There are few things in this world more squishy than Wonder Bread. Exception: Biogen’s answers to the question of when it will submit aducanumab to the Food and Drug Administration.

On Thursday, Biogen said a filing for the controversial Alzheimer’s drug would be completed “as soon as possible.” That’s slightly different but no more definitive than the company’s previous guidance for an aducanumab submission in “early 2020.”

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

GET STARTED

What is it?

STAT Plus 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
  • Online intelligence briefings
  • Frequent opportunities to engage with veteran beat reporters and industry experts
  • 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.
  • Dear Adam,

    It might be worthwhile to mention that a BLA application (or any type of submission for that matter) is no small undertaking, especially with multiple complex clinical trials that I imagine would constitute the aducanumab filing. Even if Biogen threw an admirable amount of talent (in-house and external), the considerable documentation would need to be reviewed, audited and filed correctly. Saying Biogen is being “squishy” about timing and filing seems a tad provocative to me.

  • The longer Biogen delays filing, the longer they keep their stock up, and uncertainty gives them false hope
    To the stock market. Their stock will not decline as long as the possibility of success hangs over it. No hurry then.
    If Biogen was turned down, the stock would be crushed.

Comments are closed.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy