In this episode of Denatured, you'll be hearing from Yaniv Sneor, founder of the Mid Atlantic Bio Angels and Alex Pederson, an investor at Mid Atlantic Bio Angels and partner at Alloy Bio Consulting. We discuss why a life sciences-only angel group matters, how they evaluate opportunities, and the importance of strong teams, capital efficiency and a realistic path to exit.

Host

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

Guests

Yaniv Sneor, Founder, Mid Atlantic Bio Angels

Alex Pederson, Investor, Mid Atlantic Bio Angels & Partner, Alloy Bio Consulting

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

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.

Listen to BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel discuss 2026 job market performance so far, sharing the latest BioSpace data.

They touch on positive signs they saw between January and March, including a reduced number of layoffs, and what this year might have in store for those seeking employment in 2026. 

In this episode of Denatured, you'll listen to Jason Jones, head of global business development at Cellular Origins and Alexander Seyf, founder & CEO of  Autolomous. They discuss how cell and gene therapy manufacturing is facing growing pressure to scale more quickly and efficiently, driving developers and manufacturers toward automation, digitization, robotics and broader collaboration across the ecosystem.

Host

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

Guests

Jason Jones, Head of Global Business Development, Cellular Origins

Alexander Seyf, Founder & CEO, Autolomous

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

Eli Lilly won FDA approval last week for orforglipron—now Foundayo— officially launching what promises to be a heated battle between Lilly and chief rival Novo Nordisk.

Elsewhere, the M&A space keeps chugging along, with Gilead Sciences gobbling up partner Tubulis for up to $5 billion and Neurocrine Biosciences nabbing Soleno Therapeutics for $2.9 billion. The industry will be on high alert for more deals, as analysts say Amgen, AbbVie and Bristol Myers Squibb all have more money to spend.

At the White House, President Donald Trump levied his long-promised tariffs on the pharma industry, but myriad carveouts mean many companies will be safe from the 100% tax, at least for now. And Trump’s Most Favored National pricing scheme is endangering access to new drugs in Europe as companies forgo launches  in countries that could pull down U.S. prices.

Meanwhile, the Trump administration came out with its proposed 2027 budget on Friday, with several requests for the FDA and Department of Health and Human Services overall. In line with the administration’s efforts to accelerate development of therapies for rare diseases, the FDA proposes is seeking to permanently authorize the rare pediatric disease priority review voucher program. Other proposals include a new clinical trial notification pathway and expanded authority to regulate post approval manufacturing changes. These requests come during a time when the agency is, as always, walking the precarious tightrope of rigor vs. unmet need—with rare disease leaders calling for clarity around topics like externally controlled trials.

In this episode of Denatured, you'll listen to Dr. Marc Hedrick, President and CEO of Plus Therapeutics and Dr. Phil Kantoff, CEO & Co-founder of Convergent Therapeutics. They discuss breakthroughs like alpha-emitting isotopes, supply chain solutions and why radiotherapeutics is biotech's next big frontier.

Host

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

Guests

Marc Hedrick, President & CEO, Plus Therapeutics

Philip Kantoff, Co-founder & CEO, Convergent Therapeutics

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