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What’s in Today’s Brief? (July 17th Preview)
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Regulatory approval – oral PCSK9 inhibitor
The FDA has approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra) for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, expanding the PCSK9 class beyond injections. The approval follows a National Priority Voucher framework and provides a convenient daily tablet option aimed at lowering LDL-C to levels substantially below statin-only therapy in clinical studies.
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Europe regulatory pathway – Duchenne gene therapy setback
Sarepta has launched a new additional Phase III trial for Elevidys (Roche-licensed) after the European Medicines Agency denied marketing authorization in 2025 for failing to meet efficacy endpoints in movement abilities at 12 months. The new registration-enabling study is designed to address EMA concerns with placebo-controlled data over 72 weeks, with Roche overseeing the trial.
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Late-stage reshuffling – GSK shelves chronic cough candidate
GSK has stopped development of camlipixant, its chronic cough drug acquired in a $2 billion Bellus Health deal, after Phase 3 results missed nearly all goals. The termination closes a blockbuster opportunity GSK had targeted for 2026, while GSK said it will continue Phase 2 work in irritable bowel syndrome.
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Corporate consolidation – Dimerix buys acute kidney injury candidate
Dimerix has agreed to acquire Mission Therapeutics’ Phase 2-ready acute kidney injury asset, paying $5 million upfront and up to $287 million in milestones. The deal positions Dimerix to push the program toward a Phase 2 setting for broader development, while Mission’s pipeline focus shifts following the sale.
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Oncology prevention – mutant KRAS peptide vaccine shows immune durability
In a Phase I first-in-human study, researchers reported that a peptide vaccine targeting six common mutant KRAS variants (mKRAS-VAX) generated durable T-cell responses in high-risk pancreatic cancer cohorts. Across 20 participants, adverse events were grade 1–2 and 18/20 (90%) developed significant mKRAS-specific T cell responses, with vaccine-induced clonotypes persisting for up to two years and no PDAC cases during a median 16.5-month follow-up.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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