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Nuvation Bio Q1 2026, The IBTROZI Engine Is Real And Now They Just Bought Themselves A Second Pillar

NUVB just dropped a quarter that does not get the attention it deserves because the stock has been in the penalty box for six months. The setup is more interesting now than it was at the December high.

The Headline Numbers

IBTROZI net product revenue, 18.5 million in Q1 2026. That is the third full quarter of US sales since the June 2025 launch.

Approximately 200 new patient starts in Q1, more than half TKI-naive. Over 600 patients have started IBTROZI since launch.

Cash, cash equivalents and marketable securities, 533.7 million as of March 31.

Net income of 5.4 million, or 0.02 per basic share. Compare to a 53.2 million net loss in Q1 2025. They flipped to profitability, helped by a 58.7 million Eisai upfront, but the IBTROZI revenue line is the durable piece.

China royalty contribution from the NRDL inclusion (effective Jan 1, 2026), 1.7 million in the quarter.

What Actually Matters

The AACR update is the part that should reset how the Street thinks about this drug. Pooled TRUST-I and TRUST-II data in TKI-naive patients (n=157):

confirmed ORR of 89.8 percent

median duration of response of 49.7 months

median PFS of 46.1 months

intracranial response rate of 76.5 percent in patients with brain metastases

Median OS not yet reached. This is the longest durability dataset in the ROS1+ NSCLC space. Four years and counting on TKI-naive patients. That is the moat.

The TKI-pretreated cohort (n=113) showed 55.8 percent cORR and 16.6 month mDOR, with 98 percent of those patients enrolled following progression on entrectinib or crizotinib (a higher bar than intolerance). Median OS in pretreated, 29.8 months.

NCCN added taletrectinib as a systemic therapy option for ROS1+ NSCLC patients with brain metastases. EMA validated the MAA in March. Both expand the funnel.

The Safusidenib Move Is Underrated

Nuvation Bio acquired Japan rights to safusidenib from Daiichi Sankyo in April. They now hold full global rights to a brain-penetrant, selective mutant IDH1 inhibitor with Phase 3 SIGMA underway in IDH1-mutant astrocytoma maintenance. Pivotal data 2029. Non-pivotal grade 3 oligodendroglioma cohort data 2027.

12 of 27 patients from the Phase 2 still on treatment with median follow-up over 5 years. That is a real signal in glioma where standard-of-care fails fast.

This turns NUVB from a one-asset story (IBTROZI) into a two-pillar oncology platform with a third leg (DDC) coming year-end 2026.

May 4
at
9:09 PM
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