NDA/BLA filedconf 0.95

zidesamtinib — NDA/BLA filed

$NUVL · Nuvalent, Inc. · tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer

Event date

September 22, 2025

257 days ago

Sponsor runway

42 mo

$1.29B liquid

Evidence

“On September 22, 2025, Nuvalent, Inc. announced the completion of its New Drug Application submission to the U.S. Food and Drug Administration for zidesamtinib in tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer.”

Source: 8-K filed 2025-09-22View on EDGAR ↗0001193125-25-209934

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

8 insiders · 0 buys · 104 sells

Grant

2025-12-10

Squarer Ron

Director

2,837 @ ——

Grant

2025-12-10

Squarer Ron

Director

4,418 @ ——

Sell10b5-1

2025-12-08

Balcom Alexandra

Chief Financial Officer

100 @ $111.32$11K

Sell10b5-1

2025-12-08

Balcom Alexandra

Chief Financial Officer

6,984 @ $110.31$770K

Exercise10b5-1

2025-11-28

Noci Darlene

Chief Development Officer

4,000 @ $27.85$111K

Sell10b5-1

2025-11-28

Noci Darlene

Chief Development Officer

645 @ $107.85$70K

Sell10b5-1

2025-11-28

Noci Darlene

Chief Development Officer

3,355 @ $108.72$365K

Sell10b5-1

2025-11-24

Shair Matthew

Director

2,026 @ $109.77$222K

Sell10b5-1

2025-11-24

Shair Matthew

Director

1,193 @ $110.42$132K

Sell10b5-1

2025-11-24

Shair Matthew

Director

336 @ $110.42$37K

Sell10b5-1

2025-11-24

Shair Matthew

Director

2,262 @ $108.73$246K

Sell10b5-1

2025-11-24

Shair Matthew

Director

638 @ $108.73$69K

Sell10b5-1

2025-11-24

Shair Matthew

Director

572 @ $109.77$63K

Sell

2025-11-24

Flynn James E

Director

371,287 @ $95.44$35.44M

Sell10b5-1

2025-11-24

Shair Matthew

Director

369 @ $107.70$40K

Sell10b5-1

2025-11-24

Shair Matthew

Director

104 @ $107.70$11K

Sell10b5-1

2025-11-18

Balcom Alexandra

Chief Financial Officer

509 @ $104.54$53K

Sell10b5-1

2025-11-18

Balcom Alexandra

Chief Financial Officer

220 @ $103.61$23K

Exercise10b5-1

2025-11-18

Balcom Alexandra

Chief Financial Officer

729 @ $72.35$53K

Sell10b5-1

2025-11-17

Miller Deborah Ann

Chief Legal Officer

608 @ $107.04$65K

Exercise10b5-1

2025-11-17

Balcom Alexandra

Chief Financial Officer

13,125 @ $72.35$950K

Sell10b5-1

2025-11-17

Balcom Alexandra

Chief Financial Officer

3,609 @ $93.80$339K

Sell10b5-1

2025-11-17

Balcom Alexandra

Chief Financial Officer

3,266 @ $95.12$311K

Sell10b5-1

2025-11-17

Balcom Alexandra

Chief Financial Officer

4,496 @ $100.58$452K

Sell10b5-1

2025-11-17

Balcom Alexandra

Chief Financial Officer

3,194 @ $102.13$326K

Sell10b5-1

2025-11-17

Balcom Alexandra

Chief Financial Officer

5,055 @ $103.27$522K

Sell10b5-1

2025-11-17

Balcom Alexandra

Chief Financial Officer

380 @ $103.68$39K

Exercise10b5-1

2025-11-17

Miller Deborah Ann

Chief Legal Officer

24,200 @ $6.89$167K

Sell10b5-1

