# Q1 earnings take off, Lilly strikes deals, Regeneron notches historic approval, FDA raises questions

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Text version: https://stenobird.com/podcast/biospace-6696251/q1-earnings-take-off-lilly-strikes-deals-regeneron-notches-historic-approval-fda-raises-questions.md
Podcast: [BioSpace](https://stenobird.com/podcast/biospace-6696251)
Published: 2026-04-29T07:00:00+00:00
Episode link: https://api.riverside.com/hosting-analytics/media/024be4efcf1c30f634c6d330bb4d80b3e264ab90bf3592ca63df504eaa98074c/eyJlcGlzb2RlSWQiOiJmNDYxMGVlYS0zNTM2LTRmYWUtYjA2My00NjQ3MTYyNjg5OWYiLCJwb2RjYXN0SWQiOiJhMmE1MjkxNi1iZmUxLTRmMmEtYjlhMy05YmU1MDI5ZWNiZTQiLCJhY2NvdW50SWQiOiI2YTE5YWE5ZTExMTVmZWU4NGJlMjI0MTUiLCJwYXRoIjoibWVkaWEvY2xpcHMvNjlmMGZjN2RmNTVjZGQxNDExNjEwMTljL2Rhbi1zYW1vcm9kbml0c2t5cy1zdHVkaW8tYTY3azAtY29tcG9zZXItMjAyNi00LTI4X18yMC0yOS0xNy5tcDMifQ==.mp3
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Duration seconds: 1334

## Resource

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?

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