Business
Manufacturers are being pushed beyond mAb‑era platforms into a new design model built around molecular engineering, complex analytics and amplified upstream and downstream processing.
FEATURED STORIES
Twenty-five biotechs have used the IPO route to go public this year—with five of those debuts occurring this month alone. It’s the most IPOs since 2021, when the industry recorded 78 during the height of the COVID-19 pandemic.
While Novartis’ Pluvicto is a blockbuster, Curium heads into talks with the FDA about the review of its rival drug candidate believing a competing product can make the supply chain more resilient.
The FDA’s August approval of Takeda’s Orzeyful for treating the full set of narcolepsy symptoms initiated a new era in the sleep market.
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At the center of Biohaven’s agreement with SK Biopharmaceutical is the ion channel platform and the lead epilepsy candidate opakalim, for which Phase 2/3 data are expected later this year.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
Haisco Pharmaceutical Group has been on a deal hot streak this year, inking major deals with Eli Lilly, AbbVie and more. The new company will take on one of Haisco’s core immunology assets.
Eli Lilly’s best play for Foundayo is to bring it overseas, a more price-sensitive market where the pharma can more readily outcompete Novo Nordisk “given the high margins of a small-molecule therapy,” Truist analyst Srikripa Devarakonda told BioSpace.
Roche, through its subsidiary Genentech, will gain access to the investigational asset HM17321, which is designed to not only elicit weight loss but also improve lean mass.
Not much is known about Boehringer Ingelheim’s drug candidate, dubbed BI 3031185, though the asset has completed at least two other Phase 1 studies this year.
Kaos Capital in a letter to other Capricor Therapeutics shareholders called for “an immediate meeting, board change, and capital-preservation plan.” The biotech recently put all other pipeline work on pause as it awaits an Aug. 22 PDUFA date for embattled cell therapy deramiocel.
Three fatalities occurring recently in Chinese clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients.