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Allergan's Depression Candidate Gets Fast Track Designation

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Allergan's Depression Candidate Gets Fast Track Designation

The FDA grants fast track designation to Allergan's (AGN) AGN-241751, developed for the treatment of patients with major depressive disorder.

Allergan Plc AGN announced that the FDA has granted a fast track designation to its pipeline candidate AGN-241751 for the treatment of major depressive disorder (MDD). The candidate is currently being evaluated in a phase II study.

The FDA grants a fast track designation to expedite development and review process of a candidate, which is being developed to treat serious and unmet medical conditions

In May, Allergan bought rights to AGN-241751 from Aptinyx, Inc., APTX. The candidate is likely to boost the company’s already strong depression portfolio.

The company already markets several anti-depressant drugs including Vraylar (schizophrenia and bipolar I disorder), Viibryd (major depressive disorder) and Saphris (bipolar I disorder). These drugs are also in several label expansion studies. Vraylar is being assessed for the treatment of adults with MDD associated with bipolar I disorder (bipolar I depression).

A key candidate in Allergan’s depression portfolio is rapastinel, an N-methyl-D-aspartate receptor modulator, which is also being evaluated for MDD, in two phase III studies — one as an adjunct therapy and the other as a monotherapy treatment. Top-line results for the adjunctive therapy trial are expected in 2019.

Notably, rapastinel, a potentially game-changing treatment, is expected to be launched in 2021. The drug is expected to generate revenues of $1-$2 billion. It was granted a breakthrough therapy status for adjunction MDD by the FDA in 2016.

Allergan’s flagship product, Botox, is currently being studied in phase II trial for the treatment of MDD.

Shares of Allergan have outperformed the industry so far this year. The stock has gained 5.3% against the industry's decline of 1.4%.

 

Allergan currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the large-cap pharma sector include Vanda Pharmaceuticals Inc. VNDA and Illumina, Inc. ILMN, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Vanda Pharmaceuticals’ earnings estimates have been revised 11.1% upward for 2018 and 3.9% for 2019 over the past 60 days. The stock has surged 37.7% so far this year.

Illumina’s current-year earnings estimates have been moved 0.2% north for 2018 and 0.1% for 2019 over the past 60 days. The stock has soared 42.4% so far this year.

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