NUVL Nuvalent, Inc.

CIK 0001861560 50 ready 8-Ks latest June 9, 2026, 7:03 AM ET RSS · JSON

Activity: NORMAL 1 filings / 30d vs 1 baseline

Ready 8-Ks 50

Latest filing June 18, 2026, 4:30 PM ET

Top materiality 0.90

Event mix other_material ×19 · earnings ×17 · leadership ×7

Sentiment 21 pos · 0 neg · 29 neu

Latest earnings reported 2025-FY

Executive change recent →

Recent 8-K filings for NUVL

Highest-materiality recent filing

GSK to acquire Nuvalent for $124/share (~$10.6B); assets under FDA review for 2026 approval

June 9, 2026, 7:03 AM ET M&A materiality 0.90 positive item 1.01 item 7.01 item 9.01 ◈ Material Agreements

All-share tender offer at $124.00 per share; aggregate equity value ~$10.6B; net cash investment ~$9.4B.
40% premium to last closing price; 26% premium to 30-day VWAP; no financing condition.

Read filing →

June 9, 2026, 7:03 AM ET M&A materiality 0.90 positive item 1.01 item 7.01 item 9.01 ◈ Material Agreements

GSK to acquire Nuvalent for $124/share (~$10.6B); assets under FDA review for 2026 approval

All-share tender offer at $124.00 per share; aggregate equity value ~$10.6B; net cash investment ~$9.4B.
May 7, 2026, 7:59 PM ET other material materiality 0.85 neutral item 2.02 item 9.01 ◈ Earnings Releases

Nuvalent submits NDA for neladalkib in ALK+ NSCLC; zidesamtinib PDUFA Sept 18, 2026

NDA for neladalkib in TKI pre-treated ALK+ NSCLC submitted; pivotal data at ASCO 2026.
April 7, 2026, 7:59 PM ET regulatory materiality 0.80 positive item 8.01

Nuvalent submits NDA to FDA for neladalkib in ALK-positive lung cancer

NDA submitted to FDA on April 7, 2026, for neladalkib in TKI pre-treated advanced ALK-positive NSCLC.
February 26, 2026, 6:59 PM ET earnings materiality 0.85 neutral item 2.02 item 9.01

Nuvalent reports Q4 and FY2025 net loss; zidesamtinib PDUFA set for Sept 18, 2026

Net loss of $118.7M in Q4 2025 and $425.4M for full year 2025.
January 14, 2026, 6:59 PM ET other material materiality 0.80 positive item 2.02 item 9.01

Nuvalent reports $1.4B cash, zidesamtinib PDUFA Sep 18, 2026; pipeline milestones

Preliminary cash, cash equivalents and securities ~$1.4B as of Dec 31, 2025; runway into 2029.
December 16, 2025, 6:59 PM ET other material materiality 0.60 neutral item 8.01

Royalty Pharma buys 1.5% royalty on Nuvalent's pipeline for up to $315M

Royalty Pharma acquired a preexisting 1.5% net-sales royalty on neladalkib and zidesamtinib from an undisclosed third party.
November 20, 2025, 6:59 PM ET other material materiality 0.70 neutral item 1.01 item 8.01 item 9.01

Nuvalent prices $500M public offering at $101/share; net proceeds ~$472M

Pricing of 4,950,496 shares at $101.00/share for gross proceeds of ~$500M.
November 17, 2025, 6:59 PM ET other material materiality 0.85 positive item 8.01

Nuvalent reports positive pivotal data for neladalkib in ALK+ NSCLC; ORR 31% in TKI pre-treated, 46% in lorlatinib-naïve

Neladalkib achieved 31% ORR (79/253) in TKI pre-treated ALK+ NSCLC; median DOR not reached at 11.3 months follow-up.
October 30, 2025, 7:59 PM ET earnings materiality 0.60 neutral item 2.02 item 9.01

Nuvalent Q3 net loss $122.4M; completes NDA for zidesamtinib; cash $943M into 2028

Completed rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC.
September 22, 2025, 7:59 PM ET regulatory materiality 0.70 positive item 8.01

Nuvalent completes NDA submission to FDA for zidesamtinib in ROS1-positive NSCLC

Completed NDA submission to FDA for zidesamtinib.
August 7, 2025, 7:59 PM ET earnings materiality 0.60 neutral item 2.02 item 9.01

Nuvalent Q2 2025 net loss $99.7M; rolling NDA for zidesamtinib initiated

Net loss $99.7M; R&D $80.9M, G&A $23.7M; cash $1.0B funding into 2028.
July 21, 2025, 7:59 PM ET other material materiality 0.70 positive item 8.01

Nuvalent initiates Phase 3 ALKAZAR trial of neladalkib in ALK-positive NSCLC

First patient dosed in Phase 3 ALKAZAR trial evaluating neladalkib for TKI-naïve advanced ALK-positive NSCLC.
June 24, 2025, 7:59 PM ET other material materiality 0.85 positive item 8.01

