Dianthus Therapeutics FY Conference Summary Company Overview - Dianthus Therapeutics is perceived as a significantly de-risked company following the presentation of positive Phase 2 data for its neuromuscular conditions treatment, specifically with a dosing regimen of 300 milligrams every two weeks [3][4] - The company is preparing for two important catalysts in 2026: an interim responder analysis for CIDP in Q2 and Phase 2 top-line data from the MMN trial in the second half of 2026 [4] Key Points on CIDP Trial - The accelerated timeline for the CIDP trial is attributed to faster recruitment following the MG data presentation, which reassured investigators about the safety and efficacy of the treatment [7][8] - The trial design is modeled after the ADHERE trial from argenx, featuring an open-label part A that allows patients to receive active treatment before randomization [10][11] - The trial is designed to be more attractive for participants compared to competitors, with less frequent dosing (every two weeks) versus weekly for other treatments [10][12] - The company emphasizes the importance of confirming CIDP diagnoses through an independent review board, ensuring a dual authentication system for patient eligibility [17][18] Efficacy Expectations - The company aims to achieve a responder rate in the range of 40%-50%, which would indicate a competitive drug compared to riliprubart [40] - There is a focus on achieving significant inhibition of the classical pathway with a lower dose and fewer injections compared to competitors [41][42] - The interim analysis may not disclose specific responder rates due to FDA guidelines, but the expectation is to demonstrate at least similar efficacy to riliprubart [24][33] MMN Trial Insights - The MMN trial is modeled after argenx's Phase 2 trial, with expectations to report top-line results in the second half of next year [54] - The primary endpoint for the Phase 3 trial is still under discussion with the FDA, with grip strength being a likely candidate based on ongoing conversations [59] New Asset Introduction - Dianthus has licensed a new bispecific fusion protein, NTH 212, from China, which is expected to be a first-in-class and best-in-class potential treatment [4][60] - The timing for the indication selection disclosure for NTH 212 is planned before the Phase 1 data release in the second half of next year [62] Additional Considerations - The company is considering removing certain burdensome tests, such as ANA titers, from the trial protocols, similar to actions taken by competitors [43][44] - The overall sentiment is optimistic, with a strong belief in the efficacy of classical pathway inhibition in CIDP and a commitment to patient-friendly dosing regimens [24][41]