Nuvation Bio’s Approach to Building a Compelling Narrative

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 makes Nuvation Bio one of the most compelling biotech companies to watch right now?
David Hung: We're in an exciting position. I've tried to create this company with a little bit of a different mission: we feel that patients don't need more drugs, they need better drugs.

In fact, I think that when you have a lot of drugs that are very similar and spend a lot of marketing dollars trying to tout really nonexistent differences between them, that's not doing patients a service. Patients need drugs that are more effective and tolerable, and that's an important part of our mission.

We're trying to develop what we believe are best in class drugs. We have two molecules right now in late stage. We have a drug called Ibtrozi for ROS1-positive non-small cell lung cancer, and that drug was approved by FDA about nine months ago. We're really excited about that drug, because Ibtrozi demonstrated a 90% response rate and 50 month duration of response, which is really the highest combined response rate and duration of response ever seen for any drug in any cancer.

We think that's going to really help a lot of patients.

We have a second drug that we're developing for brain tumors that targets a mutation called IDH1, and this is a really terrible disease. Brain tumors are divided into high-grade and low-grade tumors, and there really is very little for glioma patients. In fact, there's only one drug approved for gliomas in low-grade disease, but nothing at all in high grade.

I think there's a lot of room for improvement across the entire spectrum of glioma. We have a drug called safusidenib, which we're now developing in a number of pivotal studies for both high- and low-grade glioma. What we're excited about is that we've shown a 44% response rate in low grade glioma so far in our early trials, and a progression rate at two years of only 12% and we have longer term follow up later this year.

We think that's exciting for patients, but perhaps even more unique is that in the high-grade setting, where no drug has shown responses, we've shown some pretty striking responses. We have one patient with a glioblastoma multiforme, the worst of the worst brain tumors. These are tumors that sometimes can kill patients in just months. We have one patient who has now had a complete response, which means a tumor has been gone for about three and a half years so far, and another patient with another high-grade glioma, whose tumor has now disappeared for about two years.

We have a third program at Nuvation Bio around what we call the drug-drug conjugate program (DDC), and this is a platform that differs from antibody drug conjugates (ADC), where a small molecule warhead, like a chemotherapy agent, is coupled to an antibody, and hopefully the antibody takes that small molecule more specifically to the tumor cell and allows it to kill that tumor more effectively with less toxicity.

The problem is that antibodies are very large molecules, and they often can't traverse the cell membrane, and in some cases, they can't cross the cell membrane to get to the target. In those cases, they must release their payload, and once you release that warhead, and it's floating free and not targeted, it can cause significant peripheral toxicity.

We've developed the DDC program, where we fuse two small molecules together. These can be warheads, targeting agents, or a combination of any or all of them. And we've shown that these are many, many times smaller than an ADC. Because of that, it can traverse a cell membrane much more easily.

We're going to be announcing our first program later this year, so we're excited about that. I think we're in a strong position financially. We have over $535 million in the bank, which is really on the high side of most biotech companies. We have additional cash coming in from a partnership we struck just a few months ago, so.

We're well capitalized, which allows us to do what we need to do to develop these drugs as quickly as possible and bring them to patients as quickly as we can. On top of all that, I would say my team is just extraordinary.

This is not my first rodeo. I was the founder of Medivation, where we developed what is today the world's largest prostate cancer drug, Xtandi. Since Medivation, we've all learned so much more. Even though Nuvation Bio today has many employees that were formerly at Medivation, I think the team that I've built at Nuvation Bio is by far the best team I've ever seen, or I've ever had the privilege to work with.

With our experience, cash, and pipeline, we're well positioned to make significant, meaningful contributions to patients.

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