We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Allergan/Paratek's Acne Candidate NDA Filing Accepted by FDA
Read MoreHide Full Article
Allergan plc along with partner Paratek Pharmaceuticals 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. 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.
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.
Zacks’ Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors.
Image: Bigstock
Allergan/Paratek's Acne Candidate NDA Filing Accepted by FDA
Allergan plc along with partner Paratek Pharmaceuticals 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. 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 - Free Report) 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.
Zacks’ Best Private Investment Ideas
While we are happy to share many articles like this on the website, our best recommendations and most in-depth research are not available to the public.
Starting today, for the next month, you can follow all Zacks' private buys and sells in real time. Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors.
Click here for Zacks' private trades >>