BioSpace

Moderna’s mRNA-based flu vaccine made headlines in February when the FDA declined to even review the application. Days later, the agency reversed course, setting a decision date for August and later scheduling an advisory committee meeting for June 18. In documents released ahead of that meeting, the FDA and Moderna seem to have reached alignment, though the agency did flag certain data gaps for advisors to review.

Biotech IPOs are off the charts—literally. This past month has seen not one but two record-setting public debuts. First there was Kailera Therapeutics, which hit the market with $625 million in April, outpacing Moderna’s 2018 IPO of $600 million. And now we have Parabilis Medicines, which last week dethroned Kailera as the largest biotech IPO of all time, with $670 million.

Meanwhile, the number of employees laid off spiked by almost 50% year-over-year in May, though that jump is mostly due to significant cuts at Takeda and BioNTech.
Genentech also made a big change last week.

Eli Lilly continued its dealmaking spree with AlzeCure, striking a licensing agreement worth up to $1 billion centering on a small-molecule asset for Alzheimer’s disease. But the bigger Lilly news in the past week was clinical results that show promise for the pharma’s $2.3 billion acquisition of Ajax Therapeutics in April.

Earlier this month, the FDA held a public session to glean feedback regarding the Commissioner’s National Priority Voucher program, in which several groups called for a temporary pause to the pilot, citing concerns about transparency and political involvement. While the future of that program hangs in the balance, two voucher holders got updates this week. First, Sanofi’s diabetes drug Tzield was greenlit for older kids and teenagers, though it’s unclear whether a voucher was associated with the approval. Meanwhile, Disc Medicine’s rejected rare disease drug bitopertin appears to be back on track, with the biotech announcing last week that the FDA will allow its current Phase 3 trial to support another regulatory filing.

In this episode of Denatured, as part of our series on the European life sciences investment ecosystem, you'll hear from Hannah Franklin, associate at Biovance Capital and Pablo Gabriel Cironi Lopez, director of life science investment at Caixa Capital Risc. We examine the rise of Southern Europe’s biotech ecosystem—from Portugal’s efforts to turn strong science into startups to Spain’s growing depth of capital and talent—and what it will take for the region to compete globally.

Host

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

Guests

Hannah Franklin, Associate, Biovance Capital

Pablo Gabriel Cironi Lopez, Director, Life Science Investment, Caixa Capital Risc

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

Everything came up roses for Eli Lilly at the American Diabetes Association, as the pharma boasted positive results for its new pill Foundayo and next-gen asset retatrutide—not just for weight loss but also for other indications.

Obesity rival Novo Nordisk, meanwhile, held a dinner, during which executives may have convinced analysts that the company is turning a corner after a rough couple of years.

Also check out ADA updates from Roche and partner Zealand Pharma, Boehringer Ingleheim, Pfizer (touting results from its Metsera buy), AstraZeneca, Kailera Therapeutics and more.

Outside of ADA, the biggest news of the past week came on Tuesday with GSK striking the biggest traditional pharma/biotech M&A of the year so far with its $10.6 billion acquisition of oncology focused Nuvalent Bio. And on Monday, J&J notched a smaller deal, buying out Firefly Bio for $1B. These deals add to continued uptick in M&A seen in biopharma this year, with much of that momentum being driven by Eli Lilly and its GLP-1 cash.

At an FDA listening meeting last week on the Commissioner’s National Priority Voucher program, the agency heard multiple calls to pause it. Confusion also still persists around all of the new rare disease pathways, including the new plausible mechanism framework.

In this episode of Denatured, you'll be hearing from Daniel Gil, CEO of Pelage Pharmaceuticals and Francisco Ramírez-Valle, senior vice president of immunology discovery at Eli Lilly. We dive into the long-overlooked hair loss space, exploring why true innovation has lagged, how a regenerative approach aims to reactivate dormant follicles and what early proof-of-concept means for patients.

Host

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

Guests
Daniel Gil, CEO, Pelage Pharmaceuticals
Francisco Ramírez-Valle, Senior Vice President, Immunology Discovery, Eli Lilly

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

At the American Society of Clinical Oncology (ASCO) annual meeting in Chicago this past weekend, packed plenary sessions from Revolution Medicines and Summit Therapeutics’ Chinese partner Akeso stole the show. For RevMed, analysts anticipate a potential approval in pancreatic cancer as early as this year, while Summit still has a tough road ahead showing that the survival benefit seen in Akeso’s clinical trial in China will hold up in a global population.
Immuneering, BMS/BioNTech, Merck, Pfizer and many more also scored oncology wins at the annual meeting, as did Moderna, with “encouraging” 5-year survival for its mRNA-based personalized melanoma vaccine.

Outside of ASCO, the past week saw Pfizer strike an unusual pact with China’s Innovent Biologics as it seeks to bolster its oncology pipeline. Reminiscent of another recent deal from BMS and Hengrui Pharma, it could signal a more collaborative approach to working with Chinese companies. We’ll also cover the latest deals from Eli Lilly, which continues to rack up partners with its GLP-1 windfall.

Finally, learn about how BrainStorm is planning another FDA bid for its experimental ALS therapy NurOwn with former regulator Peter Pitts now on the board, and check out a preview of the 2026 American Diabetes Association, or ADA, which kicks off this weekend in New Orleans.