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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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CAMBRIDGE, MASS. , DEC. 10, 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 APPOINTMENT OF RON SQUARER TO ITS BOARD OF DIRECTORS.

NUVALENT APPOINTS RON SQUARER TO BOARD OF DIRECTORS

CAMBRIDGE, MASS. , NOV. 26, 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 PIPER SANDLER 37TH ANNUAL HEALTHCARE CONFERENCE

CAMBRIDGE, MASS. , NOV. 24, 2025 /PRNEWSWIRE/ -- NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATING PRECISELY TARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THE CLOSING OF ITS PREVIOUSLY ANNOUNCED UNDERWRITTEN PUBLIC OFFERING OF 4,950,496 SHARES OF CLASS A COMMON STOCK AT A PRICE TO THE PUBLIC OF $101.00 PER SHARE.

NUVALENT ANNOUNCES CLOSING OF PUBLIC OFFERING OF COMMON STOCK AND FULL EXERCISE BY UNDERWRITERS OF OPTION TO PURCHASE ADDITIONAL SHARES FROM SELLING STOCKHOLDERS

NDA BASED ON DATA FROM GLOBAL ARROS-1 PHASE 1/2 CLINICAL TRIAL FDA ASSIGNS PDUFA TARGET ACTION DATE OF SEPTEMBER 18, 2026 CAMBRIDGE, MASS. , NOV. 19, 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 U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS ACCEPTED FOR FILING ITS NEW DRUG APPLICATION (NDA) FOR ZIDESAMTINIB, AN INVESTIGATIONAL ROS1-SELECTIVE INHIBITOR, FOR THE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WHO RECEIVED AT LEAST 1 PRIOR ROS1 TYROSINE KINASE INHIBITOR (TKI).

NUVALENT ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR ZIDESAMTINIB FOR THE TREATMENT OF TKI PRE-TREATED PATIENTS WITH ADVANCED ROS1-POSITIVE NSCLC

CAMBRIDGE, MASS. , NOV. 18, 2025 /PRNEWSWIRE/ -- NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATING PRECISELY TARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THE PRICING OF AN UNDERWRITTEN PUBLIC OFFERING OF SHARES OF CLASS A COMMON STOCK AT A PRICE TO THE PUBLIC OF $101.00 PER SHARE.

NUVALENT ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK

CAMBRIDGE, MASS. , NOV. 17, 2025 /PRNEWSWIRE/ --NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATING PRECISELY TARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THAT IT HAS COMMENCED AN UNDERWRITTEN PUBLIC OFFERING OF SHARES OF CLASS A COMMON STOCK.

NUVALENT ANNOUNCES PUBLIC OFFERING OF COMMON STOCK

IN 253 ALK TKI PRE-TREATED PATIENTS, ORR BY BICR WAS 31% (95% CI: 26, 37), WITH INITIAL ESTIMATED DURABILITY OF RESPONSE OF 64% AND 53% AT THE 12-MONTH AND 18-MONTH LANDMARKS, RESPECTIVELY IN THE SUBSET OF 63 TKI PRE-TREATED PATIENTS WHO WERE LORLATINIB-NAVE, ORR BY BICR WAS 46% (95% CI: 33, 59), WITH INITIAL ESTIMATED DURABILITY OF RESPONSE OF 80% AND 60% AT THE 12- AND 18-MONTH LANDMARKS, RESPECTIVELY NELADALKIB DEMONSTRATED INTRACRANIAL RESPONSES, ABILITY TO ADDRESS KEY DRIVERS OF DISEASE PROGRESSION, AND A GENERALLY WELL-TOLERATED SAFETY PROFILE WITH LOW RATES OF DOSE DISCONTINUATION (5%) AND DOSE REDUCTION (17%) DUE TO TEAES, CONSISTENT WITH ITS ALK-SELECTIVE, TRK-SPARING DESIGN COMPANY PLANS TO DISCUSS PIVOTAL DATA FOR THE TKI PRE-TREATED ALK-POSITIVE NSCLC POPULATION WITH THE FDA AT A PRE-NDA MEETING; DETAILED STUDY RESULTS ARE PLANNED FOR PRESENTATION AT A FUTURE MEDICAL MEETING COMPANY TO HOST A CONFERENCE CALL TODAY, NOVEMBER 17 TH AT 8:00AM ET CAMBRIDGE, MASS. , NOV. 17, 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 TOPLINE PIVOTAL DATA FOR NELADALKIB, AN 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 CLINICAL TRIAL.

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

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

Nuvalent, Inc.

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