Healthcare and Pharmaceutical Sector
Moderna gained FDA approval for mFLUSIVA, the first mRNA flu vaccine, while Takeda received FDA clearance for its novel narcolepsy type 1 treatment, Orzeyful. Capital markets showed strength with Attovia Therapeutics raising $289 million in an upsized IPO and Expedition Therapeutics securing $115 million in Series B funding. Meanwhile, Hinge Health acquired Cylinder Health for $105 million, and Novo Nordisk shifted toward bolt-on acquisitions after abandoning a major deal and facing trial setbacks.
Moderna received FDA approval for mFLUSIVA, making it the first messenger RNA flu vaccine licensed in the United States. The decision provides standard approval for adults aged 50 to 64 and accelerated approval for seniors aged 65 and older, contingent on a Phase 4 trial comparing it to existing high-dose vaccines. Trial data showed participants aged 50 to 64 were 27% less likely to contract test-confirmed influenza compared to standard-dose alternatives. This approval comes six months after the FDA's then-head of biologics issued a refusal-to-file notice, a decision overturned a week later following public pushback. The official left the agency in April. mFLUSIVA marks Moderna's fourth product to enter the U.S. market. Traditional flu vaccines rely on egg- or cell-based manufacturing that requires decisions on viral strains months before flu season begins. That long lead time frequently causes a mismatch with circulating strains. Because mRNA manufacturing is substantially faster, Moderna can select target strains closer to winter, threatening market share held by traditional vaccine makers. Licensing a seasonal mRNA flu shot also shortens the regulatory timeline for pandemic flu vaccines if a outbreak occurs.
The FDA approved Takeda’s Orzeyful tablets to treat narcolepsy type 1 in adults, making it the first drug cleared to target the underlying biological cause of the condition. Narcolepsy type 1 affects roughly 1 in 2,000 Americans and stems from the loss of brain cells that produce orexin, a chemical messenger responsible for regulating wakefulness and muscle tone. Legacy options rely on stimulants and sedatives like sodium oxybates. These treatments carry a risk of misuse and only mask symptoms without fixing the root chemical deficit. Orzeyful works as an orexin receptor agonist, taking the place of the missing natural protein to directly restore wakefulness signals. In two Phase 3 trials totaling 273 patients, a 2 mg twice-daily dose significantly increased patients' ability to stay awake while curbing muscle weakness episodes known as cataplexy. Takeda cannot launch the oral drug immediately. Commercial sales remain paused until the Drug Enforcement Administration completes its mandatory controlled-substance scheduling decision.
Attovia Therapeutics raised $289 million in an upsized Nasdaq IPO, selling 17 million shares at $17 apiece. Underwriters hold an option to buy an additional 2.5 million shares, which would add $43.3 million to the total. Trading under the ticker ATTO, the Silicon Valley biotech initially aimed to raise $182.4 million before raising its target to $265.1 million in net proceeds. It is the 12th drugmaker to bank at least $250 million in an IPO this year. Attovia uses a proprietary platform to build modular, multi-target engineered biologics called attobodies. The 45-person company will use the cash to launch two phase 2 trials next year for ATTO-1310, its treatment for chronic pruritus, a severe itch condition affecting over 15 million Americans. While Galderma’s rival drug Nemluvio binds to the IL-31 receptor, ATTO-1310 binds to the IL-31 ligand directly to deliver faster relief with less frequent dosing. Attovia also plans to advance two preclinical assets into phase 1 trials early next year, including a bispecific biologic designed to challenge Sanofi and Regeneron's blockbuster med Dupixent before its patent protections expire in 2031.