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Nuvalent, Inc., a clinical stage biopharmaceutical company, develops therapies for patients with cancer. Its lead product candidates are NVL-520, a brain-penetrant ROS1-selective inhibitor to inhibit ROS1 fusions that express the normal ROS1 kinase domain without any drug-resistant mutations and remain active in the presence of mutations conferring resistance to approved and investigational ROS1 inhibitors, which is under Phase I development; and NVL-655, a brain-penetrant ALK-selective inhibitor, to address the clinical challenges of emergent treatment resistance, central nervous system-related adverse events, and brain metastases that might limit the use of first-, second-, and third-generation ALK inhibitors that is under Phase I/II clinical trial. The company was incorporated in 2017 and is headquartered in Cambridge, Massachusetts.

Nuvalent, Inc.

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COMPANY TO HOST WEBCAST AND CONFERENCE CALL ON NOVEMBER 17, 2025 AT 8:00AM ET CAMBRIDGE, MASS. , NOV. 14, 2025 /PRNEWSWIRE/ -- NUVALENT, INC.(NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THAT THE COMPANY WILL HOST A WEBCAST AND CONFERENCE CALL ON MONDAY, NOVEMBER 17, 2025 AT 8:00 A.M.

NUVALENT ANNOUNCES TIMING OF TOPLINE PIVOTAL DATA FOR TKI PRE-TREATED PATIENTS WITH ADVANCED ALK-POSITIVE NSCLC FROM ALKOVE-1 CLINICAL TRIAL OF NELADALKIB

ENCORE PIVOTAL EFFICACY AND SAFETY DATA FROM THE ARROS-1 TRIAL ALSO TO BE PRESENTED DURING POSTER SESSION CAMBRIDGE, MASS. , NOV. 4, 2025 /PRNEWSWIRE/ -- NUVALENT, INC.(NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THE FIRST PRESENTATION OF PATIENT-REPORTED OUTCOMES DATA FROM THE PHASE 2 PORTION OF THE ARROS-1 PHASE 1/2 CLINICAL TRIAL OF ZIDESAMTINIB, AN INVESTIGATIONAL ROS1 INHIBITOR, AS WELL AS ENCORE PIVOTAL EFFICACY AND SAFETY DATA FROM THE ARROS-1 TRIAL, DURING TWO POSTER PRESENTATIONS AT THE 2025 IASLC ASCO NORTH AMERICA CONFERENCE ON LUNG CANCER BEING HELD DECEMBER 5-7, 2025 IN CHICAGO.

NUVALENT TO PRESENT PATIENT-REPORTED OUTCOMES DATA FROM ARROS-1 TRIAL OF ROS1-SELECTIVE INHIBITOR, ZIDESAMTINIB, AT 2025 IASLC ASCO NORTH AMERICA CONFERENCE ON LUNG CANCER

COMPLETED ROLLING NDA SUBMISSION FOR ZIDESAMTINIB IN TKI PRE-TREATED ADVANCED ROS1-POSITIVE NSCLC ON TRACK TO REPORT TOPLINE PIVOTAL DATA FOR NELADALKIB IN TKI PRE-TREATED ADVANCED ALK-POSITIVE NSCLC BY YEAR-END 2025 STRONG FINANCIAL POSITION WITH OPERATING RUNWAY ANTICIPATED INTO 2028 CAMBRIDGE, MASS. , OCT. 30, 2025 /PRNEWSWIRE/ -- NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY OUTLINED PIPELINE PROGRESS, REITERATED KEY ANTICIPATED MILESTONES, AND REPORTED THIRD QUARTER 2025 FINANCIAL RESULTS.

