6. Nuvation Bio Inc. (NYSE:NUVB)
On May 6, 2026, Nuvation Bio Inc. (NYSE:NUVB) announced that the U.S. FDA accepted a supplemental New Drug Application containing updated data for IBTROZI in both TKI-naive and TKI-pretreated advanced ROS1-positive non-small cell lung cancer. The FDA assigned a target action date of January 4, 2027.
On May 4, 2026, Nuvation Bio Inc. (NYSE:NUVB) reported Q1 EPS of 1c, versus the consensus estimate of 5c. Revenue totaled $83.23M, versus the consensus estimate of $62.34M. Founder, President, and CEO David Hung said the company continues to see positive launch trends for IBTROZI as adoption expands across additional lines of therapy in advanced ROS1-positive NSCLC. Hung also highlighted updated long-term follow-up data presented at AACR showing durability exceeding four years in TKI-naive patients, which management believes further supports physician confidence in the treatment. Hung added that Nuvation recently secured exclusive global development and commercialization rights to safusidenib and plans to advance the Phase 3 SIGMA study in high-risk IDH1-mutant glioma. The company also expects to provide updates later this year on its drug-drug conjugate platform.
Last month, Nuvation Bio Inc. (NYSE:NUVB) announced updated pooled long-term follow-up data from the pivotal TRUST-I and TRUST-II trials evaluating IBTROZI, also known as taletrectinib, in advanced ROS1-positive NSCLC patients. The data were presented at the AACR Annual Meeting 2026 and included both oral and poster presentations. In TKI-naive patients, pooled data showed a confirmed objective response rate of 89.8%, median duration of response of 49.7 months, and median progression-free survival of 46.1 months. The company also reported an intracranial response rate of 76.5% among patients with brain metastases.
For TKI-pretreated patients, pooled results showed a confirmed objective response rate of 55.8%, a median duration of response of 16.6 months, a median progression-free survival of 9.7 months, and an intracranial response rate of 65.6% in patients with brain metastases. The company said pooled safety data remained consistent with the current prescribing profile, with treatment discontinuation rates due to treatment-emergent adverse events remaining low at 8.5%. No new safety signals were identified during longer-term follow-up.
Nuvation Bio Inc. (NYSE:NUVB) is a clinical-stage biopharmaceutical company focused on developing cancer therapies.
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