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Immutep’s Phase‑3 miss sinks stock — LAG‑3 candidate stopped for futility
Australian immunotherapy company Immutep halted its global Phase‑3 lung cancer trial after an independent data monitoring committee recommended stopping for futility, a surprise outcome that sent...
Ultragenyx posts Phase‑3 win: gene therapy lowers ammonia in urea‑cycle disorder
Ultragenyx reported that its gene therapy candidate achieved one of two co‑primary endpoints in a Phase‑3 study for ornithine transcarbamylase (OTC) deficiency, a rare urea‑cycle disorder that...
Enodia acquires Kezar Sec61 programs — push into targeted protein degradation
Enodia Therapeutics acquired Kezar Life Sciences’ Sec61 discovery and development assets, including clinical‑stage candidate KZR‑261, under a deal that includes an initial $1 million upfront...
In vivo CAR‑T via nanoparticles: Johns Hopkins demonstrates systemic T‑cell engineering
Johns Hopkins researchers reported a biodegradable, polymer‑based nanoparticle that delivers mRNA encoding an anti‑CD19 chimeric antigen receptor (CAR) directly into T cells in vivo, producing...
Amino‑acid boost supercharges LNP delivery — simple metabolic tweak improves mRNA and CRISPR efficacy
Researchers at Biohub reported that co‑injecting a three‑amino‑acid cocktail with lipid nanoparticles (LNPs) markedly improved in vivo mRNA delivery and CRISPR editing efficiency in preclinical...
Vitestro raises $70M to scale robotic phlebotomy — clinical pilots and FDA path in focus
Netherlands‑based medical robotics company Vitestro closed a $70 million Series B to commercialize its Aletta Autonomous Robotic Phlebotomy Device (ARPD) and expand clinical pilots across Europe...
Vima expands movement disorder program — Series A reaches $100M as Parkinson’s added
Neuroscience startup Vima Therapeutics extended its Series A financing by $40 million, bringing total raised to $100 million to fund clinical development of its muscarinic receptor antagonist...
FDA to unify adverse‑event trackers: single platform for safety surveillance
The FDA announced plans to consolidate multiple adverse‑event reporting systems into a single Adverse Event Monitoring System (AEMS) to centralize safety data for drugs, vaccines and other...
Ultragenyx gene therapy hits co‑primary ammonia endpoint — Phase 3 posts mid‑trial win
Ultragenyx reported a positive mid‑trial readout from its Phase 3 program testing a gene therapy for ornithine transcarbamylase (OTC) deficiency, meeting one of two co‑primary endpoints. The...
Immutep halts Phase 3 efti trial for futility — stock collapses
Immutep disclosed that an independent data monitoring committee recommended stopping its pivotal Phase 3 study of eftilagimod alfa (efti) combined with pembrolizumab for first‑line non‑small cell...
Evotec to cut 800 jobs, shutter four sites — multi‑year ‘Horizons’ restructure
Drug discovery and CDMO partner Evotec announced plans to eliminate up to 800 positions—roughly one‑sixth of its workforce—and to close four facilities as part of a wide restructuring labelled...
Vima expands Series A to $100M — adds Parkinson’s to movement‑disorder remit
Neuroscience startup Vima Therapeutics extended its Series A by $40 million, bringing total funding to $100 million to advance VIM0423, its trihexyphenidyl‑based muscarinic antagonist formulation....
Vitestro secures $70M to scale robotic phlebotomy — US De Novo pathway targeted
Dutch med‑robotics company Vitestro closed a $70 million Series B to commercialize Aletta, its autonomous robotic phlebotomy device designed for high‑volume diagnostic workflows. The firm said the...
FDA to unify adverse‑event reporting — agency rolls AEMS into single safety platform
The U.S. Food and Drug Administration announced plans to consolidate its fragmented adverse‑event surveillance systems into a single Adverse Event Monitoring System (AEMS), aiming to improve...
Biodegradable mRNA nanoparticles generate CAR‑T cells in vivo — preclinical B‑cell depletion
Johns Hopkins researchers reported in Science Advances that targeted biodegradable polymer nanoparticles encoding anti‑CD19 CAR mRNA can program a patient’s T cells in vivo to express CARs and...
Immune‑evasive DNA donors license kilobase insertions — safer path for large gene writing
Two complementary preclinical advances outline strategies to insert gene‑sized payloads without provoking fatal innate immune reactions. One team described 'stealth' circular single‑stranded DNA...
Tumors present extracellular Src 'flag' — UCSF identifies broad antibody target
Scientists at UCSF discovered that the oncogenic kinase Src, long thought to be exclusively intracellular, can appear on the outer membrane of many tumor cells via autophagolysosomal exocytosis....
Enodia acquires Kezar’s Sec61 program — $1M upfront, $127M in milestones
Enodia Therapeutics agreed to acquire Kezar Life Sciences’ Sec61‑based discovery and development assets, obtaining extensive preclinical datasets and chemical space for Sec61 modulation. Kezar...
Vitestro raises $70m — robot to scale autonomous blood draws
Vitestro closed a $70 million Series B to accelerate clinical and commercial rollout of its Aletta Autonomous Robotic Phlebotomy Device (ARPD). The Netherlands-based medical robotics developer...
FDA to consolidate adverse‑event tracking — AEMS centralizes safety reports
The U.S. Food and Drug Administration announced plans to consolidate its fragmented adverse‑event reporting systems into a single Adverse Event Monitoring System (AEMS). The agency says the...