INDIANAPOLIS — Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of ALIMTA(R) (pemetrexed for injection) as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell...
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DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1 (NT1), based on phase 1 and phase 2 clinical data, including positive results from Vibrance-1, a large (n=92) phase 2 study evaluating...
DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Alixorexton is the company’s novel, investigational, oral, selective orexin 2...
DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced initiation of the Vibrance-1 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in patients with narcolepsy type 1 (NT1). ALKS 2680 is the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist...
DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced positive topline results from the randomized double-blind treatment period of the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, formerly referred to as ALKS 2680, is the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in...
DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced positive topline results from the Vibrance-2 dose-ranging phase 2 study evaluating alixorexton in patients with narcolepsy type 2 (NT2). Alixorexton, formerly referred to as ALKS 2680, is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2 development for...
DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI® (olanzapine and samidorphan) in patients with schizophrenia, schizophreniform disorder or bipolar I disorder for up to four years of treatment, following treatment...
DUBLIN, Ireland – Alkermes plc (Nasdaq: ALKS) today announced positive topline results from the REVITALYZ℠ double-blind, placebo-controlled, randomized withdrawal, multicenter phase 3 study evaluating the investigational use of LUMRYZ® (sodium oxybate) extended-release oral suspension in adults with idiopathic hypersomnia (IH). LUMRYZ met the study’s primary endpoint, demonstrating statistically significant improvements in excessive...
DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, formerly ALKS 2680, is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2 development as a once-daily treatment for NT1,...
DUBLIN, Oct. 23, 2023 — Alkermes plc (Nasdaq: ALKS) announced preliminary results, including initial proof-of-concept data, from a phase 1 study evaluating ALKS 2680, the company’s novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy. The ongoing phase 1 study is evaluating the safety, tolerability,...