Nuvalent Details FDA Timelines for ROS1, ALK Drugs as $1.4B Cash Fuels Global Launch Plans

11 hours ago 1

MarketBeat

Sat, February 14, 2026 astatine 11:03 AM CST 8 min read

Nuvalent logo

Nuvalent has an FDA PDUFA day of Sept. 18 for zidesamtinib successful TKI‑pretreated ROS1 NSCLC, plans to taxable frontline (TKI‑naïve) information successful the second fractional of the year to question a line‑agnostic label, and expects to record an NDA for NVL‑655 (ALK) successful the first fractional of the year.
The institution ended the twelvemonth with astir $1.4 billion successful cash, which absorption says provides operating runway into 2029 and supports plans to physique retired planetary commercialized capabilities and "go it alone" ex‑U.S.
Management positions zidesamtinib arsenic differentiated by enactment against ROS1 fusions and absorption mutations, CNS penetration and selectivity for tolerability, portion NVL‑655 is reported to amusement durable responses (about 60+% inactive successful effect astatine 1.5 years successful lorlatinib‑naïve patients) with manageable transaminase elevations addressed via aboriginal monitoring and dose management.
Interested successful Nuvalent, Inc.? Here are 5 stocks we similar better.

Nuvalent (NASDAQ:NUVL) executives highlighted ongoing regulatory milestones for the company’s pb oncology programs and discussed commercialization strategy, pipeline plans, and fiscal positioning during a league fireside chat.

Chief Executive Officer Jim Porter described Nuvalent arsenic a institution built astir heavy chemistry and structure-based cause plan expertise, with an accent connected clinically validated kinase targets. Porter said the institution works intimately with physicians to recognize limitations of existing therapies—such arsenic people coverage, cardinal tense strategy (CNS) activity, and tolerability—and past applies “innovative chemistry” to code those gaps.

→ Is Albemarle Setting Up for a Lithium-Fueled Rebound?

Chief Financial Officer Alex Balcom outlined guidance and cardinal upcoming catalysts crossed the portfolio:

ROS1: The FDA accepted Nuvalent’s NDA for zidesamtinib successful TKI-pretreated ROS1-positive non-small compartment lung crab (NSCLC), with a PDUFA day of Sept. 18. Balcom said commercialized readiness efforts are underway to enactment a imaginable U.S. motorboat aboriginal this year. The institution besides plans to taxable information to enactment a imaginable indication enlargement successful TKI-naïve ROS1 successful the 2nd fractional of the year.
ALK: Nuvalent completed a pre-NDA gathering with the FDA for NVL-655 successful TKI-pretreated ALK-positive NSCLC and is connected way to submit an NDA successful the archetypal fractional of the year. The institution is besides progressing the signifier 3 ALCAZAR survey successful TKI-naïve ALK.
HER2: Nuvalent continues advancing a signifier 1b/2 survey successful HER2-altered NSCLC.
Additional pipeline: Management reiterated guidance to disclose a new improvement campaigner by year-end.