MaaT PharmaMaaT’s bid to overturn microbiome approval refusal suffers setbackMaaT Pharma has received a “negative trend” opinion in response to its request for EMA to re-examine its opposition to approving a microbiome therapy. more ➔
clinical dataAxoltis ALS drug misses Phase 2 endpointFrench biotech Axoltis Pharma’s NX210c missed the primary endpoint of a Phase 2 trial in amyotrophic lateral sclerosis (ALS), but post-hoc analyses showing slower functional decline are giving the … more ➔
StrategyCellectis scraps CAR-T pipeline in gene editing pivotFrench biotech Cellectis is abandoning development of its two internal allogeneic CAR-T programs and repositioning itself as an in vivo gene editing company focused initially on cardiovascular disea … more ➔
MAES-AREA-Englosclinical trialGenfit plans Phase 2 liver failure trial after acquiring immunomodulator from InotremFrench biotech Genfit acquired nangibotide from Inotrem in the summer and plans to start a Phase 2a trial in acute-on-chronic liver failure (ACLF) in the fourth quarter. more ➔
clinical dataGSK and Roche Chinese ADC bets deliver positive phase 3 data in SCLCTwo B7-H3-targeted antibody-drug conjugates licensed from Chinese biotechs have now delivered positive phase 3 survival data in relapsed small-cell lung cancer, strengthening the oncology bets GSK and … more ➔
BioNTech SEOncologyBioNTech adds clinical weight to its oncology pivot at WCLC 2026New data from the World Conference on Lung Cancer in Seoul are giving BioNTech’s oncology strategy more substance beyond its mRNA platform. Gotistobart has shown a marked survival benefit in previously … more ➔
fundraisingAllogenetics adds €3.8M for rejection-resistant donor lungsHanover-based Allogenetics has raised €3.8 million in a Pre-Series A round to advance ALG-115, an ex vivo gene therapy for donor lungs, through IND-enabling studies and toward a first-in-human trial … more ➔
StrategySimris steps on Heidelberg Pharma’s toes with amanitin pivotSimris Group is making amanitin-based ADCs the center of its strategy under former Heidelberg Pharma CEO Andreas Pahl — less than two months after hiring the executive who helped build Heidelberg Pharma’s … more ➔
EthrisInfectious diseaseEIB backs Ethris with €30 million for broad-spectrum antiviral mRNAThe European Investment Bank (EIB) is providing German Ethris with €30 million to advance clinical development of its mRNA-based antiviral candidate ETH47. The Munich-based RNA specialist has been … more ➔
CDMONorthway opens €61M Vilnius plant built for personalized medicineCDMO company Northway Biotech has opened a €61 million cell therapy and personalized medicine center in Vilnius that is being qualified for GMP manufacturing, and the company says it expects a manufacturing … more ➔