Q2 earnings underway, FDA’s CRL kerfuffle, IPOs full speed ahead in H2

Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics space; more drama unfolds at FDA as the agency goes back and forth on its policy of publishing complete response letters in real-time; and IPO fever continues.

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Novartis followed Johnson & Johnson this week in kicking off biopharma’s second quarter earnings, with the news that it plans to stick to its M&A strategy of bolt-on deals. Next up are Roche, AstraZeneca, GSK and Biogen as the Q2 earnings parade rolls on.

Bolt-on acquisitions are a common occurrence for Eli Lilly, but analysts say the company’s most recent deal—the pick-up of AtaiBeckley for up to $3.8 million—is a boon to the fledgling psychedelic therapeutics space. The deal “is the clearest strategic validation to date of psychedelics and interventional psychiatry as an emerging pharmaceutical category,” H.C. Wainwright wrote in a Monday note to investors.

On the regulatory front, a minor drama is unfolding around the FDA’s one-year-old policy of releasing complete response letters (CRLs) in real-time. Earlier this month, the agency announced it would pause the initiative, amid a citizen petition challenging the legality of the effort. Then, just days later, the FDA uploaded another batch of CRLs to its online portal. BioSpace unpacks the controversy with former regulators and other experts.

Back to business, biopharma’s IPO train—which welcomed 18 new riders in the first half of 2026—shows no signs of slowing down. Several more biotechs have announced their bids in the past week. And one company, Axiom Biosciences, is betting on a Hong Kong IPO to secure new capital.

Finally, BioSpace takes a deep dive into the Phase 3 flop of AstraZeneca and Ionis’ Wainua in transthyretin amyloidosis cardiomyopathy (ATTR-CM) and what it means for AstraZeneca’s hopes to hit $80 billion in revenue by 2030.

Jef Akst is managing editor of BioSpace. You can reach her at jef.akst@biospace.com. Follow her on LinkedIn and Twitter @JefAkst.
Heather McKenzie is senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Also follow her on LinkedIn.
Gabrielle is a senior editor at BioSpace. You can reach her at gabrielle.masson@biospace.com.
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