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What’s in Today’s Brief? (October 28th Preview)
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Retatrutide beats Ozempic in head-to-head Phase 3
Eli Lilly reported topline results from a large head-to-head Phase 3 trial showing its investigational triple agonist retatrutide lowered A1c and produced greater weight loss than Novo Nordisk’s Ozempic in adults with type 2 diabetes. In the highest-dose retatrutide arm, A1c fell more than in the Ozempic arm at 80 weeks, while weight loss also favored retatrutide. The report also noted higher side-effect rates and more treatment discontinuations associated with retatrutide versus Ozempic. The data add direct comparative evidence to a crowded incretin/anti-obesity landscape and set up an immediate commercial and pipeline pressure test for competitors ahead of 2027 and beyond.
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FDA sets a path for personalized gene editing approvals
The FDA laid out an approval framework for individualized gene-editing therapies aimed at single patients carrying specific disease-causing mutations. The agency described steps drugmakers can take to pursue regulatory approval for tailored gene-editing products, positioning the guidance as a structured route to bring precision medicines through development and review despite manufacturing and evidentiary challenges. For developers, the framework signals regulators are actively formalizing expectations for individualized approaches—an area that has outpaced conventional trial models and standard CMC planning timelines.
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Coherus posts interim tagmokitug data in esophageal squamous cell carcinoma
Coherus Oncology released interim clinical data from its TREGCHECK development program evaluating tagmokitug, a cytolytic CCR8 antibody, in combination with toripalimab with or without chemotherapy in multiple solid tumor settings. In evaluable front-line esophageal squamous cell carcinoma (ESCC), the company reported a confirmed overall response rate of 75% irrespective of PD-L1 status, and 100% in PD-L1–positive patients as of the October 14, 2026 cutoff. In second-line ESCC, durable disease stabilization and activity in PD-1 refractory patients were highlighted. Coherus said safety remained acceptable with no new safety signals to date, and it plans to expand enrollment in ESCC cohorts based on the selected dose and the interim clinical proof of concept.
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HHS loosens enforcement for compounded wellness peptides
HHS moved to allow compounding pharmacies to manufacture six specific peptide products for “wellness” use via enforcement discretion, while the FDA continues rulemaking on whether compounding should be permitted. The policy expands access for certain multi-peptide mixtures if peptides are produced by registered manufacturers and dispensed with a prescription, according to HHS documentation. The agency acknowledged that compounded peptides carry safety and efficacy risks due to a regulatory gap versus FDA-approved drugs. This shift matters for biotech-adjacent supply chains and clinicians because it changes how quickly unapproved peptide combinations can reach patients through licensed channels while enforcement remains deferred.
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Formation Bio raises $600M fund for AI asset acquisition strategy
Formation Bio unveiled a $600 million investment fund designed to deepen its operating model: acquire external assets, develop them using AI-driven workflows, and then hand them off. The company positioned the new pool as a way to scale dealflow and accelerate development across its portfolio, leaning on its framework to identify assets and progress them through key technical milestones. For investors and development partners, the fund underscores how computational biology companies are turning into capital-allocators and execution engines—rather than purely research platforms.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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