2025-11-17

Miller Deborah Ann

Chief Legal Officer

15,075 @ $105.16$1.59M

Sell10b5-1

2025-11-17

Miller Deborah Ann

Chief Legal Officer

8,517 @ $105.98$903K

Exercise10b5-1

2025-11-17

Balcom Alexandra

Chief Financial Officer

6,875 @ $6.89$47K

Sell10b5-1

2025-10-30

Miller Deborah Ann

Chief Legal Officer

2,121 @ $102.00$216K

Exercise10b5-1

2025-10-30

Noci Darlene

Chief Development Officer

4,000 @ $27.85$111K

Sell10b5-1

2025-10-30

Noci Darlene

Chief Development Officer

57 @ $98.91$6K

Sell10b5-1

2025-10-30

Noci Darlene

Chief Development Officer

350 @ $100.69$35K

Sell10b5-1

2025-10-30

Noci Darlene

Chief Development Officer

1,170 @ $102.07$119K

Sell10b5-1

2025-10-30

Noci Darlene

Chief Development Officer

1,091 @ $103.09$112K

Sell10b5-1

2025-10-30

Noci Darlene

Chief Development Officer

1,114 @ $104.21$116K

Sell10b5-1

2025-10-30

Noci Darlene

Chief Development Officer

218 @ $104.58$23K

Exercise10b5-1

2025-10-30

Miller Deborah Ann

Chief Legal Officer

21,800 @ $6.89$150K

Sell10b5-1

2025-10-30

Miller Deborah Ann

Chief Legal Officer

700 @ $96.65$68K

Sell10b5-1

2025-10-30

Miller Deborah Ann

Chief Legal Officer

1,273 @ $97.98$125K

Sell10b5-1

2025-10-30

Miller Deborah Ann

Chief Legal Officer

500 @ $99.66$50K

Sell10b5-1

2025-10-30

Miller Deborah Ann

Chief Legal Officer

600 @ $100.96$61K

Sell10b5-1

2025-10-30

Miller Deborah Ann

Chief Legal Officer

3,733 @ $102.88$384K

Sell10b5-1

2025-10-30

Miller Deborah Ann

Chief Legal Officer

3,491 @ $103.90$363K

Sell10b5-1

2025-10-30

Miller Deborah Ann

Chief Legal Officer

9,382 @ $104.78$983K

Sell10b5-1

2025-10-28

Shair Matthew

Director

9,154 @ $100.27$918K

Sell10b5-1

2025-10-28

Shair Matthew

Director

32,455 @ $100.27$3.25M

Sell10b5-1

2025-10-27

Shair Matthew

Director

4,046 @ $100.23$406K

+ 109 more

Date	Insider	Action	Shares	Price	Value
2025-12-10	Squarer RonDirector	Grant	2,837	—	—
2025-12-10	Squarer RonDirector	Grant	4,418	—	—
2025-12-08	Balcom AlexandraChief Financial Officer	Sell10b5-1	100	$111.32	$11K
2025-12-08	Balcom AlexandraChief Financial Officer	Sell10b5-1	6,984	$110.31	$770K
2025-11-28	Noci DarleneChief Development Officer	Exercise10b5-1	4,000	$27.85	$111K
2025-11-28	Noci DarleneChief Development Officer	Sell10b5-1	645	$107.85	$70K
2025-11-28	Noci DarleneChief Development Officer	Sell10b5-1	3,355	$108.72	$365K
2025-11-24	Shair MatthewDirector	Sell10b5-1	2,026	$109.77	$222K
2025-11-24	Shair MatthewDirector	Sell10b5-1	1,193	$110.42	$132K
2025-11-24	Shair MatthewDirector	Sell10b5-1	336	$110.42	$37K
2025-11-24	Shair MatthewDirector	Sell10b5-1	2,262	$108.73	$246K
2025-11-24	Shair MatthewDirector	Sell10b5-1	638	$108.73	$69K
2025-11-24	Shair MatthewDirector	Sell10b5-1	572	$109.77	$63K
2025-11-24	Flynn James EDirector	Sell	371,287	$95.44	$35.44M
