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Lilly and Ascidian strike up-to-$1.9B RNA exon editing deal
Eli Lilly entered a global research and licensing collaboration with Ascidian Therapeutics worth up to $1.9 billion to pursue RNA exon editor therapies for inherited kidney diseases. Ascidian’s...
Phase 3 daraxonrasib doubles survival in advanced pancreatic cancer
Revolution Medicines’ daraxonrasib produced a major survival improvement in a Phase 3 trial of advanced pancreatic cancer, with median overall survival increasing to 13.2 months versus 6.7 months...
Regulatory guidance clarifies how cell and gene therapy sponsors can reuse prior knowledge
The FDA’s Center for Biologics Evaluation and Research (CBER) published draft guidance describing how cell and gene therapy developers can leverage prior knowledge across clinical, nonclinical,...
IMU raises $53M Series A to scale high-definition immune profiling
IMU Biosciences closed an expanded Series A funding round totaling £40 million (about $53.9 million), adding £28.5 million to an earlier close in January 2024. The company says it has built a...
Chinese trial clearance expands CSPC’s SYS-6063 mRNA-LNP CAR T into SLE
CSPC Pharmaceutical Group’s SYS-6063 gained clinical trial clearance from China’s National Medical Products Administration for systemic lupus erythematosus. SYS-6063 is described as an...
Agilent wins expanded FDA nod for Keytruda CDx on Dako Omnis
Agilent Technologies received expanded FDA approval for its Keytruda CDx companion diagnostic, enabling the PD-L1 IHC 22C3 pharmDx Code GE006 assay to be used across additional cancers on the...
New CAR T and trial-era signals: Regeneron expands CytomX pact value
Regeneron expanded its partnership with CytomX Therapeutics by paying $37 million and adding options on conditionally active bispecifics targeting two targets. The expansion increases the deal’s...
China trial-data protection rules move closer to global standard alignment
China’s National Medical Products Administration issued final implementation measures for drug trial data protection, a step intended to align China’s pharmaceutical intellectual property...
FDA and Companion-Diagnostics Updates
Agilent Technologies expanded FDA approval for its Keytruda companion diagnostic, enabling its PD-L1 IHC 22C3 pharmDx Code GE006 assay to be used across additional cancers on the automated Dako...
Phase 3 Oncology Readouts and Label-Relevant Signals
Revolution Medicines’ daraxonrasib delivered a major phase 3 result in previously treated metastatic pancreatic ductal adenocarcinoma, with the drug extending overall survival by more than six...
Big Pharma Genetics Dealmaking
Eli Lilly and Ascidian Therapeutics launched an RNA exon editing research collaboration targeting inherited kidney diseases that could be worth up to $1.9 billion. The pact funds discovery and...
Biotech Licensing and Pipeline Expansion in Rare Kidney Disease
Travere Therapeutics broadened its rare kidney portfolio by exclusively licensing civorebrutinib from Everest Medicines in a deal potentially worth more than $1.14 billion. The agreement adds...
Sickle Cell Program Disruption After FDA Safety Concerns
Fulcrum Therapeutics halted development of its sickle cell disease candidate pociredir and initiated a strategic review after the FDA raised heightened concerns about risks and benefits in the...
Large-Scale Financing: Anti-Aging Startup NewLimit Moves to Human Testing
NewLimit raised $435 million in a Series C round at a $3B+ valuation to push an anti-aging program toward human testing. The financing, led by Founders Fund, includes participation from Thrive...
Diagnostic Data and Lab Automation Partnerships
NanoMosaic and Solid Biosciences agreed to comarket offerings to support gene therapy developers’ analytics workflows, pairing NanoMosaic’s Tessie platform with Solid’s Polaris-101 capsid...
Strategic AI-to-Healthcare Collaboration: Mayo and Microsoft
Mayo Clinic and Microsoft launched a collaboration to develop a frontier AI model for healthcare use, combining Mayo’s clinical expertise with de-identified data assets and Microsoft’s AI...
Gene Therapy Trial Mechanics: IND Clearances and Trial Enablers
Voyager Therapeutics received FDA IND clearance for VY-1706, an investigational gene therapy aimed at intracellular and extracellular tau for Alzheimer’s disease. The IND approval allows Voyager...
Clinical Trials, Biomarkers, and Platform-Driven Oncology Monitoring
A new spatial transcriptomics–guided biomarker approach presented at ASCO aimed to predict which metastatic hormone-sensitive prostate cancer patients are more likely to benefit from adding...
Pancreatic cancer: RAS-pathway targeted survival benefit at Phase 3 readout
Revolution Medicines’ daraxonrasib delivered a practice-changing overall survival gain in the Phase 3 RASolute 302 trial for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC),...
Sickle cell gene regulation drug: FDA risk concerns derail Fulcrum’s PRC2 inhibitor program
Fulcrum Therapeutics said the U.S. FDA has heightened concerns about the risks and benefits of pociredir, prompting the company to discontinue its sickle cell disease (SCD) development program and...