This Week’s Biopharma News: ADCs, Biosimilars, and Microbiome Moves - Takeaways - MDSpire

This Week’s Biopharma News: ADCs, Biosimilars, and Microbiome Moves

  • May 26, 2026

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  • 1

    Merck's sacituzumab tirumotecan met phase 3 endpoints in advanced endometrial cancer, showing improved overall and progression-free survival.

  • 2

    Microbiotica's MB097, a microbiome therapy, demonstrated positive phase 1b results in advanced melanoma when combined with pembrolizumab.

  • 3

    Akeso's ligufalimab, an anti-CD47 monoclonal antibody, showed a survival signal in phase 2 trials for treatment-naïve acute myeloid leukemia.

  • 4

    Regeneron's phase 3 trial of fianlimab and cemiplimab in melanoma did not achieve statistical significance for progression-free survival.

  • 5

    The FDA finalized guidance on postapproval pregnancy safety studies to enhance safety data collection for drugs and biologics used during pregnancy.

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