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Rare kidney disease pipeline expansion via licensing
Travere Therapeutics is stepping up its rare kidney disease pipeline by paying Everest Medicines $112.5 million upfront for a drug program targeting a broader set of rare kidney indications beyond...
Bipolar depression regulatory acceleration
Autobahn Therapeutics received FDA Fast Track designation for elunetirom (ABX-002) as an adjunctive treatment for depressive episodes in adults with bipolar I or bipolar II disorder. The...
Immunotherapy and oncology: PD-(L)1/VEGF bispecific overall survival win in China
Akeso’s ivonescimab delivered a statistically significant overall survival improvement in a Phase 3 lung cancer regimen presented at ASCO. In interim data from the Harmoni-6 trial in China,...
Diagnostics regulation: FDA clears FoundationOne CDx as CDx in prostate cancer
The FDA approved Foundation Medicine’s FoundationOne CDx assays as companion diagnostics for Pfizer’s Talzenna plus Xtandi regimen in metastatic castration-resistant prostate cancer with...
Cell and gene therapy innovation: IND clearance for tau-targeted Alzheimer’s gene therapy
Voyager Therapeutics received FDA IND clearance for VY-1706, an investigational gene therapy targeting intracellular and extracellular tau for Alzheimer’s disease. The company’s IND path indicates...
Clinical and regulatory: TIL therapy IND clearance for Iovance
Iovance Biotherapeutics received FDA IND clearance for IOV-5001, a next-generation tumor-infiltrating lymphocyte (TIL) therapy engineered with an interleukin-12 (IL-12) tethering component. The...
Microbial and antibiotic innovation: CRISPR therapy approach for Shiga toxin-producing E. coli
French researchers at Eligo Bioscience and collaborators published results on EB-003, a CRISPR-based antimicrobial approach targeting Shiga toxin-producing E. coli (STEC). The strategy comes amid...
Oncology diagnostics product launch: Veracyte begins Prosigna LDT in the US
Veracyte launched Prosigna Breast Risk of Recurrence as a laboratory-developed test (LDT) in the US after ASCO data suggested the assay can safely guide adjuvant treatment decisions for patients...
FDA approvals—new companion diagnostics and label expansions
The FDA approved new Foundation Medicine companion diagnostics tied to Pfizer’s prostate cancer regimen, extending the clinical footprint of FoundationOne CDx as a decision tool for specific...
Big pharma dealmaking—acquisitions and licensing that reshape pipelines
Servier agreed to acquire Edgewise Therapeutics’ muscular dystrophy business in a transaction valued at up to $2.65 billion, betting that neuromuscular franchise scale can accelerate its neurology...
Clinical setbacks and label-driven market swings
Abivax’s ulcerative colitis maintenance results showed a high-efficacy signal, but reported cancer cases among recipients pulled the focus away from effectiveness and weighed heavily on sentiment....
ASCO 2026—oncology efficacy updates and trial readouts
At ASCO 2026, Revolution Medicines delivered detailed Phase 3 data for daraxonrasib, a pan-RAS inhibitor, in previously treated metastatic pancreatic ductal adenocarcinoma. The report follows...
ASCO 2026—diagnostics adoption steps after clinical evidence
Veracyte launched its Prosigna breast risk of recurrence assay in the U.S. after investors received trial data presented at ASCO demonstrating that the test can guide adjuvant therapy decisions...
Private placements and reverse mergers—companies aiming for Nasdaq access
Rallybio moved to a new reverse-merger structure with Avenzo to reach Nasdaq after its prior Candid deal was overtaken by a UCB acquisition. The new transaction pairs a reverse merger with a $215...
Advancing biomarkers and treatment selection through AI-enabled methods
A spatial-transcriptomics approach presented at ASCO predicted docetaxel benefit in metastatic hormone-sensitive prostate cancer using only routine H&E slides as a starting point. The biomarker...
Immuno-oncology competition in lung cancer—Phase 3 overall survival data
Akeso’s ivonescimab, a PD-1/VEGF bispecific, met a key Phase 3 overall survival milestone in Harmoni-6, with an interim analysis presented at ASCO 2026. The data showed a statistically significant...
Regulatory and safety disruption—companies exiting or pausing programs after feedback
Fulcrum Therapeutics scrapped its sole clinical-stage sickle cell ambitions and will seek an exit after FDA feedback tied to safety concerns referenced a recently withdrawn cancer drug from Ipsen....
Imaging and diagnostics tools—new platforms for faster detection
A University of Waterloo initiative described a real-time brain monitoring system intended for intensive care settings, aiming to flag infections earlier through continuous monitoring in patients...
Obesity care funding
Ilant Health, a virtual obesity-care startup, raised a $15 million Series A to expand its personalized approach for weight management. The funding is aimed at scaling the company’s employer and...
Epilepsy clinical setback
Praxis Precision Medicines paused enrollment in its POWER2 phase 3 study of vormatrigine after the drug missed the primary endpoint in the POWER1 phase 2/3 trial for focal onset seizures (FOS)....