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.’s Chief Development Officer Darlene Noci reported option exercises and share sales. On February 26, 2026, she exercised stock options for 5,500 shares of Class A common stock and acquired those shares via derivative conversion.
On the same date, she sold a total of 5,500 Class A common shares in open-market transactions at weighted average prices between $102.04 and $104.41 per share, under a Rule 10b5-1 trading plan adopted on November 18, 2024. After these transactions, she held 58,117 Class A common shares directly.
Nuvalent, Inc. Chief Legal Officer Deborah Ann Miller exercised stock options for 5,500 shares of Class A common stock on
Nuvalent, Inc. is a clinical-stage biopharmaceutical company focused on precisely targeted kinase inhibitors for cancer, with no approved products or revenue and a history of net losses. Its strategy centers on overcoming resistance, off‑target toxicities and limited brain penetrance seen with current therapies.
Lead drug zidesamtinib (NVL‑520) targets ROS1‑positive non-small cell lung cancer (NSCLC). A New Drug Application has been accepted by the FDA for adults with locally advanced or metastatic ROS1‑positive NSCLC previously treated with at least one ROS1 TKI, with a PDUFA target action date of September 18, 2026. Nuvalent also plans to seek a label expansion in TKI‑naïve patients using data from the ongoing ARROS‑1 Phase 2 trial.
Neladalkib (NVL‑655), an ALK‑selective, brain‑penetrant inhibitor for ALK‑positive NSCLC, has FDA Breakthrough Therapy designation. Positive topline data in TKI pre‑treated patients were reported from the ALKOVE‑1 Phase 1/2 trial, and Nuvalent intends to submit an NDA in the first half of 2026. The ALKAZAR Phase 3 trial is comparing neladalkib to alectinib in TKI‑naïve ALK‑positive NSCLC.
NVL‑330, a HER2‑selective, brain‑penetrant inhibitor for HER2‑altered NSCLC, is in the HEROEX‑1 Phase 1a/1b trial, supported by preclinical data showing broad HER2 activity and CNS penetration. Under its OnTarget 2026 plan, Nuvalent aims for its first potential U.S. commercial launch of zidesamtinib in 2026, pending FDA review, an NDA submission for neladalkib, continued development of NVL‑330, and disclosure of a new development candidate by year-end 2026.
Nuvalent, Inc. reported a larger net loss while advancing its lung cancer drug pipeline. For the fourth quarter of 2025, net loss was $118.7 million, and for the full year 2025 net loss was $425.4 million, driven by research and development and growing administrative expenses.
Cash, cash equivalents and marketable securities were $1.4 billion as of December 31, 2025, and the company expects its cash runway to extend into 2029. The FDA accepted the NDA for zidesamtinib in ROS1-positive NSCLC with a PDUFA target action date of September 18, 2026, and Nuvalent plans an NDA for neladalkib in ALK-positive NSCLC in the first half of 2026.
Nuvalent, Inc. insider-related trust plans modest stock sale under Rule 144. A Form 144 notice reports that the Matthew Shair 2021 Irrevocable Trust intends to sell 1,650 shares of Nuvalent Class A common stock through J.P. Morgan Securities on Nasdaq, with an aggregate market value of
Nuvalent, Inc. insider-related trust plans stock sale under Rule 144. A holder of Nuvalent Class A common stock filed notice to sell 5,850 shares through J.P. Morgan Securities LLC, with an aggregate market value of
The securities were originally acquired as founder shares from the issuer on
Nuvalent, Inc. received an amended Schedule 13G/A showing that investment entities affiliated with Deerfield report significant beneficial ownership of its Class A common stock. Deerfield Management Company, L.P. and James E. Flynn each report beneficial ownership of 22,852,280 shares, or 24.21% of the Class A shares outstanding.
This position includes 17,248,450 existing Class A shares, 5,435,254 Class A shares issuable upon conversion of Class B shares, and 168,576 Class A shares underlying options and restricted stock units held by Nuvalent employees for Deerfield’s benefit. Several related Deerfield funds individually report 11.56% or 0.91% stakes.
The Class B shares are subject to an Ownership Cap that generally limits conversions so that the holder and its affiliates do not exceed 4.9% of Nuvalent’s outstanding Class A common stock upon conversion.
Nuvalent, Inc.’s Chief Development Officer, Darlene Noci, reported an options exercise and related share sales. On January 29, 2026, she exercised 5,500 stock options at $27.85 per share, receiving the same number of Class A common shares.
That same day she sold portions of Class A common stock in several trades: 189 shares at $100.95, 3,429 shares at $101.8, 1,819 shares at $102.67, and 63 shares at $103.39, with prices reported as weighted averages. These transactions were executed under a Rule 10b5-1 trading plan adopted on November 18, 2024.
After the reported transactions, Noci directly held 58,117 shares of Class A common stock and 108,829 stock options. The option underlying the 5,500-share exercise vests in equal monthly installments over four years following January 6, 2023, subject to continued service.
Nuvalent, Inc. Chief Legal Officer Deborah Ann Miller reported option exercises and share sales under a pre-arranged trading plan. On January 21, 2026 she exercised 700 stock options at an exercise price of $27.85 per share and sold 700 shares of Class A common stock at a weighted average price of $109.84 per share, leaving 59,634 shares owned directly. On January 22, 2026 she exercised an additional 14,300 options at $27.85 per share and sold 14,300 shares at a weighted average price of $110.16 per share, again leaving 59,634 shares owned directly. The transactions were executed pursuant to a Rule 10b5-1 trading plan adopted on November 18, 2024, and the underlying options vest in equal monthly installments over four years following January 6, 2023, subject to continued service.