The Status of Nuvation Bio’s Pipeline

Pharmaceutical Executive recently spoke with Nuvation Bio’s president, CEO, and founder David Hung. The growing biotech is focused on oncology treatments is building a strong reputation in the space following a string of regulatory wins.

In June of 2025, Nuvation announced FDA’s approval of Ibtrozi, a next-generation oral ROS1 tyrosine kinase inhibitor (TKI), for the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). More recently, the biotech announced that UK’s drug regulatory body accepted the marketing application for taletrectinib.¹

During his conversation with Pharmaceutical Executive, Hung discussed the company’s relationship with the market, it’s current pipeline and upcoming goals, along with his approach to leadership and building a team that’s able to produce strong results.

Pharmaceutical Executive: What is the status of Nuvation’s pipeline?
David Hung: Ibtrozi is our lung cancer drug. We're in our third quarter of launch right now, so that's been very successful, and we continue to develop that drug in earlier stages of lung cancer.

We're doing an adjuvant study in ROS1 patients, and we're actually the only ROS1 tyrosine kinase inhibitor being developed in the adjuvant setting, which speaks not only to the efficacy of the drug that we've observed so far, but also its tolerability. To give a drug that early in the treatment course, the drug must be really tolerable, and we've had an excellent tolerability profile so far with Ibtrozi, so we're developing that upstream.

We're also trying to get safusidenib through a number of pivotal studies. Brain tumors are divided into high- and low-grade tumors. Right now, there's only one drug approved in gliomas in the low grade setting, and our drug has shown significant responses in both the low- and high-grade setting. In fact, we have some data showing a number of patients with extremely aggressive high-grade glioma with some really promising responses.

We've had one patient with a glioblastoma, the worst of the worst, an aggressive tumor, and that patient has been in a complete response, which is, which means the tumor has been gone for about three and a half years.

We have another high-grade glioma where that tumor has actually now been gone for about two years. We believe that those types of high-grade responses really compel the development of the drug in a high-grade indication, but we're also developing in low-grade, because we've shown some very promising low grade responses. We just announced in a recent publication that a 44% response rate in the low-grade setting, and as of our most recent five year follow up, almost half of those patients are still on Safusidenib.

We think that's a testament to both its efficacy and tolerability.

Source

1. Can Nuvation Bio Inc (NUVB) Stock Soar 150% From Current Level. Yahoo Finance. July 13, 2026. https://finance.yahoo.com/markets/stocks/articles/nuvation-bio-inc-nuvb-stock-092851856.html