Every 8-K that Nuvalent, Inc. (NUVL) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow NUVL and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full NUVL filings page.
Nuvalent, Inc. completed its sale to GlaxoSmithKline LLC through a tender offer and short-form merger, valuing the equity at approximately $10.6 billion. Shareholders receive $124.00 in cash per share, without interest and subject to tax withholding, for both Class A and Class B common stock.
The tender offer, which expired July 14, 2026, resulted in 72,518,967 shares (about 91.3% of those outstanding) being validly tendered, satisfying the minimum condition and enabling a merger without a stockholder vote under Section 251(h) of the DGCL. Nuvalent is now a wholly owned subsidiary of GlaxoSmithKline LLC; its Nasdaq-listed shares will be delisted, and the company plans to terminate its SEC reporting obligations. All prior directors and officers were replaced by acquiror designees, and all stock options, RSUs, and PSUs were cancelled in exchange for cash payments calculated using the $124.00 offer price.
Nuvalent, Inc. reported the results of its 2026 annual meeting of stockholders held on June 16, 2026. A total of 71,190,894 shares of Class A common stock were represented, about 96.80% of shares outstanding as of the April 20, 2026 record date.
Stockholders elected Class II directors Michael L. Meyers, M.D., Ph.D. and Ron Squarer to three-year terms ending at the 2029 annual meeting. They also approved, on an advisory basis, the compensation of the company’s named executive officers and ratified KPMG LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
Nuvalent, Inc. entered into a Merger Agreement for GSK to acquire all Class A and Class B shares via a tender offer at $124.00 per share in cash. Following the offer, GSK’s subsidiary will merge into Nuvalent under Delaware law, with remaining shares also cashed out at the same price.
The offer requires at least a majority of Nuvalent’s Class A shares to be tendered and customary regulatory clearances, including expiration of the Hart-Scott-Rodino waiting period. An outside date of December 9, 2026 applies. Certain shareholders owning about 28% of Class A shares agreed to tender. Nuvalent must pay a $350,475,000 termination fee in specified scenarios, including accepting a superior proposal or a board recommendation change.
GSK values the equity of Nuvalent at about $10.6 billion and expects the deal, funded mainly with debt and cash, to contribute to its revenue growth from 2027. GSK states the $124 price reflects a 40% premium to the last closing price and a 26% premium to the 30-day VWAP.
Nuvalent, Inc. reported first quarter 2026 results and highlighted major regulatory milestones for its lung cancer pipeline. Cash, cash equivalents and marketable securities were $1.3 billion as of March 31, 2026, and the company expects this to fund operations into 2029.
For the quarter, Nuvalent recorded a net loss of $109.3 million, with research and development expenses of $83.6 million and general and administrative expenses of $35.8 million. An NDA for neladalkib in ALK-positive NSCLC was submitted, and the NDA for zidesamtinib in ROS1-positive NSCLC is under FDA review with a PDUFA target action date of September 18, 2026.
Nuvalent, Inc. reported that on April 7, 2026 it announced submitting a New Drug Application to the U.S. Food and Drug Administration for neladalkib. The application covers use in tyrosine kinase inhibitor pre-treated, advanced ALK-positive non-small cell lung cancer.
This step moves neladalkib from clinical development into formal regulatory review, an important stage toward potential U.S. market availability if the FDA later approves the drug.
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. furnished an update indicating that it preliminarily estimates having approximately $1.4 billion in cash, cash equivalents and marketable securities as of December 31, 2025. This figure is described as a preliminary, unaudited estimate as of January 12, 2026 and may change once year-end financial closing procedures are completed, so it does not provide a full picture of the company’s financial condition at that date. The estimate was disclosed via a press release attached as Exhibit 99.1, which is being furnished rather than filed, and the company notes that related statements are forward-looking and subject to risks outlined in its prior SEC reports.
Nuvalent, Inc. reports that Royalty Pharma plc has acquired a preexisting royalty interest related to Nuvalent’s neladalkib and zidesamtinib investigational product candidates from an undisclosed third party for up to $315 million. These product candidates are already subject to a revenue share agreement with Nuvalent’s scientific founder, which is described in the company’s Annual Report on Form 10-K for the year ended December 31, 2024.
Nuvalent explains that the “low single digit preexisting royalty” referenced in Royalty Pharma’s announcement is a 1.5% royalty on net sales of both neladalkib and zidesamtinib. This update clarifies the precise royalty rate that would apply to potential future sales of these drug candidates.
Nuvalent, Inc. entered into an underwriting agreement for an underwritten public offering of 4,950,496 shares of its Class A common stock at a price to the public of $101.00 per share, with underwriters purchasing at $95.445 per share. The company estimates net proceeds of approximately $471.9 million after underwriting discounts and expenses.
