXSM	—	2025-12-31	unknown
$RCKT	kresladi	2025-10-14	unknown
$ALDX	reproxalap	2025-07-17	unknown
$ETON	et-600	2025-07-08	unknown
$BCRX	orladeyo (berotralstat)	2025-05-14	unknown
$CORT	relacorilant	2025-03-03	unknown
$ALDX	reproxalap	2024-11-01	unknown
$AXSM	axs-07	2024-09-04	unknown
$RCKT	kresladi	2023-10-02	unknown
$GERN	imetelstat	2023-08-21	unknown

Recent insider activity· ±90 days

11 insiders · 0 buys · 8 sells

Grant

2023-06-08

George Simeon

Director

13,000 @ ——

Grant

2023-06-08

High Katherine A

Director

13,000 @ ——

Grant

2023-06-08

Fleming Harold Edward

Director

13,000 @ ——

Grant

2023-06-08

Treco Douglas A

Director

13,000 @ ——

Grant

2023-06-08

Greene John

Director

13,000 @ ——

Grant

2023-06-08

Fardis Maria

Director

13,000 @ ——

Grant

2023-06-08

Behbahani Ali

Director

13,000 @ ——

Exercise10b5-1

2023-05-30

Kulkarni Samarth

Chief Executive Officer

25,000 @ $19.12$478K

Sell10b5-1

2023-05-30

Kulkarni Samarth

Chief Executive Officer

7,301 @ $63.61$464K

Sell10b5-1

2023-05-30

Kulkarni Samarth

Chief Executive Officer

5,999 @ $64.46$387K

Sell10b5-1

2023-05-30

Kulkarni Samarth

Chief Executive Officer

9,300 @ $65.63$610K

Sell10b5-1

2023-05-30

Kulkarni Samarth

Chief Executive Officer

2,400 @ $66.83$160K

Tax

2023-05-24

Morrow Phuong Khanh

Chief Medical Officer

2,527 @ $65.91$167K

Exercise

2023-05-23

Morrow Phuong Khanh

Chief Medical Officer

6,938 @ ——

Exercise10b5-1

2023-04-25

Kulkarni Samarth

Chief Executive Officer

25,000 @ $19.12$478K

Sell10b5-1

2023-04-25

Kulkarni Samarth

Chief Executive Officer

20,607 @ $50.50$1.04M

Sell10b5-1

2023-04-25

Kulkarni Samarth

Chief Executive Officer

4,393 @ $51.45$226K

Sell

2023-03-29

Kulkarni Samarth

Chief Executive Officer

19,719 @ $44.37$875K

Sell

2023-03-29

Kulkarni Samarth

Chief Executive Officer

5,281 @ $44.78$237K

Exercise

2023-03-29

Kulkarni Samarth

Chief Executive Officer

25,000 @ $19.12$478K

Grant

2023-03-14

Prasad Raju

Chief Financial Officer

100,000 @ ——

Grant

2023-03-14

Prasad Raju

Chief Financial Officer

40,000 @ ——

Tax

2023-03-13

Kulkarni Samarth

Chief Executive Officer

5,358 @ $43.22$232K

Tax

2023-03-13

KASINGER JAMES R.

General Counsel and Secretary

1,022 @ $43.22$44K

Tax

2023-03-13

KASINGER JAMES R.

General Counsel and Secretary

1,283 @ $43.22$55K

Tax

2023-03-13

Kulkarni Samarth

Chief Executive Officer

4,086 @ $43.22$177K

Exercise

2023-03-11

KASINGER JAMES R.

General Counsel and Secretary

2,250 @ ——

Exercise

2023-03-11

Kulkarni Samarth

Chief Executive Officer

9,000 @ ——

Grant

2023-03-10

Kulkarni Samarth

Chief Executive Officer

77,000 @ ——

Grant

2023-03-10

Morrow Phuong Khanh

Chief Medical Officer

44,620 @ ——

Grant

2023-03-10

Morrow Phuong Khanh

Chief Medical Officer

22,000 @ ——

Exercise

2023-03-10

KASINGER JAMES R.

General Counsel and Secretary

2,833 @ ——

Grant

2023-03-10

KASINGER JAMES R.

