Alkermes plc (ALKS - Free Report) initiated the rolling submission of a New Drug Application (NDA) to the FDA for pipeline candidate ALKS 5461.
The NDA seeks FDA approval for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). The company expects to complete the submission by year-end 2017.
In June 2017, Alkermes initiated study 217, a phase IIIb study of ALKS 5461, for the adjunctive treatment of MDD. In October 2013, the FDA granted Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies. The Fast Track designation from the FDA facilitates the development and expedites the review of drugs that are intended to treat serious conditions and address medical needs. The designation will allow for the submission of completed portions of the NDA on a rolling basis as well as eligibility for Priority Review.
We remind investors that the company and the agency had agreed upon the proposed content and timing of the ALKS 5461 NDA submission in July 2017 at a pre-NDA interaction.
Alkermes’ revenues continue to be driven by proprietary products, Vivitrol and Aristada, and the five partnered products – Risperdal Consta, Invega Sustenna/Xeplion, Invega Trinza/Trevicta, Ampyra/Fampyra and Bydureon.
Alkermes continues to witness robust sales of Vivitrol in both the Medicaid and commercial setting. We expect these products to continue contributing to the company’s top line in the coming quarters. Further, Alkermes has a robust pipeline. Interesting late-stage candidates in the company’s pipeline include ALKS 5461 (major depressive disorder/MDD), ALKS 3831 (schizophrenia) and ALKS 8700 (multiple sclerosis).
Meanwhile, Alkermes’ stock price has declined 8.8% year to date against the industry’s gain of 6.2%.
Zacks Rank & Stocks to Consider
Alkermes is a Zacks Rank #3 (Hold) stock.
Some better-ranked stocks in the healthcare sector are Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Gilead Sciences, Inc. (GILD - Free Report) and Aduro Biotech, Inc. (ADRO - Free Report) . While Regeneron sport a Zacks Rank #1, Gilead Sciences and Aduro carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings per share estimates have increased from $10.52 to $13.81 for 2017 and from $12.10 to $14.54 for 2018 over the last 30 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 6.29%.
Gilead’s earnings per share estimates increased from $7.98 to $8.53 for 2017, over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 8.18%.
Aduro Biotech’s loss per share estimates narrowed from $1.46 to $1.32 for 2017 and from $1.41 to $1.24 over the last 30 days. The company delivered positive surprises in two of the trailing four quarters with an average beat of 2.53%.
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