Company Expects to Complete Submission for Fast Track Designated Medicine by Year-End 2017 DUBLIN–(BUSINESS WIRE)–Aug. 21, 2017– Alkermes plc (NASDAQ:ALKS) today announced the initiation of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a […]
Once-Daily, Oral Product Candidate Demonstrated Antipsychotic Efficacy Statistically Superior to Placebo and Similar to Olanzapine in ENLIGHTEN-1 Study Management to Hold Conference Call Today at 4:30 p.m. ET DUBLIN–(BUSINESS WIRE)–Jun. 29, 2017– Alkermes plc (NASDAQ: ALKS) today announced positive preliminary topline results from ENLIGHTEN-1, the first of two key phase 3 studies in the ENLIGHTEN […]
Phase 3b Study Designed to Further Evaluate ALKS 5461’s Potential Benefits on Mood Domains Regulated by Endogenous Opioid Modulation Company Reiterates Plans to Submit New Drug Application to FDA by Year-End 2017 DUBLIN–(BUSINESS WIRE)–Jun. 12, 2017– Alkermes plc (NASDAQ: ALKS) today announced the initiation of study 217, a phase 3b trial of ALKS 5461, a […]
Designed to Assess Weight Gain Profile of Olanzapine Compared to ALKS 3831 in Patients Diagnosed With Schizophrenia, Schizophreniform or Bipolar I Disorder Who Are Early in Their Illness Supportive Study in the ENLIGHTEN Clinical Development Program for ALKS 3831, an Investigational, Novel, Once-Daily, Oral Atypical Antipsychotic for the Treatment of Schizophrenia DUBLIN–(BUSINESS WIRE)–Jun. 8, 2017– […]
First and Only Long-Acting Atypical Antipsychotic With Two-Month Dosing Option Approval Expands ARISTADA’s Product Offerings to Include Once-Monthly, Once-Every-Six-Weeks and Once-Every-Two-Months Dosing Durations DUBLIN–(BUSINESS WIRE)–Jun. 6, 2017– Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved two-month ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. […]
Once-Daily, Oral Product Candidate Showed Efficacy Equivalent to Olanzapine With Clinically Meaningful and Statistically Significant Lower Weight Gain in 300-Patient Study Company Plans to Initiate Pivotal Development Program in 2015 DUBLIN–(BUSINESS WIRE)–Jan. 7, 2015– Alkermes plc (NASDAQ: ALKS) today announced positive topline results from the 12-week, randomized, double-blind, active-controlled, dose-ranging stage of a phase 2 […]
Safety and Tolerability Profile of ALKS 5461 Confirmed in FORWARD-1 Study, a Supportive Study in the FORWARD Phase 3 Pivotal Program Dosing Regimen Confirmed; Efficacy Data Showed Statistically Significant Improvements in Depression Scores Beginning at Week One and Continuing Through Eight-Week Treatment Period DUBLIN–(BUSINESS WIRE)–Jan. 6, 2015– Alkermes plc (NASDAQ: ALKS) today announced topline results […]