{"filings":[{"id":96358,"accession_number":"0001861560-26-000020","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2026-05-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Nuvalent submits NDA for neladalkib in ALK+ NSCLC; zidesamtinib PDUFA Sept 18, 2026","event_type":"other_material","confidence":"high","bullets":["NDA for neladalkib in TKI pre-treated ALK+ NSCLC submitted; pivotal data at ASCO 2026.","Zidesamtinib NDA under FDA review; PDUFA target action date September 18, 2026.","Plan to submit data in 2H 2026 for zidesamtinib label expansion in TKI-naïve ROS1+ NSCLC.","Cash $1.3B; net loss $109.3M in Q1 2026 (R&D $83.6M, G&A $35.8M).","Leadership promotions: Dr. Benjamin Lane to Chief Technology Operations Officer; Dr. Kirsten Duncan to VP Medical Affairs."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":96357,"accession_number":"0001861560-26-000003","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2026-04-07T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Nuvalent submits NDA to FDA for neladalkib in ALK-positive lung cancer","event_type":"regulatory","confidence":"high","bullets":["NDA submitted to FDA on April 7, 2026, for neladalkib in TKI pre-treated advanced ALK-positive NSCLC.","Neladalkib is a novel ALK inhibitor targeting advanced ALK+ non-small cell lung cancer.","Submission marks regulatory milestone; no additional details on acceptance or review timeline provided.","Nuvalent (NUVL) expects FDA review of the NDA for potential market approval."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.8,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":110189,"accession_number":"0001193125-26-073304","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2026-02-26T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Nuvalent reports Q4 and FY2025 net loss; zidesamtinib PDUFA set for Sept 18, 2026","event_type":"earnings","confidence":"high","bullets":["Net loss of $118.7M in Q4 2025 and $425.4M for full year 2025.","Cash, equivalents and marketable securities of $1.4B, runway into 2029.","FDA accepted zidesamtinib NDA; PDUFA target action date September 18, 2026.","NDA submission for neladalkib in ALK+ NSCLC planned first half 2026.","Closed $500M public offering of common stock in November 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-5.85,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-FY","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":110188,"accession_number":"0001193125-26-012243","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2026-01-14T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Nuvalent reports $1.4B cash, zidesamtinib PDUFA Sep 18, 2026; pipeline milestones","event_type":"other_material","confidence":"high","bullets":["Preliminary cash, cash equivalents and securities ~$1.4B as of Dec 31, 2025; runway into 2029.","FDA accepted NDA for zidesamtinib in TKI pre-treated ROS1+ NSCLC; PDUFA Sep 18, 2026.","NDA submission for neladalkib in TKI pre-treated ALK+ NSCLC planned for H1 2026.","Potential indication expansion submission for zidesamtinib in TKI-naïve ROS1+ NSCLC in H2 2026.","Progressing ALKAZAR Phase 3 (neladalkib, TKI-naïve ALK+) and HEROEX-1 Phase 1a/1b (NVL-330, HER2-altered NSCLC)."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.8,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":126751,"accession_number":"0001193125-25-320150","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-12-16T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Royalty Pharma buys 1.5% royalty on Nuvalent's pipeline for up to $315M","event_type":"other_material","confidence":"high","bullets":["Royalty Pharma acquired a preexisting 1.5% net-sales royalty on neladalkib and zidesamtinib from an undisclosed third party.","The deal value is up to $315 million; Nuvalent is not a party to the transaction.","Nuvalent clarifies the 'low single digit preexisting royalty' is exactly 1.5% of net sales of both candidates.","Nuvalent's revenue share agreement with its scientific founder remains unchanged."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":126750,"accession_number":"0001193125-25-314165","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-12-10T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Nuvalent director Matthew Shair resigns; Ron Squarer elected to board","event_type":"leadership","confidence":"high","bullets":["Matthew Shair, Ph.D., resigned from the Board effective Dec 9, 2025, and not due to any disagreement.","Ron Squarer elected as Class II independent director effective Dec 10, 2025, until 2026 annual meeting.","Squarer receives initial equity award with aggregate fair value $600,000 (option + RSU).","Option capped at 14,850 shares, RSU capped at 7,425 shares; vesting over 3 years.","Squarer eligible for annual director cash retainers and committee fees per policy."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.3,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":126749,"accession_number":"0001193125-25-288770","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-11-20T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"Nuvalent prices $500M public offering at $101/share; net proceeds ~$472M","event_type":"other_material","confidence":"high","bullets":["Pricing of 4,950,496 shares at $101.00/share for gross proceeds of ~$500M.","Net proceeds to Nuvalent of ~$471.9M after underwriting discounts and expenses.","Selling stockholders (Deerfield funds) have 30-day option to sell 742,574 additional shares; Nuvalent receives no proceeds.","Closing expected on November 20, 2025; net proceeds plus existing cash expected to fund operations into 2029.","Joint book-running managers: J.P. Morgan, Jefferies, TD Cowen, and Cantor."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":126748,"accession_number":"0001193125-25-283893","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-11-17T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Nuvalent reports positive pivotal data for neladalkib in ALK+ NSCLC; ORR 31% in TKI pre-treated, 46% in lorlatinib-naïve","event_type":"other_material","confidence":"high","bullets":["Neladalkib achieved 31% ORR (79/253) in TKI pre-treated ALK+ NSCLC; median DOR not reached at 11.3 months follow-up.","In lorlatinib-naïve subset (n=63), ORR 46% (29/63); DOR ≥12 months 80%. Intracranial ORR 63% with 21% CR.","Preliminary TKI-naïve cohort (n=44): ORR 86% (38/44), CR 9%, intracranial ORR 78% with 44% CR.","Safety consistent with ALK-selective design; most common TEAEs: ALT/AST elevations, constipation, dysgeusia. 