Allergan plc and partner Medicines360, a nonprofit global women's health pharmaceutical company, announced that the FDA has accepted a supplemental New Drug Application (sNDA) for its marketed intrauterine system (IUS), Liletta. The companies are looking to update Liletta’s label to extend its use for the prevention of pregnancy from up to three years to up to four years.
Allergan’s past one-month share price movement shows that the stock has outperformed the Zacks classified Medical-Generic Drugs industry. Specifically, the company gained 12.9%, while the industry lost 9.3%.
Liletta is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to three years and is more than 99% effective.
The sNDA was filed on the basis of data from a phase III hormonal IUD trial, ACCESS IUS, which was intended to determine comprehensive contraceptive efficacy & safety of Liletta. The study was conducted in 1,751 women. Liletta was found to be safe and effective for a broad range of women regardless of age, race, parity or Body Mass Index (BMI).
We note that in Feb 2015, Liletta was approved by the FDA for use with a two-handed inserter, followed by an approval in Jan 2016 for use with a new single-handed inserter, which is commercially available in the U.S.
Liletta raked in revenues of $15 million for the nine months ended Sep 2016, up 40.2% year over year.
Zacks Rank & Key Picks
Allergan currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Arena Pharmaceuticals, Inc. , Cambrex Corporation and Kamada Ltd. . While Cambrex sports a Zacks Rank #1 (Strong Buy), Arena and Kamada carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Arena’s loss estimates declined from 36 cents to 34 cents for 2016 and from 33 cents to 32 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 11.43%.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 90 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 8.6% in the past one month.
Kamada’s earnings estimates widened from 6 cents to 10 cents for 2016 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 31.25%.
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Allergan (AGN) Liletta sNDA Accepted for Review in the U.S.
Allergan plc and partner Medicines360, a nonprofit global women's health pharmaceutical company, announced that the FDA has accepted a supplemental New Drug Application (sNDA) for its marketed intrauterine system (IUS), Liletta. The companies are looking to update Liletta’s label to extend its use for the prevention of pregnancy from up to three years to up to four years.
Allergan’s past one-month share price movement shows that the stock has outperformed the Zacks classified Medical-Generic Drugs industry. Specifically, the company gained 12.9%, while the industry lost 9.3%.
Liletta is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to three years and is more than 99% effective.
The sNDA was filed on the basis of data from a phase III hormonal IUD trial, ACCESS IUS, which was intended to determine comprehensive contraceptive efficacy & safety of Liletta. The study was conducted in 1,751 women. Liletta was found to be safe and effective for a broad range of women regardless of age, race, parity or Body Mass Index (BMI).
We note that in Feb 2015, Liletta was approved by the FDA for use with a two-handed inserter, followed by an approval in Jan 2016 for use with a new single-handed inserter, which is commercially available in the U.S.
Liletta raked in revenues of $15 million for the nine months ended Sep 2016, up 40.2% year over year.
ALLERGAN PLC Price
ALLERGAN PLC Price | ALLERGAN PLC Quote
Zacks Rank & Key Picks
Allergan currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Arena Pharmaceuticals, Inc. , Cambrex Corporation and Kamada Ltd. . While Cambrex sports a Zacks Rank #1 (Strong Buy), Arena and Kamada carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Arena’s loss estimates declined from 36 cents to 34 cents for 2016 and from 33 cents to 32 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 11.43%.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 90 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 8.6% in the past one month.
Kamada’s earnings estimates widened from 6 cents to 10 cents for 2016 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 31.25%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to 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. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>