Strong Patient Growth for LUMRYZ
2,300 active patients on therapy as of September 30, with 700 new patients initiating LUMRYZ therapy in Q3, resulting in $50 million in net revenue during the third quarter.
FDA Approval and Orphan Drug Exclusivity for Pediatric Use
Received FDA approval for LUMRYZ in treating cataplexy or excessive daytime sleepiness in pediatric patients 7 years and older with narcolepsy, along with a second orphan drug exclusivity award.
Successful Legal Outcomes
District of Columbia Court's favorable ruling affirming the FDA's approval and clinical superiority decision for LUMRYZ based on its unique once-nightly dosing profile.
Initiation of Phase III IH Trial
Enrollment is ongoing in the Phase III REVITALYZ study, evaluating LUMRYZ's potential clinical benefit in adults with idiopathic hypersomnia.
Positive Financial Results
Reported net revenue of $50 million and gross profit of $43.9 million for Q3, with a positive adjusted EBITDA of $6.1 million.