Moderna appears to have aligned with the FDA ahead of an advisory committee meeting for its mRNA-based flu vaccine, which the regulator initially turned away in February; biotech IPOs are going gangbusters, including two new records raises in as many weeks; layoffs continue across biopharma; plus much more.
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Moderna’s mRNA-based flu vaccine made headlines in February when the FDA’s Vinay Prasad personally issued a refusal to file letter, declining 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.
But while the IPO window may now be open, Big Pharma is still facing some serious patent cliffs—and cutting staff as a result. 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, laying off an undisclosed number of workers that included longtime veteran Vishva Dixit, who had been with Genentech since 1997.
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 patient, industry and trade 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.
Other CNPVs have gone to psychedelics makers after President Donald Trump signed an executive order aimed at accelerating the development of psychedelic therapies for serious mental conditions in late April. That order also resulted in an FDA greenlight to begin human testing of another psychedelic—noribogaine. It’s a metabolite of ibogaine, a plant-derived compound with a complicated biology and notorious for its safety risks.
