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Eczema readouts lift stocks: Evommune posts Dupixent-like Phase II; Nektar shows one-year maintenance
Two mid-stage immunology results shifted competitive dynamics in atopic dermatitis. Evommune reported EVO301 achieved a statistically significant Eczema Area and Severity Index (EASI) reduction...
ILiAD raises $115M to push live-attenuated pertussis vaccine into Phase III
ILiAD Biotechnologies closed an oversubscribed $115 million Series B led by RA Capital and joined by institutional investors to advance BPZE1, a live-attenuated intranasal pertussis vaccine, into...
CMS covers Personalis MRD assay for lung cancer surveillance: commercial access expands
The Centers for Medicare & Medicaid Services granted coverage for Personalis’ NeXT Personal molecular residual disease (MRD) test for surveillance of stages I–III non–small cell lung cancer. The...
AI-designed antibody company Generate files IPO as Phase III asthma dosing begins
Generate Biomedicines filed for an initial public offering shortly after dosing the first patient in Phase III trials of GB-0895, an AI-designed anti-TSLP antibody for severe asthma. The company...
Oncolytic virus reshapes glioblastoma microenvironment – one-injection immune remodelling
Researchers at Mass General Brigham and Dana-Farber demonstrated that a single injection of a genetically engineered oncolytic virus can reshape the glioblastoma tumor microenvironment, increasing...
Thermo Fisher teams with Datavant to link research datasets with real‑world patient records
Thermo Fisher Scientific’s PPD clinical research business has partnered with Datavant to enable privacy-preserving linkage of clinical research datasets to broad real-world data (RWD) sources....
FDA refuses review of Moderna’s mRNA flu shot — company pushes back
The U.S. Food and Drug Administration issued a refusal-to-file (RTF) letter for Moderna’s mRNA influenza vaccine candidate mRNA-1010, and Moderna publicly disputed the agency’s rationale. The FDA...
Evommune’s IL‑18 fusion posts Dupixent-like phase II gains — stock rockets
Evommune reported phase 2a results for EVO301, an IL‑18–binding long‑acting fusion protein, showing statistically significant improvement in Eczema Area and Severity Index (EASI) versus placebo....
Madrigal pays upfront to add six siRNA MASH programs — $4.4B upside
Madrigal Pharmaceuticals struck a licensing and option deal to add six preclinical siRNA programs from Ribo Life Science to its metabolic dysfunction‑associated steatohepatitis (MASH) portfolio,...
ILiAD raises $115M Series B to fast‑track intranasal pertussis vaccine
ILiAD Biotechnologies closed an oversubscribed $115 million Series B to advance BPZE1, a live‑attenuated intranasal pertussis vaccine, into Phase III development. RA Capital led the round and...
FDA issues CRL to Regenxbio — gene‑therapy approval delayed
The FDA issued a complete response letter (CRL) for Regenxbio’s RGX‑121 gene therapy for mucopolysaccharidosis II (Hunter syndrome), marking a significant regulatory setback. The agency raised...
Capsida confirms cerebral edema in halted AAV trial — investigation continues
Capsida Biotherapeutics reported that autopsy results in a halted SYNRGY clinical trial confirmed cerebral edema as the cause of a patient’s death following intravenous AAV gene‑therapy dosing for...
CMS covers Personalis NeXT Personal MRD test for lung cancer surveillance
The Centers for Medicare & Medicaid Services granted Medicare coverage for Personalis’ NeXT Personal molecular residual disease (MRD) test to support surveillance of stages I–III non‑small cell...
Thermo Fisher and Datavant tie trial data to real‑world records — privacy tokens enabled
Thermo Fisher Scientific’s PPD clinical research business partnered with Datavant to enable privacy‑preserving linkage of de‑identified research datasets to real‑world patient records across a...
Generate Biomedicines files IPO as Phase III dosing begins for AI‑designed antibody
Generate Biomedicines filed for an initial public offering days after initiating Phase III dosing for GB‑0895, an AI‑designed anti‑TSLP antibody for severe asthma. The company said proceeds will...
Microbiotica’s oral live biotherapeutic posts positive Phase Ib UC remission rates
Microbiotica reported positive Phase Ib data for MB‑310, an orally administered live biotherapeutic for ulcerative colitis: 12 of 19 treated patients achieved clinical remission versus 3 of 10 on...
FDA refuses to review Moderna’s mRNA flu shot: regulator flags trial design
The FDA has refused to begin formal review of Moderna’s mRNA influenza vaccine application, citing deficiencies in the pivotal trial’s control arm and trial design. The decision was signed by...
PTAB invalidates Exact Sciences patents: Geneoscopy says it clears path for ColoSense
The Patent Trial and Appeal Board issued a final written decision invalidating claims from Exact Sciences’ US Patent No. 11,970,746 after an inter partes review requested by Geneoscopy. The PTAB...
ILiAD raises $115M to push live pertussis vaccine into pivotal testing
ILiAD Biotechnologies closed an oversubscribed $115 million Series B led by RA Capital to advance BPZE1, a live attenuated intranasal pertussis vaccine, toward Phase III development. The funding...
Eczema readouts shake up immunology field — Evommune and Nektar post strong Phase II data
Two mid-stage immunology readouts delivered large market reactions: Evommune reported Dupixent‑comparable EASI reductions with EVO301 in atopic dermatitis, while Nektar said rezpegaldesleukin...