BP-205 Phase 1 SAD data showed favorable PK and safety.
Phase 1 MAD data are expected in Q4, with a Phase 1b study starting in Q3.
Second-quarter results and guidance
Harmony Biosciences posted Q2 net product revenue of $261.3 million, up 30% year over year, with average patients rising 450 to 8,950.
Net income climbed to $75.4 million; diluted EPS rose to $1.28.
Cost of product sold increased 66% to $63.2 million, lifting it to 24.2% of net product revenue due to new Novitium license royalties.
The company reiterated 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion, and said it had $962.5 million in cash, cash equivalents and investments at June 30.