2025-11-24	Shair MatthewDirector	Sell10b5-1	369	$107.70	$40K
2025-11-24	Shair MatthewDirector	Sell10b5-1	104	$107.70	$11K
2025-11-18	Balcom AlexandraChief Financial Officer	Sell10b5-1	509	$104.54	$53K
2025-11-18	Balcom AlexandraChief Financial Officer	Sell10b5-1	220	$103.61	$23K
2025-11-18	Balcom AlexandraChief Financial Officer	Exercise10b5-1	729	$72.35	$53K
2025-11-17	Miller Deborah AnnChief Legal Officer	Sell10b5-1	608	$107.04	$65K
2025-11-17	Balcom AlexandraChief Financial Officer	Exercise10b5-1	13,125	$72.35	$950K
2025-11-17	Balcom AlexandraChief Financial Officer	Sell10b5-1	3,609	$93.80	$339K
2025-11-17	Balcom AlexandraChief Financial Officer	Sell10b5-1	3,266	$95.12	$311K
2025-11-17	Balcom AlexandraChief Financial Officer	Sell10b5-1	4,496	$100.58	$452K
2025-11-17	Balcom AlexandraChief Financial Officer	Sell10b5-1	3,194	$102.13	$326K
2025-11-17	Balcom AlexandraChief Financial Officer	Sell10b5-1	5,055	$103.27	$522K
2025-11-17	Balcom AlexandraChief Financial Officer	Sell10b5-1	380	$103.68	$39K
2025-11-17	Miller Deborah AnnChief Legal Officer	Exercise10b5-1	24,200	$6.89	$167K
2025-11-17	Miller Deborah AnnChief Legal Officer	Sell10b5-1	15,075	$105.16	$1.59M
2025-11-17	Miller Deborah AnnChief Legal Officer	Sell10b5-1	8,517	$105.98	$903K
2025-11-17	Balcom AlexandraChief Financial Officer	Exercise10b5-1	6,875	$6.89	$47K
2025-10-30	Miller Deborah AnnChief Legal Officer	Sell10b5-1	2,121	$102.00	$216K
2025-10-30	Noci DarleneChief Development Officer	Exercise10b5-1	4,000	$27.85	$111K
2025-10-30	Noci DarleneChief Development Officer	Sell10b5-1	57	$98.91	$6K
2025-10-30	Noci DarleneChief Development Officer	Sell10b5-1	350	$100.69	$35K
2025-10-30	Noci DarleneChief Development Officer	Sell10b5-1	1,170	$102.07	$119K
2025-10-30	Noci DarleneChief Development Officer	Sell10b5-1	1,091	$103.09	$112K
2025-10-30	Noci DarleneChief Development Officer	Sell10b5-1	1,114	$104.21	$116K
2025-10-30	Noci DarleneChief Development Officer	Sell10b5-1	218	$104.58	$23K
2025-10-30	Miller Deborah AnnChief Legal Officer	Exercise10b5-1	21,800	$6.89	$150K
2025-10-30	Miller Deborah AnnChief Legal Officer	Sell10b5-1	700	$96.65	$68K
2025-10-30	Miller Deborah AnnChief Legal Officer	Sell10b5-1	1,273	$97.98	$125K
2025-10-30	Miller Deborah AnnChief Legal Officer	Sell10b5-1	500	$99.66	$50K
2025-10-30	Miller Deborah AnnChief Legal Officer	Sell10b5-1	600	$100.96	$61K
2025-10-30	Miller Deborah AnnChief Legal Officer	Sell10b5-1	3,733	$102.88	$384K
2025-10-30	Miller Deborah AnnChief Legal Officer	Sell10b5-1	3,491	$103.90	$363K
2025-10-30	Miller Deborah AnnChief Legal Officer	Sell10b5-1	9,382	$104.78	$983K
2025-10-28	Shair MatthewDirector	Sell10b5-1	9,154	$100.27	$918K
2025-10-28	Shair MatthewDirector	Sell10b5-1	32,455	$100.27	$3.25M
2025-10-27	Shair MatthewDirector	Sell10b5-1	4,046	$100.23	$406K

+ 109 more transactions

← All catalysts for $NUVL