Biotech Values

[DewDiligence]

GILD—FDA accepts resubmitted NDAs for standalone Elvitegravir and standalone Cobicstat:

http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1920297&highlight

The PDUFA dates are 10/3/14 for Cobicstat and 10/4/14 for Elvitegravir.

Due to a regulatory quirk, both of these drugs are already on the market as components of GILD’s Stribild, but as standalone agents they received a CRL in Apr 2013 (#msg-87357861).

Separately, BMY has an NDA pending for the combination of Reyataz and Cobicstat (#msg-100574469).

In the EU, standalone Elvitegravir is approved under the brand name, Vitekta (#msg-94184330) and standalone Cobicstat is approved under the brand name, Tybost.