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Microbiotica’s oral live therapeutic posts robust Phase Ib remission rates
Microbiotica reported positive Phase Ib results for MB‑310, an oral live biotherapeutic for ulcerative colitis: 12 of 19 treated patients achieved clinical remission versus three of 10 on placebo....
Medicare expands coverage for Personalis MRD assay in lung cancer surveillance
The Centers for Medicare & Medicaid Services granted coverage for Personalis’s NeXT Personal molecular residual disease (MRD) test for surveillance of stages I–III non‑small cell lung cancer. CMS...
Thermo Fisher and Datavant link RWD platforms — privacy tokens at scale
Thermo Fisher Scientific’s PPD clinical research business announced a strategic partnership with Datavant to enable privacy‑preserving linkage of real‑world data (RWD) for biopharma customers. The...
Capsida confirms cerebral edema in AAV trial fatality — probe continues
Capsida Biotherapeutics reported that the autopsy of a participant in its halted SYNRGY trial confirmed cerebral edema as the cause of death after IV dosing with CAP‑002, an AAV gene therapy for...
FDA refuses to review Moderna’s mRNA flu vaccine: regulator flags trial design
The U.S. Food and Drug Administration has refused to accept Moderna’s biologics license application for its mRNA seasonal influenza candidate, citing shortcomings in the pivotal trial’s design and...
FDA issues complete response for Regenxbio gene therapy – approval pathway stalls
The FDA has issued a complete response letter to Regenxbio for its AAV-based therapy RGX-121 intended for mucopolysaccharidosis II (Hunter syndrome), leaving the program without U.S. approval and...
Capsida confirms cerebral edema in AAV trial fatality: autopsy stops short of cause
Capsida Biotherapeutics confirmed that the autopsy of a patient who died after receiving its intravenous AAV therapy showed cerebral edema but did not establish a definitive underlying cause. The...
Madrigal buys six Ribo siRNA programs – $60M upfront, $4.4B potential
Madrigal Pharmaceuticals agreed to license six preclinical siRNA programs from Ribo Life Science and Ribocure to broaden its metabolic dysfunction-associated steatohepatitis (MASH) portfolio,...
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...