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What’s in Today’s Brief? (February 18th Preview)
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FDA reverses, will review Moderna flu shot: PDUFA set for Aug. 5
The FDA abruptly reversed course and agreed to review Moderna’s mRNA influenza vaccine candidate mRNA-1010, setting a PDUFA target date of Aug. 5, 2026. The agency moved from a refusal-to-file stance to acceptance after a Type A meeting in which Moderna proposed a revised regulatory approach that divides indications by age and commits to a post‑marketing study in older adults. Moderna will seek standard approval for adults 50–64 and accelerated approval for those 65 and older, with a required post-approval trial in the latter group. The decision follows public controversy over earlier internal disagreements at the FDA and underscores regulatory uncertainty affecting vaccine developers. The turnaround has immediate implications for vaccine timelines and market planning: if approved, mRNA-1010 could be available for the 2026–27 flu season for targeted age groups. Industry watchers are watching both the agency’s handling of mRNA dossiers under new leadership and the precedent the reversal sets for future vaccine reviews.
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Compass scores second phase III: Psilocybin heads toward NDA
Compass Pathways reported a second positive Phase III trial for COMP360, its synthetic psilocybin therapy for treatment‑resistant depression, and said it will move toward a rolling NDA submission. The company plans to meet with the FDA to discuss a filing timeline and aims to submit in late 2026, positioning COMP360 to be the first classic psychedelic therapy seeking U.S. approval. The second pivotal study replicated efficacy and tolerability signals observed in the earlier trial; Compass highlighted statistically significant reductions on depression rating scales at primary endpoints. The results prompted a sharp re‑rating across psychedelic biotech stocks and reignited commercial conversations about therapy delivery, reimbursement and clinic rollout. Compass executives said the dataset supports regulatory engagement and commercialization planning. Competitors and investors are now recalibrating timelines for other late‑stage psychedelic programs as the field pivots from exploratory research to potential market entry.
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Merck partners with Mayo Clinic: AI and clinical genomics to drive discovery
Merck signed a collaboration with the Mayo Clinic to combine clinical and genomic datasets, AI tools and advanced analytics to accelerate drug discovery across inflammatory and immune‑mediated diseases. The agreement gives Merck access to Mayo Clinic Platform assets—clinical registries, biorepositories and international datasets—with plans to integrate these resources with Merck’s AI-enabled virtual cell technologies. The initial focus areas include inflammatory bowel disease, atopic dermatitis and multiple sclerosis. Merck said the partnership will validate AI models against real-world clinical data and support translation of insights into therapeutic targets and development strategies. Merck CEO Robert Davis framed the alliance as a convergence of high‑quality clinical data and computational biology, aiming to improve target identification and program success probabilities. The deal underlines Big Pharma’s continued strategy of marrying institutional datasets with proprietary AI stacks to de‑risk preclinical pipelines.
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Gilead pays into synthetic‑lethality pipeline: $1.53B deal for Genhouse MAT2A asset
Gilead Sciences licensed a clinic‑ready MAT2A inhibitor from Suzhou‑based Genhouse Bio in a deal that could total up to $1.53 billion. The agreement gives Gilead access to GH31, a candidate targeting synthetic lethality in MTAP‑deleted tumors, with IND clearance already filed in the U.S. and China. Genhouse will receive an upfront payment and is eligible for development, regulatory and commercial milestones plus tiered royalties. Gilead said the therapy expands its oncology portfolio into metabolic synthetic‑lethality approaches and complements its existing targeted programs. The transaction highlights continued Big Pharma interest in Asia‑originated assets and in synthetic‑lethality strategies that aim to exploit tumor‑specific vulnerabilities. The deal also signals cross‑border sourcing remains a core M&A and licensing vector for pipeline replenishment.
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Lilly buys rights to CSL’s IL‑6 antibody: $100M upfront to expand inflammation lineup
Eli Lilly paid $100 million up front to license clazakizumab, an IL‑6–blocking monoclonal antibody from CSL, securing rights to develop the drug in indications outside CSL’s retained kidney disease program. CSL will keep rights for end‑stage kidney disease while Lilly will pursue other inflammatory and immunologic indications. The license includes milestone and royalty provisions and follows Lilly’s recent string of external acquisitions and licensing moves to broaden its immunology pipeline alongside its obesity and diabetes franchises. Lilly framed the deal as a strategic bolt‑on to its broader inflammation strategy. CSL retains development in its Phase III kidney program; Lilly gains a validated IL‑6 asset that could compete with established IL‑6 pathway drugs depending on trial results and positioning.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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