Nuvalent reports positive pivotal data for zidesamtinib in ROS1+ NSCLC; NDA submission set for July 2025

Zidesamtinib achieved 44% ORR (51/117) in TKI pre-treated ROS1+ NSCLC; intracranial ORR 48% (27/56) with 20% complete responses.
May 8, 2025, 7:59 PM ET earnings materiality 0.75 positive item 2.02 item 9.01

Nuvalent reports Q1 net loss $84.6M; reiterates zidesamtinib pivotal data in H1 2025, NDA by mid-2025

Cash $1.1B at March 31, 2025; expected to fund operations into 2028.
February 27, 2025, 6:59 PM ET earnings materiality 0.60 neutral item 2.02 item 9.01

Nuvalent reports Q4 net loss $74.8M, cash $1.1B; pivotal data on track for 2025

Net loss $74.8M (Q4 2024) and $260.8M (FY 2024); cash & equivalents $1.1B, expected to fund into 2028.
January 14, 2025, 6:59 PM ET other material materiality 0.80 positive item 8.01 item 9.01

Nuvalent Plans Initial NDA Submission for Zidesamtinib by Mid-2025 and Reports Pivotal Data Milestones

As of Dec 31, 2024, 430 patients enrolled in ARROS-1 trial of zidesamtinib for ROS1-positive NSCLC.
November 12, 2024, 6:59 PM ET earnings materiality 0.75 positive item 2.02 item 9.01

Nuvalent reports Q3 net loss $84.3M; cash $1.2B; pipeline on track for 2025 pivotal data

Net loss $84.3M for Q3 2024; R&D expenses $60.6M, G&A $15.8M.
September 17, 2024, 7:59 PM ET other material materiality 0.75 neutral item 1.01 item 8.01 item 9.01

Nuvalent prices upsized $500M public offering of 5M shares at $100/sh

Offering of 5,000,000 shares at $100.00/share; gross proceeds ~$500M.
September 16, 2024, 7:59 PM ET other material materiality 0.75 positive item 8.01 item 9.01

Nuvalent reports promising Phase 1 data for zidesamtinib and NVL-655; pivotal data expected 2025

Zidesamtinib ORR 44% in pre-treated ROS1+ NSCLC; 72% in G2032R mutation subset.
August 8, 2024, 7:59 PM ET earnings materiality 0.80 positive item 2.02 item 9.01

Nuvalent reports $658M cash, FDA breakthrough therapy for two candidates, net loss $57.2M in Q2

Cash, equivalents and securities $658.0M as of June 30, 2024; operating runway into 2027.
July 22, 2024, 7:59 PM ET other material materiality 0.60 positive item 8.01

Nuvalent doses first patient in Phase 1 trial of HER2-selective inhibitor NVL-330 for NSCLC

Initiated HEROEX-1 Phase 1a/1b trial evaluating NVL-330 in pre-treated patients with HER2-altered NSCLC.
May 16, 2024, 7:59 PM ET regulatory materiality 0.80 positive item 8.01

FDA grants Breakthrough Therapy designation to Nuvalent's NVL-655 for ALK+ NSCLC

NVL-655 received FDA Breakthrough Therapy designation for ALK-positive non-small cell lung cancer.
May 9, 2024, 7:59 PM ET earnings materiality 0.60 neutral item 2.02 item 9.01 ◈ Earnings Releases

Nuvalent reports Q1 net loss of $44.5M; cash $691.8M; pipeline milestones on track

Q1 2024 net loss of $44.5M; R&D expense $38.6M, G&A $14.0M.
February 27, 2024, 6:59 PM ET earnings materiality 0.65 neutral item 2.02 item 9.01 ◈ Earnings Releases ×2

Nuvalent reports Q4 net loss $38.3M; cash $719.9M; NVL-520 gets FDA BTD

Cash, cash equivalents and marketable securities $719.9M at Dec 31, 2023; operating runway into 2027.
January 9, 2024, 6:59 PM ET other material materiality 0.70 positive item 2.02 item 9.01

Nuvalent reports $719.9M cash; launches 'OnTarget 2026' plan targeting first approval in 2026

Cash, cash equivalents and marketable securities of $719.9M as of Dec 31, 2023 (unaudited); expected to fund operations into 2027.
November 14, 2023, 6:59 PM ET earnings materiality 0.60 positive item 2.02 item 9.01 ◈ Earnings Releases

Nuvalent Q3 net loss $33.6M; cash runway into 2027 after $300M offering; ALK/ROS1 data positive

Net loss of $33.6M ($0.59 per share) for Q3 2023; R&D expenses $29.6M, G&A $9.2M.
October 17, 2023, 7:59 PM ET other material materiality 0.75 neutral item 1.01 item 8.01 item 9.01 ◈ Material Agreements

Nuvalent prices $300M public offering of 5.36M shares at $56.00/share

Sold 5,357,143 shares at $56.00 each; gross proceeds ~$300M.
October 13, 2023, 7:59 PM ET other material materiality 0.75 positive item 8.01 item 9.01

