Alkermes plc

ALKS

Held by 10 specialist biotech funds

High Convergence

10 funds opened new positions. Next phase3 readout (Medisorb naltrexone 190 mg): Sep 2003. Short interest: 16.5% of float.

BiotechnologyCEO: Richard F. PopsIPO: 1991Website ↗

Alkermes plc, a biopharmaceutical company, researches, develops, and commercializes pharmaceutical products to address unmet medical needs of patients in various therapeutic areas in the United States, Ireland, and internationally. Its marketed products include ARISTADA, an intramuscular injectable suspension for the treatment of schizophrenia; VIVITROL for the treatment of alcohol and prevention of opioid dependence; RISPERDAL CONSTA for the treatment of schizophrenia and bipolar I disorder; INVEGA SUSTENNA for the treatment of schizophrenia and schizoaffective disorder; XEPLION, INVEGA TRINZA, and TREVICTA to treat schizophrenia and schizoaffective; and VUMERITY for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting and active secondary progressive diseases. The company is also developing LYBALVI, an oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and bipolar I disorder; and nemvaleukin alfa, an engineered fusion protein to expand tumor-killing immune cells and to avoid the activation of immunosuppressive cells. It has collaboration agreements primarily with Janssen Pharmaceutica N.V., Janssen Pharmaceutica Inc, and Janssen Pharmaceutica International. Alkermes plc was founded in 1987 and is headquartered in Dublin, Ireland.

Catalysts

Phase 3PositiveQ3 2003Medisorb naltrexone 190 mgAlcoholismNCT01218958

Primary: Percentage of Heavy Drinking Days Over the Treatment Period (Baseline through Week 24 (168 days))Enrollment:624/624RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2009PlaceboChronic Obstructive Pulmonary Disease (COPD)NCT00801684

Primary: Spirometry Parameter: Peak Forced Expiratory Volume in 1 Second(FEV1)in Liters (L) (15 minutes to 24 hours post-treatment)Enrollment:24/24Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2009N1539Dental PainNCT00945763

Primary: Pain Intensity Difference at End of Study (0-24 hours)Enrollment:230/230Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q1 2011N1539HysterectomyNCT01084161

Primary: To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours. (at 60 minutes post dose and at 24 hours)Enrollment:486/486Sites: 12RANDOMIZED, TRIPLE, TREATMENT

Phase 3PositiveQ1 2011VIVITROL 380 mgAlcohol DependenceNCT00501631

Primary: Cumulative Percentage of Participants by Heavy Drinking Rate (up to 12 weeks)Enrollment:300/300RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2011RDC-0313 (ALKS 33)Binge Eating DisorderNCT01098435

Primary: Number of participants in each dose group reporting at least 1 treatment-emergent adverse event (TEAE) (6 Weeks)Enrollment:69/69Sites: 6RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2012ALKS 37Opioid-induced ConstipationNCT01382797

Primary: Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response. (4 weeks)Enrollment:157/157Sites: 20RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2012ALKS 37OICNCT01418092

Primary: Change from baseline in the weekly average of complete spontaneous bowel movements during treatment (Weeks 1 through 4 of treatment)Enrollment:91/91Sites: 13RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2014ALKS 5461Major Depressive DisorderNCT02085135

Primary: Number of Subjects With Adverse Events (AEs) (8 weeks)Enrollment:66/66Sites: 9RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2014Samidorphan (Low Dose)SchizophreniaNCT01903837

Primary: Absolute Change in Total Positive and Negative Syndrome Scale (PANSS) Score (Baseline (Day 8) to Day 92 (end of study Part A))Enrollment:347/347Sites: 61RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2015High Dose ALKS 5461Major Depressive DisorderNCT02158533

Primary: Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Baseline and 5 weeks for each stage)Enrollment:385/385Sites: 49RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ4 2015ALKS 5461Major Depressive DisorderNCT02158546

Primary: Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Baseline and week 6)Enrollment:447/447Sites: 58RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2016ALKS 5461Major Depressive DisorderNCT02218008

Primary: Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2) (Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect)Enrollment:407/407Sites: 44RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q1 2017Samidorphan + olanzapine (ALKS 3831)Schizophrenia, Alcohol Use DisorderNCT02161718

Primary: Number of Participants With Independent Adjudication Committee (IAC) Adjudicated Event of Exacerbation of Disease (EEDS) (Up to 15 months)Enrollment:300/300Sites: 71RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q1 2019Paliperidone PalmitateSchizophreniaNCT03345979

Primary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 (Baseline and 4 weeks)Enrollment:200/200Sites: 16RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2025ALKS 2680Narcolepsy Type 1NCT06358950

Phase 2Q2 2026ALKS 2680Idiopathic HypersomniaNCT06843590

Phase 3Q3 2026OLZ/SAMSchizophrenia, Bipolar I DisorderNCT05303064

Phase 3Q2 2027ALKS 2680 Dose 1Narcolepsy Type 1NCT07455383

Phase 3Q2 2027ALKS 2680 Dose 1Narcolepsy Type 2NCT07502443

Phase 3Q2 2027ALKS 2680 Dose 1Narcolepsy Type 1NCT07540897

Phase 3Q3 2027OLZ/SAMBipolar I Disorder, SchizophreniaNCT04987229

Phase 3Q2 2028ALKS 2680, 4mgNarcolepsy Type 1, Narcolepsy Type 2, Idiopathic HypersomniaNCT06767683

Alkermes plc

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