- Nuvalent recently completed its **first NDA submission** for **Zetacentenib** in ROS1-positive non-small cell lung cancer for previously treated patients.  **[1861560_2164166_0]** 
- Initial data for Zetacentenib in TKI naive patients showed an **89% response rate** and **96% 12-month duration of response** in the first 35 patients, with **104 patients** enrolled in the cohort.  **[1861560_2164166_4]** 
- **Pivotal top-line data** for the ALK inhibitor **nanodelcub** is expected by **year-end** via a press release, with a poster presentation on ALK-positive solid tumors at ESMO.  **[1861560_2164166_5]** 
- The company is also advancing **NVL-330** for HER2-altered non-small cell lung cancer, targeting HER2 exon 20 insertions with a focus on brain penetration.  **[1861560_2164166_7]**

Nuvalent Provides Updates on Oncology Pipeline and Regulatory Submissions

- **Nuvalent, Inc.** announced the **completion of its New Drug Application (NDA) submission** to the U.S. Food and Drug Administration (FDA) for **zidesamtinib** on **September 22, 2025**.  **[1861560_0001193125-25-209934_nuvl-20250922.htm:1]** 
- The NDA is intended for the treatment of **tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer**.  **[1861560_0001193125-25-209934_nuvl-20250922.htm:1]**

Nuvalent (NUVL)