While policy shifts and leadership shakeups at institutions like the Food and Drug Administration dominated headlines in 2025, drugmakers would do well to sift through the noise and remain focused on what they do best—developing novel medicines to address unmet needs.
That was the consensus among leaders from three biopharma companies—Perspective Therapeutics, Lineage Cell Therapeutics and Catalyst Pharmaceuticals—who sat down with Fierce late last year to weigh in on the trends that defined 2025, plus their outlooks heading into the next 12 months.
Overall, the leaders espoused optimism around the thawing of investment dollars flowing to biotechs, as well as the strength of the fundamental principles undergirding the industry, despite whatever curveballs the current administration or its new-look FDA might throw.
The CEOs—Thijs Spoor from Perspective, Brian Culley at Lineage and Catalyst’s Rich Daly—also rallied around the importance of companies honing their manufacturing chops, regardless of the tariff environment, and touched on the continued impact of direct-to-patient drug sales channels in a wide-ranging discussion that will air in full on Fierce’s podcast, The Top Line, this Friday.
Catalyst is a commercial-stage rare disease company focused on central nervous system (CNS) indications. Lineage is a clinical-stage biotech developing allogeneic, or off-the-shelf, cell therapies for neurological and ophthalmic conditions. And Perspective is a publicly-traded radiopharmaceutical company with three programs in the clinic.
VC dollar recovery
Chief among the factors driving a sense of optimism among the biopharma leaders was the unfreezing of the biotech investing environment, which started to show in the second half of 2025 and looks poised to continue at a more healthy gait in the new year.
The investment environment heading into 2026 is “night and day” compared to the beginning of 2025, Spoor said during the roundtable discussion.
“Thinking about that sort of drift coming out of the [2025] J.P. Morgan conference, the investors were pretty despondent,” he admitted. “The thought really was, ‘how many more years can we take being down?’”
Investment dollars remained icy through much of the first half of 2025, Spoor added.
“Even through June [2025], we had major healthcare specialists, truly the smartest guys in the room, saying their funds were down 15%, 30%,” he said. “And then coming out of 2025, a lot of these funds are now saying they’re up 60%, 70%.”
Meanwhile, it’s not just about the money itself but the “money system,” Spoor explained. When investors are up, they “feel more comfortable with money to deploy,” he added. Couple that with fresh cash coming into the system through M&A, and investors are starting to feel that the situation has largely reverted “back to normal,” he said.
Rich Daly at Catalyst concurred that a “thawing” has occurred.
“It’s pretty interesting to see some of the generalists come back, as Thijs said,” he noted. “They exited pretty quickly because of some of the, what we would call ‘choppy waters’ in this market. And now, to see them come back in, see the markets unfreeze quite a bit—and again, the M&A that he referred to—frees up a lot of cash that needs to be deployed.”
That recovery appears here to stay, Lineage’s Culley predicted.
“I think we’ve seen a couple of false starts,” he said during the roundtable. “We started using the phrase cautiously optimistic, but I think now we can actually be authentically optimistic.”
“Things can’t stay out of favor forever, or at least that’s the conventional wisdom,” Culley continued. “So, I do think there’s good reason to finally let yourself have some of that optimism about the future.”
Crunching the production numbers
One element of the biopharma business often neglected by investors is production, but prioritizing in-house manufacturing capabilities confers many benefits for drugmakers, even beyond the threat of pharmaceutical import tariffs, the leaders pointed out.
With regards to the push for domestic drug manufacturing that resurfaced in the U.S. last year, the reality of achieving end-to-end production at home “really depends on what you’re manufacturing,” Culley noted.
While considering the impact of tariffs and other potential policy factors is always prudent, “if you’re developing a very complex biologic, like a whole cell, the complexity is challenging, and a lot of smaller companies don’t have the ability to manufacture these complicated molecules,” Culley acknowledged.
That in turn prompts companies to rely on contract manufacturers, who might not always have the innovative production processes needed to crank out advanced therapeutics.
