FDA Signals Accelerated Approval Path for uniQure’s Huntington’s Gene Therapy AMT-130
uniQure receives positive FDA feedback for accelerated approval of its one-time gene therapy AMT-130 for Huntington’s disease. BLA submission planned for Q3 2026.
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Moderna Strengthens Commercial Leadership Ahead of Flu and Norovirus Vaccine Launches
Moderna names Ester Banque, ex-Zoetis/Novartis, as Chief Commercial Officer as it prepares for potential 2027 launches of combined flu-COVID, standalone flu, and norovirus vaccines. FDA advisory on mFLUSIVA this week.
Eli Lilly Acquires 4E Therapeutics to Strengthen Non-Opioid Pain Pipeline
Eli Lilly has acquired 4E Therapeutics, a neuroscience biotech developing non-opioid treatments for chronic pain. This marks Lilly’s 11th deal of 2026 and strengthens its non-opioid pain pipeline.
Altaris to Acquire Simulations Plus for $375 Million in All-Cash Deal
Shareholders get $18.50 per share. The company is expected to combine with Chemical Computing Group after closing. Deal expected to close in Q4 2026.
Edgewise Shares Fall Despite Encouraging Phase 2 Results in Obstructive and Nonobstructive HCM
Edgewise shared encouraging Phase 2 CIRRUS-HCM results for EDG-7500, showing strong improvements in symptoms, biomarkers, and diastolic function across both types of HCM. Larger Phase 3 trials will be required before any approval.
Adaptive Biotechnologies Plans to Split Its MRD and Immune Medicine Units
The company expects to decide the best path by year-end 2026.