Bayer (BAYRY) Closes Registration Process For Kyleena In EU

Bayer AG (DE:BAYGN) (OTC:BAYRY) announced that it has completed the EU registration procedure for the marketing authorization of its new low-dose levonorgestrel-releasing intrauterine system (LNG-IUS).

The product has been found to release the lowest daily dose of the levonorgestrel hormone in an IUS for up to five years as an effective protection against pregnancy using the smallest T-shaped device available.

The company expects a response from the European Commission in the next few months. The new five-year contraceptive will be marketed as Kyleena, upon approval. Bayer anticipates launching the product in Jan 2017 in the EU.

We remind investors that last month, the FDA had approved Kyleena on the basis of results of a phase III study in both nulliparous and parous women. Results had demonstrated that Kyleena was highly effective and well tolerated regardless of age and parity. Moreover, the product was generally well tolerated, with no unexpected adverse events reported.

In the U.S., the company expects to launch the product this month.

In a separate press release, Bayer announced that it has completed the sale of the Consumer business from Environmental Science to SBM. The Consumer business, a unit of the Crop Science division, consists of the Bayer Garden and Bayer Advanced businesses, which offer a range of high-quality weed and pest control products for professionals and consumers.

Note that in 2015, Bayer Garden and Bayer Advanced businesses have contributed €239 million to the total turnover of €819 million at Environmental Science.

Bayer currently carries a Zacks Rank #3 (Hold).

Stocks to Consider

Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) , Anika Therapeutics, Inc. (NASDAQ:ANIK) and Geron Corporation (NASDAQ:GERN) . All these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Achillion has posted a positive earnings surprise in each of the last four quarters, with an average beat of 364.79%.

Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 9.5% and 11.5%, over the last 60 days. The company has beaten earnings estimates in each of the last four quarters with an average surprise of 42.19%. Its share price has jumped 22.8% year to date.

Geron has delivered a positive earnings surprise in each of four trailing quarters, bringing the average beat to 20.78%.

Confidential from Zacks

Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>