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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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NDA SUBMITTED FOR NELADALKIB IN TKI PRE-TREATED ADVANCED ALK-POSITIVE NSCLC NDA FOR ZIDESAMTINIB IN TKI PRE-TREATED ADVANCED ROS1-POSITIVE NSCLC UNDER FDA REVIEW WITH PDUFA TARGET ACTION DATE OF SEPTEMBER 18, 2026 SUBMISSION FOR POTENTIAL LABEL EXPANSION OF ZIDESAMTINIB IN TKI-NAVE ADVANCED ROS1-POSITIVE NSCLC PLANNED FOR THE SECOND HALF OF 2026 STRENGTHENED LEADERSHIP TEAM WITH KEY INTERNAL PROMOTIONS CAMBRIDGE, MASS., MAY 7, 2026 /PRNEWSWIRE/ --NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATING PRECISELY TARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY OUTLINED PIPELINE PROGRESS, REITERATED KEY ANTICIPATED MILESTONES, AND REPORTED FIRST QUARTER 2026 FINANCIAL RESULTS.

NUVALENT HIGHLIGHTS RECENT PIPELINE PROGRESS, REITERATES KEY ANTICIPATED MILESTONES, AND REPORTS FIRST QUARTER 2026 FINANCIAL RESULTS

PALO ALTO, CALIF.--(BUSINESS WIRE)--GUARDANT HEALTH, INC. (NASDAQ: GH), A LEADING PRECISION ONCOLOGY COMPANY, TODAY ANNOUNCED A MULTI-YEAR STRATEGIC COLLABORATION WITH NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATING PRECISELY TARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TO SUPPORT THE DEVELOPMENT AND POTENTIAL COMMERCIALIZATION OF NUVALENT'S ONCOLOGY PIPELINE USING THE TISSUE AND LIQUID OFFERINGS OF THE GUARDANT INFINITY PLATF.

GUARDANT HEALTH ANNOUNCES MULTI-YEAR STRATEGIC COLLABORATION WITH NUVALENT TO DEVELOP COMPANION DIAGNOSTICS AND SUPPORT POTENTIAL COMMERCIALIZATION OF TARGETED CANCER THERAPIES USING THE GUARDANT INFINITY PLATFORM

COMPANY TO ALSO PRESENT PRELIMINARY DATA FOR ZIDESAMTINIB IN ADVANCED ROS1-POSITIVE SOLID TUMORS OUTSIDE OF NSCLC FROM THE GLOBAL ARROS-1 TRIAL CAMBRIDGE, MASS., APRIL 21, 2026 /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 PIVOTAL DATA FOR NELADALKIB, AN INVESTIGATIONAL ALK-SELECTIVE INHIBITOR, IN TKI PRE-TREATED PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)FROM THE GLOBAL ALKOVE-1 PHASE 1/2 CLINICAL TRIAL, IN ADDITION TO PRELIMINARY DATA FOR TKI-NAVE PATIENTS, WILL BE PRESENTED DURING AN ORAL PRESENTATION AT THE 2026 AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) ANNUAL MEETING FROMMAY 29JUNE 2, 2026, INCHICAGO.

NUVALENT TO PRESENT PIVOTAL DATA FROM ALKOVE-1 TRIAL OF NELADALKIB IN TKI PRE-TREATED ADVANCED ALK-POSITIVE NSCLC AT THE 2026 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING

NEW DRUG APPLICATION (NDA) BASED ON DATA IN TKI PRE-TREATED PATIENTS FROM THE GLOBAL ALKOVE-1 PHASE 1/2 CLINICAL TRIAL CAMBRIDGE, MASS., APRIL 7, 2026 /PRNEWSWIRE/ -- NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATINGPRECISELYTARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY ANNOUNCED THE SUBMISSION TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) OF THE COMPANY'S NDA FOR NELADALKIB, AN INVESTIGATIONAL ALK-SELECTIVE INHIBITOR, IN TKI PRE-TREATED ADVANCED ALK-POSITIVE NSCLC.

