SUPERNUS PHARMACEUTICALS, INC. — Form 8-K
Filed October 21, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 68/100
What the filing says
The FDA granted seven years of orphan-drug exclusivity for ONAPGO (apomorphine HCl) for motor fluctuations in advanced Parkinson's disease, effective February 3, 2025. Supernus also submitted a supplemental NDA for a second supplier, with expected FDA approval by mid-year 2027, addressing earlier supply issues.
Why this rating
Orphan exclusivity protects ONAPGO's market position for seven years; second supplier resolves supply risk. Material for $1.7B company given ONAPGO as approved, marketed product, but magnitude depends on current sales (not disclosed).
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