Get the Daily Brief
Latest Biotech News
Immutep’s phase III flop – Stock tumbles after futility stop
Immutep halted its phase III TACTI-004 trial of eftilagimod alfa (IMP-321, “efti”) in first-line non-small-cell lung cancer after an independent data monitoring committee recommended stopping for...
Lantheus wins tentative FDA ANDA – Patent battle with Novartis heats up
The FDA issued a tentative approval for Lantheus’ abbreviated new drug application (ANDA) for PNT2003, a generic version of Novartis’ radioligand Lutathera (lutetium Lu 177 dotatate), opening the...
HER2 ADC shows activity in urothelial cancer – High response rates in phase 2
Disitamab vedotin (DV), a HER2-targeted antibody–drug conjugate, produced robust response rates in a phase 2 RC48G001 study of previously treated locally advanced or metastatic urothelial...
Engineering CAR‑T persistence: cytokine scaffolds extend durability
Two independent approaches reported by researchers at Albert Einstein College of Medicine aim to solve CAR‑T cell persistence. One Science Advances paper described a modular protein scaffold...
Antibody‑siRNA conjugate reaches muscle—first signals in myotonic dystrophy trial
Delpacibart etedesiran (del‑desiran, AOC 1001), an antibody‑siRNA conjugate designed to silence DMPK in muscle, showed target engagement in the Phase I/II MARINA trial and achieved muscle DMPK...
Ultragenyx gene therapy clears a Phase 3 milestone in urea cycle disorder
Ultragenyx reported that its gene therapy candidate for ornithine transcarbamylase (OTC) deficiency met one of two co‑primary endpoints in a Phase 3 study involving 37 patients. The company...
Vitestro raises $70M to scale robotic blood draws – Push toward FDA De Novo
Vitestro closed a $70 million Series B to advance Aletta, an autonomous robotic phlebotomy device designed for high‑volume blood collection. The company plans clinical pilots, manufacturing...
Scientists unlock doxorubicin bottleneck – Engineered bacteria boost chemo production
An international consortium published work in Nature Communications identifying and engineering key biosynthetic steps that had limited microbial production of the anthracycline doxorubicin for...
Stanley Family adds $280M to Broad’s psychiatric genetics push
The Stanley Family Foundation committed an additional $280 million to the Broad Institute’s Stanley Center for Psychiatric Research, bringing the foundation’s total investment in the center to...
High‑throughput SPR moves upstream: Carterra’s Vega aims at primary screening
Carterra unveiled the Vega platform to scale surface plasmon resonance (SPR) to tens of thousands of interactions per day, positioning label‑free binding kinetics earlier in discovery workflows....
Immutep’s phase‑III flop – efti trial stopped for futility
Immutep announced that its Phase III TACTI‑004 trial of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer was halted after an independent data monitoring committee recommended...
Lantheus wins tentative FDA ANDA nod amid Lutathera patent war
The FDA issued a tentative approval for Lantheus’ ANDA for PNT2003, a generic version of Novartis’ radioligand Lutathera (lutetium Lu 177 dotatate), used to treat somatostatin receptor‑positive...
New HER2 ADC posts high response in urothelial cancer – RC48 data
Phase 2 data from the RC48G001 study show the HER2‑targeted antibody‑drug conjugate disitamab vedotin (DV) produced confirmed overall response rates above 50% in previously treated metastatic...
Ultragenyx gene therapy hits primary endpoint in rare metabolic trial
Ultragenyx reported that its gene therapy candidate achieved one of two primary endpoints in a Phase 3 trial for ornithine transcarbamylase (OTC) deficiency, a rare urea cycle disorder. The...
FDA draft guidance loosens rules for biosimilar testing – a market opener
The FDA released draft guidance that, in certain situations, would allow biosimilar developers to rely on comparator data generated outside the U.S., potentially lowering the cost and time...
Evaluate predicts $409B rare‑disease market by 2032 – industry growth forecast
Evaluate’s 2026 Orphan Drugs Report forecasts global annual sales of rare‑disease therapies will exceed $409 billion by 2032, claiming more than 21% of total global prescription sales. The...
AI biotechs advance: Insilico joins Hang Seng; Waiv spins out with $33M
Insilico Medicine secured inclusion in the Hang Seng Composite Index, granting broader market access and eligibility for Stock Connect—an institutional milestone that increases the company’s...
New CAR‑T manufacturing tricks extend persistence – scaffold and cytokine fusions
Two independent academic teams reported manufacturing innovations aimed at prolonging CAR‑T cell efficacy. Researchers at Albert Einstein College of Medicine described a modular protein scaffold...
Vitestro raises $70M to scale robotic phlebotomy ahead of US push
Vitestro closed a $70 million Series B to accelerate global deployment of Aletta, its autonomous robotic phlebotomy device designed to standardize venous access and blood collection. The...
Antibody‑siRNA conjugate reaches muscle in humans – del‑desiran shows promise
Clinical data from the Phase I/II MARINA trial of delpacibart etedesiran (del‑desiran, AOC‑1001), an antibody‑siRNA conjugate targeting DMPK mRNA in myotonic dystrophy type 1 (DM1), demonstrate...