Strong Revenue Growth for OGSIVEO
Generated $49.3 million in net product revenue in Q3, representing a 23% growth quarter-over-quarter, driven by robust demand in the U.S. market.
Positive Market Trends and Physician Adoption
High enthusiasm for OGSIVEO with 90% of prescribers likely to use it as a frontline treatment. 65% of patients transitioned to new blister packs, improving adherence.
Significant Opportunity with Mirdametinib
NDA for mirdametinib granted priority review with a potential for approval in early 2025. Strong efficacy and safety profile reported in pivotal trials.
Expansion into European Markets
EU regulatory reviews for OGSIVEO and mirdametinib underway with anticipated approvals in 2025. European headquarters established and commercial leadership onboarded.
Robust Financial Position
Strong balance sheet with $498 million in cash and marketable securities, expected to fund operations through profitability by the first half of 2026.