BioSpace

First quarter earnings are coming in at a rapid pace, with Sanofi and Novartis defending patents for Dupixent and Lutathera, respectively, and Sanofi welcoming Belén Garijo as CEO. Still to come this week are Eli Lilly, AstraZeneca, Regeneron and many more.

Lilly will undoubtedly discuss its recent streak of dealmaking, including a $2.25 billion pact with AI biotech Profluent, plus buyouts of Ajax Therapeutics for up to $2.3 billion and Kelonia Therapeutics for up to $7 billion.

Meanwhile, Regeneron earned FDA approval for the highly anticipated gene therapy that will now be known as Otarmeni. The same day the approval came down, Regeneron also struck a deal with the White House.

Over at the FDA, the agency has requested—again—that Amgen remove the autoimmune therapy Tavneos from the market. Separately, the FDA has issued three Commissioner’s National Priority Vouchers to unnamed psychedelic drug developers.

Finally, who will replace Vinay Prasad, the head of the agency’s Center for Biologics Evaluation and Research (CBER), who departs at the end of April after one year as the biologics chief?

In this episode of Denatured, you'll be hearing from Dr. Sarah Howell, CEO at Arecor Therapeutics and Dr. Wendy S. Lane, clinical endocrinologist and diabetologist. We examine how increasingly connected and tailored diabetes technologies are reframing the field’s central opportunity around minimizing the day-to-day demands of managing the condition.

After entering the CAR T arena in February, Eli Lilly jumped onto the in vivo bandwagon, penning a deal worth up to $7 billion for Kelonia Therapeutics and its gene therapy delivery tech iGPS. Meanwhile, Belgium-based UCB scooped up Neurona Therapeutics for $650 million upfront and up to $500 million in milestone payments.

On the policy front, President Donald Trump signed a new executive order that analysts believe could help psychedelic therapies become the “key next wave” of mental health therapies. The EO instructs the FDA to grant Commissioner’s National Priority Vouchers (CNPVs) to “appropriate psychedelic drugs” that have secured breakthrough designation, a move that could cut review timelines from 10-12 months to 1-2 months for these therapies.

Elsewhere, the FDA’s rebuff of Replimune’s advanced melanoma drug RP1 continues to make waves, with CEO Sushil Patel slamming the agency for failing to exercise flexibility, while experts have lamented the regulator’s inconsistency.

On the business side, Kailera managed to break biopharma’s all-time IPO record, raising $625 million last week. The new all-time high prompted BioSpace to take a look back at other historic IPOs in the industry, with mRNA heavyweight Moderna’s 2018 debut falling into second place.

BioSpace also spoke with Denali Therapeutics CEO Ryan Watts about the company’s long-awaited FDA approval for Hunter syndrome drug Avlayah. “It was the greatest professional moment of my life,” Watts said during an event put on by Utah’s biotech community hub, BioHive.

In this episode of Denatured, you'll be hearing from Edoardo Negroni, co-founder & managing partner at AurorA-TT and Naveed Siddiqi, senior partner, Venture Investments at Novo Holdings. We debate whether Europe’s world-class science can be matched by a truly integrated venture ecosystem—and what it would take, in practice, to get there.

Host

Jennifer C. Smith-Parker, Director of Insights, BioSpace

Guests

Edoardo Negroni, Co-Founder & Managing Partner, AurorA-TT
Naveed Siddiqi, Senior Partner, Venture Investments, Novo Holdings

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Johnson & Johnson kicked off Q1 earnings season with a “modest” beat, raking in $24.1 billion in sales as it targets $100 billion in revenue in 2026. J&J, as always, is the first to report results from a first quarter that has seen a wave of deals across biopharma; this M&A rush is expected to headline investor calls as more companies, including Novo Nordisk and Eli Lilly, report their Q1 results in the coming days. Meanwhile, IPOs are also on an upswing, with Kailera Therapeutics eyeing a raise that could reach as high as $533 million.
 
On the regulatory front, Replimune failed for a second time to secure approval for its advanced melanoma therapy RP1, as the FDA held its ground, requesting a Phase 3 trial that CEO Sushil Patel indicated in a statement last week “will not be viable.” This comes as analysts say the FDA’s new policy of making complete response letters public is increasing accountability.
 
Along with transparency, another key theme for the FDA this year has been its promise to be flexible, particularly when it comes to therapies for rare diseases. While BioSpace has closely covered the myriad cases where the agency has appeared to reverse its guidance to sponsors, two companies—Rezolute & CERo Therapeutics—lauded recent interactions with the FDA, calling reviewers “collaborative” and “curious.”
 
Finally, heading into the American Association for Cancer Research’s annual meeting this weekend, several companies—including Revolution Medicines, Allogene and IDEAYA Biosciences and Servier—got a jump start, reporting positive data in a number of indications. Revolution’s report was especially seminal. The company’s therapy, daraxonrasib, doubled survival in pancreatic cancer—a disease that has just a 13% survival rate five years after diagnosis.