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Regulatory approval: prostate cancer companion diagnostic
Japan’s Ministry of Health, Labour and Welfare approved Myriad Genetics’ MyChoice as a companion diagnostic for selecting prostate cancer patients who may benefit from AstraZeneca’s PARP inhibitor...
Corporate dealmaking: Lilly acquires CrossBridge Bio for ADC platform expansion
Eli Lilly agreed to buy Houston-based CrossBridge Bio for up to $300 million to expand its antibody-drug conjugate (ADC) portfolio. The acquisition adds CrossBridge’s dual-payload ADC approach and...
Oncology trial readout: Revolution’s daraxonrasib posts interim-to-final survival endpoints
Revolution Medicines reported that daraxonrasib met overall survival and progression-free survival endpoints in a Phase 3 trial in metastatic pancreatic ductal adenocarcinoma, with results...
Cell therapy: Allogene reports off-the-shelf CAR-T MRD signal in lymphoma
Allogene Therapeutics provided an interim futility readout from its randomized Phase 2 Alpha3 trial evaluating cema-cel, an off-the-shelf CAR-T, in first-line consolidation large B-cell lymphoma....
Immuno-oncology diagnostics: Harbinger secures $100M to commercialize multi-cancer blood tests
Harbinger Health announced a $100 million Series B financing to support commercialization plans for its Resolve blood-based multi-cancer detection tests. The company said the funding will back the...
Translational neuro/clinical research: ARPA-H backs sonogenetics therapy push
The Salk Institute said its sonogenetics team, led by associate professor Sreekanth Chalasani, received $41.3 million from ARPA-H to advance ultrasound-controlled protein therapeutics toward human...
Regulatory strategy and access: CMS accelerates prior authorization timelines
The U.S. Centers for Medicare & Medicaid Services proposed a rule intended to bring prior authorization into a faster, more transparent workflow. CMS would require insurers to respond within 24...
Biotech market activity: Sidewinder raises for next-generation bispecific ADCs
Sidewinder Therapeutics closed a $137 million Series B financing to advance a pipeline of bispecific ADCs. The company plans to use the funding to progress SWT012 toward an Investigational New...
Radiopharmaceutical collaboration: Regeneron enters radiopharma via Telix deal
Regeneron agreed to partner with Telix Pharmaceuticals to co-develop and co-commercialize multiple radiopharmaceutical programs, marking Regeneron’s entry into radiopharmaceuticals. Under the...
Immunology diagnostics/biomarkers: Biognosys and MJFF collaborate on LRRK2 targeted proteomics assays
Biognosys and the Michael J. Fox Foundation for Parkinson’s Research (MJFF) announced a collaboration to develop targeted mass spectrometry biomarker assays for Parkinson’s disease drug...
Pancreatic cancer—registrational win for RAS inhibition
Revolution Medicines reported Phase 3 success for daraxonrasib (RAS inhibitor) in metastatic pancreatic ductal adenocarcinoma, saying the drug met survival and progression endpoints in a...
Kidney disease—first US approval for FSGS therapy
The FDA expanded Travere Therapeutics’ Filspari (sparsentan) label, making it the first US-approved therapy for focal segmental glomerulosclerosis (FSGS). The update builds on Filspari’s earlier...
Cell therapy—early Phase 2 futility analysis supports off-the-shelf CAR-T in lymphoma
Allogene Therapeutics disclosed an early look at Phase 2 consolidation data for its off-the-shelf CAR-T, cema-cel, in first-line large B-cell lymphoma (LBCL), reporting deeper minimal residual...
Radiopharmaceuticals—Regeneron and Telix expand into radiopharma via co-development deal
Regeneron moved into radiopharmaceuticals through a collaboration with Telix Pharmaceuticals, expanding the antibody portfolio into next-generation solid-tumor radiopharma and diagnostics. Under...
Inflammatory bowel disease—Phase 2 ulcerative colitis data for SPY001
Spyre Therapeutics reported early Phase 2 results for SPY001 in ulcerative colitis, with statistically significant improvements on a disease activity index and remission rates at 12 weeks. The...
FDA oversight—clinical trial results reporting enforcement
The FDA urged clinical trial sponsors to report outcomes of registered studies, citing a results-reporting gap across the clinical registry landscape. An FDA review found that results were not...
Neuroscience deals—Takeda ends Denali partnership, regains DNL593 rights
Takeda ended its long-term neuroscience partnership with Denali Therapeutics, returning full global rights to DNL593, a therapy for frontotemporal dementia, to Denali. Takeda said the decision...
Drug discovery partnerships—Lilly’s $2.75 billion AI collaboration with Insilico
Eli Lilly signed a global R&D collaboration with Insilico Medicines worth up to $2.75 billion, extending the company’s push to apply AI to end-to-end drug discovery. Insilico will receive an $115...
Gene editing—compact CRISPR system targets in-body editing with high efficiency
Researchers reported a compact CRISPR-based gene-editing system designed for targeted delivery inside the body, aiming to address a key bottleneck for therapeutic genome editing. The approach uses...
Oncology pipeline financing—Sidewinder funds next-gen bispecific ADC development
Sidewinder Therapeutics raised $137 million in a Series B to advance a pipeline of bispecific antibody-drug conjugates (ADCs). The financing, co-led by Frazier Life Sciences and the Novartis...