Nuvalent submits NDA for neladalkib in ALK+ lung cancer, reports Q1 loss of $109.3M

Filed May 7, 2026 · Period ending May 7, 2026 · ~1 min read

Key Changes

• high

  Submitted New Drug Application to FDA for neladalkib in ALK-positive non-small cell lung cancer patients previously treated with tyrosine kinase inhibitors, based on ALKOVE-1 Phase 1/2 trial data showing encouraging activity and intracranial responses.

  Exhibit 99.1 verify on EDGAR →
• high

  Reported Q1 2026 net loss of $109.3M with R&D expenses of $83.6M and G&A expenses of $35.8M. Cash position of $1.3B expected to fund operations into 2029.

  Exhibit 99.1 verify on EDGAR →
• medium

  Plans to submit data to FDA in second half of 2026 to support label expansion of zidesamtinib for treatment-naïve ROS1-positive NSCLC patients, broadening potential patient population.

  Exhibit 99.1 verify on EDGAR →