NUVALENT HIGHLIGHTS RECENT PIPELINE PROGRESS, REITERATES KEY ANTICIPATED MILESTONES, AND REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS

ENCOURAGING PRELIMINARY ACTIVITY OBSERVED ACROSS DIVERSE SET OF ADVANCED ALK-POSITIVE SOLID TUMORS GLOBAL ENROLLMENT ONGOING FOR ADULT AND ADOLESCENT PATIENTS WITH ADVANCED ALK-POSITIVE SOLID TUMORS BEYOND NSCLC IN A PHASE 2 COHORT OF THE ALKOVE-1 TRIAL CAMBRIDGE, MASS. , OCT. 18, 2025 /PRNEWSWIRE/ -- NUVALENT, INC.(NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED PRELIMINARY DATA FROM THE ONGOING ALKOVE-1 PHASE 1/2 CLINICAL TRIAL OF NELADALKIB,AN INVESTIGATIONAL ALK-SELECTIVE INHIBITOR, IN PATIENTS WITH ADVANCED ALK-POSITIVE SOLID TUMORS OUTSIDE OF NON-SMALL CELL LUNG CANCER (NSCLC).

NUVALENT PRESENTS PRELIMINARY DATA FOR NELADALKIB IN ADVANCED ALK-POSITIVE SOLID TUMORS BEYOND NSCLC AT ESMO 2025

CAMBRIDGE, MASS. , OCT. 13, 2025 /PRNEWSWIRE/ --NUVALENT, INC.(NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED AN UPCOMING POSTER PRESENTATION FURTHER CHARACTERIZING THE PRECLINICAL INTRACRANIAL ACTIVITY OF ITS NOVEL HER2-SELECTIVE INHIBITOR, NVL-330,AT THE AACR-NCI-EORTC INTERNATIONAL CONFERENCE ON MOLECULAR TARGETS AND CANCER THERAPEUTICS BEING HELD OCTOBER 22-26, 2025 IN BOSTON.

NUVALENT TO PRESENT NEW PRECLINICAL DATA FOR HER2-SELECTIVE INHIBITOR, NVL-330, AT AACR-NCI-EORTC INTERNATIONAL CONFERENCE ON MOLECULAR TARGETS AND CANCER THERAPEUTICS

CAMBRIDGE, MASS. , SEPT. 24, 2025 /PRNEWSWIRE/ -- NUVALENT, INC.(NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THAT JAMES PORTER, PH.D.

NUVALENT TO PARTICIPATE IN THE UBS 2025 VIRTUAL ONCOLOGY DAY

CAMBRIDGE, MASS. , AUG. 28, 2025 /PRNEWSWIRE/ --NUVALENT, INC.(NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THAT JAMES PORTER, PH.D.

NUVALENT TO PARTICIPATE IN THE CANTOR GLOBAL HEALTHCARE CONFERENCE 2025

CAMBRIDGE, MASS. , AUG. 13, 2025 /PRNEWSWIRE/ -- NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THAT PIVOTAL DATA FOR ZIDESAMTINIB, A NOVEL ROS1-SELECTIVE INHIBITOR, IN TKI (TYROSINE KINASE INHIBITOR) PRE-TREATED PATIENTS WITH ADVANCED ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) FROM THE GLOBAL ARROS-1 PHASE 1/2 CLINICAL TRIAL, IN ADDITION TO PRELIMINARY DATA FOR TKI-NAVE PATIENTS, WILL BE PRESENTED AS PART OF THE PRESIDENTIAL SYMPOSIUM AT THE IASLC 2025 WORLD CONFERENCE ON LUNG CANCER (WCLC 2025).

NUVALENT TO PRESENT PIVOTAL DATA FROM ARROS-1 CLINICAL TRIAL OF ZIDESAMTINIB FOR TKI PRE-TREATED PATIENTS WITH ADVANCED ROS1-POSITIVE NSCLC AT WCLC 2025 PRESIDENTIAL SYMPOSIUM

INITIATED ROLLING NDA SUBMISSION FOR ZIDESAMTINIB FOR TKI PRE-TREATED PATIENTS WITH ADVANCED ROS1-POSITIVE NSCLC, WITH TARGET COMPLETION IN THE THIRD QUARTER OF 2025 INITIATED ALKAZAR PHASE 3 RANDOMIZED, CONTROLLED TRIAL OF NELADALKIB FOR FRONT-LINE ALK-POSITIVE NSCLC TOPLINE PIVOTAL DATA FOR NELADALKIB FOR TKI PRE-TREATED PATIENTS WITH ADVANCED ALK-POSITIVE NSCLC EXPECTED BY YEAR-END 2025 PRELIMINARY DATA FOR NELADALKIB IN PATIENTS WITH ALK-POSITIVE SOLID TUMORS BEYOND NSCLC TO BE PRESENTED AT THE ESMO CONGRESS 2025 JASON WATERS, MBA, PROMOTED TO SENIOR VICE PRESIDENT, COMMERCIAL CAMBRIDGE, MASS. , AUG. 7, 2025 /PRNEWSWIRE/ -- NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY OUTLINED PIPELINE AND BUSINESS ACHIEVEMENTS, REITERATED KEY ANTICIPATED MILESTONES, AND REPORTED SECOND QUARTER 2025 FINANCIAL RESULTS.