5% discontinuation.","Company plans pre-NDA meeting with FDA for TKI pre-treated population; detailed results at future medical meeting."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":126747,"accession_number":"0001193125-25-257347","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-10-30T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Nuvalent Q3 net loss $122.4M; completes NDA for zidesamtinib; cash $943M into 2028","event_type":"earnings","confidence":"high","bullets":["Completed rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC.","On track to report topline pivotal data for neladalkib in ALK-positive NSCLC by year-end 2025.","Cash, cash equivalents and marketable securities of $943.1M as of Sept 30, 2025; expected runway into 2028.","Q3 2025 net loss of $122.4M, R&D expenses $83.8M, G&A expenses $28.9M.","Presented preliminary data for neladalkib in ALK-positive solid tumors at ESMO and preclinical data for NVL-330 in HER2-altered NSCLC."],"consensus_eps_estimate":null,"consensus_eps_actual":-4.27,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.6,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":143539,"accession_number":"0001193125-25-209934","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-09-22T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Nuvalent completes NDA submission to FDA for zidesamtinib in ROS1-positive NSCLC","event_type":"regulatory","confidence":"high","bullets":["Completed NDA submission to FDA for zidesamtinib.","Indication: TKI pre-treated advanced ROS1-positive non-small cell lung cancer.","Submission date: September 22, 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":143538,"accession_number":"0000950170-25-104531","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-08-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Nuvalent Q2 2025 net loss $99.7M; rolling NDA for zidesamtinib initiated","event_type":"earnings","confidence":"high","bullets":["Net loss $99.7M; R&D $80.9M, G&A $23.7M; cash $1.0B funding into 2028.","Rolling NDA for zidesamtinib (ROS1+ NSCLC) initiated; target completion Q3 2025; FDA RTOR pilot.","ALKAZAR Phase 3 of neladalkib (ALK+ NSCLC) dosed; topline TKI pre-treated data expected year-end 2025.","Preliminary data for neladalkib in ALK+ solid tumors at ESMO 2025 (Oct 17-21).","Jason Waters promoted to SVP Commercial; Christy Oliger appointed to board."],"consensus_eps_estimate":null,"consensus_eps_actual":-2.57,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.6,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":143537,"accession_number":"0000950170-25-097069","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-07-21T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Nuvalent initiates Phase 3 ALKAZAR trial of neladalkib in ALK-positive NSCLC","event_type":"other_material","confidence":"high","bullets":["First patient dosed in Phase 3 ALKAZAR trial evaluating neladalkib for TKI-naïve advanced ALK-positive NSCLC.","Trial compares neladalkib head-to-head against ALECENSA (alectinib), a front-line standard of care.","ALKAZAR is a registrational study designed to support potential approval of neladalkib in this indication."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":161733,"accession_number":"0000950170-25-089213","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-06-24T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Nuvalent reports positive pivotal data for zidesamtinib in ROS1+ NSCLC; NDA submission set for July 2025","event_type":"other_material","confidence":"high","bullets":["Zidesamtinib achieved 44% ORR (51/117) in TKI pre-treated ROS1+ NSCLC; intracranial ORR 48% (27/56) with 20% complete responses.","In TKI-naïve cohort, preliminary ORR 89% (31/35) with intracranial ORR 83% (5/6) and 67% complete responses; 104 patients enrolled.","FDA agreed to RTOR for zidesamtinib; rolling NDA to start July 2025, completion targeted Q3 2025, for TKI pre-treated advanced NSCLC.","ALKAZAR Phase 3 trial of neladalkib vs alectinib in ALK+ NSCLC expected to begin enrollment early H2 2025.","Zidesamtinib well tolerated: 2% discontinued due to TEAEs; median exposure 5 months; common TEAEs included peripheral edema (36%)."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":161732,"accession_number":"0000950170-25-088542","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-06-20T23:59:59+00:00","items":["5.02","5.07"],"status":"ready","headline":"Nuvalent elects Christy Oliger as new board member; 2025 annual meeting results disclosed","event_type":"leadership","confidence":"high","bullets":["Christy J. Oliger elected to Board as Class III director, effective June 18, 2025; appointed to Audit Committee.","Ms. Oliger receives initial grant: option for 6,119 shares at $75.53, RSU for 3,971 shares, each vesting over 3 years.","Annual Meeting held June 18; 97.01% of shares represented. All three Class I director nominees elected: Bogle, Porter, Protopapas.","Advisory vote on exec comp approved (53.5M for, 10.4M against, 2.5K abstain). Ratification of KPMG as auditor approved (64.4M for, 10.8K against).","Broker non-votes: 500,127 on director and say-on-pay proposals; none on auditor ratification."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.3,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":161731,"accession_number":"0000950170-25-084385","cik":1861560,"company_name":"Nuvalent, Inc.","ticker":"NUVL","form_type":"8-K","filed_at":"2025-06-10T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Director Emily Conley resigns from Nuvalent board effective at 2025 annual meeting","event_type":"leadership","confidence":"high","bullets":["Emily Conley notified Nuvalent of her resignation from the Board and all committees, effective at the 2025 annual meeting.","Resignation not due to any disagreement with the Company on operations, policies, or practices.","No replacement announced; board size will be reduced accordingly."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.25,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}