NUVL News & Events

Nuvalent announced the acceptance of its new drug application, or NDA, for neladalkib for filing by the FDA. The FDA has granted the application priority review and assigned a Prescription Drug User Fee Act target action date of November 27. The company further announced that Georg Pirmin Meyer has joined the company as chief international officer, or CIO. In this newly created role, Meyer will be responsible for spearheading Nuvalent's international expansion strategy and establishing the company's presence in key markets outside the U.S. Most recently, he served as senior VP and general manager, international at Blueprint Medicines.

"The forward momentum continues at Nuvalent, with both of our parallel-lead programs advancing toward key US regulatory milestones and the opportunity to bring our first new medicine to patients this year," said James Porter, Chief Executive Officer of Nuvalent. "We recently submitted our NDA for neladalkib in TKI pre-treated ALK-positive NSCLC and are continuing to build our commercial infrastructure in preparation for a potential US launch of zidesamtinib in TKI pre-treated ROS1-positive NSCLC, if approved."