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Gene therapy delivery and redosing hurdles for AAV
ASGCT highlighted strategies to address AAV’s long-standing “one-and-done” limitation, focusing on redosing approaches and overcoming pre-existing immunity that can blunt subsequent...
Clinical trial readout pressures for nonviral gene therapy in bladder cancer
enGene’s Phase II LEGEND interim updates for detalimogene voraplasmid delivered a deterioration versus earlier expectations, triggering a sharp investor selloff. The updated data showed complete...
Early clinical data update for AbCellera’s ABCL635
AbCellera reported Phase 1 data for ABCL635, adding new evidence for the company’s pipeline momentum as it advances its antibody-development platform. While the excerpt does not provide outcome...
Cardiovascular siRNA licensing deal
GSK took rights to a cardiovascular siRNA program from China-based SiranBio, targeting ALK7. The agreement covers most global rights but excludes mainland China, Hong Kong, Macau and Taiwan, where...
Gene-therapy regulatory test in Europe for GLP-1 replacement strategy
European regulators cleared Fractyl Health’s clinical test of a GLP-1 gene therapy, placing the company at the center of the race to deliver “one-and-done” alternatives to chronic GLP-1 injections...
Digital pathology M&A consolidation
Roche agreed to acquire PathAI in a deal valued at $750 million upfront, aiming to strengthen AI-powered digital pathology capabilities used by pathology labs and biopharma customers. The...
Obesity biotech celebrates early Phase 1 signal in crowded GLP-1 field
MBX Biosciences drew investor attention after preliminary Phase 1 data suggested efficacy and tolerability for its monthly obesity drug MBX-4291, a GLP-1/GIP co-agonist prodrug. The company...
Venture-scale funding for respiratory antibody programs
Windward Bio secured $165 million for clinical trials targeting respiratory diseases, according to the company’s financing announcement. The round will support a lead program in respiratory...
Big Pharma makes a China push via a large cross-pipeline deal
Bristol Myers Squibb moved deeper into China’s oncology R&D ecosystem by signing a broad partnership with Hengrui Pharma, agreeing to pay $600 million upfront for 13 early-stage programs spanning...
FDA approval lands for a bispecific targeting an ultra-rare NRG1-driven cancer
Partner Therapeutics secured its first FDA approval with Bizengri, a bispecific antibody for advanced cholangiocarcinoma driven by NRG1 gene fusions. The approval adds a new targeted option for a...
Roche buys PathAI to accelerate AI digital pathology inside pharma workflows
Roche announced it will acquire PathAI in a deal valued at $750 million upfront, aiming to expand AI-powered digital pathology capabilities for pathology labs and biopharma development. PathAI’s...
Gene therapy setbacks and investor repricing in nonviral delivery
enGene’s stock tumbled after updated Phase II LEGEND trial data for its nonviral gene therapy candidate detalimogene voraplasmid in high-risk BCG-unresponsive nonmuscle invasive bladder cancer....
AAV redosing pressure grows as ASGCT spotlights one-and-done constraints
ASGCT highlighted a core challenge for AAV gene therapy: redosing constraints driven by pre-existing immunity and immune responses that can limit future administrations. In a roundup of...
FDA clears an abdominal sensor expanding multichannel urodynamics
Bright Uro received FDA 510(k) clearance for the Glean abdominal sensor, expanding the Glean urodynamics system to support multichannel urodynamic studies. The sensor enables clinicians to capture...
GSK secures siRNA cardiovascular rights from SiranBio for ALK7 target
GSK took rights to a cardiovascular siRNA program from China-based SiranBio, centered on ALK7 knockdown linked to reductions in visceral fat and cardiovascular risk markers. The agreement grants...
Windward Bio raises $165M to push long-acting respiratory antibodies into trials
Windward Bio raised $165 million to support clinical testing of its respiratory antibody programs, positioning the company for trials in asthma, COPD, and related inflammatory indications. The...
New AI gene-ordering platform targets faster, more reliable research execution
Genewiz launched Gene Synthesis 2.0, upgrading how researchers design and order genes through a faster, packaged ordering experience and updated codon optimization. The platform includes Sprint,...
Immunology and platform scaling: Nuclera launches antibody triage service
Nuclera introduced an antibody triage screening service designed to speed the transition from AI or in silico hit generation to lead selection and mammalian validation. The service screens large...
Regulatory approval — ultra-rare fusion cancer
Partner Therapeutics’ Bizengri (bispecific antibody) became the first FDA-approved therapy for advanced cholangiocarcinoma driven by NRG1 gene fusions, marking a regulatory milestone for a...
M&A — Roche buys PathAI to scale AI in pathology
Roche agreed to acquire PathAI in a deal valued at $750 million upfront, aiming to accelerate AI-powered digital pathology across pathology laboratories and biopharma workflows. The transaction...