Gilead Sciences Inc. (GILD - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion on the company’s marketing authorization application for its hepatitis B virus (HBV) drug, Vemlidy (tenofovir alafenamide; 25 mg). The company is looking to get Vemlidy approved for the once-daily treatment of chronic HBV infection in adults and adolescents (≥ 12 years of age and ≥ 35 kg body weight).
The data included in the regulatory application support the use of Vemlidy for treatment-naïve and treatment-experienced adults and adolescents with HBeAg-negative and HBeAg-positive HBV infection.
Now that the CHMP has given favorable opinion, the application will be reviewed by the European Commission. But a positive CHMP opinion has significantly increased the chances of Vemlidy gaining EU approval.
The news came a day after Vemlidy gained approval in the U.S. for the once-daily treatment of chronic HBV infection in adults with compensated liver disease. However, Vemlidy’s U.S. approval was accompanied by a boxed warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post-treatment acute exacerbation of HB.
Nevertheless, Vemlidy has demonstrated antiviral efficacy similar to another HBV drug in Gilead’s portfolio, Viread (tenofovir disoproxil fumarate; 245 mg), at one-tenth the dose, leading to improved renal and bone laboratory safety parameters. Given Vemlidy’s lower dose, efficacy and safety profile, we believe it has the potential to offer patients an improved treatment option for chronic HBV.
We are positive on the latest regulatory developments in the U.S. and the EU. With Gilead’s HCV franchise currently under intense competitive and pricing pressure, approval of new products will be a huge boost for the company.
GILEAD SCIENCES Price
Zacks Rank & Stocks to Consider
Gilead is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Vanda Pharmaceuticals, Inc. (VNDA - Free Report) and Exelixis, Inc. (EXEL - Free Report) . While Anika and Vanda sport a Zacks Rank #1 (Strong Buy), Exelixis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company has posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 19% year to date.
Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016 while earnings estimates increased from 16 cents to 17 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged 78% year to date.
Exelixis’ loss estimates narrowed from 71 cents to 51 cents for 2016 and from a loss of 16 cents to earnings of 4 cents for 2017 over the last 60 days. The company has posted a positive surprise twice in the trailing four quarters with an average beat of 38.52%. Its share price has skyrocketed above 150% year to date.
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