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Immutep’s LAG‑3 drug fails Phase III — Stock tumbles
Immutep disclosed that an independent data monitoring committee recommended stopping its Phase III TACTI‑004 trial of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer for futility,...
Cadonilimab combo extends control in advanced cervical cancer — Phase 3 readout
COMPASSION‑16 Phase III data show that adding cadonilimab to first‑line chemotherapy, with or without bevacizumab, improved outcomes in advanced cervical cancer, according to the trial...
Ultragenyx gene therapy hits co‑primary endpoint — Mid‑trial success in urea cycle disorder
Ultragenyx reported that its AAV‑based gene therapy reached one of two co‑primary endpoints in the Phase III study for ornithine transcarbamylase (OTC) deficiency, demonstrating a significant...
FDA draft allows non‑US comparators — Biosimilar testing bar lowered
The U.S. Food and Drug Administration issued draft guidance permitting sponsors to use comparator data from non‑U.S. reference products in certain biosimilar development programs, the agency said....
Triple‑cytokine scaffold boosts CAR‑T durability — Preclinical persistence gains
Researchers at Albert Einstein College of Medicine published preclinical results showing a modular protein scaffold that links IL‑7, IL‑15 and IL‑21 during CAR‑T manufacture generated cells with...
Src flips to cell surface: antibody payloads shrink tumors in mice
UCSF researchers published that the oncogene Src, long considered an intracellular kinase, appears on the extracellular membrane of multiple tumor types via autophagolysosomal exocytosis and can...
OpenAI and Ginkgo: AI designs and runs real biology experiments
OpenAI and Ginkgo Bioworks demonstrated that generative AI integrated with an autonomous laboratory workflow can design, iterate and execute real biology experiments at scale, accelerating...
Lucence leads S$6M multiomic tumor profiling push — UNITED 2.0
Lucence Diagnostics, A*STAR’s DxD Hub and the National Cancer Centre Singapore launched UNITED 2.0, a S$6 million program to develop a clinical whole‑genome and whole‑transcriptome sequencing...
Rare disease drug sales to top $400B by 2032 — Evaluate forecast
Evaluate released its 2026 Orphan Drugs Report projecting global orphan drug sales will exceed $400 billion annually by 2032, up from 15% of prescription drug sales in 2022 to over 21% of the...
Evotec to cut 800 jobs, close four sites — Large restructuring under way
Contract research and development company Evotec announced a restructuring—code‑named Horizons—that will eliminate up to 800 roles (about one‑sixth of its workforce), close four facilities and...
Immutep trial stops for futility — shares crater
Immutep’s phase III TACTI-004 study of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer was halted after an independent data monitoring committee recommended stopping for futility....
Ultragenyx gene therapy clears key phase‑3 endpoint — rare disease win
Ultragenyx reported that its gene therapy candidate met a primary (and in one report, a co‑primary) endpoint in a phase III study for an inherited urea cycle disorder, demonstrating a...
Stryker systems down after cyberattack — restoration under way
Stryker confirmed a global disruption of internal systems following a cyberattack that affected order processing and manufacturing operations. The company indicated it believes the incident is...
FDA broadens GSK RSV shot clearance — wider label granted
The U.S. Food and Drug Administration expanded the approved indication for GSK’s RSV vaccine, granting broader clearance for use in additional adult populations. The decision follows post‑launch...
China approves first commercial brain implant — BCI enters clinic
China’s regulator approved a coin‑sized, wireless brain‑computer interface (BCI) developed by Shanghai‑based Neuracle Medical Technology for commercial use in patients with spinal cord injuries....
Orphan drugs to exceed $400B by 2032 — Evaluate projects surge
Evaluate’s 2026 Orphan Drugs Report forecasts global annual orphan drug sales reaching roughly $409 billion by 2032, up from an estimated 15% share of prescription medicines in 2022 to more than...
Cytokine scaffold extends CAR‑T life — durability advances in preclinical models
Researchers at Albert Einstein College of Medicine reported a modular protein scaffold (HCW9206) that links IL‑7, IL‑15 and IL‑21 to generate CAR‑T cells enriched in T memory stem cells,...
AI in biotech: Insilico joins index — models speed lab discovery
Insilico Medicine secured inclusion in the Hang Seng Composite Index, signaling wider investor access to a clinical‑stage AI‑driven biotech and strengthening its market profile. The listing will...
Tumor surface 'flag' and trispecific engager open new immunotherapy routes
UCSF researchers discovered that the oncogene Src can appear on the exterior of tumor cells via autophagolysosomal exocytosis, presenting an extracellular Src (eSrc) antigen that antibody...
Amino acids and new assays boost nanoparticle delivery — delivery bottleneck loosened
A team at Biohub reported that co‑injecting a three‑amino‑acid cocktail with lipid nanoparticles markedly increased in vivo mRNA delivery and CRISPR editing efficiency in preclinical models,...