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AbbVie: HCV Regimen Obtains Breakthrough Therapy Status
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AbbVie Inc. (ABBV - Free Report) announced that its investigational HCV regimen has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic hepatitis C virus (HCV) in patients who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including treatment with an NS5A inhibitor and/or protease inhibitor.
The HCV regime is a pan-genotypic course of therapy with glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P). Notably, glecaprevir (GLE) is a potent protease inhibitor while pibrentasvir (PIB) is a new NS5A inhibitor.
GLE was discovered during the collaboration between AbbVie and Enanta Pharmaceuticals (ENTA - Free Report) for HCV protease inhibitors.
A breakthrough therapy designation from the FDA is expected to expedite the development and review of drugs that are intended to treat serious or life threatening conditions and provide access to patients as soon as possible.
The breakthrough therapy status for pan-genotypic regimen was granted on the basis of positive results from the phase II MAGELLAN-1 clinical study.
G/P is currently in phase III program evaluating the safety and efficacy of G/P across all major HCV genotypes (genotypes 1-6). Data from the program is expected to be presented at the upcoming scientific congress. The commercialization of the HCV regime is expected in 2017.
AbbVie also has an extensive pipeline consisting of several interesting late-stage candidates. Promising candidates include elagolix (developed for the treatment of endometriosis and uterine fibroids), atrasentan (for chronic kidney disease), veliparib (indications including triple negative breast cancer and previously treated squamous NSCLC), and ABT-494 (rheumatoid arthritis, Crohn’s disease and ulcerative colitis). The company expects to move several immuno-oncology candidates into development in 2016.
Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 9.4% and 11.5% over the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters, the average being 42.19%. Its share price rallied 25.6% year to date.
ANI Pharmaceuticals witnessed a 9.5% and 4.7% increase in its earnings estimates for 2016 and 2017, respectively, over the last 60 days. The company beat estimates twice in the last four quarters, taking the average surprise to 46.85%. The company’s share price has surged 50.6% year to date.
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AbbVie: HCV Regimen Obtains Breakthrough Therapy Status
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Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Anika Therapeutics Inc (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , both the stocks sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
ANI Pharmaceuticals witnessed a 9.5% and 4.7% increase in its earnings estimates for 2016 and 2017, respectively, over the last 60 days. The company beat estimates twice in the last four quarters, taking the average surprise to 46.85%. The company’s share price has surged 50.6% year to date.
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Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>