Daily Snap - 25. November 2025

Author

Joachim Eeckhout
November 25, 2025

 

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Good morning! If you feel like antibody drug conjugates (ADCs) have been all over the news lately, you're not alone. According to GlobalData, in 2024, the FDA granted a record 63 review designations to ADCs, nearly doubling the previous high of 35 in 2023. ADCs, which link monoclonal antibodies with cytotoxic drugs for selective tumor cell killing, have seen growing interest due to their clinical success and improved outcomes over traditional chemotherapy. Since a landmark year in 2019—when three ADCs were approved—the industry has been pushing hard to develop more ADCs, which is reflected in the recent number of FDA designations. But with most of the new ADCs being developed by Chinese biotech companies, the race might take an interesting turn in the coming years. We’ll be sure to keep an eye out for it.

Enjoy today’s read!

—Joachim E.

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What’s happening in biotech today?

đź’Ą ADC breakthrough: Kelun-Biotech, in partnership with Merck & Co., announced that its TROP2-directed antibody-drug conjugate sacituzumab tirumotecan (sac-TMT), combined with Keytruda, met the primary endpoint of improved progression-free survival (PFS) in the Phase 3 OptiTROP-Lung05 trial for first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC). This marks the first Phase 3 trial to show success for an ADC paired with an immune checkpoint inhibitor in this setting. While promising, the trial’s comparison against Keytruda monotherapy, rather than the global standard Keytruda-chemo combo, limits its relevance outside China. Merck is pursuing additional global studies, including TroFuse-007, to explore broader applications.

 đź§  Tau trouble: Johnson & Johnson’s anti-tau antibody posdinemab failed to meet its primary endpoint in the Phase 2 Autonomy trial for early Alzheimer’s disease, prompting the company to halt the study. The trial, which involved over 500 participants, showed no statistically significant slowing of clinical decline on the iADRS scale at 104 weeks. This setback deals a blow to the therapeutic strategy of targeting tau's mid-domain, also pursued by UCB’s similarly unsuccessful bepranemab. Despite previous optimism and a projected $5 billion market potential, J&J is shifting focus to other tau-targeting approaches, including active immunotherapy and additional pipeline candidates in early clinical development.

🛡️ Stroke shield: Bayer’s oral FXIa inhibitor asundexian significantly reduced the risk of stroke without increasing major bleeding in a Phase 3 trial for secondary stroke prevention, marking a key milestone for the FXIa inhibitor class after recent high-profile failures. The trial enrolled patients who had experienced a non-cardioembolic ischemic stroke or high-risk ischemic attack and administered asundexian or placebo alongside antiplatelet therapy. This success contrasts with Bayer’s earlier termination of an atrial fibrillation study and recent setbacks for similar drugs from Bristol Myers Squibb and Johnson & Johnson. Analysts view the results as a renewed validation of FXIa inhibition's potential in anticoagulation.

🔍 FDA probe: The FDA is investigating Takeda Pharmaceutical’s rare disease drug Adzynma following the death of a pediatric patient who developed neutralizing antibodies after treatment. Approved in 2023 for congenital thrombotic thrombocytopenic purpura, Adzynma is a lab-engineered enzyme replacement aimed at preventing life-threatening complications in affected patients. While no neutralizing antibodies were reported during clinical trials, the FDA has since received reports, including from the fatal case, and is assessing whether further regulatory action is needed. Takeda maintains no confirmed causal link to the drug but is cooperating with authorities. Adzynma generated approximately $32 million in sales in early FY2025.

🛏️ Lab-to-bedside: The Academy of Medical Sciences and Wellcome have announced a £27.3 million, five-year partnership to strengthen the UK’s biomedical and health research sector by supporting research talent, fostering cross-sector collaboration, and informing workforce policy. The renewed agreement will fund key initiatives, including the Future Leaders in Innovation, Enterprise and Research (FLIER) programme, Starter Grants for Clinical Lecturers, Springboard awards, and the Cross-sector Programme. Leaders from both organizations emphasized the need to address declining numbers of medical researchers and the importance of mentorship, protected research time, and cross-disciplinary skills in translating scientific advances into improved patient care.

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