Travere Therapeutics (TVTX) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Strategic focus and recent approvals

• Focused on rare kidney and metabolic disorders, with a lead product recently receiving full FDA approval for IgA nephropathy, expanding its label to all at-risk patients and including two-year efficacy and safety data.

• The addressable patient population for Filspari has more than doubled due to label expansion and updated KDIGO guidelines, now exceeding 70,000 patients.

• New guidelines recommend earlier and broader treatment, emphasizing kidney protection and supporting Filspari as foundational therapy.

Market dynamics and physician adoption

• Early physician feedback is positive, with field teams trained on new guidelines and label; physicians are expected to prescribe earlier and more aggressively.

• High compliance and adherence rates are reported, attributed in part to REMS requirements, with commercial impact expected to accelerate in Q4 and into next year.

• Access is strong, with 96% of patients having a reimbursement pathway; efforts are underway to update payer criteria to reflect the new label and guidelines.

Regulatory and development updates

• Discussions with FDA are ongoing regarding REMS modification, leveraging robust safety and efficacy data; a supplemental NDA may be submitted soon.

• FSGS program awaits regulatory feedback following the PARASOL group’s endpoint recommendations, with potential for rapid sNDA submission if a path is identified.

• Intellectual property for Filspari extends to 2033.