AbbVie Inc. (ABBV, Financial) announced Thursday through the PR Newswire that the U.S. Food & Drug Administration validated its New Drug Application (NDA) for its “investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P).”
The G/P regimen, which is now under priority review by the FDA, is used to treat genotypes 1–6 of the chronic hepatitis C virus.
Once approved, the medication can be commercialized for use in the U.S.
AbbVie's treatment application is backed by results collected from eight studies conducted on more than 2,300 patients in 27 countries.
The company says it is also assessing the therapy as an option for treating patients who are infected with genotype 3 of HCV. These are patients who were not cured with previous DDA treatments or who are suffering from chronic kidney disease.
AbbVie's shares are currently trading around $60.76, down 13 cents per share or -0.21% from the previous trading day, with a price-sales (P/S) ratio of 3.85 and a price-book (P/B) ratio of 15.26. The 52-week range is between $51.60 per share and $68.12 per share.
The stock is more volatile than the stock market with a beta of 1.49. It has underperformed the S&P 500 by 4.83% year to date.
AbbVie has a market capitalization of $98.74 billion and an enterprise value of $128.31 billion. The company has 1.63 billion shares outstanding, of which 1.62 billion is float. The percentage of shares held by insiders is 0.10% and by institutions is 73.60%.
The price-earnings (P/E) ratio is 16.43 and the EPS is $3.7.
The company pays a dividend of $2.56 through quarterly payments of 64 cents. The dividend yield is 4.19% and the payout ratio is 60%.
The company has approximately $7.95 billion of cash on hand, or $4.89 per share. The total debt is $37.31 billion and the book value per share (mrq) is $3.98.
In fourth-quarter 2016, Ken Fisher (Trades, Portfolio) increased his position in AbbVie by 1.83%. The guru holds 696,569 shares.
Disclosure: I have no position in AbbVie Inc.
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