BioSpace

This year has been partly defined by a return to M&A. In the first quarter of 2026, biopharma spent nearly $47 billion in acquisitions across 19 deals, and this week, AbbVie notched another one for the second quarter, scooping up Apogee Therapeutics and its IL-23 blocker for atopic dermatitis for around $10.9 billion. The deal follows GSK’s $10.6 billion Nuvalent Bio acquisition earlier this month. These deals come as several big pharmas face patent cliffs. Sanofi, for example, will lose patent protection on Dupixent in 2031. New CEO Belén Garijo made a major play to build out Sanofi’s pipeline this week, announcing that Xaira veteran Paulo Fontoura will step in as R&D chief as Houman Ashrafian exits. Another key trend over the past 18 months has been regulatory uncertainty. This trend continues, with both uniQure and REGENXBIO announcing FDA reversals for their gene therapies for Huntington’s disease and Hunter syndrome, respectively. Both companies will submit for approval of their products—a first submission for uniQure and a resubmission for REGENXBIO—in the third quarter, after the agency, under the leadership of acting commissioner Kyle Diamantas, deemed their current data sufficient. Also at the FDA, a policy memo on the agency’s consideration of Sanofi’s Commissioner’s Priority Review Voucher for type 1 diabetes drug Tzield threw more fire on the CNPV program, which has already been mired in controversy. And the agency debuted an investigational new drug pilot program that would leverage collaborations with U.S. research institutions to reduce early trial timelines by as much as 12 months. For a special treat, we heard from BioSpace Managing Editor Jef Akst and Senior Editor Annalee Armstrong who are currently in San Diego enjoying BIO 2026. And finally, on the Eli Lilly front, a new report from Evaluate projects that the company’s weight loss franchise will account for nearly half of the total sales of the top 10 drugs in 2032. But Lilly isn’t resting on this envisioned success: the juggernaut is one of two companies circling Sangamo’s assets as the biotech files for bankruptcy.

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.