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AMAG's Vyleesi Gets FDA NOD for Women with Low Sexual Desire

AMAG Pharmaceuticals, Inc.  AMAG announced that the FDA has approved Vyleesi (bremelanotide injection) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The drug is an injection to be taken before sex and is the first treatment for this patient population. Share price of the company rose about 4% following the news.

The FDA approval is based on data from about 1,200 women in two phase 3 studies (RECONNECT). In both the studies, Vyleesi met the pre specified co-primary efficacy endpoints of improvement in desire and reductions in distress as measured by validated patient-reported outcome instruments.

Upon completion of the study, women had the option to continue in a voluntary open-label safety extension study for an additional 12 months. Nearly 80% percent of patients who completed the phase 3 studies elected to remain in the open-label portion of the study, wherein all these patients received Vyleesi.

In March 2018, AMAG had submitted a new drug application for Vyleesi to treat HSDD and the application was accepted by the FDA in June 2018.  

Shares of the company have decreased 41% year to date against the industry’s 6.7% growth.


Vyleesi will be commercially available this September. AMAG in-licensed Vyleesi from Palatin Technologies, Inc. in February 2017. Palatin will get $60 million from AMAG for the approval plus additional payments for certain sales milestones and royalties.

AMAG will also pay Palatin sales milestones based on escalating annual net sales thresholds, the first of which is $25 million, triggered at annual net sales of $250 million. The approval of this candidate will provide a big boost to AMAG, as it caters to a huge unmet medical need for women.


Zacks Rank and Stocks to Consider

AMAG currently has a Zacks Rank #2 (Buy).

Some better-ranked stocks in the biotech sector are Anika Therapeutics Inc. ANIK, Applied Genetics Technologies Corp. AGTC and Acorda Therapeutics Inc. ACOR, each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings per share estimates have moved up from $1.21 to $1.31 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company beat estimates in the trailing four quarters, with the average being 72.00%.         

Applied Genetics’ loss per share estimates have narrowed from $1.25 to 1 cent for 2019 and from $2.39 to $2.15 for 2020 in the past 60 days. The company surpassed estimates in three of the trailing four quarters, with average positive surprise of 83.47%.    

Acorda’s loss per share estimates have narrowed from $3.84 to $3.59 for 2019 and from $3.32 to $3.09 for 2020 in the past 60 days. The company outpaced estimates in the trailing four quarters, with the average being 79.32%.    

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