Get the Daily Brief
Latest Biotech News
KRAS G12C in lung cancer — Phase 3 head-to-head results
Genentech’s KRAS G12C inhibitor divarasib reported superior Phase 3 results in previously treated NSCLC patients in the Krascendo 1 trial, showing clinically meaningful and statistically...
Rare kidney transplant virology — Ipsen buys Memo Therapeutics
Ipsen agreed to acquire Memo Therapeutics AG for up to €700 million to expand its rare-disease pipeline with potravitug, Memo’s Phase II clinical-stage monoclonal antibody targeting BK...
Cell therapy approvals in HSCT — Orca Bio’s Tregzi gets FDA nod
The FDA approved Orca Bio’s personalized regulatory T-cell therapy, Tregzi, for matched-donor allogeneic hematopoietic stem cell transplantation (HSCT), with the goal of reducing chronic...
Neurostimulation device gets FDA breakthrough — prevention after brain bleed
Aurenar’s V-Link earned FDA breakthrough device designation after early trials showed it reduced cerebral vasospasm by more than 40%, targeting complications tied to brain hemorrhage. The...
Lung cancer KRAS G12C — Roche Phase 3 head-to-head win
Roche said its KRAS G12C inhibitor divarasib beat Amgen’s Lumakras and Bristol Myers Squibb’s Krazati in a Phase 3 head-to-head study, providing a second, confirmatory push toward standard-of-care...
IPF therapeutics — Celea raises $180m to launch deupirfenidone into late-stage
PureTech-backed Celea Therapeutics raised $180 million to advance deupirfenidone, its retooled pirfenidone program for idiopathic pulmonary fibrosis (IPF), toward late-stage testing beginning in...
PTSD neurostimulation — Neurovalens gets FDA de novo clearance via VA pathway
Neurovalens’ Modius Spero became the first FDA-cleared neuromodulation device for treating PTSD symptoms, with access routed through the US Department of Veterans Affairs after FDA de novo...
Biopharma financing momentum — H1 2026 fundraising surges
Biopharma financings more than doubled in the first half of 2026, reaching $59.76 billion across 567 deals, according to an analysis of public, private, and other financings. The total compares...
Genomics platform for rare disease — Talos enables automated genomic reanalysis
An open-source tool called Talos demonstrated a scalable path for automated genomic reanalysis in an evaluation of 4,735 unsolved rare disease genomes, reporting 241 diagnoses, with over half...
Genomics data infrastructure — Genomics England and Lifebit build trusted environment
Genomics England said it will work with Lifebit to develop a trusted research environment for studies in cancer and rare disease, using secure digital workspaces designed to keep sensitive genomic...
Late-stage oncology readouts: KRAS G12C precision battle heats up
Roche’s Genentech reported superior Phase 3 interim results for its KRAS G12C inhibitor divarasib in previously treated non-small-cell lung cancer in the head-to-head Krascendo 1 trial. The...
Regenerative medicine & transplantation: Orca’s Tregzi wins FDA approval
The FDA approved Orca Bio’s personalized T-cell therapy, branded Tregzi, for matched-donor allogeneic hematopoietic stem cell transplantation (HSCT) in adults with hematologic malignancies. Orca...
Rare disease M&A: Ipsen buys Memo Therapeutics’ BK virus antibody
Ipsen agreed to acquire Memo Therapeutics AG, aiming to add potravitug, a monoclonal antibody targeting BK polyomavirus associated nephropathy in kidney transplant recipients, to its rare disease...
Cell therapy coverage & diagnostics access: Guardant Health wins broader CRC screening reimbursement
UnitedHealthcare said it will cover Guardant Health’s Guardant Shield multicancer screening test for colorectal cancer as a first-line screening assay, expanding access for average-risk patients....
Regulatory technology & medical devices: Aurenar’s ear-based therapy gets FDA breakthrough designation
Aurenar’s V-Link, a non-invasive nerve stimulation device intended to prevent cerebral vasospasm after brain hemorrhage, received FDA breakthrough device designation after early trials showed it...
Funding and late-stage bets: PureTech-backed Celea raises $180M to push deupirfenidone in IPF
Celea Therapeutics, backed by PureTech, raised $180 million to advance deupirfenidone, its retooled pirfenidone program for idiopathic pulmonary fibrosis. The company said proceeds will be used to...
Clinical evidence platform: Talos automates rare-disease genomic reanalysis at scale
A research team from Australia’s Centre for Population Genomics, in collaboration with Australian Genomics, the Broad Institute, and Microsoft Research, reported an open-source automated...
Neurostimulation commercialization: Neurovalens Modius Spero clears FDA for PTSD in veterans
Neurovalens’ Modius Spero became the first FDA-approved neuromodulation device cleared for treating PTSD symptoms in the U.S., with access planned through the Department of Veterans Affairs. The...
Cancer diagnostics: SkylineDx melanoma gene expression test wins FDA breakthrough designation
SkylineDx said its Merlin CP-GEP clinicopathologic gene expression profiling assay received FDA breakthrough device designation for early-stage cutaneous melanoma risk assessment. The binary test...
Oncology drug pairing strategy: Revolution’s early data points to Phase 3 KRAS combination in pancreatic cancer
Revolution Medicines shared early-stage data supporting a planned Phase 3 trial in pancreatic cancer that combines two KRAS-targeting drugs. The company said it will evaluate the combination after...