7:05AM Alkermes receives Fast Track Designation for ALKS 5461 for major depressive disorder (ALKS) 30.17 : Co announced that the FDA has granted Fast Track status for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard therapies. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and with the potential to address an unmet medical need.
Recent ALKS News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/23/2026 12:08:26 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/23/2026 12:04:37 AM
- Form 4/A - Statement of changes in beneficial ownership of securities: [Amend] • Edgar (US Regulatory) • 05/22/2026 11:59:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2026 08:59:13 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2026 08:57:44 PM
- Alkermes Showcases Data From Psychiatry Portfolio and Sleep Research into Real World Patient Experience at Spring 2026 Scientific Conferences • Business Wire • 05/21/2026 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/20/2026 08:10:47 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/13/2026 09:03:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/12/2026 11:07:58 AM
- Alkermes Announces Positive Topline Results From REVITALYZ℠ Phase 3 Study Evaluating LUMRYZ® (sodium oxybate) Extended-Release in Adults With Idiopathic Hypersomnia • Business Wire • 05/12/2026 11:00:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/05/2026 08:30:23 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/05/2026 11:05:17 AM
- Alkermes plc Reports First Quarter 2026 Financial Results • Business Wire • 05/05/2026 11:00:00 AM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/04/2026 08:30:48 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/02/2026 01:05:20 AM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 05/01/2026 08:51:50 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 05/01/2026 08:22:08 PM
- Alkermes to Report First Quarter Financial Results on May 5, 2026 • Business Wire • 04/21/2026 08:05:00 PM
- Alkermes to Present Additional Data From Vibrance-1 Phase 2 Study of Alixorexton in Patients with Narcolepsy Type 1 at the American Academy of Neurology (AAN) 2026 Annual Meeting • Business Wire • 04/16/2026 11:00:00 AM
- Findings From Long-Term Analysis of the Effects of LYBALVI® (olanzapine and samidorphan) on Negative Symptoms of Schizophrenia Published in The Journal of Clinical Psychiatry • Business Wire • 04/14/2026 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 04/06/2026 11:56:39 PM
