Recent 8-K filings for NUVL

• May 07, 2026 23:59 UTC other_material materiality 0.85 neutral item 2.02item 9.01

  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.

• Apr 07, 2026 23:59 UTC 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.

• Feb 26, 2026 23:59 UTC earnings materiality 0.85 neutral item 2.02item 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.

• Jan 14, 2026 23:59 UTC other_material materiality 0.80 positive item 2.02item 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.

• Dec 16, 2025 23:59 UTC 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.

• Nov 20, 2025 23:59 UTC other_material materiality 0.70 neutral item 1.01item 8.01item 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.

• Nov 17, 2025 23:59 UTC 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.

• Oct 30, 2025 23:59 UTC earnings materiality 0.60 neutral item 2.02item 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.

• Sep 22, 2025 23:59 UTC 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.

• Aug 07, 2025 23:59 UTC earnings materiality 0.60 neutral item 2.02item 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.

• Jul 21, 2025 23:59 UTC 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.

• Jun 24, 2025 23:59 UTC 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.

Executive changes

Earnings & guidance

Materiality & sentiment trend

Max materiality 0.85 · Median 0.70 · Most common event other_material

6 positive 0 negative 9 neutral

source · NUVL on sec.gov