Indication Expansion And Commercial PotentialPlanned trials in non-IPF interstitial lung diseases and refractory chronic cough, along with analyst expectations of a standalone chronic cough franchise, broaden Haduvio's commercial opportunity.
Regulatory ClarityFDA scheduling of an End-of-Phase 2 meeting clarifies the regulatory pathway and supports plans to initiate a pivotal Phase 3 program for Haduvio in IPF-associated chronic cough.
Safety And Drug Interaction ProfileSafety review observed no respiratory depression in sentinel cohorts and drug-drug interaction testing showed no meaningful interactions with standard IPF therapies, reducing safety concerns for combination use.