Medicxi Ventures’ asset-focused investment model has scored another hit, in a $450 million deal with Servier SA, for KER-0193, an oral small molecule that is ready for phase II development in the treatment of the inherited autism spectrum disorder, fragile X.

Detailed data are expected later, but partners Biontech SE and Duality Biologics Co. Ltd. are celebrating a phase III interim analysis readout demonstrating that HER2-targeting antibody-drug conjugate (ADC) trastuzumab pamirtecan hit the primary endpoint of progression-free survival in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy.

The funding is in place for a phase IIb trial of its lead gut microbiome live biotherapeutic, after MRM Health NV closed a €55 million (US$64 million) series B round.

Phase III results from Sanofi SA’s study of amlitelimab in treating atopic dermatitis met the primary and key secondary endpoints, but investors took a step back.

There have been numerous improvements in the treatment of cardiovascular disease since the European Society of Cardiology (ESC) first met in 1950, but unmet medical need remains and the science continues to advance, as delegates heard at the 75^th annual meeting in Madrid, Spain, Aug. 29-Sept. 1.

Charm Therapeutics Ltd. is heading to the clinic after closing an oversubscribed series B, which will fund initial development of a menin inhibitor that is AI-designed to circumvent shortcomings of first-generation molecules.

Mitochondrial transfer is known to occur from the tumor microenvironment into cancer cells, but now, Swiss researchers have shown a possible precursor to this is that cancer cells smuggle their mitochondria into healthy connective tissue cells, prompting their reprogramming to cancer-associated fibroblasts.

Twenty-two years since its formation, Bioarctic AB expects to become profitable in 2025, as milestones for marketing approvals and royalties on sales of the Alzheimer’s drug Leqembi (lecanemab) roll in, and partners sign up to use its proprietary Braintransporter drug delivery technology.

Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.