On May 27, 2026 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the acceptance of its New Drug Application (NDA) for neladalkib for filing by the U.S. Food and Drug Administration (FDA). The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. The company further announced that Georg Pirmin Meyer, M.D., has joined the company as Chief International Officer.
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"With today’s announcement, New Drug Applications for both zidesamtinib and neladalkib in TKI pre-treated populations are now under review with the FDA, and TKI-naïve expansion strategies are underway," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "Our U.S. commercial and medical affairs teams are in place and focused on establishing the strong foundational systems and infrastructure required to effectively deliver on multiple synergistic launches in biomarker-driven NSCLC."
Dr. Porter continued, "Nuvalent’s commitment to patients is global, and we are thrilled to welcome Georg Pirmin as we develop an international strategy with the goal of delivering new medicines beyond the U.S. His proven track record of establishing global operations and strategic partnerships that maximize patient access will be instrumental in realizing the full potential for Patient Impact with our parallel-lead programs."
"Nuvalent presents a unique near-term opportunity to advance multiple potential best-in-class product candidates for patients with cancer, backed by robust clinical experience demonstrating clear global medical need and enthusiasm," said Dr. Meyer. "I am excited to join at this pivotal moment and to partner with the team to realize our shared vision of global leadership in ROS1- and ALK-positive NSCLC."
Neladalkib NDA Accepted for Filing with Priority Review
The U.S. FDA has accepted for filing Nuvalent’s NDA for neladalkib, an investigational ALK-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated advanced ALK-positive non-small cell lung cancer (NSCLC). The application has been granted Priority Review and assigned a PDUFA target action date of November 27, 2026.
The submission is based on data in TKI pre-treated patients with advanced ALK-positive NSCLC treated with neladalkib in the global, registration-directed ALKOVE-1 Phase 1/2 clinical trial. These data, along with preliminary data for TKI-naïve patients, will be shared during an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026, in Chicago.
Georg Pirmin Meyer, M.D. Joins as Chief International Officer
In this newly created role, Dr. Meyer will be responsible for spearheading Nuvalent’s international expansion strategy and establishing the company’s presence in key markets outside the U.S.
Dr. Meyer brings extensive expertise in global commercial strategy, market access, product launches, and business development across major international markets. Most recently, he served as Senior Vice President and General Manager, International at Blueprint Medicines, where he held full P&L accountability for international operations. In this role, Dr. Meyer led the European market preparation and successful launches of Ayvakit (avapritinib) across three indications, while building and scaling a cross-functional team spanning nine European countries. Prior to Blueprint Medicines, Dr. Meyer served as General Manager, Germany at Vertex Pharmaceuticals, where he held full P&L responsibility for the German market, scaled commercial operations for four marketed orphan disease products, and drove uncompromising market access strategies including HTA submissions and complex price negotiations. Earlier in his career, he held progressive global commercial operational roles at Amgen and Sanofi, establishing a strong foundation in biopharmaceutical commercialization. Dr. Meyer received his M.D. from the University of Freiburg, Germany and the University of Innsbruck, Austria.
About Neladalkib
Neladalkib is an investigational, brain-penetrant, ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy.
Based on data in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ALKOVE-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for neladalkib in TKI pre-treated advanced ALK-positive NSCLC. The application has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. Neladalkib has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.
About the ALKOVE-1 Phase 1/2 Clinical Trial
The ALKOVE-1 trial (NCT05384626) is a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ALK-positive NSCLC patients who previously received at least one ALK TKI, or patients with other ALK-positive solid tumors who had been previously treated or for whom no satisfactory standard of care exists. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of neladalkib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The global, single arm, open label Phase 2 portion is designed with registrational intent for TKI pre-treated patients with advanced ALK-positive NSCLC. Global enrollment in ALKOVE-1 remains ongoing for adult and adolescent patients with ALK-positive solid tumors outside of NSCLC, and adolescent patients with ALK-positive NSCLC.
About Zidesamtinib
Zidesamtinib is an investigational, brain-penetrant, ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy.
Based on results for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial, the U.S. Food and Drug Administration (FDA) has accepted for filing Nuvalent’s NDA submission for zidesamtinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who received at least 1 prior ROS1 TKI. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 TKIs and orphan drug designation for ROS1-positive NSCLC.
(Press release, Nuvalent, MAY 27, 2026, View Source;and-alk-positive-nsclc-302782393.html [SID1234666114])