SUPERNUS PHARMACEUTICALS, INC.

SUPN

Held by 1 specialist biotech fund

1 fund opened new positions. Next phase3 readout (SPN-812): Sep 2026. Short interest: 10.5% of float.

Drug Manufacturers - Specialty & GenericCEO: Jack A. KhattarIPO: 2012Website ↗

Supernus Pharmaceuticals, Inc. is a biopharmaceutical firm dedicated to developing and marketing therapies for central nervous system (CNS) disorders within the United States. Its portfolio of marketed products includes Trokendi XR, an extended-release topiramate formulation prescribed for both epilepsy management and migraine prevention. Another key product is Oxtellar XR, an extended-release oxcarbazepine designed for the standalone treatment of partial-onset epileptic seizures in patients aged 6 to 17 and adults. The company also offers Qelbree, a selective norepinephrine reuptake inhibitor approved for attention-deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17. For advanced Parkinson's Disease (PD) patients, APOKYN offers acute, intermittent relief during "off" episodes of hypomobility, and XADAGO serves as an adjunctive treatment with levodopa/carbidopa for those experiencing similar off periods. Other offerings include GOCOVRI, which targets dyskinesia in PD patients, and Osmolex ER, used for Parkinson's disease and drug-induced extrapyramidal reactions in adults. MYOBLOC, a Type B toxin, is indicated for cervical dystonia and sialorrhea in adults. Beyond its commercial portfolio, Supernus is actively developing several investigational therapies. These include Qelbree (SPN-812), which has successfully completed Phase III trials for ADHD. SPN-830, a late-stage drug/device combination, aims to prevent off episodes in PD patients. SPN-817 is a novel compound in Phase I trials for severe epilepsy. SPN-820 is undergoing Phase II trials for resistant depression, and SPN-443 and SPN-446 are in earlier, preclinical stages for various CNS indications. Products are distributed through a network of pharmaceutical wholesalers, specialty pharmacies, and authorized distributors. Established in 2005, Supernus Pharmaceuticals is headquartered in Rockville, Maryland.

Catalysts

Phase 2Q3 2009SPN-810Attention Deficit Disorder With Hyperactivity, Conduct DisorderNCT00626236

Primary: The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score (Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks))Enrollment:78/78Sites: 9RANDOMIZED, TREATMENT

Phase 3Q2 2010PlaceboEpilepsies, PartialNCT00772603

Primary: PCH(T), ITT (Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline)Enrollment:366/366Sites: 71RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2010IR ViloxazineAttention-Deficit/Hyperactivity Disorder (ADHD)NCT01107496

Primary: Incidence of Adverse Events During 6 Weeks of Treatment (Weeks 1-6)Enrollment:52/52Sites: 4RANDOMIZED, QUADRUPLE, OTHER

Phase 3Q4 2011Oxcarbazepine XRPartial EpilepsyNCT00908349

Primary: Percent Change in Seizure Rate (one year)Enrollment:214/214Sites: 58NA, TREATMENT

Phase 2Q2 2012TPM XREpilepsyNCT01284530

Primary: steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability (14 days)Enrollment:30/30Sites: 10RANDOMIZED, TREATMENT

Phase 2Q4 2012SPN-810Impulsive Aggression Comorbid With ADHDNCT01364662

Primary: Reduction in aggressive behavior as assessed by R-MOAS score (Change from baseline to Visit 10)Enrollment:121/121Sites: 27RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q1 2013MolindoneImpulsive Aggression Comorbid With ADHD in ChildrenNCT01416064

Primary: Long Term Safety and tolerability of repeated oral dosing of 810M as an adjunctive therapy in children exhibiting impulsive aggression comorbid w/ ADHD (over 6 months)Enrollment:78/78Sites: 28NA, TREATMENT

Phase 2PositiveQ2 2015SAGE-547Super-refractory Status EpilepticusNCT02052739

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Up to Day 29)Enrollment:25/25Sites: 17RANDOMIZED, TREATMENT

Phase 2PositiveQ2 2015SAGE-547Postpartum DepressionNCT02285504

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (TEAEs: Up to Day 11, TESAEs: Up to Day 34)Enrollment:4/4Sites: 1NA, TREATMENT

Phase 2PositiveQ2 2016SAGE-547Severe Postpartum DepressionNCT02614547

Primary: Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score (Baseline, 60 Hours)Enrollment:21/21Sites: 4RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q3 2016PlaceboAttention-Deficit/Hyperactivity Disorder (ADHD)NCT02633527

Primary: The Efficacy of SPN-812 on the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV) (Baseline to Week 8 (End of Study))Enrollment:222/222Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2017SAGE-547Super-Refractory Status EpilepticusNCT02477618

Primary: Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo Infusion (7 days)Enrollment:132/132Sites: 171RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q3 2017PlaceboPostpartum DepressionNCT02942017

Primary: Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score (Baseline, Hour 60)Enrollment:108/108Sites: 32RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 2017PlaceboPostpartum DepressionNCT02942004

Primary: Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score (Baseline, Hour 60)Enrollment:138/138Sites: 32RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 2018PlaceboADHDNCT03247530

Primary: Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale, 5th Edition (ADHD-RS-5) (Baseline and Week 6 (End of Study))Enrollment:477/477Sites: 7RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2018PlaceboADHDNCT03247517

Primary: Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) (Baseline and Week 6 (End of Study))Enrollment:310/310Sites: 12RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2018PlaceboADHDNCT03247543

Primary: Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) (Baseline and Week 8 (End of Study))Enrollment:313/313Sites: 10RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q1 2019PlaceboADHDNCT03247556

