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Lexeo pursues accelerated path: FDA open to pooled‑data submission
Lexeo Therapeutics said U.S. FDA discussions positioned its LX‑2006 gene therapy for Friedreich ataxia (FA) to pursue an accelerated approval pathway if the company submits pooled data from...
Serial tumor biopsies: real‑time sampling reveals hidden GBM responses
Two independent reports showed serial, longitudinal tumor sampling in recurrent glioblastoma (rGBM) exposes therapy effects and immune responses that standard MRI failed to reveal. Break Through...
Nilo raises $101M: targeting brain‑body circuits to reset immunity
Nilo Therapeutics closed a $101 million Series A to develop small‑molecule drugs that target neural circuits regulating systemic inflammation. The preclinical startup was founded on...
ARPA‑H backs in‑vivo cell and gene therapy projects to reprogram immunity
The Advanced Research Projects Agency for Health (ARPA‑H) awarded funding to seven teams to accelerate in‑vivo approaches that program immune cells directly inside the body. The grants target...
Programmable proteins... logic gates steer therapeutics to their targets
Researchers at the University of Washington reported a platform for engineering therapeutic proteins that incorporate logical decision‑making to restrict activity to desired tissues. These...
Owlstone gets $49.1M ARPA‑H award to build at‑home multi‑cancer test
Owlstone Medical won up to $49.1 million from ARPA‑H to develop over‑the‑counter, at‑home breath tests capable of detecting more than 30 cancers at early (stage I) disease. The funding aims to...
Chiesi–Arbor pact targets PH1: $2.1B gene‑editing collaboration
Chiesi Group struck an exclusive collaboration and license with Arbor Biotechnologies to develop ABO‑101, an in‑vivo CRISPR gene‑editing candidate for primary hyperoxaluria type 1 (PH1), in a deal...
FDA clears Jascayd for IPF: first new pill in more than a decade
The US Food and Drug Administration approved Boehringer Ingelheim’s nerandomilast, marketed as Jascayd, for idiopathic pulmonary fibrosis (IPF), the first new approval in the indication in over...
Nilo launches with $101M: neuro‑immune startup aims to reset inflammation
Nilo Therapeutics launched with a $101 million Series A to develop small molecules that target defined neural circuits controlling systemic inflammation. The New York‑based preclinical company,...
Arthrosi nets $153M: bankroll to finish two Phase 3 gout trials
Arthrosi Therapeutics closed a $153 million Series E to complete two fully enrolled Phase 3 trials of its URAT1 inhibitor pozdeutinurad (AR882) as an oral treatment for gout. The San Diego biotech...
Real‑time tumor biopsies expose hidden glioblastoma responses – study
Serial, multi‑omics tumor biopsies in patients with recurrent glioblastoma uncovered robust intratumoral immune and pharmacodynamic signals that MRI and routine clinical metrics missed, according...
Lexeo lines up accelerated path for Friedreich ataxia gene therapy
Lexeo Therapeutics said discussions with the US FDA have positioned its LX‑2006 gene therapy for Friedreich ataxia cardiomyopathy on an accelerated approval pathway if pooled data from ongoing...
Sanofi’s AlphaMedix hits Phase 2 goals: targeted alpha radiotherapy shows activity
Sanofi and partners reported positive Phase 2 results for AlphaMedix, a lead targeted‑alpha radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors (GEP‑NETs). The compound met...
FDA updates Xeloda label: DPYD genetic testing recommended before capecitabine
The FDA revised the boxed warning for Genentech’s Xeloda (capecitabine) to explicitly recommend testing patients for DPYD gene variants prior to initiating therapy, unless immediate treatment is...
TALE epigenetic editor yields durable silencing in primates: translational step
A TALE‑based epigenetic editor produced durable therapeutic gene silencing after transient expression in non‑human primates, according to a Nature Biotechnology report. The approach used...
FDA clears first blood‑based AD test: plasma pTau217/Ab42 ratio authorized
The FDA cleared Fujirebio Diagnostics’ Lumipulse plasma pTau217/β‑amyloid 1‑42 ratio test for detecting amyloid pathology in adults aged 50 and older with cognitive impairment, marking the first...
Chiesi, Arbor Strike up-to-$2.1B Gene‑Editing Pact for Rare Liver Diseases
Chiesi Group agreed to an exclusive collaboration and license with Arbor Biotechnologies to develop Arbor’s ABO‑101, an in‑vivo liver‑directed CRISPR Cas12i2 therapy for primary hyperoxaluria type...
FDA Clears Boehringer’s Jascayd — First New IPF Pill in a Decade
The U.S. Food and Drug Administration approved Boehringer Ingelheim’s Jascayd (nerandomilast), a twice‑daily oral preferential PDE4B inhibitor, for idiopathic pulmonary fibrosis (IPF), the first...
Serial Tumor Biopsies… Reveal GBM Immune Signals Missed by MRI
Teams at Mass General Brigham, Harvard Medical School and Break Through Cancer reported that serial, longitudinal tumor biopsies in patients with recurrent glioblastoma exposed deep intratumoral...
Nilo Launches With $101M… Targets Neural Circuits to Quiet Inflammation
Nilo Therapeutics launched with a $101 million Series A to develop small molecules that modulate defined brain–body neural circuits controlling systemic inflammation. The round was led by The...