NUVALENT HIGHLIGHTS PIPELINE AND BUSINESS ACHIEVEMENTS, REITERATES KEY ANTICIPATED MILESTONES, AND REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS

CAMBRIDGE, MASS. , JULY 21, 2025 /PRNEWSWIRE/ -- NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THAT THE FIRST PATIENT HAS BEEN DOSED IN ALKAZAR, THE COMPANY'S GLOBAL PHASE 3 RANDOMIZED, CONTROLLED TRIAL EVALUATING NELADALKIB FOR TKI-NAVE PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), VERSUS ALECENSA (ALECTINIB),A FRONT-LINE STANDARD OF CARE.

NUVALENT ANNOUNCES INITIATION OF ALKAZAR PHASE 3 RANDOMIZED, CONTROLLED TRIAL EVALUATING NELADALKIB FOR PATIENTS WITH TKI-NAVE ALK-POSITIVE NSCLC

ALIGNED WITH FDA ONNDA SUBMISSION STRATEGY FOR TKI PRE-TREATED PATIENTS WITH ADVANCED ROS1-POSITIVE NSCLC AND PARTICIPATION IN REAL-TIME ONCOLOGY REVIEW; THE COMPANY PLANS TO INITIATE A ROLLING NDA SUBMISSION IN JULY 2025 WITH TARGET COMPLETION IN THE THIRD QUARTER OF 2025 IN 117 ROS1 TKI PRE-TREATED PATIENTS, INCLUDING 50% WHO HAD RECEIVED  2 PRIOR ROS1 TKIS  CHEMOTHERAPY, ORR BY BICR WAS 44% (95% CI: 34, 53) WITH INITIAL ESTIMATED DURABILITY OF RESPONSE OF 78% AT THE 12-MONTH LANDMARK AND 62% AT THE 18-MONTH LANDMARK IN THE SUBSET OF 55 PATIENTS TREATED WITH 1 PRIOR ROS1 TKI (CRIZOTINIB OR ENTRECTINIB)  CHEMOTHERAPY, ORR WAS 51% (95% CI: 37, 65) WITH INITIAL ESTIMATED DURABILITY OF RESPONSE OF 93% AT THE 12- AND 18-MONTH LANDMARKS ZIDESAMTINIB DEMONSTRATED INTRACRANIAL RESPONSES, ACTIVITY AGAINST TUMORS WITH A ROS1 G2032R RESISTANCE MUTATION, AND A GENERALLY WELL-TOLERATED SAFETY PROFILE, INCLUDING LOW RATES OF DOSE REDUCTION (10%) AND DISCONTINUATION (2%), CONSISTENT WITH ITS ROS1-SELECTIVE, TRK-SPARING DESIGN COMPANY ANNOUNCES PROGRESS IN THE FRONT-LINE DEVELOPMENT STRATEGIES FOR ITS PARALLEL LEAD PROGRAMS IN ROS1-POSITIVE AND ALK-POSITIVE NSCLC COMPANY TO HOST A CONFERENCE CALL TODAY, JUNE 24TH AT 8:00AM ET CAMBRIDGE, MASS. , JUNE 24, 2025 /PRNEWSWIRE/ --NUVALENT, INC.(NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED POSITIVE PIVOTAL DATA FOR ZIDESAMTINIB, A NOVEL ROS1-SELECTIVE INHIBITOR, IN TKI (TYROSINE KINASE INHIBITOR) PRE-TREATED PATIENTS WITH ADVANCED ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) FROM THE GLOBAL ARROS-1 PHASE 1/2 CLINICAL TRIAL.

Nuvalent, Inc.

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