Tag Archives: ema

Gilead Sciences Gets Price-Target Cut After Cancer Trials Stopped

Big biotech Gilead Sciences ( GILD ) got a price-target cut from investment bank Leerink on Wednesday, after the company cancelled clinical trials on its cancer drug Zydelig due to safety problems. The European Medicines Agency (EMA) said last Friday that it was looking into reports of serious adverse events, including deaths, in Gilead’s trials of Zydelig in various forms of blood cancer. Later, the U.S. Food and Drug Administration said that it was doing the same, and on Monday it issued a notice saying that Gilead had agreed to suspend six trials in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and indolent non-Hodgkin lymphomas (NHLs). Zydelig, first launched in July 2014, is now approved for relapsed CLL and as a third-line treatment for B-cell NHL and SLL. “The FDA is reviewing the findings of the clinical trials and will communicate new information as necessary,” the agency said in its statement. Gilead also said that it’s suspending trials of Zydelig as a front-line treatment for any cancer. On Wednesday, Leerink analyst Geoffrey Porges slashed his peak annual sales estimate on the drug from $935 million to $174 million in 2020, which he estimates will shave 1% to 3% off EPS in the 2017-2020 period. He therefore cut his price target to 127 from 130 while maintaining an outperform rating on Gilead stock. “Though accretive to revenue, oncology accounts for a small portion of Gilead’s total revenue, 93% of which consists of antivirals,” Porges wrote. “We have never been convinced that oncology would become a major franchise for the company, and given these recent events, maintain this outlook.” Gilead stock was up 1% in early trading on the stock market today , near 90, but it’s down more than 10% this year and sports a lowest-possible IBD Accumulation/Distribution Rating of E.

Bristol-Myers, Pfizer, Regeneron Drugs Get EU Nods

Several key drugs from major drugmakers got endorsements from the European Medicines Agency (EMA) Friday, making commercial approval in the European Union’s enormous market much more likely. Bristol-Myers Squibb’s (BMY) hepatitis C drug daclatasvir, now branded Daklinza, was endorsed by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for use in combination with other hep C drugs, notably Gilead Sciences’ (GILD) Sovaldi. Sovaldi and