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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...
Soufflé Raises $200M — Langer‑Backed RNA Startup Targets Cell‑Specific siRNA
Soufflé Therapeutics emerged from stealth with a $200 million Series A to develop cell‑specific siRNA therapeutics, the company announced. The financing and founding team include figures tied to...
US Pumps Money into In‑Vivo Cell Therapies: ARPA‑H Backs Multiple Teams
The U.S. government, led by ARPA‑H, awarded funding to several teams to accelerate development of in‑vivo cell and gene therapies aimed at programming immune cells directly inside the body....
NIH Backs Longevity Study—$80M to Sequence 7.8K with PacBio HiFi
The Long Life Family Study (LLFS) secured $80 million in NIH funding to expand a longevity cohort and apply Pacific Biosciences’ Revio HiFi long‑read sequencing to as many as 7,800 participants....
Tagomics Publishes Active‑Seq… New Enzymatic Route for cfDNA Epigenomics
Tagomics published a methods paper in Cell Reports Methods describing Active‑Seq, an enzymatic, methyltransferase‑directed tagging and enrichment approach that profiles unmodified (unmethylated)...
Intellia CSO Updates ESGCT… LNP Editing Shows Durable Kallikrein Knockdown
Intellia Therapeutics provided a clinical update at ESGCT on its in‑vivo LNP editing programs. CSO Birgit Schultes reported that NTLA‑2002 (lonvo‑z), an LNP‑delivered therapy for hereditary...
Ex‑CBER Chief Peter Marks Joins Lilly as SVP of Molecule Discovery
Peter Marks, formerly director of the FDA’s Center for Biologics Evaluation and Research (CBER), joined Eli Lilly as senior vice president for molecule discovery and head of infectious disease....
FDA clears Boehringer pill for IPF: first new approval in a decade
The U.S. Food and Drug Administration approved Boehringer Ingelheim’s nerandomilast, to be marketed as Jascayd, for idiopathic pulmonary fibrosis (IPF). The decision, announced Oct. 7, 2025,...
FDA orders DPYD testing on Xeloda: boxed warning now mandates genetic screening
The FDA updated the label for Genentech’s capecitabine (Xeloda) to include an explicit boxed warning recommending DPYD genetic testing before initiating therapy when clinically possible. The...
Intellia clinical update: lonvo‑z cuts kallikrein long term – HAE program leads pipeline
At the ESGCT meeting in Seville, Intellia Therapeutics provided clinical updates on its in vivo CRISPR and LNP delivery programs, highlighting NTLA‑2002 (lonvo‑z) for hereditary angioedema (HAE)....
Neuro‑immune startup Nilo lands $101M: targets brain circuits to fix immune disease
Nilo Therapeutics launched with $101 million in Series A financing to develop therapies that modulate specific neural circuits to restore immune homeostasis. The New York‑based company was founded...
Arthrosi closes $153M Series E to race to Phase 3 gout readouts
Arthrosi Therapeutics raised $153 million in a Series E financing led by Prime Eight Capital to complete two fully enrolled Phase 3 trials of AR882 (pozdeutinurad), a next‑generation URAT1...
Sanofi’s alpha radioligand hits Phase 2 goals – response in neuroendocrine tumors
Sanofi reported that AlphaMedix, its lead targeted alpha therapy developed with Orano Med and RadioMedix, met the primary endpoints in a Phase 2 study of unresectable or metastatic...