Zidesamtinib (NVL-520) - (ARROS-1)

May 7, 2026: Nuvalent, Inc. (NASDAQ: NUVL) reported pipeline/regulatory updates and reiterated milestones for its NSCLC programs.

ROS1 program (zidesamtinib): The NDA is under FDA review for adult locally advanced/metastatic ROS1-positive NSCLC after ≥1 prior ROS1 TKI; PDUFA target action date is September 18, 2026. Nuvalent plans a potential label-expansion submission in 2H 2026 for TKI-naïve advanced ROS1-positive NSCLC. At AACR 2026, it presented new clinical/preclinical data from ARROS-1, including activity in a heavily pre-treated subgroup previously treated with repotrectinib and/or taletrectinib, including tumors with ROS1 G2032R and intracranial complete responses in patients with CNS disease; preclinical analyses suggested higher brain penetrance and sustained intracranial efficacy versus repotrectinib/taletrectinib in mouse models. Preliminary ARROS-1 data in ROS1-positive solid tumors outside NSCLC are planned for ASCO 2026 (May 29–June 2, 2026).

ALK program (neladalkib): Nuvalent submitted an NDA to the FDA for TKI pre-treated advanced ALK-positive NSCLC based on ALKOVE-1 Phase 1/2; pivotal and preliminary (TKI-naïve) data are planned for an ASCO 2026 oral presentation. Phase 3 ALKAZAR (neladalkib vs alectinib) enrollment is ongoing, with progress expected through 2026.

HER2 program (NVL-330): HEROEX-1 Phase 1a/1b in pre-treated HER2-altered NSCLC is ongoing; progress expected through 2026. Nuvalent expects to disclose a new development candidate by year-end 2026.