Bayer AG (BAYRY - Free Report) submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
The submission is based on data from the phase III ARAMIS study in men with nmCRPC showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT). Darolutamide plus ADT has shown a favorable safety profile compared to placebo plus ADT.
Shares of Bayer have declined 34.3% in the past year against the industry’s growth of 9.6%.
In February 2019, Bayer completed the rolling submission of a new drug application (NDA) for darolutamide to the FDA. The company has also submitted an application for marketing authorization to the Ministry of Health, Labor and Welfare (MHLW) in Japan for darolutamide for the treatment of patients with castration-resistant prostate cancer (CRPC). Bayer is also in discussions with other health authorities regarding submissions.
Bayer has been granted Fast Track designation by the FDA for darolutamide in men with nmCRPC. The compound is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
We note that another company, Johnson & Johnson’s (JNJ - Free Report) Erleada was approved in EU in January 2019 for the treatment of nmCRPC who are at high risk of developing metastatic disease. It is presently marketed in the United States for the same indication.
Zacks Rank and Other Key Picks
Bayer currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the same space are AstraZeneca Plc. (AZN - Free Report) and BioDelivery Bristol-Myers Squibb Company (BMY - Free Report) , each carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AstraZeneca’s earnings per share estimates have increased from $1.76 to $1.79 for 2019 and from $1.99 to $2.19 for 2020 in the past 90 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 106.40%.
Bristol-Myers’ earnings per share estimates have increased from $4.12 to $4.16 for 2019 and from $4.36 to $4.64 for 2020 over the past 90 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 14.26%.
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