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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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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 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, Inc.

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Nuvalent, Inc.

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