EU Approval Of Gilead Sciences, Inc.'s Zydelig Nothing But Good News, Says Analyst

September 17, 2014

By Riley McDermid, BioSpace.com Breaking News Sr. Editor

News that the European Commission has approved Gilead Sciences, Inc.'s drug Zydelig for two blood cancers means nothing but upside for investors, an analyst with Guggenheim Securities said Friday.

The EC approved Zydelig for the treatment of follicular lymphoma and chronic lymphocytic leukemia. The approval by European regulators sent Gilead’s stock soaring in Friday trading, after it hit a record high of $110.64 earlier this month.

Analyst Bret Holley of Guggenheim said they predict that price to gain traction in coming months as further Gilead drugs are debuted.

“Although we do not view the E.U. approval of Zydelig as a surprise, following a positive CHMP recommendation, we view it as an incremental positive for GILD,” wrote Holley in a note to investors. “We continue to view GILD as attractive ahead of the launch of Sovaldi+ledipasvir and believe the value of Zydelig and the company's growing oncology pipeline is not fully reflected in the stock's current price.”

Zydelig was approved for use in combination with Rituxan, another cancer therapy sold jointly by Roche and Biogen Idec (BIIB). Analysts tracking weekly prescription data from IMS Health (IMS) have predicted that Zydelig could see around 10 to 15 percent market share in the sector.

"Trends are still early and unclear, although Zydelig scripts have been at less than a third of what Imbruvica was," wrote RBC Capital Markets analyst Michael Yee in a Sept. 12 research note.

Holley wrote that further testing on the drug would like mean a broader share of the market. “We expect additional positive Phase III from the '115/'118 trials in '15 to drive accelerated adoption of the combination in later-line CLL/FL,” he wrote.