Competitive DynamicsA competitor received an FDA complete response letter over administration and labeling issues, which could delay that rival’s market entry and reduce near-term competitive pressure.
Labeling And UsabilityFDA label updates removed prior age restrictions and allowed practical administration changes such as sniffing and post-thaw use, increasing real-world usability and expanding the eligible pediatric and adult patient population.
Salesforce Expansion And MarketingExpansion of the salesforce funded by reallocating existing resources, together with direct-to-consumer campaigns and an integrated virtual prescribing program, is positioned to raise prescriber engagement and broaden patient awareness.