Supernus Pharmaceuticals, Inc. SUPN
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) is a CNS/neurology/psychiatry drug developer. Its lead program, Qelbree (viloxazine extended-release), is in Phase 2 for ADHD in pediatric patients 6+ and adults. Its next catalyst on record is SPN-443: Initiate Phase 1 SAD/MAD study in healthy volunteers (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: SPN-443 — Initiate Phase 1 SAD/MAD study in healthy volunteers (H2 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Qelbree (viloxazine ER) | ADHD | small molecule | Approved |
| ZURZUVAE (zuranolone), co-commercialized with Biogen | postpartum depression | small molecule | Approved |
| ONAPGO (apomorphine infusion) | motor fluctuations in advanced Parkinson's disease | device-combination | Approved |
| GOCOVRI (amantadine ER) | dyskinesia in Parkinson's disease | small molecule | Approved |
| SPN-817 (huperzine A) | treatment-resistant focal seizures | small molecule | Phase 2 |
| SPN-820 (NV-5138) | major depressive disorder (adjunctive) | small molecule | Phase 2 |
| SPN-443 | ADHD (triple reuptake inhibitor stimulant) | small molecule | Phase 1 |
Recent results and decisions
- Oct 22, 2026submitted Company submitted supplemental NDA to FDA for a second supplier for ONAPGO, with potential approval by mid-year 2027.
The Company submitted a supplemental New Drug Application (sNDA) to the FDA for a second supplier for ONAPGO and continues to expect potential FDA approval of the second supplier by mid-year 2027.
Filing - Feb 3, 2025approval FDA grants seven years of orphan-drug exclusivity for ONAPGO, beginning February 3, 2025.
The seven-year market exclusivity for ONAPGO began on February 3, 2025, the date of FDA approval.
Filing - Feb 3, 2025n/a The FDA recognized seven years of orphan-drug exclusive approval for ONAPGO, beginning February 3, 2025.
The U.S. Food and Drug Administration (FDA) has recognized seven years of orphan-drug exclusive approval for ONAPGO (apomorphine HCl) for the treatment of motor fluctuations in adults with advanced Parkinson's disease.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.