Contribute Try STAT+ Today

Fresh off its first drug approval, Alnylam announced positive interim data from a trial of another gene-silencing treatment on Thursday and said it hopes to file with the Food and Drug Administration for accelerated approval of the drug, givosiran, likely by the end of the year.

The Cambridge, Mass.-based company did not release any data Thursday, but said in a statement that an interim analysis of a Phase 3 trial of givosiran showed it successfully lowered levels of a chemical that regulators have said they will consider a surrogate endpoint to gauge the drug’s effectiveness.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!


What is it?

STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.