Welcome to our dedicated page for Nuvalent SEC filings (Ticker: NUVL), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Nuvalent, Inc. (NUVL) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. Nuvalent is a clinical-stage biopharmaceutical company listed on The Nasdaq Global Select Market, and its filings offer detailed information on clinical progress, financing activities, and key business agreements related to its targeted oncology pipeline.
Recent Form 8-K filings describe pivotal and preliminary data for neladalkib in ALK-positive NSCLC from the ALKOVE-1 Phase 1/2 trial, pivotal data for zidesamtinib in ROS1-positive NSCLC from the ARROS-1 Phase 1/2 trial, and the initiation of the ALKAZAR Phase 3 trial in TKI-naïve ALK-positive NSCLC. Other 8-Ks outline the completion and FDA acceptance of a New Drug Application for zidesamtinib in TKI pre-treated ROS1-positive NSCLC, plans for an NDA submission for neladalkib, and the assignment of a PDUFA target action date for zidesamtinib.
Filings also document Nuvalent’s capital markets activity, including an underwriting agreement for a public offering of Class A common stock under an automatically effective shelf registration statement on Form S-3, and the company’s estimate that proceeds from the offering, together with existing cash, cash equivalents, and marketable securities, would fund operations into 2029. Additional disclosures cover a preexisting royalty interest on future net sales of neladalkib and zidesamtinib, as well as periodic 8-Ks furnishing quarterly financial results press releases.
On Stock Titan, these SEC filings are paired with AI-powered summaries that highlight the main points of each document, helping readers quickly understand clinical data updates, NDA milestones, financing terms, and other material events. Users can review 10-K and 10-Q reports, 8-K current reports, registration statements, and exhibits, and use the AI-generated insights to navigate lengthy technical and legal language more efficiently while researching NUVL.
Nuvalent, Inc. reported positive topline pivotal data for neladalkib, its investigational ALK-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) from the global ALKOVE-1 Phase 1/2 trial. Among 253 evaluable TKI pre-treated patients treated at the recommended Phase 2 dose, the objective response rate was 31%, rising to 46% in the 63 lorlatinib‑naïve patients, with high estimated durability of responses through 18 months. Strong activity was also observed in patients with the G1202R resistance mutation and those with measurable brain metastases, including intracranial complete responses.
Nuvalent also shared encouraging preliminary data in 44 TKI‑naïve advanced ALK‑positive NSCLC patients, showing an 86% objective response rate and 9% complete response rate, with most responses ongoing beyond 6 and 12 months. Across 656 NSCLC patients treated at the recommended dose, neladalkib showed a generally well‑tolerated safety profile; the most common side effects were liver enzyme elevations and manageable gastrointestinal and constitutional events, with 17% requiring dose reductions and 5% discontinuing due to adverse events. The company plans a pre‑NDA meeting with the FDA and continues its Phase 3 ALKAZAR trial versus alectinib.
Nuvalent, Inc. (NUVL) reported an insider transaction by its Chief Development Officer on 10/30/2025. The officer exercised 4,000 stock options at $27.85 and, the same day, sold 4,000 Class A shares across multiple trades, executed under a Rule 10b5-1 trading plan adopted on November 18, 2024.
The reported sales were in tranches including 57 shares at $98.91 (weighted average, range $98.16–$99.13) and additional lots at weighted average prices of $100.69, $102.07, $103.09, $104.21, and a final sale at $104.58. Following these transactions, the officer directly held 48,034 Class A shares. Derivative holdings reported after the exercise were 122,329 stock options outstanding, with the option series expiring on 01/06/2033 and vesting monthly over four years from January 6, 2023.
Nuvalent (NUVL) reported insider activity by its Chief Legal Officer on 10/30/2025. The officer exercised 21,800 stock options at an exercise price of $6.89 and sold an equal 21,800 Class A shares in multiple same‑day open‑market transactions with weighted average prices disclosed for each tranche.
