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Intellectia

NUVL News

Nuvalent Secures FDA Review for Second Drug Application

May 27 2026seekingalpha

FDA Accepts NDA for Neladalkib with Priority Review

May 27 2026PRnewswire

FDA Grants Priority Review for Nuvalent's Neladalkib NDA

May 27 2026Newsfilter

Nuvalent Presents Pivotal Data for Neladalkib in Advanced ALK-positive NSCLC

May 21 2026PRnewswire

Biotech Fund Sells Erasca Stake After 700% Rally

May 18 2026Yahoo Finance

Nuvalent Submits NDA for Lung Cancer Drug, Advancing Treatment Options

May 07 2026PRnewswire

Guardant Health and Nuvalent Forge Long-Term Partnership to Create Companion Diagnostics and Aid in the Commercialization of Targeted Cancer Treatments via the Guardant Infinity™ Platform

Apr 30 2026moomoo

Nuvalent Announces Clinical Trial Data Presentation

Apr 21 2026PRnewswire

NUVL Events

05/27 06:40
Nuvalent's New Drug Application Accepted by FDA for Priority Review
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.
05/07 06:40
Nuvalent Submits NDA for neladalkib
"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."

NUVL Monitor News

Nuvalent's Neladalkib NDA Receives FDA Priority Review

Jun 01 2026

Nuvalent's NDA for Zidesamtinib Accepted by FDA, Targeting 2026 Launch

Jan 12 2026

Nuvalent Hits 52-Week High on Promising Data

Nov 17 2025

NUVL Earnings Analysis

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