WAKIX - (Pitolisant GR)

May 7, 2026: Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY) reported Q1 2026 WAKIX (pitolisant) net product revenue of $215.4M (+17% YoY) and reiterated FY2026 guidance of $1.0B–$1.04B; it expects >$1B in 2026 narcolepsy net sales. The company noted FDA approval on Feb. 13, 2026 for a pediatric cataplexy indication and began full promotional efforts.

Pitolisant franchise/IP: In Q1, Harmony reached three additional ANDA settlements (6 of 7 filers settled). It also acquired an exclusive license to an issued patent through 2042 for a novel amorphous form of pitolisant. In April, Harmony and Novitium filed a patent-infringement suit against AET Pharma US and Sandoz alleging infringement of patents covering an amorphous form of pitolisant hydrochloride. WAKIX exclusivity is stated to extend into 2030 (including 6 months pediatric exclusivity), with potential into the 2040s via additional patents/applications.

Pipeline/formulation catalysts:

• Pitolisant in Prader-Willi syndrome: Phase 3 topline readout expected 2H 2026.
• Pitolisant GR (gastro-resistant): NDA submission targeted for Q2 2026; anticipated PDUFA in Q1 2027.
• Pitolisant HD: Phase 3 ONSTRIDE 1 (narcolepsy) and ONSTRIDE 2 (idiopathic hypersomnia) ongoing; topline data expected 2027; anticipated PDUFA in 2028.
• BP-205 (orexin-2 agonist): Phase 1 SAD/MAD ongoing in Europe; SAD PK/safety/tolerability data expected mid-2026; U.S. IND planned mid-2026; Phase 1b in 2H 2026.
• EPX-100 (clemizole HCl): Two global Phase 3 trials enrolling (LGS LIGHTHOUSE; DS ARGUS); DS OLE data presented at AAN April 2026; topline data anticipated 1H 2027 with potential PDUFA in 2028.