#United States #Cambridge #Nuvalent #Neladalkib #ALK-positive NSCLC

Nuvalent Submits New Drug Application for Neladalkib to the FDA

CAMBRIDGE, Mass., April 7, 2026 – Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, has announced the submission of a New Drug Application (NDA) for neladalkib, an investigational drug designed to target advanced ALK-positive non-small cell lung cancer (NSCLC) in patients who have already received treatment with two or more ALK inhibitors. This milestone reflects significant achievements in drug development, occurring within just four years from the initiation of clinical trials.

Darlene Noci, the Chief Development Officer at Nuvalent, expressed the team’s commitment to advancing neladalkib, stating, "The speed of our progression from the first clinical trial to this application showcases our dedication to the ALK-positive NSCLC community. We are incredibly grateful for the contributions of patients, families, and investigators who have supported this journey."

The NDA is based on promising results from the global ALKOVE-1 Phase 1/2 clinical trial. In this study, patients with advanced ALK-positive NSCLC who had previously undergone treatment with other tyrosine kinase inhibitors (TKIs) showed encouraging responses while being treated with neladalkib. The drug was also noted for its ability to handle key disease progression factors and exhibited a favorable safety profile in line with its distinct design as an ALK-selective and TRK-sparing agent.

Neladalkib is engineered to penetrate the blood-brain barrier, addressing a significant limitation of existing ALK inhibitors by targeting tumor types that develop resistance to earlier generations of therapies. This includes patients with specific mutations like G1202R. The design aims to reduce adverse effects related to TRK suppression, a critical consideration in this treatment group.

The ongoing global clinical trial, ALKOVE-1, continues to enroll participants, including both adult and adolescent patients with advanced ALK-positive solid tumors. The Phase 1 segment, which evaluates the drug’s safety and tolerability, along with measuring pharmacokinetic characteristics, has already concluded, leading into the registrational Phase 2 portion.

In September of last year, the FDA granted neladalkib breakthrough therapy designation for its potential effectiveness in patients with locally advanced or metastatic ALK-positive NSCLC. This designation is intended to expedite the development and review process, aiming to bring the drug to market sooner for those who urgently need it.

Future Outlook

Nuvalent is committed to sharing detailed results from the ALKOVE-1 trial at upcoming medical conferences. The expectation is that a successful review by the FDA could pave the way for neladalkib to become a new treatment option for patients battling advanced stages of ALK-positive NSCLC, especially those who have limited options due to previous therapies.

As Nuvalent continues to innovate in the field of cancer treatment, they remain focused on developing therapies that leverage cutting-edge research to provide patients with more tailored and effective solutions in the fight against cancer. With a robust pipeline and strong emphasis on overcoming therapeutic barriers, the future appears promising not just for neladalkib, but for several other investigational candidates in their development portfolio.