Alkermes PLC | $ALKS Stock | Shares Rise After FDA Welcomes New Drug Application (NDA)




The Food and Drug Administration (FDA) has accepted to review a new drug application for Alkermes PLC’s ALKS 5461 drug.

The decision by the FDA comes barely two weeks after it refused to accept an application for the drug, which the biopharmaceutical company says is going to be an important milestone in the treatment of major depression disorder (MDD). Shares of the company had sunk 22% when the FDA issued a letter refusing to review the drug.

But in in a new turn of events that has sent the shares flying high on Monday, Alkermes issued a press release saying the regulator has accepted the NDA surrounding the depression drug for review.

At the time of writing this article, shares of the company had gained $2.82, or 6.63% to trade at $42.53.

ALKS Earnings & Outlook

Alkermes reported adjusted earnings per share of $0.31 in the fourth quarter of fiscal 2017 finishing above analysts’ consensus estimate of $0.21. Year-over-year revenue increased by 29% to stand at $275.4 million during the quarter.

The results were propelled by solid growth of the proprietary products (Aristada and Vivitrol) of the company, royalty revenues and higher manufacturing. The company is expected to report its earnings for first quarter of fiscal 2018 on April 26.

Alkermes Comments  

Craig Hopkinson, the company’s Chief Medical Officer made the following comment: “FDA’s filing of the ALKS 5461 application is a positive step forward for patients suffering from major depressive disorder, a serious disease where inadequate response to existing antidepressants remains a well-known and significant treatment limitation, and where there have been no new pharmacological treatment approaches in 30 years. We will continue to engage with the FDA throughout the review process, as we work to bring this important medicine to patients.”

Alkermes PLC Company Profile

Alkermes PLC is a Dublin-based biopharmaceutical company that was incorporated in 2011. The company engages in the commercialization, research, and development of medicines intended to address patients’ medical needs. Alkermes segments of operation are as follows: Ireland, United States, Other, and Rest of the World. Its proprietary products include the Vivitrol and Aristada brands.

The competitors of the company include Otsuka Pharmaceutical Co., Bayer HealthCare Pharmaceuticals, Eli Lilly & Company., Novo Nordisk A/S, Indivior plc, Novartis AG, BioDelivery Sciences, Teva Pharmaceutical Industries Ltd, Braeburn Pharmaceuticals, Sanofi Aventis, Biogen MA Inc., Orexo US, Inc., Novo Nordisk A/S, and EMD Serono, Inc. –YahooFinance