Nuvalent reports Phase 1 ALKOVE-1 data: NVL-655 shows 39% ORR in heavily pre-treated ALK+ NSCLC

ORR 39% (20/51) in response-evaluable NSCLC patients; 44% (18/41) at ≥50 mg QD dose levels.
October 4, 2023, 7:59 PM ET other material materiality 0.75 positive item 8.01 item 9.01

Nuvalent reports NVL-655 Phase 1 data: 45% ORR in evaluable ALK+ NSCLC patients

57 patients received 15–200 mg once daily; 51% had baseline CNS metastases; 77% post-lorlatinib.
November 10, 2022, 6:59 PM ET earnings materiality 0.80 positive item 2.02 item 9.01

Nuvalent Q3 net loss $19.7M; NVL-520 shows proof-of-concept; $264.5M offering extends runway into H2 2025

Q3 net loss $19.7M ($0.41/sh); cash $240.1M; with $264.5M offering extends runway into H2 2025.
November 1, 2022, 7:59 PM ET other material materiality 0.65 neutral item 1.01 item 8.01 item 9.01 ◈ Material Agreements ×2

Nuvalent prices $230M public offering of 6.87M shares at $33.50/share

6,865,672 shares of Class A common stock priced at $33.50/share; gross proceeds ~$230M.
October 28, 2022, 7:59 PM ET other material materiality 0.75 positive item 8.01 item 9.01

Nuvalent reports preliminary Phase 1 data for NVL-520: 48% ORR in heavily pre-treated ROS1+ NSCLC

48% ORR (10/21) in heavily pre-treated ROS1+ NSCLC; 78% (7/9) in G2032R mutation patients.
August 10, 2022, 7:59 PM ET earnings materiality 0.60 neutral item 2.02 item 9.01

Nuvalent reports Q2 2022 net loss of $18.5M; pipeline on track with NVL-520 data expected H2 2022

Net loss of $18.5M ($0.38 per share); cash, equivalents and marketable securities $257.0M expected to fund operations into 2024.
May 12, 2022, 7:59 PM ET earnings materiality 0.75 positive item 2.02 item 9.01

Nuvalent reports Q1 net loss $17.5M; cash $272.7M; ALK trial expected Q2 2022

Net loss of $17.5M ($0.36 diluted EPS); R&D expenses $12.7M, G&A $5.0M.

Executive changes

Appointed

Christy J. Oliger

Class III director

NUVL · Nuvalent, Inc.

Effective: 2025-06-18
Filed: June 20, 2025, 7:59 PM ET

the Board elected Christy J. Oliger as a member of the Board, effective immediately.

Departed

Emily Conley

Director

NUVL · Nuvalent, Inc.

Filed: June 10, 2025, 7:59 PM ET

On June 9, 2025, Emily Conley, a member of the board of directors (the “Board”) of Nuvalent, Inc. (the “Company”), notified the Company of her decision to resign from the Board and from all committees of the Board on which she serves, effective as of the date and time of the Company’s 2025 annual meeting of stockholders.

Departed

D. Gary Gilliland

member of the board of directors

NUVL · Nuvalent, Inc.

Filed: April 17, 2025, 7:59 PM ET

On April 11, 2025, D. Gary Gilliland, M.D., Ph.D., a member of the board of directors (the “Board”) of Nuvalent, Inc. (the “Company”), notified the Company of his decision to resign from the Board and from all committees of the Board on which he serves, effective as of the date and time of the Company’s 2025 annual meeting of stockholders.

Appointed

Michael L. Meyers

Director

NUVL · Nuvalent, Inc.

Effective: 2022-10-04
Filed: October 6, 2022, 7:59 PM ET

On October 4, 2022, in accordance with the recommendation of the Nominating and Corporate Governance Committee (“NCG Committee”) of the Board of Directors (the “Board”) of Nuvalent, Inc. (the “Company”), the Board elected Michael L. Meyers, M.D., Ph.D., as a member of the Board, effective immediately.

Appointed

Anna Protopapas

Chairperson of the Board

NUVL · Nuvalent, Inc.

Effective: 2022-03-30
Filed: March 31, 2022, 7:59 PM ET

On March 30, 2022, in accordance with the recommendation of the Nominating and Corporate Governance Committee of the Board of Directors (the “Board”) of Nuvalent, Inc. (the “Company”), the Board elected Anna Protopapas as a member of the Board, effective immediately.

Appointed

Emily Conley

Director

NUVL · Nuvalent, Inc.

Effective: 2022-02-02
Filed: February 3, 2022, 6:59 PM ET

the Board elected Emily Conley as a member of the Board, effective immediately.

Earnings & guidance

2025-FY EPS reported -$5.85 filing →

Materiality & sentiment trend

Max materiality 0.90 · Median 0.65 · Most common event other_material

21 positive 0 negative 29 neutral

source · NUVL on sec.gov