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Italy’s Newron Pharmaceuticals has disclosed that the FDA kept U.S. enrollment in a Phase 3 trial of its schizophrenia drug evenamide on hold, citing five deaths across all the drug’s clinical studies. The company will ask the agency to lift the hold by screening patients for hidden heart-rhythm disorders, including with genetic tests.

The Leadership Edit Thumbnail European Biotechnology

Every Friday, The Leadership Edit follows people taking new roles across European biotech and what their moves may tell us about the companies they join. This week: a CEO transition shaped by a strategic retreat, a finance hire ahead of a gene therapy trial and a medical appointment as an influenza antibody approaches the clinic.

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Swiss biotech ADC Therapeutics has secured an $86.6 million (€77.5 million) financing agreement alongside debt and royalty deal amendments that extend its expected cash runway into 2029 and remove a potential obstacle to a takeover.

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Zealand Pharma shares fell about 4% in Thursday trading after new Phase 2 results for its Roche-partnered obesity drug petrelintide showed encouraging weight loss but a modest improvement in blood sugar control. It’s the second positive trial readout that has failed to reassure investors in the course of a week.

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Roche has partnered with China’s Defand Therapeutics to discover molecular glue degraders for cancer and immune diseases, in a research and licensing agreement reportedly worth close to $1 billion (€895 million).

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Argenx is stopping its Phase 3 UNITY trial of efgartigimod in Sjögren’s disease after an interim analysis showed the study could not meet its primary endpoint. Shares fell about 18% in Euronext Brussels trading following the announcement, overshadowing positive Phase 2 results for its recently acquired celiac disease drug FB102.

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Paris-based Rivercell has raised $25 million (about €22 million) in seed funding to generate experimental data and build AI models that predict how human cells respond to drugs and genetic changes.

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Exclusive European data from BIO-Europe’s inaugural C-suite survey, shared with European Biotechnology, shows a sector expecting better funding conditions while struggling with investor caution. Among 69 executives at European-headquartered companies, 84% identify investor risk aversion as biotech investment’s biggest constraint, even as 70% expect their company’s access to capital to improve over the next year.

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Dutch life sciences investor Forbion has raised €2.3 billion across two new funds to finance about 30 biotech companies, setting a fundraising record for the firm.

Marian Kupculak, Co-Founder and CSO of Sensible Biotechnologies, and Miroslav “Miro” Gasparek, Co-Founder and CEO

Oxford-based Sensible Biotechnologies has secured a $47 million (€42 million) financing package to scale a platform that makes mRNA in living cells, targeting manufacturing costs and unwanted immune activation that can limit its use in treatments beyond vaccines.