Primary: Efficacy of SPN-812 Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) (Baseline and Week 7 (End of Study))Enrollment:297/297Sites: 14RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 2019SPN-810 (18 mg)Attention Deficit Hyperactivity Disorder (ADHD)NCT02618408

Primary: Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary (Daily measure from Visit 2 (Week-2) to Visit 6 (Week 5) for a total of 7 weeks)Enrollment:333/333Sites: 28RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2NegativeQ4 2019SPN-810Attention Deficit Hyperactivity Disorder (ADHD), Impulsive AggressionNCT03638466

Primary: Aggression-related Change in the Whole Brain in BOLD (Blood Oxygenation Level-dependent) Signal fMRI Contrast in Response to the PSAP Task (Baseline/Visit 2 (Day -5) to Visit 5 (Day 28) for a total of 4 weeks.)Enrollment:7/7Sites: 3RANDOMIZED, QUADRUPLE, BASIC_SCIENCE

Phase 3Q4 2019SPN-810 (18 mg)Attention Deficit Hyperactivity Disorder (ADHD)NCT02618434

Primary: Efficacy and Safety of SPN-810 on the Frequency of Impulsive Aggression (IA) Measured by the Impulsive Aggression Diary (Daily measure from Visit 2 (Week -2) to Visit 6 (Week 5) for a total of 7 weeks)Enrollment:297/297Sites: 32RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3NegativeQ1 2020SPN-810Attention Deficit Hyperactivity DisorderNCT03597503

Primary: Effect of SPN-810 Treatment on the Frequency of Impulsive Aggression (IA) Behaviors Measured by the Impulsive Aggression Diary (Daily measure from Visit 2 (Day -15) to Visit 7 (Day 36) for a total of 7 weeks)Enrollment:41/41Sites: 38RANDOMIZED, TRIPLE, TREATMENT

Phase 3Q3 2020PlaceboADHDNCT04016792

Primary: Efficacy of SPN-812 assessed by Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale- Combined Score (SKAMP-CS) (29 days)0RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2020PlaceboAttention-Deficit/Hyperactivity Disorder (ADHD)NCT04016779

Primary: Efficacy of SPN-812 on Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) as Assessed by the Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score (Baseline and Week 6)Enrollment:374/374Sites: 37RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2021BrexanolonePost Partum DepressionNCT03665038

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (From first dose of study drug up to end of follow-up period (up to Day 30))Enrollment:28/28Sites: 17NA, TREATMENT

Phase 3NegativeQ2 2021SPN-810Attention Deficit Hyperactivity Disorder (ADHD)NCT02691182

Primary: Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score (17-time points: Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9), 18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).)Enrollment:491/491Sites: 1NA, TREATMENT

Phase 2Q3 2021SAGE-718Alzheimer Disease, Cognitive Dysfunction, Mild DementiaNCT04602624

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (From first dose of study drug up to last follow up visit (up to 28 days))Enrollment:26/26Sites: 10NA, TREATMENT

Phase 2Q1 2022SAGE-718Parkinson Disease, Cognitive DysfunctionNCT04476017

Primary: Part A: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (From first dose of study drug up to 28 days)Enrollment:18/18Sites: 4NON_RANDOMIZED, TREATMENT

Phase 3ApprovedQ3 2022SPN-812Attention-Deficit/Hyperactivity DisorderNCT04143217

Primary: Incidence of Adverse Events (Up to 156 weeks)Enrollment:159/159Sites: 38NA, TREATMENT

Phase 2Q4 2023BrexanoloneTinnitusNCT05645432

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAE) (Up to Day 15)Enrollment:10/10Sites: 2NA, TREATMENT

Phase 2Q1 2024SAGE-718-matching placeboParkinson Disease, Cognitive DysfunctionNCT05318937

Primary: Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score (Baseline, Day 42)Enrollment:86/86Sites: 38RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q1 2024SAGE-718Huntington DiseaseNCT05358821

Primary: Difference in Huntington's Disease Cognitive Assessment Battery (HD-CAB) Composite Score Between Participants With HD vs HP at Baseline (Baseline)Enrollment:69/69Sites: 14RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2024SAGE-718Mild Cognitive Impairment, Mild Dementia, Alzheimer's DiseaseNCT05619692

Primary: Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score (Baseline, Day 84)Enrollment:174/174Sites: 39RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2024SAGE-718Huntington's DiseaseNCT05107128

Primary: Change From Baseline in the SDMT (Baseline, Day 84)Enrollment:189/189Sites: 49RANDOMIZED, TRIPLE, TREATMENT

Phase 3NegativeQ1 2025SAGE-718Huntington's DiseaseNCT05655520

Primary: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) (Up to 24 months)Enrollment:153/153Sites: 43NON_RANDOMIZED, TREATMENT

Phase 3Q3 2026SPN-812Attention-Deficit/Hyperactivity DisorderNCT02736656

Primary: Incidence of adverse events (up to 72 months)Enrollment:Target 1,400Sites: 16NA, TREATMENT

Phase 2Q4 2026BIS-001ERFocal Impaired Awareness SeizuresNCT03474770

Primary: Effect of BIS-001ER on Seizure Count (6 Weeks)Enrollment:Target 16Sites: 2NA, TREATMENT

Phase 2Q4 2026SPN-821 2400 mgMajor Depressive Disorder (MDD)NCT07226661

Primary: Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. (4 weeks)Enrollment:Target 230Sites: 1RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q3 2027SPN-817Focal Onset SeizuresNCT06798896

Phase 2Q4 2027SPN-817Focal Onset SeizuresNCT07141329

Phase 2Q4 2027SPN-817Epilepsy, Seizures, EpilepticNCT05518578

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