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CRISPR gene editing regulatory push
Intellia Therapeutics advanced its in vivo CRISPR program for hereditary angioedema, signaling potential FDA momentum after Phase 3 results. The company’s one-time lonvo-z treatment cut hereditary...
Big Pharma M&A heats up around next-gen oncology and women’s health
Eli Lilly agreed to acquire Ajax Therapeutics for up to $2.3 billion to expand its next-generation JAK franchise for myeloproliferative neoplasms. Lilly will gain access to AJ1-11095, a Type II...
RAS-targeting oncology rivalry escalates with new early efficacy readouts
Erasca reported preliminary efficacy data for its RAS-targeting oral drug ERAS-0015, reporting tumor shrinkage in 40% of patients with advanced pancreatic cancer and 62% of patients with advanced...
Bispecific antibody setbacks in biliary tract cancer
Compass Therapeutics shared additional results from its Companion-002 Phase 2/3 program for the DLL4/VEGF-A bispecific tovecimig in second-line biliary tract cancer. The new data included mixed...
Regenerative medicine and cell therapy outcomes
Fred Hutchinson Cancer Center reported a transplantation approach using pooled umbilical cord blood stem cells that achieved a 96% survival rate and eliminated graft-versus-host disease in...
Immunology and autoimmune drug development signals
Oruka Therapeutics reported mid-stage psoriasis results for ORKA-001, an IL-23 monoclonal antibody with long-acting potential. In a Phase 2 trial, Oruka said 40 of 63 patients achieved PASI 100 at...
Cardiovascular AI/biomarker and diagnostic platform funding
PlaqueTec raised $5 million in an oversubscribed financing round to support its coronary artery disease biomarker effort. The company is running a clinical trial called BIOPATTERN designed to...
Microbiology diagnostics market activity and stewardship
Cepheid and other diagnostics players presented updates on rapid multiplex infectious disease testing at ESCMID, including workflow improvements designed to improve diagnostic stewardship....
Clinical evidence for procedural first-line management of advanced atrial fibrillation
An international clinical trial led by the University of British Columbia reported results in advanced atrial fibrillation that challenge the default approach of beginning with medication....
Genetic medicine delivery and production optimization
Whitehead Institute researchers reported a genome-wide screening platform to identify modifications in producer cells that improve the production and delivery potency of engineered virus-like...
Women’s health and biosimilars M&A
Sun Pharmaceutical agreed to acquire Organon, the Merck spinoff women’s health and biosimilars business, in an all-cash $11.75B deal. The transaction is intended to push Sun toward a top three...
Next-gen RAS targeting in pancreatic and lung cancer
Erasca reported preliminary tumor-shrinking data for its RAS-targeting pill ERAS-0015 in advanced pancreatic and non-small cell lung cancer, describing results that exceeded its expectations. The...
Patent risk around RAS cancer programs
Revolution Medicines’ lawyers issued a legal threat targeting Erasca’s RAS program, setting up the risk of a dispute over patents and efficacy claims. Erasca said it received the threat after a...
CRISPR gene editing reaches Phase 3 milestone for hereditary angioedema
Intellia’s in vivo CRISPR therapy lonvo-z succeeded in a Phase 3 trial for hereditary angioedema, sharply reducing attack rates in patients with the rare swelling disorder. Intellia said it...
AI-designed gene therapy delivery improvements (eVLP production)
Researchers from Whitehead Institute reported a genome-wide screening approach to identify producer-cell modifications that improve production and delivery potency of engineered virus-like...
Oncology dealmaking: Lilly expands JAK portfolio with Ajax buy
Eli Lilly agreed to acquire Ajax Therapeutics for up to $2.3B in cash to gain access to next-generation JAK2 inhibitor assets in myeloproliferative neoplasms. Lilly will receive Ajax’s lead...
Immunotherapy failure signal in biliary cancer
Compass Therapeutics released additional results from its Companion-002 phase II/III study of tovecimig in combination with paclitaxel in second-line biliary tract cancer. The new update included...
Psoriasis competition heats up with Oruka’s IL-23 long-acting data
Oruka Therapeutics reported mid-stage results for ORKA-001, a long-acting IL-23 monoclonal antibody, in plaque psoriasis and also provided updated exposure analysis supporting once-per-year...
Biomarker tech financing for coronary artery disease
PlaqueTec raised $5M in an oversubscribed round to expand its work on intracoronary blood-protein biomarkers for coronary artery disease. The company’s BIOPATTERN clinical trial uses a device that...
Diagnostics regulation pressure in Europe (IVDR concerns)
Clinical microbiologists warned at ESCMID that Europe’s IVDR implementation may reduce patient access to diagnostic tests and constrain development of new assays. Stakeholders cited real-world...