GSK’s first lung cancer approval, a new IPO path and more

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0:30Today is Friday, July 24th, and you're listening to The Topline, brought to you by Fierce Pharma and Fierce Biotech. I'm your host, Ayla Ellison. I'm recording this from Chicago, where the air quality is finally better.

1:01And I say finally because for several days, smoke from wildfires burning hundreds of miles away in Canada had settled over the city. The winds carried it south, creating a thick haze and pushing the air quality into very unhealthy and at times hazardous territory. Going outside felt a little like walking into the smoke from a campfire you could not actually see. And the skyline disappeared, and the air had that dry, acrid smell that catches in the back of your throat.

1:36And all day, every weather app seemed to be issuing some new warning. But today, the sky is clearer, the air is better, Chicago looks like Chicago again. So, that is one piece of good news. We are doing something a little different on The Topline this week. Usually you hear from me or one of our reporters talking with someone from the biotech or pharmaceutical industry, or you hear members of our editorial team digging into one big story. This week, I wanted to step back and talk through a few of the stories that stood out to us.

2:12These are stories that, on the surface, are about very different things. Animal testing, the authority of the FDA, a major cancer drug approval, and an unusual biotech IPO strategy. But, they are also connected by a larger question. How is the system that develops, finances, and regulates new medicines changing? Before we dig into all of that, I want to share a quick update from our newsroom. A few weeks ago, Marissa Russo joined Fierce Biotech as a staff writer.

2:47Marissa has a PhD in neuroscience. And, many of you have probably already started seeing her byline on the site. You will also hear from her on future episodes of The Topline. It is genuinely an exciting time for our editorial team. We are growing. We are adding new roles. And, we're building a team that can take on some of the most ambitious and interesting reporting Fierce Pharma and Fierce Biotech have ever done. And, I think that matters, especially right now.

3:20There is an enormous amount of information coming at all of us every day. Some of it is useful. Some of it is thoughtful. And, some of it is what people have started calling AI slop. Content created quickly, cheaply, and at enormous scale, without much care for whether it is accurate, original, or even particularly helpful to the person reading it. That is not what we are here to do. We are humans writing for humans.

3:51We are writing for the people working across the biopharma industry, the people studying it, and the people following it closely. Our reporters bring expertise, judgment, curiosity, and skepticism to their work. They talk to people. They read the filings. They examine the data. They ask follow-up questions. And, they try to tell you not just what happened, but why it matters and what you should be watching next. That means continuing to bring readers the daily news they need, but it also means going deeper, asking harder questions, and looking closely at where the industry is heading.

4:30Let's get into it.

4:42The first story I'm going to dig into today begins in Washington. The House passed legislation directing the FDA to update its rules around animal testing. Now, this is the kind of headline that can sound very sweeping. You might read it and think Congress just voted to end animal testing and drug development. And that is not what happened. What the bill would do is push the FDA to modernize its regulations so they better account for newer testing methods,

5:12including computational models, organoids, and other approaches that could, in some cases, reduce the need for animal studies. And the phrase, in some cases, is important here. That is not a moment where one system simply disappears and another takes its place. The science is more complicated than that. Some alternative methods are already showing real promise. Others still need to be validated. And drug makers need much clearer guidance from the FDA about what the agency will accept.

5:45And that is really the heart of the story. The technology is advancing. The policy is trying to catch up. And now the question is whether regulators can create a framework that allows companies to use these newer tools without lowering the evidentiary bar for safety. The bill still has to move through the Senate. And even if it becomes law, the bigger changes would come later as the FDA translates that direction into actual regulations and guidance. So this is not the end of animal testing.

6:16It may be the beginning of a much more serious shift in how drug developers think about preclinical research. You can read the full story we published this week on Fierce Biotech from Will Maddox. And the link is in the show notes. The third story this week takes us to GSK. The company has secured the first lung cancer approval in its history with Jadetro, a drug it acquired through its purchase of Nuvalent. And the timing is almost unusually neat.

6:49GSK completed the acquisition, and then about a week later, the FDA approved the drug ahead of its expected decision date. That is the version of a biotech acquisition that pharmaceutical companies probably dream about. You spend billions of dollars buying a company, and almost immediately, one of those assets becomes an improved product. Of course, as we all know, it is never really that simple. The drug still has to launch, doctors have to use it, GSK has to persuade the market that it belongs in the treatment landscape,

7:23and the company has to show that there is more value in the rest of Nuvalent's pipeline. But the approval does give GSK something tangible and very quickly. It also helps explain why large pharmaceutical companies are willing to pay so much for late-stage biotech assets. You can find full coverage of this story on Fierce Pharma and the link to the stories in our show notes. And finally, there is Axiom Biosciences. Marissa Russo reported this week on the San Diego Biotech's unusual plan to begin its public market journey in Hong Kong and later pursue a co-listing on NASDAQ.

8:01The company says this would be a first for U.S. biotech. And the timing is interesting because Axiom is pursuing this unconventional route during what has otherwise been a pretty remarkably active year for biotech IPOs. After several very difficult years, the market has shown signs of life in 2026. More than 15 biopharma companies went public in the first half of the year, and that's already more than the total for all of 2025.

8:34So we have seen a particularly busy run of new offerings, especially over the past month. And these have not been small, cautious debuts. Two offerings this year reportedly set records as the largest biotech IPOs ever. So companies are raising hundreds of millions of dollars at a time, and the size of the typical offerings has increased considerably. I would be remiss not to recognize that. The IPO market is not fully open to every biotech with a pipeline and a pitch deck, but it is meaningfully healthier than it has been in years.

9:11So Axiom's decision is not simply a response to a closed U.S. market. Instead, the company appears to see a different opportunity and wants to use Hong Kong as its first entry into the public markets and then pursue a NASDAQ listing later. For years, NASDAQ has been the obvious destination for U.S. biotechs looking to go public. And despite Axiom's strategy, it remains the center of gravity for the industry. But Axiom is asking whether there is another way in. So the company believes a Hong Kong listing could give it access to investors with a particular interest in cell and gene therapy, as well as closer proximity to parts of its business and the broader Asian biotech market.

9:53Will the strategy work? We don't know yet. Will other U.S. biotechs follow? That is also unclear. But in a year when the traditional IPO market is reopening, Axiom is choosing to test an entirely different path. And that makes it a company worth watching. So those are a few of the stories that stood out to us this week. They are very different stories that show us how the rules are changing, the science is advancing, money is flowing through new and old channels, and companies are trying to understand where they fit in all of it.

10:27And that is what our reporters will continue watching. We'll be back next week with another episode of The Top Line.

10:37That's it for The Top Line. I'm your host, Ayla Ellison. You can find out more about this topic in our show notes at fiercebiotech.com. Look for podcasts. And that's the bottom line from The Top Line. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison.

11:07I'm your host, Ayla Ellison. I'm your host, Ayla Ellison. I'm your host, Ayla Ellison.