Clovis Snags FDA Designation: What's Next?

By Michael Douglass and Dave Williamson – May 20, 2014 at 7:11PM

NASDAQ: CLVS

Clovis Oncology

The coveted breakthrough designation comes through for CO-1686.

Investors in Clovis Oncology (CLVS) received some welcome good news when the company announced that its EGFR blocker CO-1686 received FDA's coveted breakthrough designation. This gives companies a speedier FDA review and easier access to regulators as they work to get individual drugs approved. CO-1686 targets a subset of non-small cell lung cancer patients -- a subset with no approved treatments thus far, according to Clovis.

While the news was good, it's important for investors not to overreach -- this is a drug still in pretty early clinical trials, as Clovis is currently beginning enrollment in two phase 2 expansion studies, with a New Drug Application (NDA) hopefully in the offing by mid-2015.

In the video below, from Tuesday's Market Checkup, The Motley Fool's health care-focused investing show, health care analysts Michael Douglass and David Williamson discuss this news and what it means for Clovis investors.

David Williamson has no position in any stocks mentioned. Michael Douglass has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.