- The FDA has approved Alkermes plc's ALKS Lybalvi, a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity, for schizophrenia and bipolar I disorder.
- The approval comes as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.
- The treatment will be commercially available later in Q4 of 2021.
- Alkermes will host a conference call today at 8:30 a.m. ET.
- Price Action: ALKS shares are up 0.60% at $22.80 during the market session on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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