Yeji
NDA/BLA filedconf 0.70

NDA/BLA filed

$NUVL · Nuvalent, Inc.
Event date
Date TBD
Sponsor runway
42 mo
$1.29B liquid

Evidence

The Company plans to discuss the topline pivotal data for TKI pre-treated ALK-positive NSCLC with the U.S. Food and Drug Administration (the "FDA") at a pre-New Drug Application ("NDA") meeting.
Source: 8-K filed 2025-11-17View on EDGAR ↗0001193125-25-283893

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

TickerDrugDateOutcome
$AXSM2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown

Recent insider activity· ±90 days

4 insiders · 0 buys · 13 sells
Exercise10b5-1
2026-05-04
Porter James Richard
President and CEO
30,000 @ $18.93$568K
Sell10b5-1
2026-05-04
Porter James Richard
President and CEO
2,111 @ $102.88$217K
Sell10b5-1
2026-05-04
Porter James Richard
President and CEO
17,353 @ $102.10$1.77M
Sell10b5-1
2026-05-04
Porter James Richard
President and CEO
7,429 @ $101.48$754K
Sell10b5-1
2026-05-04
Porter James Richard
President and CEO
1,408 @ $99.77$140K
Sell10b5-1
2026-05-04
Porter James Richard
President and CEO
1,699 @ $98.54$167K
Sell10b5-1
2026-05-01
Balcom Alexandra
Chief Financial Officer
124 @ $99.97$12K
Exercise10b5-1
2026-05-01
Balcom Alexandra
Chief Financial Officer
7,159 @ $1.08$8K
Exercise10b5-1
2026-05-01
Balcom Alexandra
Chief Financial Officer
4,271 @ $6.89$29K
Sell10b5-1
2026-05-01
Balcom Alexandra
Chief Financial Officer
3,872 @ $98.42$381K
Sell10b5-1
2026-05-01
Balcom Alexandra
Chief Financial Officer
7,434 @ $99.29$738K
Sell10b5-1
2026-04-30
Miller Deborah Ann
Chief Legal Officer
1,082 @ $99.57$108K
Sell10b5-1
2026-04-30
Miller Deborah Ann
Chief Legal Officer
4,418 @ $99.13$438K
Exercise10b5-1
2026-04-30
Miller Deborah Ann
Chief Legal Officer
5,500 @ $6.89$38K
Sell10b5-1
2026-04-29
Noci Darlene
Chief Development Officer
700 @ $100.14$70K
Sell10b5-1
2026-04-29
Noci Darlene
Chief Development Officer
300 @ $101.17$30K
Sell10b5-1
2026-04-29
Noci Darlene
Chief Development Officer
4,500 @ $99.35$447K
Exercise10b5-1
2026-04-29
Noci Darlene
Chief Development Officer
5,500 @ $27.85$153K