Nuvalent Inc - Class A "1Q26: Zidesamtinib Launch Prep On Track Ahead of..."

Research evidence excerpt

Nuvalent Inc - Class A "1Q26: Zidesamtinib Launch Prep On Track Ahead of..."

Global Research

12 May 2026ab

Nuvalent Inc - Class A Equities

United States1Q26: Zidesamtinib Launch Prep On Track Ahead

of Sept 18 PDUFA; Neladalkib 2L+ ALK Biotechnology

12-month rating Buy *+ NSCLC NDA Submitted

12m price target US$138.00

Key Takeaways from 1Q EPS and Mgmt Call Back Price (11 May 2026) US$104.55

Following NUVL’s 1Q26 press release, we spoke with management. Key 1Q highlights RIC: NUVL.O BBG: NUVL US

are: 1) commercial ramp ahead of zidesamtinib potential approval in 2L+ ROS1+

NSCLC (Sept 18 PDUFA date) and 2) submission of neladalkab in TKI pre-treated ALK+ Trading data and key metrics

NSCLC. Zidesamtinib commercial buildup is well underway, with the full commercial 52-wk range US$111.99-71.00

organization (~80 commercial personnel) have been onboarded. We continue to believe Market cap. US$8.26b

zide could be off to a strong launch given the initial bolus of 500-1,000 Expanded Shares o/s 79.0m (COM)

Access Program (EAP) patients that could be transitioned to commercial product at Free float 84%

launch, a metric that remains somewhat underappreciated by the Street. Mgmt also Avg. daily volume ('000) 563

highlighted ongoing preparation for potential ex-U.S. opportunities, including progress Avg. daily value (m) US$57.6

in identifying an international strategic lead, while remaining selective on partners that

Common s/h equity (12/26E) US$1.44b

could bring incremental value vs. self-commercialization. Neladalkib’s NDA in TKI pre-

P/BV (12/26E) 5.8x

treated ALK+ NSCLC has now been submitted, with potential approval in 2027 (UBSe).

Net debt to EBITDA (12/26E) 3.0x

Enrollment in the Phase 3 ALKAZAR trial remains on track, and we continue to assume a

2H29 readout.