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Industry Daily Summary

Industry Daily Summary: What Happened on October 27, 2026

FDA approves GSK’s hepatitis B drug for some adults without cirrhosis

Menarini paid $45 million upfront for a preclinical cancer immunotherapy, while Novartis ended an Alzheimer’s program and Windward Bio filed for a U.S. IPO.

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Today in brief

The FDA cleared GSK’s bepirovirsen, made with Ionis and sold as Hibsago, for certain adults with chronic hepatitis B who lack cirrhosis, alongside other antiviral drugs.1 At 24 weeks off all hepatitis B therapy, 19% of treated participants still had viral control and no detectable hepatitis B surface antigen.1 Menarini licensed Georgiamune’s preclinical cancer immunotherapy worldwide, agreeing to pay $45 million upfront.2

Novartis discontinued its Phase 2 Alzheimer’s drug lifonebart after a scheduled committee review of biomarker data.1 Windward Bio submitted a U.S. IPO filing to fund antibody trials in respiratory and inflammatory conditions.1

FDA approves GSK’s hepatitis B drug for selected adults without cirrhosis

The FDA approved GSK’s bepirovirsen, developed with Ionis and sold as Hibsago, for selected adults with chronic hepatitis B who don’t have cirrhosis, alongside existing antiviral drugs.1 In the reported trial results, 19% of treated participants still had viral control and no detectable hepatitis B surface antigen 24 weeks after ending all hepatitis B therapy.1

Hibsago’s label warns of severe liver reactions and reduced platelet counts. Patients need regular monitoring.1

Menarini pays $45 million upfront for Georgiamune cancer immunotherapy

Menarini agreed to pay Georgiamune $45 million upfront for worldwide rights to a preclinical cancer immunotherapy. The program is set to join the pipeline at Menarini subsidiary Stemline Therapeutics.2 Menarini said it believes the program could be first in its class for solid tumors.2 This is Menarini’s second licensing deal in two months. Its prior agreement expanded its cardiometabolic pipeline with Gan & Lee Pharmaceuticals.2

Also worth knowing

  • Idorsia plans a dedicated study of daridorexant in autism spectrum disorder after exploratory signals in a two-week pediatric sleep study. The company expects to share more in the first half of 2027.1

  • After one of two oncology programs met its research criteria, Servier agreed to pay Insilico Medicine $32 million in combined upfront and near-term payments. The collaboration could reach $888 million.1

  • ScionxBio and Sanofi will test whether ScionxBio’s TERA platform can extend protein production from selected Sanofi mRNA candidates.1

  • Eleven Therapeutics’ businesses now operate as two companies: ScionxBio, which develops durable RNA medicines, and Undecimal Bio, which focuses on siRNA delivery.1

  • Spica Therapeutics named Jeff Abbey CEO as it plans to extend its platform beyond oncology, the company said.3

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    Acumetis named Ramil Burden CEO. Founder Brent Herspiegel is leaving the role but will remain on the board.4

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    A judge ruled for Lilly in Novo’s lawsuit over weight-loss drug advertisements.5