Selling stockholders granted the underwriters a 30-day option to buy up to 742,574 additional shares, which would provide them with approximately $75 million of gross proceeds; Nuvalent will not receive any proceeds from these additional shares. The company expects the offering to close on November 20, 2025, subject to customary conditions, and estimates that the net proceeds, combined with existing cash, cash equivalents and marketable securities, will fund operating and capital expenditure needs into 2029.
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. filed a current report to share that it announced its financial results for the quarter ended September 30, 2025, along with other corporate updates. The company furnished a press release as Exhibit 99.1, which contains the detailed quarterly results and information. This material is being treated as “furnished” rather than “filed,” meaning it is not subject to certain liability provisions under the securities laws or automatically incorporated into other SEC filings unless specifically referenced.
Nuvalent, Inc. filed a current report describing a key regulatory milestone for its lead oncology program. On September 22, 2025, the company completed submission of a New Drug Application to the U.S. Food and Drug Administration for zidesamtinib as a treatment for tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer. This step means Nuvalent has finished providing the clinical and other data the agency needs to begin its formal review of the drug candidate for this specific patient group.
Nuvalent, Inc. (NASDAQ: NUVL) filed an 8-K disclosing pivotal Phase 1/2 data and regulatory progress for its lead ROS1-selective inhibitor, zidesamtinib, in ROS1-positive non-small cell lung cancer (NSCLC).
Pivotal dataset – TKI pre-treated setting (n = 117)
- Objective response rate (ORR, RECIST 1.1, BICR): 44 % (51/117; 95 % CI 34-53).
- Durability: Kaplan-Meier probability of remaining in response ≥6, ≥12 and ≥18 months was 84 %, 78 % and 62 %, respectively; emerging median DOR 22.0 months.
- Activity across resistance profiles: ORR 54 % in patients with ROS1 G2032R mutation (n = 26) and 51 % in those with only one prior TKI (crizotinib or entrectinib; n = 55).
- Intracranial efficacy (baseline measurable CNS disease, n = 56): IC-ORR 48 % with 20 % complete responses; IC-DOR ≥ 12 months 71 %.
- Safety (n = 432 at RP2D): most frequent TEAEs ≥15 % were peripheral edema (36 %), constipation (17 %), CPK increase (16 %), fatigue (16 %), dyspnea (15 %); dose reductions 10 %, discontinuations 2 %.
Preliminary TKI-naïve data (n = 35)
- ORR 89 % (31/35); DOR ≥6 & ≥12 months 96 %.
- Intracranial subset (n = 6): IC-ORR 83 % with 67 % CR; no CNS progression among responders.
- Global enrollment for the TKI-naïve cohort has reached 104 patients.
Regulatory & pipeline milestones
- Completed pre-NDA meeting; FDA agreed to accept zidesamtinib NDA into the Real-Time Oncology Review (RTOR) pilot.
- Rolling NDA submission to begin July 2025, targeted completion Q3 2025; company is also discussing “line-agnostic” expansion with FDA.
- Front-line strategy advances: first preliminary data from TKI-naïve cohort reported; Phase 3 ALKAZAR trial of neladalkib vs. alectinib in ALK-positive NSCLC set to initiate enrollment early H2 2025.
Investor takeaways: The pivotal efficacy, durability and intracranial activity in a heavily pre-treated population, combined with an RTOR-enabled NDA timeline and a diversified front-line development plan, collectively strengthen Nuvalent’s near-term commercial prospects and strategic positioning in the competitive ROS1/ALK TKI landscape.
Nuvalent, Inc. (NASDAQ: NUVL) filed a Form 8-K covering two corporate-governance items dated June 18, 2025.
Board change (Item 5.02): The Board unanimously elected Christy J. Oliger as an independent Class III director, effective immediately. She will serve until the 2027 annual meeting and join the Audit Committee. Compensation aligns with the existing non-employee director policy and includes:
- Initial stock option for 6,119 shares at an exercise price of $75.53, vesting monthly over three years.
- Initial RSU award of 3,971 shares, vesting annually over three years.
- Annual cash retainers and ongoing equity grants as stipulated in the policy.
2025 Annual Meeting results (Item 5.07): Quorum was strong with 64.38 million votes representing 97.01 % of outstanding shares. Outcomes were:
- Director elections: Grant Bogle (99.87 % support); James R. Porter, Ph.D. (99.78 %); Anna Protopapas (86.27 %).
- Say-on-pay: Approved with 83.8 % (53.52 m for, 10.36 m against).
- Auditor ratification: KPMG LLP re-approved with 99.98 % support.
Investor take-away: The filing is largely procedural. The addition of an experienced independent director strengthens oversight, while voting results confirm broad shareholder support for existing leadership and compensation structure.