NUVALENT ANNOUNCES SUBMISSION OF NEW DRUG APPLICATION TO FDA FOR NELADALKIB IN TKI PRE-TREATED ADVANCED ALK-POSITIVE NSCLC

COMMERCIAL PREPARATIONS WELL UNDERWAY TO SUPPORT POTENTIAL U.S. LAUNCH OF ZIDESAMTINIB IN TKI PRE-TREATED ADVANCED ROS1-POSITIVE NSCLC POPULATION, PENDING FDA REVIEW; PDUFA TARGET ACTION DATE OF SEPTEMBER 18, 2026 NDA SUBMISSION FOR NELADALKIB IN TKI PRE-TREATED ADVANCED ALK-POSITIVE NSCLC POPULATION PLANNED FOR THE FIRST HALF OF 2026 SUBMISSION FOR POTENTIAL LABEL EXPANSION OF ZIDESAMTINIB IN TKI-NAVE ADVANCED ROS1-POSITIVE NSCLC POPULATION PLANNED FOR THE SECOND HALF OF 2026 STRONG FINANCIAL POSITION WITH OPERATING RUNWAY ANTICIPATED INTO 2029 CAMBRIDGE, MASS., FEB. 26, 2026 /PRNEWSWIRE/ -- NUVALENT, INC. (NASDAQ: NUVL), A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY FOCUSED ON CREATING PRECISELY TARGETED THERAPIES FOR CLINICALLY PROVEN KINASE TARGETS IN CANCER, TODAY OUTLINED PIPELINE PROGRESS, REITERATED KEY ANTICIPATED MILESTONES, AND REPORTED FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS.

NUVALENT OUTLINES RECENT PIPELINE PROGRESS, REITERATES KEY ANTICIPATED MILESTONES, AND REPORTS FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS

CAMBRIDGE, MASS., FEB. 5, 2026 /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 JAMES PORTER, PH.D.

NUVALENT TO PARTICIPATE IN THE GUGGENHEIM EMERGING OUTLOOK: BIOTECH SUMMIT 2026

FDA ACCEPTEDNDA FOR ZIDESAMTINIB FOR THE TREATMENT OF TKI PRE-TREATED PATIENTS WITH ADVANCED ROS1-POSITIVE NSCLC; PDUFA TARGET ACTION DATE OF SEPTEMBER 18, 2026 NDA SUBMISSION FOR NELADALKIB IN TKI PRE-TREATED ADVANCED ALK-POSITIVE NSCLC POPULATION PLANNED FOR THE FIRST HALF OF 2026 SUBMISSION FOR POTENTIAL INDICATION EXPANSION OF ZIDESAMTINIB IN TKI-NAVE ADVANCED ROS1-POSITIVE NSCLC POPULATION PLANNED FOR THE SECOND HALF OF 2026 WELL CAPITALIZED WITH OPERATING RUNWAY ANTICIPATED INTO 2029 COMPANY TO PRESENT AT 44TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE ON TUESDAY, JANUARY 13TH AT 9:00 A.M.

NUVALENT ANNOUNCES ONTARGET 2026 OPERATING PLAN PROGRESS AND OUTLINES KEY ANTICIPATED 2026 MILESTONES

CAMBRIDGE, MASS. , DEC. 22, 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 PRESENT AT THE 44TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

NEW YORK, DEC. 16, 2025 (GLOBE NEWSWIRE) -- ROYALTY PHARMA PLC (NASDAQ: RPRX) TODAY ANNOUNCED THAT IT HAS ACQUIRED A PRE-EXISTING ROYALTY INTEREST IN NUVALENT'S NELADALKIB AND ZIDESAMTINIB FROM AN UNDISCLOSED THIRD PARTY FOR UP TO $315 MILLION.

ROYALTY PHARMA ACQUIRES ROYALTY INTEREST IN NUVALENT'S NELADALKIB AND ZIDESAMTINIB FOR UP TO $315 MILLION

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, Inc.

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