Nuvalent: Neladalkib Priority Review Sets Stage for Two Potential Commercial Launches in 2026; Reiterate OW

Research evidence excerpt

Nuvalent: Neladalkib Priority Review Sets Stage for Two Potential Commercial Launches in 2026; Reiterate OW

Equity Research

U.S. Small & Mid Cap Biotechnology

27 May 2026

Nuvalent

Neladalkib Priority Review Sets

Stage for Two Potential First Look

NUVL OVERWEIGHTCommercial Launches in 2026;

U.S. Small & Mid Cap POSITIVE BiotechnologyReiterate OW Price Target USD 152.00

Price (26-May-26) USD 104.95

FDA has granted a priority review to neladalkib in patients Potential Upside/Downside +44.8%

with previously treated ALK+ NSCLC with a November 27 Source: Bloomberg, Barclays Research

PDUFA, following September 18 PDUFA for zidesamtinib in

ROS1 NSCLC. Etzer Darout, PhD, MBA

+1 212 526 6940

etzer.darout@barclays.comNUVL announced via press release the FDA acceptance of the New Drug Application (NDA) for

BCI, US

neladalkib (ALK TKI) in ALK+ NSCLC patients previously treated with a TKI (2L+), with a

prescription user fee action (PDUFA) date set for November 27. The filing was based on the Lukas Shumway, PhD

Phase 1/2 ALKOVE-1 trial that demonstrated a best-in-class profile for neladalkib, in our view. +1 212 526 7293

lukas.shumway@barclays.comNeladalkib had received Breakthrough Therapy Designation for use in patients previously

treated with 2 or more TKI, so the expanded label with priority review speaks to the quality of

the data. Jordan Becker, PhD

+1 212 526 3960

Two PDUFA dates in 2H are important steps as NUVL shifts to a commercial company jordan.becker1@barclays.com

BCI, USNeladalkib's November 27 PDUFA date, which falls on Black Friday, comes after the scheduled

September 18 PDUFA for zidesamtinib in patients with TKI pre-treated ROS1 NSCLC. The Gustave Diep, MD

company is advancing commercial preparations ahead of the potential launches. NUVL intends +1 212 526 0347