Tranche prices reported include weighted averages of $96.65, $97.98, $99.66, $100.96, $102.00, $102.88, $103.90, and $104.78. Following the transactions, the officer directly owned 49,086 shares. The filing notes the trades were effected under a Rule 10b5-1 plan adopted on November 18, 2024, and the option exercised was fully vested; 118,808 derivative securities were beneficially owned after the transactions.
Nuvalent, Inc. (NUVL) reported a larger quarterly loss while advancing its oncology pipeline. For Q3 2025, net loss was
Liquidity remains strong with cash, cash equivalents and marketable securities of
Program updates included completion of a rolling NDA for zidesamtinib in TKI pre-treated ROS1-positive NSCLC and ongoing Phase 2 work in TKI-naïve patients. Neladalkib advanced with Phase 2 enrollment completed in TKI pre-treated NSCLC and initiation of the Phase 3 ALKAZAR trial in TKI‑naïve ALK‑positive NSCLC. NVL‑330 progressed in Phase 1 with new preclinical data highlighting brain‑penetrant properties.
Nuvalent (NUVL) director Matthew D. Shair reported open-market sales of Class A common stock executed under a Rule 10b5-1 trading plan adopted on November 20, 2024.
On 10/27/2025, he sold 14,345 shares at a weighted average price of $100.23 and 4,046 shares held indirectly by the Matthew D. Shair 2021 Irrevocable Family Trust at a weighted average price of $100.23. On 10/28/2025, he sold 32,455 shares at a weighted average price of $100.27 and 9,154 indirect shares at a weighted average price of $100.27. Following these transactions, he beneficially owned 1,383,044 shares directly and 203,322 shares indirectly.
Nuvalent, Inc. (NUVL) reported an insider transaction by its Chief Legal Officer. On 10/20/2025, the officer exercised 5,000 stock options at an exercise price of $6.89 per share and sold 5,000 Class A shares at a weighted average price of $94.91 (range $94.80–$95.00). These trades were executed under a Rule 10b5-1 trading plan adopted on November 18, 2024.
Following the transactions, the reporting person directly beneficially owned 49,086 Class A shares and held 140,608 derivative securities (stock options) with an option expiration date of 04/29/2031. The filing notes the underlying option shares are fully vested.
Nuvalent (NUVL): CEO insider transaction — On 10/16/2025, the President and CEO (also a Director) exercised 27,000 stock options at $18.93 per share and sold an aggregate 27,000 Class A shares in multiple tranches pursuant to a Rule 10b5-1 trading plan.
Weighted-average sale prices by tranche were $90.01 for 11,310 shares, $90.91 for 13,876 shares, $92.19 for 1,114 shares, and $92.63 for 700 shares. Following these transactions, the reporting person beneficially owned 249,062 Class A shares directly. Derivative holdings reported include 222,400 stock options remaining after the exercise.
Nuvalent, Inc. (NUVL): The Chief Legal Officer reported option exercises and open-market sales under a Rule 10b5-1 plan. On 10/15/2025, 15,624 Class A shares were acquired via option exercise at $6.89 and 15,624 shares were sold at a weighted average price of $89.98. On 10/16/2025, 12,376 shares were acquired via option exercise at $6.89, followed by sales of 2,277 shares at a weighted average price of $90.54, 5,199 shares at $91.37, and 4,900 shares at $92.5.
Following these transactions, the reporting person directly owned 49,086 Class A shares. The transactions were effected pursuant to a Rule 10b5-1 trading plan adopted on November 18, 2024. After the exercises, stock options (right to buy) remaining were 145,608 at a $6.89 exercise price, fully vested, expiring on 04/29/2031.
Nuvalent (NUVL) reported insider activity by its Chief Scientific Officer. On 10/15/2025, the officer exercised stock options for 3,668 shares at $18.93, 7,495 shares at $27.85, and 3,042 shares at $72.35, then sold 14,205 Class A shares at a weighted average price of $90.04 (range $89.84–$90.23).
The transactions were made under a Rule 10b5-1 trading plan adopted on November 1, 2024. Following these trades, the officer directly beneficially owned 65,963 Class A shares.
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