Allergan/Paratek's Acne Candidate NDA Filing Accepted by FDA

Allergan plc AGN along with partner Paratek Pharmaceuticals PRTK announced that its new drug application (NDA) for its investigational, once-daily, Seysara (sarecycline) has been accepted for review by the FDA for treatment of patients aged nine years and above with moderate to severe acne vulgaris. The company expects a response from the FDA in the second half of 2018.

A look at Allergan’s share price movement so far this year shows that the stock has outperformed the industry. Though the stock has lost 21.1%, the industry has decreased 27.9%. Also shares of Paratek were up 15.2% during the period.

Allergan completed its NDA submission for Seysara in October, based on positive data from two phase III (n=2002) studies — SC1401 and SC1402 — respectively. The trials met the primary endpoints and revealed that patients treated with Seysara (1.5 mg/kg) demonstrated a statistically significant improvement in acne severity compared with placebo at week 12.

Notably, Allergan owns the rights for development and commercialization of Seysara in the United States while Paratek retains the rights in the ex-U.S. markets.

Among other players conducting trials on candidates in the same space, Foamix Pharmaceuticals Ltd. FOMX is developing FMX101 in late-stage studies for treating moderate to severe acne.

We remind investors that Allergan has more than 55 projects in mid-to-late stage development. The company has extended its R&D pipeline to adjacent categories like NASH, Parkinson's disease and gene therapy with many promising phase II/III programs on development track.

Allergan also boasts a strong branded pipeline with meaningful data read-outs expected next year.

Allergan PLC. Price

Allergan PLC. Price | Allergan PLC. Quote

Zacks Rank & Key Pick

Allergan carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Corcept Therapeutics Incorporated CORT carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Corcept’s earnings per share estimates have moved up from 78 cents to 88 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 14.32%. Share price of the company has skyrocketed 117.7% year to date.

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Allergan PLC. (AGN) : Free Stock Analysis Report
 
Paratek Pharmaceuticals, Inc. (PRTK) : Free Stock Analysis Report
 
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