Editor's Note: An earlier version of this article included the ticker VRX with Vertex Pharmaceuticals (Vertex's ticker is VRTX). The Fool regrets the error.
Bristol-Myers is a fountain of good news this morning
Shares of Bristol-Myers should move higher today following two pieces of good news on the regulatory front in the EU. First off, the company announced that its pan-genotypic NS5A inhibitor Daklinza received a positive opinion from the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency. The drug has been studied as part of an all-oral combo therapy with Gilead Sciences' Sovaldi, where it produced strong efficacy results and a similar safety profile compared to currently approved therapies.
In a separate announcement, the company said that its oral anticoagulant Eliquis has been recommended for treating deep vein thrombosis, pulmonary embolism, and in the prevention of recurrent cases. Eliquis is co-owned by Pfizer (NYSE:PFE) and is expected to compete in a broad market of next generation blood thinners that could see combined sales of $10 billion within the next few years.
United Therapeutics to buyback $500 million worth of common stock
United Therapeutics could be in for a good day after announcing an additional $500 million worth of share buybacks set to commence on Aug 1 of this year. According to the release, the purchase period will be 1 year in duration. United recently completed a repurchase program where it bought $4.6 million of its own shares, so this new program is a major step up in terms of its buyback program.
United's share price has a tough go of it this year, falling 22% year to date. What's interesting is that this drop has occurred despite rising revenues from key products like Remodulin and Tyvaso. Put simply, today's large share buyback program suggests that the company believes in their growth prospects moving forward and the current share price represents a compelling valuation scenario. So you may want to keep a close watch on this mid-cap drugmaker.
Vertex moving higher today on label expansion for Kalydeco
Shares of Vertex Pharmaceuticals are up nearly 4% in premarket this morning following a positive opinion from the CHMP for Kalydeco as a treatment for people with cystic fibrosis who have one of eight non-G551D gating mutations in the cystic fibrosis, or CF, transmembrane conductance regulator gene.
Put simply, an approval would expand the drug's use to include an additional 8 gating mutations that cause CF. Kalydeco was first approved in 2012 as a treatment for CF in people with the G551D mutation and saw sales of $100 million in the first-quarter of this year for this indication. Given that a major label expansion like this one should translate into higher top-line growth moving forward, I think Vertex is a stock worth putting on your watchlist.