General Counsel and Secretary

40,000 @ ——

Grant

2023-03-10

KASINGER JAMES R.

General Counsel and Secretary

22,000 @ ——

Exercise

2023-03-10

Kulkarni Samarth

Chief Executive Officer

11,833 @ ——

Grant

2023-03-10

Kulkarni Samarth

Chief Executive Officer

188,000 @ ——

Date	Insider	Action	Shares	Price	Value
2023-06-08	George SimeonDirector	Grant	13,000	—	—
2023-06-08	High Katherine ADirector	Grant	13,000	—	—
2023-06-08	Fleming Harold EdwardDirector	Grant	13,000	—	—
2023-06-08	Treco Douglas ADirector	Grant	13,000	—	—
2023-06-08	Greene JohnDirector	Grant	13,000	—	—
2023-06-08	Fardis MariaDirector	Grant	13,000	—	—
2023-06-08	Behbahani AliDirector	Grant	13,000	—	—
2023-05-30	Kulkarni SamarthChief Executive Officer	Exercise10b5-1	25,000	$19.12	$478K
2023-05-30	Kulkarni SamarthChief Executive Officer	Sell10b5-1	7,301	$63.61	$464K
2023-05-30	Kulkarni SamarthChief Executive Officer	Sell10b5-1	5,999	$64.46	$387K
2023-05-30	Kulkarni SamarthChief Executive Officer	Sell10b5-1	9,300	$65.63	$610K
2023-05-30	Kulkarni SamarthChief Executive Officer	Sell10b5-1	2,400	$66.83	$160K
2023-05-24	Morrow Phuong KhanhChief Medical Officer	Tax	2,527	$65.91	$167K
2023-05-23	Morrow Phuong KhanhChief Medical Officer	Exercise	6,938	—	—
2023-04-25	Kulkarni SamarthChief Executive Officer	Exercise10b5-1	25,000	$19.12	$478K
2023-04-25	Kulkarni SamarthChief Executive Officer	Sell10b5-1	20,607	$50.50	$1.04M
2023-04-25	Kulkarni SamarthChief Executive Officer	Sell10b5-1	4,393	$51.45	$226K
2023-03-29	Kulkarni SamarthChief Executive Officer	Sell	19,719	$44.37	$875K
2023-03-29	Kulkarni SamarthChief Executive Officer	Sell	5,281	$44.78	$237K
2023-03-29	Kulkarni SamarthChief Executive Officer	Exercise	25,000	$19.12	$478K
2023-03-14	Prasad RajuChief Financial Officer	Grant	100,000	—	—
2023-03-14	Prasad RajuChief Financial Officer	Grant	40,000	—	—
2023-03-13	Kulkarni SamarthChief Executive Officer	Tax	5,358	$43.22	$232K
2023-03-13	KASINGER JAMES R.General Counsel and Secretary	Tax	1,022	$43.22	$44K
2023-03-13	KASINGER JAMES R.General Counsel and Secretary	Tax	1,283	$43.22	$55K
2023-03-13	Kulkarni SamarthChief Executive Officer	Tax	4,086	$43.22	$177K
2023-03-11	KASINGER JAMES R.General Counsel and Secretary	Exercise	2,250	—	—
2023-03-11	Kulkarni SamarthChief Executive Officer	Exercise	9,000	—	—
2023-03-10	Kulkarni SamarthChief Executive Officer	Grant	77,000	—	—
2023-03-10	Morrow Phuong KhanhChief Medical Officer	Grant	44,620	—	—
2023-03-10	Morrow Phuong KhanhChief Medical Officer	Grant	22,000	—	—
2023-03-10	KASINGER JAMES R.General Counsel and Secretary	Exercise	2,833	—	—
2023-03-10	KASINGER JAMES R.General Counsel and Secretary	Grant	40,000	—	—
2023-03-10	KASINGER JAMES R.General Counsel and Secretary	Grant	22,000	—	—
2023-03-10	Kulkarni SamarthChief Executive Officer	Exercise	11,833	—	—
2023-03-10	Kulkarni SamarthChief Executive Officer	Grant	188,000	—	—

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