Accelerated Approval PotentialThe current clinical data package could support an accelerated approval pathway for efzofitimod, offering a faster route to market if regulators accept the evidence.
Patient-reported OutcomesPrior clinical data showed efzofitimod improved a validated patient-reported lung symptom score by an amount considered clinically meaningful, supporting evidence of functional benefit for patients.
Phase 2 Interim ResultsInterim results from the Phase 2 EFZO-CONNECT study showed encouraging signals in patients with scleroderma-related interstitial lung disease, bolstering the case for advancing development.