Lineage has elected to in-house its production “for that very reason,” said Culley, who added that, “as a general rule, whether you’re talking antibodies, or small molecules or the very complex cell manufacturing, I think if you’re losing sight or you’re not putting attention into the early stages of your manufacturing—and have a clear line-of-sight all the way through—you’re doing yourself a great disservice.”
The challenge for smaller or earlier-stage companies, to hear Culley tell it, is that “you’re not often rewarded by investors for that work, but it’s absolutely necessary.”
Another key data point for companies weighing how to go commercial or scale their business came in the trove of Complete Response Letters the FDA released last year, many of which were directly tied to production shortfalls, Spoor pointed out during the conversation.
“That was a big wake-up call to a lot of our peers to say, ‘Wow, you know you really need to get this right,’” he said.
“Part of the challenge though comes into your experience and how many manufacturing campaigns you run,” he continued. For companies like Perspective operating in the radiopharmaceutical space, manufacturing is part and parcel to the development process. But emphasizing production early is a trickier proposition for companies working with other modalities.
“I think it’s always easy, and it feels like a fast way, to use a CDMO,” he explained. “But fundamentally, I think we’re all going to feel a lot more comfortable if we get the in-house things to where we can—or a hybrid model,” he added.
Daly echoed the point that “CMC is the number one reason why filed drugs get dinged,” stressing that a developer has also “got to be a master at manufacturing.”
Meanwhile, as details around tariffs and other policy shifts in the U.S. remain murky, investing in localized manufacturing remains a solid proposition, both for Catalyst and other drugmakers, Daly stressed. “Gaining as much control as possible in the long run is the right call,” he said.
Commercial shifts and a word of advice
The leaders also weighed in on the direct-to-patient drug sales that proliferated in 2025.
“Companies are going to continue to look for ways to demonstrate lower prices that don’t have to go through a middleman,” Daly explained. “You see it in every industry over time, and because of the complexity of our industry, it’s just taken a lot longer, and the incentives are completely misaligned.”
But while Daly views the advent of DTP sales as expected, he noted that he remains “skeptical” that the practice is “actually going to result in lower costs for patients.”
Lineage’s Cully said he shared Daly’s skepticism but added that he’s also “encouraged by bold attempts,” citing the examples of telehealth outfits like Hims aiming to approach drug sales—and high costs for patients—in a new way.
As for what the leaders are looking forward to in the new year, Spoor predicted that 2026 could be a banner year for radiopharmaceuticals. While the commercial stage has been set for the class and a proliferation of new radiopharmaceutical companies has taken place, many members of that freshman class have yet to produce clinical data. That could change this year, Spoor reckons.
“I think all the animal data has been terrific and very supportive,” he said, “but 2026 will be a great year to start to see these turn into real-world, patient-driven safety [and] efficacy profiles across a whole range of isotopes and targets.”
Culley, for his part, expressed optimism about the burgeoning cell therapy “revolution going on outside of oncology.”
He highlighted Vertex’s Type 1 diabetes candidate and Bayer’s Parkinson’s disease program. Over at his company Lineage, “we’ve got data in dry AMD with GA that appears to be doing the same thing, and three other companies have now shown similar results,” Culley added.
In terms of how companies should remain focused on their missions amid a turbulent policy environment in the U.S. and abroad, “it comes down back to the basics, which is can you develop a safe and effective medicine,” Spoor noted toward the end of the dialogue.
“Despite all the swings or things that may be happening with the new administration or a new leadership at [the] FDA, at its core, safe and effective medicines will win out,” he emphasized.
Culley concurred, adding that “policy changes a lot faster than the development cycle of a new product,” which he admitted makes it “difficult to be responsive.”
Daly also espoused the benefit of internal discipline, even as the external environment presents potential hurdles or roadblocks.
“From an external standpoint, do you understand what’s going on at [the] FDA and legislation? Do you understand what the competition looks like out there?” Daly said. “And from an internal structure, do you have the financial discipline?”
“Having worked in a number of startups,” he continued, “it can be really challenging, but taking measured risk is really the best advice, I think you can give to anybody, and being very, very thoughtful about where you invest your cash.”