Alkermes PLC

Alkermes started at buy with $60 stock price target at B. Riley FBR

Alkermes started at buy with $60 stock price target at B. Riley FBR

• Jun. 6, 2018 at 2:05 p.m. ET
• by Tomi Kilgore

Alkermes's stock soars after FDA accepts NDA review, 2 weeks after refusing

Shares of Alkermes PLC soared 21% in premarket trade Monday, after the biopharmaceutical company said the Food and Drug Administration accepted for review the company's new drug application (NDA) for its treatment of major depressive disorder (MDD). The acceptance comes after the FDA had initially issued a "refusal to file" letter for the MDD treatment, ALKS 5461, on March 30. The stock had plunged 22% on April 2, when the news of the letter was released. Alkermes said the rescission of the refusal letter followed "productive interactions" with the FDA, in which it "clarified" certain aspects of the NDA submission, without any additional data or analyses submitted. Alkermes's stock had tumbled 22.3% year to date through Friday, while the SPDR S&P Biotech ETF had gained 5.6% and the S&P 500 had slipped 0.7%.

• Apr. 16, 2018 at 7:27 a.m. ET
• by Tomi Kilgore

Alkermes's stock soars 21% premarket after FDA accepts NDA for review

Alkermes's stock soars 21% premarket after FDA accepts NDA for review

• Apr. 16, 2018 at 7:16 a.m. ET
• by Tomi Kilgore

Alkermes shares tumble 22% after FDA 'refusal' letter for depression treatment

Alkermes PLC shares tumbled 21.5% in premarket trade Monday after the company received a "refusal to file" letter from the Food and Drug Administration regarding its new drug application for ALKS 5461, a treatment for major depressive disorder (MDD). Alkermes said the FDA has taken the position that it is unable to complete a substantive review of the NDA given insufficient evidence of overall effectiveness, and said additional clinical trials are needed before the NDA is resubmitted. Alkermes said it "strong disagrees" with the FDA and will appeal its decision. "We are extremely disappointed with this decision and the implications for patients in the U.S. suffering from major depressive disorder, a serious disease where there is a clear and urgent need for new treatment options for patients and their families," said Alkermes Chief Executive Richard Pops. The company said it is evaluating the impact of the FDA's decision on previously provided financial guidance. The stock had gained 5.0% over the past three months through Thursday, while the iShares Nasdaq Biotechnology ETF had lost 2.4% and the S&P 500 has slipped 2.0%.

• Apr. 2, 2018 at 8:12 a.m. ET
• by Tomi Kilgore

Alkermes' stock resumes trade, tumbles 19% premarket after FDA 'refusal' letter

Alkermes' stock resumes trade, tumbles 19% premarket after FDA 'refusal' letter

• Apr. 2, 2018 at 7:33 a.m. ET
• by Tomi Kilgore

Alkermes receives FDA refusal letter regarding NDA for treatment of depressive disorder

Alkermes receives FDA refusal letter regarding NDA for treatment of depressive disorder

• Apr. 2, 2018 at 7:08 a.m. ET
• by Tomi Kilgore

Alkermes narrows loss by 54% to top estimates

• Feb. 14, 2018 at 7:25 a.m. ET

Biogen price target raised 20% to $420 at Instinet, citing 'meaningful 2018 for the company'

• Dec. 21, 2017 at 3:22 p.m. ET
• by Emma Court

UPDATE: Alkermes shares rise 6% on Biogen multiple sclerosis drug partnership

• Nov. 27, 2017 at 8:49 a.m. ET
• by Emma Court

Alkermes shares rise 2% on $28 mln Biogen multiple sclerosis drug partnership

• Nov. 27, 2017 at 7:18 a.m. ET
• by Emma Court

Alkermes upgraded to overweight from neutral at J.P. Morgan

• Oct. 21, 2016 at 8:12 a.m. ET
• by Tomi Kilgore

Alkermes stock price target raised to $78 from $51 at J.P. Morgan

• Oct. 21, 2016 at 8:12 a.m. ET
• by Tomi Kilgore

Alkermes shares soar more than 40% after depression drug results

• Oct. 20, 2016 at 4:25 p.m. ET
• by Wallace Witkowski

Alkermes shares surge 48% after promising depression drug data

• Oct. 20, 2016 at 4:13 p.m. ET
• by Wallace Witkowski