Yeji

$ALKS

Alkermes plc.

Runway:6 mo
NasdaqMarket cap: —CIK 0001520262

Upcoming catalysts

1 surfaced
FDA approvalDate TBD~ low confidence
$ALKSAlkermes plc.
“contingent upon final FDA approval of LUMRYZ ® for the treatment of idiopathic hypersomnia in adults by the end of 2028”

Drug pipeline

lybalvi
Aripiprazole Lauroxil
Schizophrenia
ALKS 9072, Low Dose
Schizophrenia
NTX/BUP
Opioid Use Disorder
ALK3831
Schizophrenia
High Dose ALKS 5461
Major Depressive Disorder
ALKS 2680, 4mg
Narcolepsy Type 1
VIVITROL 380 mg
Alcohol Dependence
alixorexton
narcolepsy type 1
Itraconazole
Pharmacokinetics
ALKS 5461
Major Depressive Disorder
Baclofen IR
Alcohol Dependence
Placebo
Central Nervous System Diseases
Lobradimil
Meningitis, Cryptococcal
ALKS 9072, Low
Schizophrenia
ALKS 3831
Healthy Volunteers
ALKS 33-BUP
Cocaine Abuse
RDN-929 oral capsule
Healthy
ALKS 9072
Schizophrenia
ALKS 2680 Dose 1
Narcolepsy Type 1
N1539
Hysterectomy
ALKS33 (RDC-0313) (1 mg)
Alcohol Dependence
Medisorb naltrexone 380 mg
Alcoholism
[11C]-UCB-J
Healthy
Samidorphan IV
Healthy
Naltrexone
Opioid Use Disorder
ALKS 37
OIC
Samidorphan
Healthy Volunteers
Medisorb naltrexone 190 mg
Alcohol Dependence
VIVITROL 380mg
Opioid Dependence
Samidorphan + olanzapine (ALKS 3831)
Schizophrenia
RDC-0313
Alcohol Dependence
Medisorb naltrexone 75 mg
Opiate Dependence
OLZ/SAM
Bipolar I Disorder
ALKS 2680
Narcolepsy Type 2
VIVITROL® 380 mg
Opiate Dependence
RDN-929
Healthy
RDC-1036 (ALKS 37)
Opioid-induced Constipation
Moxifloxacin
Healthy
Samidorphan (Low Dose)
Schizophrenia
RDC-0313 (ALKS 33)
Binge Eating Disorder

Recent & active trials

NCTDrugPhaseStatusPrimary completion
NCT06767683ALKS 2680, 4mgPhase 3Recruiting2028-06-01
NCT04987229OLZ/SAMPhase 3Enrolling By Invitation2027-09-01
NCT07540897ALKS 2680 Dose 1Phase 3Recruiting2027-06-01
NCT07502443ALKS 2680 Dose 1Phase 3Recruiting2027-05-01
NCT07455383ALKS 2680 Dose 1Phase 3Recruiting2027-05-01
NCT06843590ALKS 2680Phase 2Recruiting2026-11-01
NCT05303064OLZ/SAMPhase 3Recruiting2026-09-01
NCT06555783ALKS 2680Phase 2Completed2025-11-11
NCT06358950ALKS 2680Phase 2Completed2025-06-19
NCT03201757ALKS 3831Phase 3Completed2023-09-06
NCT04987658OLZ/SAMPhase 1Completed2023-08-11
NCT03919994——Completed2023-01-04
NCT05547100lybalviPhase 1Completed2022-11-19
NCT05019105PlaceboPhase 1Terminated2022-08-23
NCT03187769ALKS 3831Phase 3Completed2021-12-01
NCT03610048ALKS 5461Phase 3Terminated2020-05-01
NCT03188185ALKS 5461Phase 3Completed2020-02-26
NCT03963973RDN-929 oral capsulePhase 1Terminated2020-01-22
NCT02873208ALKS 3831Phase 3Completed2019-10-17
NCT03577262[11C]-UCB-JEarly Phase 1Completed2019-08-02

Recent catalysts

NDA/BLA filedJan 6, 2026· 202d ago
$ALKSAlkermes plc.
alixorexton · narcolepsy type 1
“On January 6, 2026, the Company announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1.”
PDUFAJan 6, 2026· 202d ago
$ALKSAlkermes plc.
alixorexton · narcolepsy type 1
“On January 6, 2026, the Company announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1.”
AdComJan 6, 2026· 202d ago
$ALKSAlkermes plc.
alixorexton · narcolepsy type 1
“On January 6, 2026, the Company announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1.”
FDA approvalJan 6, 2026· 202d ago
$ALKSAlkermes plc.
alixorexton · narcolepsy type 1
“On January 6, 2026, the Company announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1.”
FDA approvalJun 1, 2021· 1882d ago
$ALKSAlkermes plc.
lybalvi
“On June 1, 2021, Alkermes plc issued a press release announcing that the U.S. Food and Drug Administration has approved LYBALVI TM (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.”
FDA approvalMay 28, 2021· 1886d ago· success
$ALKSAlkermes plc.
lybalvi
“openFDA ORIG (TYPE 1/4) approval of LYBALVI — application NDA213378”