Couldn't Have Happened To a Nicer Team; Moving to Neutral

Research evidence excerpt

Couldn't Have Happened To a Nicer Team; Moving to Neutral

June 9, 2026

TKI-naive ALKm NSCLC; NUVL recently estimated study readout

around YE29.

●PFE recently reported long-term follow-up data for Lorbrena in

TKI-naive ALKm NSCLC and has emphasized that dose reductions

can improve CNS side effects without compromising efficacy.

This was highlighted by a physician during the ALK Positive ASCO

webinar, suggesting an intense marketing battle may away the

two companies when both are commercializing for 1L ALKm

NSCLC.

●Zidesamtinib and neladalkib were differentiated from other ROS1 and

ALK inhibitors by avoiding the CNS tox that arose from inhibiting TRK,

while still providing potent inhibition with good CNS penetration to

address brain lesions.

●NVL-330 is a brain-penetrant HER2 inhibitor in the P1 HEROEX-1 study

for HER2 altered NSCLC. The trial started in 2024; the company has not

provided any data from this trial thus far.

●The company was also planning to disclose another development

candidate by YE26, but the transaction with GSK will likely close before

that.

Our Impression:

●We see this as a good transaction for NUVL. The company had

significant traction enrolling patients in the expanded access programs

for both zidesamtinib and neladalkib, in part based on the close

relationships it had forged with patient advocacy groups such as the

ROS1ders and ALK Positive.

●Based on our conversations with those patient advocacy groups, they

valued the innovation NUVL brought to the table, but were also keen

to support development of other ROS1 and ALK targeting candidates.

●We were keen to see whether NUVL's engagement with the patient

advocacy groups would be relevant for sustaining momentum in the

commercial setting, but now that's something GSK will have to execute

on.