Nuvalent filed a rolling New Drug Application for its ROS1 inhibitor zidesamtinib, targeting patients with TKI‑pre‑treated advanced ROS1‑positive non‑small cell lung cancer. The filing marks the first regulatory milestone for the drug and initiates the FDA review process.
The company’s Phase 2 ARROS‑1 trial enrolled 326 patients and is expected to deliver topline data in the first half of 2025. Earlier reports indicated 104 patients in the TKI‑naïve cohort and 432 patients across Phase 1 and 2 as of March 21, 2025. The data support zidesamtinib’s ability to overcome resistance mutations such as G2032R and provide improved brain penetration compared with existing ROS1 therapies.
Nuvalent reported $943.1 million in cash, cash equivalents, and marketable securities as of September 30, 2025, giving the company a runway into 2028. The company’s net loss for Q3 2025 was $122.4 million, up from $84.3 million in Q3 2024, driven by increased R&D and G&A expenses. Management noted that the higher expenses reflect accelerated development of zidesamtinib and the company’s ALK‑positive NSCLC candidate neladalkib.
The filing follows the company’s Breakthrough Therapy Designation from the FDA and positions zidesamtinib against competitors such as crizotinib, entrectinib, repotrectinib, and taletrectinib. The drug’s design aims to address limitations of current therapies, particularly resistance and central nervous system penetration.
Nuvalent also highlighted progress on its ALK‑positive NSCLC program, with topline pivotal data expected by year‑end 2025. The company’s strong cash position and ongoing clinical development support its long‑term growth prospects.
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