1차 출처 기록
결정급FDA 승인
Viridian: FDA, 2026년 6월 26일 갑상선안병증(TED) 치료제 Lumvoa(veligrotug) 승인
The FDA approved Lumvoa (veligrotug) for thyroid eye disease on June 26, 2026, ahead of the target PDUFA date, and the product was immediately launched in the U.S. Viridian has transitioned to a commercial-stage company with early physician engagement at 95% of core prescribers and first patient doses administered in July 2026.
핵심 사실
출처 발췌
EX-99.1 2 d174744dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Viridian Therapeutics Highlights Recent Business Progress and Reports Second Quarter 2026 Financial Results - Lumvoa ™ (veligrotug-vvze) approved by the FDA for thyroid eye disease (TED) on June 26, 2026, ahead of target PDUFA date and immediately launched in the U.S. - - Elegrobart, potentially the first subcutaneous autoinjector for the treatment of TED, on track for BLA submission Q1 2027 - - Pipeline progress continues, with FcRn and TSHR program development milestones on track in 2026 - - Completed convertible debt and equity financing in May 2026 with gross proceeds of $394 million; cash, cash equivalents, and marketable securities of $982 million as of June 30, 2026 - WALTHAM, Mass. – August 6, 2026 – Viridian Therapeut