commitment
From year-end, the D2T RA approval direction will be discussed with the FDA, and GD (Phase 2b) and MG (Phase 3) top-line results are scheduled for 2027.
A commitment by 하나증권 제약/바이오 김선아. Statements are as reported by the cited publishers — not verified by DecisionGateway.
연말부터 D2T RA 허가 방향을 FDA와 협의하고, ‘27년 GD(2b상)와 MG(3상) 탑라인 발표 예정
Discussion
Related claims
In the D2T RA Phase 2b Period 2 results, the 600mg continuous dosing group achieved statistical significance (p-value), a surprise exceeding market expectations.report author · statementTopline data from the Graves' disease (GD) Phase 2b and myasthenia gravis (MG) Phase 3 registrational trials are expected in 2027.report author · predictionFollowing the D2T RA clinical success, the risk discount is reduced from 50% to 40%, leading to a revaluation of IMVT-1402.report author · statementIn the D2T RA Phase 2b Period 2 results, the 600mg continuous dosing group achieved a p-value.하나증권 제약/바이오 김선아 · statement在2026年10月13日或之后提交的申请将不会被受理，直至另行通知。汇丰香港 · predictionCoverage initiated with a target price of 80,000 won, expecting MG and GD clinical results in 2027.하나증권 제약/바이오 김선아 · commitment