Gilead (GILD) announced that the European Medicines Agency has validated for parallel accelerated review the company’s marketing authorization application and EU-Medicines for all application for lenacapavir-the company’s twice-yearly injectable HIV-1 capsid inhibitor-for the prevention of HIV as pre-exposure prophylaxis. Based on the assessment of EMA’s Committee for Medicinal Products for Human Use that twice-yearly lenacapavir for prevention is a product of major interest for public health and therapeutic innovation, both applications will be assessed under an accelerated assessment review timeline.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on GILD:
- Optimistic Buy Rating for Gilead Sciences Driven by Anticipated FDA Approval and Strategic Market Positioning
- Largest borrow rate increases among liquid names
- Gilead price target raised to $120 from $105 at Bernstein
- Gilead Sciences: Buy Rating Backed by Strong Q4 Performance, Strategic Initiatives, and Promising Pipeline
- Gilead’s Seladelpar granted conditional European marketing authorization