Moderna’s mRNA-based flu vaccine is set for review by an advisory committee on June 18, following a reversal by the Food and Drug Administration after initially declining to review the application in February. The agency had issued a refusal to file letter through Vinay Prasad, but later scheduled a decision date for August. Recent documents indicate that Moderna and the FDA have reached alignment on key issues, though some data gaps remain for advisors to consider.
The biotech sector has experienced record-setting initial public offerings in recent months. Kailera Therapeutics debuted with $625 million in April, surpassing Moderna’s previous record of $600 million from 2018. Parabilis Medicines exceeded both companies last week with a $670 million IPO, now holding the title of largest biotech public debut.
Despite strong IPO activity, large pharmaceutical companies are contending with patent expirations and responding with workforce reductions. Employee layoffs increased by nearly 50% year-over-year in May, largely due to significant cuts at Takeda and BioNTech. Genentech also implemented layoffs last week affecting an undisclosed number of workers, including longtime employee Vishva Dixit, who had been with the company since 1997.
Eli Lilly continued its acquisition strategy by reaching a licensing agreement worth up to $1 billion with AlzeCure focused on Alzheimer’s disease treatment. Additionally, clinical results released this past week highlighted progress related to Eli Lilly's $2.3 billion acquisition of Ajax Therapeutics completed in April.
Earlier this month, the FDA held a public session seeking feedback about the Commissioner’s National Priority Voucher program amid calls from patient groups and industry representatives for a temporary pause due to transparency concerns and political involvement. Meanwhile, Sanofi received approval for its diabetes drug Tzield for older children and teenagers—though it is unclear if a voucher was used—and Disc Medicine announced that its rare disease drug bitopertin may proceed toward another regulatory filing after positive feedback from regulators regarding its Phase 3 trial.
Recent developments also include new approvals under President Donald Trump’s executive order aimed at advancing psychedelic therapies for serious mental health conditions signed in late April. This action resulted in FDA authorization to begin human testing of noribogaine—a metabolite of ibogaine known both for complex biology and safety risks.
