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What’s in Today’s Brief? (February 11th Preview)
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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 Vinay Prasad, director of the agency’s biologics office, and prompted immediate public rebuttal from Moderna that the action contradicts prior agency guidance. Moderna said the agency raised no safety or efficacy concerns but concluded the trial did not meet the FDA’s "adequate and well-controlled" standard. The refusal-to-file has ripple effects across regulators and markets: Moderna has requested a Type A meeting to clarify next steps and said the filing is under review in the EU, Canada and Australia. The move prompted a sharp sell-off in Moderna shares and reopened industry debate over comparator choice and shifting regulatory expectations for next-generation vaccine trials. Observers and industry leaders are watching whether the FDA will require new comparator trials or narrower target populations, which could delay market entry and combination vaccine plans.
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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 found all ten challenged claims unpatentable, following an earlier invalidation of Exact’s US Patent No. 11,634,781. Geneoscopy said the rulings remove asserted patent barriers to its ColoSense colorectal screening test and called the decisions critical to protecting patient choice. Exact Sciences said it is evaluating all options, including an appeal to the Federal Circuit. The dispute stems from litigation that began in 2023, and the case remains scheduled for trial in November 2026. The PTAB rulings could reshape intellectual property leverage and competitive dynamics in noninvasive colorectal cancer screening, where Cologuard has been a market leader.
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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 will support a planned pivotal human challenge study slated to start in 2026 and initial data expected in 2027, the company said. BPZE1, developed at Institut Pasteur de Lille, is designed to induce systemic and mucosal immunity via needle-free administration. ILiAD’s CEO framed the financing as meeting an urgent global need for improved pertussis prevention, particularly to protect vulnerable infants. Investors including Janus Henderson and BNP Paribas joined the round, underscoring continued investor appetite for next‑generation vaccines with transmission-blocking potential.
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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 maintained and deepened skin‑clearance responses at one year. Evommune’s result produced a meaningful placebo-adjusted EASI improvement in a Phase 2a cohort, and the company plans a Phase 2b subcutaneous program. Nektar presented maintenance data showing high rates of sustained EASI‑75 with less frequent dosing. Both readouts raise the prospect of new competitors to established biologics in atopic dermatitis and prompted material share moves. Companies cited differentiated mechanisms — IL‑18 neutralization for Evommune and engineered IL‑2 modulation for Nektar — as potential clinical differentiators while planning larger, registrational studies.
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FDA issues complete response letter to Regenxbio gene therapy — regulator flags data gaps
Regenxbio received a complete response letter for RGX‑121, its AAV‑based gene therapy for mucopolysaccharidosis II (Hunter syndrome), after the agency raised concerns about the surrogate endpoint and use of historical controls. The FDA previously placed clinical holds on related AAV programs following a brain‑tumor event in a different study, complicating the review environment. Regenxbio said it will request meetings with the FDA to discuss potential paths forward listed in the CRL, including new trial designs or longer follow‑up. The decision underscores heightened regulatory scrutiny for systemic AAV gene therapies and the difficulties of demonstrating durable benefit in ultra‑rare diseases using surrogate comparators.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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