Nuvalent plans FDA submission for lung cancer drug zidesamtinib

CAMBRIDGE, Mass. - Nuvalent, Inc. (NASDAQ:NUVL), a $5.4 billion market cap biotechnology company with strong financial health according to InvestingPro metrics, plans to initiate a rolling New Drug Application (NDA) submission in July 2025 for its ROS1-selective inhibitor zidesamtinib, following positive pivotal data in previously treated ROS1-positive non-small cell lung cancer (NSCLC) patients. The company announced Tuesday it has aligned with the FDA on its submission strategy and participation in the Real-Time Oncology Review program, with target completion in the third quarter of 2025. With a robust current ratio of 14.48 and more cash than debt on its balance sheet, Nuvalent appears well-positioned to execute its development plans.

Data from the global ARROS-1 Phase 1/2 trial showed an objective response rate (ORR) of 44% in 117 patients previously treated with tyrosine kinase inhibitors (TKIs). In the subset of 55 patients who received only one prior ROS1 TKI, the ORR was 51%. The drug demonstrated durability with 78% of all responders maintaining their response at 12 months and 62% at 18 months. Among patients with brain metastases, the intracranial ORR was 48%. While the clinical data appears promising, InvestingPro analysis reveals that 8 analysts have recently revised their earnings expectations downward for the upcoming period.

Get access to more detailed insights and 6 additional ProTips with an InvestingPro subscription. Zidesamtinib also showed activity against tumors with the ROS1 G2032R resistance mutation, with a 54% response rate in this subset of patients. The safety profile was generally well-tolerated, with only 10% of patients requiring dose reductions and 2% discontinuing treatment due to adverse events. The most common side effects included peripheral edema (36%), constipation (17%), and increased blood CPK (16%). In preliminary data from 35 TKI-naïve patients, the ORR was 89%, with responses lasting from 1.9 to 13.9 months.

The company is also advancing neladalkib, an ALK-selective inhibitor, with enrollment in a global Phase 3 trial expected to begin in the second half of 2025. This article is based on a press release statement from Nuvalent. With a beta of 1.34 and an overall Financial Health score rated as "FAIR" by InvestingPro, investors seeking comprehensive analysis can access the detailed Pro Research Report, available exclusively to subscribers, covering this and 1,400+ other US stocks. In other recent news, Nuvalent, Inc. has announced the appointment of Christy Oliger to its Board of Directors.

Oliger, who brings extensive experience from her previous role as Senior Vice President of the Oncology Business Unit at Genentech, is expected to strengthen the board as the company prepares for potential commercialization. Meanwhile, board member Emily Conley has announced her resignation, effective at the company’s annual meeting in 2025, with no successor named yet. Additionally, Nuvalent has revealed preclinical data on its ROS1 inhibitor, zidesamtinib, which shows promise in treating ROS1-positive non-small cell lung cancer. The drug has been recognized with breakthrough therapy and orphan drug designations, and pivotal clinical data is expected in the first half of 2025. These developments are part of Nuvalent’s ongoing efforts to advance its pipeline of cancer treatments.

The company has made the necessary regulatory disclosures regarding these changes and continues to focus on innovative therapies. This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.