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Allergan’s Uterine Fibroids Candidate’s NDA Accepted by FDA

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Allergan plc AGN announced that the FDA has accepted the new drug application (NDA) for its pipeline candidate, ulipristal acetate. Allergan is looking to get ulipristal acetate approved for the treatment of abnormal uterine bleeding from fibroids in that organ. The company expects the FDA to give its decision in the first half of 2018. Once approved, ulipristal acetate will be the first once-daily non-surgical oral treatment option approved for the condition.

Allergan’s shares have declined 1.2% compared with the industry’s decline of 20.4%.


There are other companies that have pipeline candidates being evaluated for uterine fibroids. In July 2017, Bayer Aktiengesellschaft BAYRY is evaluating vilaprisan in women suffering from uterine fibroids and in July initiated a phase III study ASTEROID for the same.

AbbVie Inc. ABBV along with Neurocrine Biosciences, Inc. is evaluating its pipeline candidate elagolix for reducing heavy menstrual bleeding in premenopausal women with uterine fibroids. In April this year, the companies announced positive results from a phase IIb study which showed that elagolix met its primary endpoint by significantly reducing the number of heavy bleeding days rapidly within the assessment period of six months from the baseline in comparison to a placebo, utilizing the alkaline hematin method.

Zacks Rank & Stock to Consider

Currently, Allergan carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is ACADIA Pharmaceuticals Inc ACAD carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the last 60 days, ACADIA’s loss per share estimates narrowed from $2.63 to $2.52 for 2017 and from $1.92 to $1.85 for 2018. The company delivered positive earnings surprises in two of the trailing four quarters, with an average beat of 7.97%. Year to date, the share price of the company has climbed 27.9%.

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