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Alkermes' Aristada Initio Approved by FDA for Schizophrenia

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Alkermes plc. ALKS announced that the FDA has approved Aristada Initio (aripiprazole lauroxil) extended-release product for the treatment of schizophrenia in adults. The approval of Aristada Initio makes Aristada the first and only long-acting atypical antipsychotic that can be initiated on day one, which plays a significant role to treat a complex disease like schizophrenia.

Aristada Initio leverages proprietary NanoCrystal technology, and the drug utilizes a smaller particle size than Alkermes’ Aristada, an injectable atypical antipsychotic medication that also contains aripiprazole lauroxil.

Previously, the standard regimen included being dosed with Aristada for 21 consecutive days once the first dose started. However, the Aristada Initio regimen provides patients with relevant levels of aripiprazole within 4 days of initiation. This is an alternative initiation regimen, which allows the physicians and caregivers to fully dose patients with up to two months of coverage with a proven medication in their system.

Although Aristada and Aristada Initio both contain aripiprazole lauroxil, the 2 medications are not interchangeable because of differing pharmacokinetic profiles. Aristada Initio provides faster dissolution, and leads to more rapid achievement of relevant levels of aripiprazole. Aristada Initio is expected to be available in mid-July. Aristada Initio can be used for initiation onto any dose of Aristada (441 mg, 662 mg or 882 mg monthly, 882 mg once every six weeks and 1064 mg once every two months), offering a wide range of flexible dosing options for patients and healthcare providers.

The approval of Aristada Initio will further strengthen Alkermes’ portfolio and will boost its revenues.

Year to date, shares of Alkermes have declined 24% compared with the industry’s decline of 6.6%.

The company has another candidate ALKS 3831 in phase III being evaluated for the treatment of schizophrenia. Top-line data from the study is expected in the fourth quarter of 2018 and if the study is positive, the company expects to submit the new drug application (NDA) in the first half of 2019.

Alkermes plc Price

 

Alkermes plc Price | Alkermes plc Quote

 

Zacks Rank & Stocks to Consider

Alkermes has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the same space are Illumina, Inc. ILMN, Aeglea BioTherapeutics, Inc. AGLE and ANI Pharmaceuticals, Inc. ANIP. All of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings per share estimates have moved up from $4.83 to $4.86 for 2018 and from $5.57 to $5.61 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with an average beat of 23.17%. The stock has rallied 28.2% so far this year.

Aeglea’s loss per share estimates have narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 103.7% so far this year.

ANI Pharmaceuticals’earnings per share estimates have moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 4.6% so far this year.

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