elegrobart (VRDN-003) / Viridian Therap, Kissei, ZAI Lab - LARVOL DELTA

Efficacy and Safety of Subcutaneously Administered Elegrobart in Active Thyroid Eye Disease (TED): Topline Results from the Phase 3 REVEAL‑1 Trial (ATA 2026) - No abstract available

Clinical • P3 data • P3 data: top line • Ophthalmology • Thyroid Eye Disease

Topline Results from the Phase 3 REVEAL‑2 Trial of Subcutaneous Administration of Elegrobart (VRDN-003) in Chronic Thyroid Eye Disease (TED) (ATA 2026) - No abstract available

P3 data • P3 data: top line • Ophthalmology • Thyroid Eye Disease

A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=108 | Active, not recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Viridian Therapeutics Highlights Recent Business Progress and Reports Second Quarter 2026 Financial Results (Businesswire) - "Viridian is on track to submit a Biologics License Application (BLA) to the FDA for elegrobart in Q1 2027."

FDA filing • Thyroid Eye Disease

Company’s first commercial product in TED with subcutaneous elegrobart on track for a biologics license application (BLA) submission in Q1 2027 (Businesswire)

FDA filing • Thyroid Eye Disease

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=87 | Completed | Sponsor: Viridian Therapeutics, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Nov 2026 ➔ May 2026

Trial completion • Trial completion date • Ophthalmology • Thyroid Eye Disease

Phase 3 trial: Positive topline results for elegrobart for the treatment of TED (Ophthalmology Times) - " REVEAL-2 demonstrated week-24 proptosis responder rates of 50% (q4w) and 54% (q8w) versus 15% with placebo (P<0.0001 for both comparisons). Diplopia improved with q4w elegrobart, achieving a 61% week-24 responder rate compared with 38% for placebo (P=0.0118). Tolerability across both dosing regimens aligned with prior experience and showed low rates of hearing impairment, supporting a differentiated safety profile within IGF-1R targeting."

P3 data: top line • Thyroid Eye Disease

Subcutaneous elegrobart showed positive topline data in REVEAL-1 and REVEAL-2 phase 3 clinical trials in active and chronic TED, respectively (Businesswire) - "REVEAL-1 in Active TED: met its primary endpoint...54% and 63% proptosis responder rates...REVEAL-2 in Chronic TED: met its primary endpoint...50% and 54% proptosis responder rates...BLA submission anticipated in Q1 2027 with the potential to be the first subcutaneous autoinjector treatment for TED."

FDA filing • Ophthalmology • Thyroid Eye Disease

A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=165 | Active, not recruiting | Sponsor: Viridian Therapeutics, Inc. | N=81 ➔ 165

Enrollment change • Ophthalmology • Thyroid Eye Disease

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=87 | Active, not recruiting | Sponsor: Viridian Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=99 | Recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology • Thyroid Eye Disease

A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=321 | Active, not recruiting | Sponsor: Viridian Therapeutics, Inc. | Trial primary completion date: Oct 2026 ➔ Apr 2026

Trial primary completion date • Ophthalmology • Thyroid Eye Disease

A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=284 | Active, not recruiting | Sponsor: Viridian Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Subcutaneous VRDN-003 topline data readout accelerated to Q1 2026 for REVEAL-1 and narrowed to Q2 2026 for REVEAL-2 for active and chronic TED, respectively; each study exceeded its enrollment target due to strong patient demand (FinancialContent)

P3 data: top line • Thyroid Eye Disease

A Study to Assess the Efficacy and Safety of ZL-1109 in Chinese Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=99 | Not yet recruiting | Sponsor: Zai Lab (Shanghai) Co., Ltd.

New P3 trial • Ophthalmology • Thyroid Eye Disease

REVEAL-1: An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Active Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=117 | Active, not recruiting | Sponsor: Viridian Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

REVEAL-2: An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=195 | Active, not recruiting | Sponsor: Viridian Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Viridian Therapeutics Announces Collaboration and License Agreement with Kissei Pharmaceutical to Develop and Commercialize Veligrotug and VRDN-003 in Japan with an Upfront Payment of $70 Million and up to $315 Million in Milestone Payments (Viridian Therap Press Release) - "Viridian Therapeutics...announced that it has entered into an exclusive collaboration and license agreement with Kissei Pharmaceutical Co., Ltd. ('Kissei') to develop and commercialize veligrotug and VRDN-003 in Japan. Both molecules are anti-insulin-like growth factor-1 receptor (IGF-1R) antibodies for the potential treatment of patients with thyroid eye disease (TED)....Under the terms of the agreement, Viridian will grant Kissei an exclusive license to develop and commercialize veligrotug and VRDN-003 in Japan. Viridian will receive an upfront cash payment of $70 million, with the potential to receive an additional $315 million in development, regulatory, and commercial milestone payments, as well as tiered royalties on net sales in Japan with percentages ranging from the 20s to mid-30s. Kissei will be responsible for all development, regulatory, and commercialization activities, and associated costs, in Japan."

Licensing / partnership • Thyroid Eye Disease

A Safety, Tolerability and Pharmacokinetics Study of VRDN-003 in Participants With Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=75 | Recruiting | Sponsor: Viridian Therapeutics, Inc.

New P3 trial • Ophthalmology • Thyroid Eye Disease

Viridian Therapeutics Highlights Recent Progress and Reports First Quarter 2025 Financial Results (Businesswire) - "Biologics License Application (BLA) submission for veligrotug on track for second half 2025 with potential for U.S. launch in 2026; preparatory commercial activities underway; REVEAL-1 and REVEAL-2, phase 3 clinical trials assessing VRDN-003 in active and chronic thyroid eye disease (TED), are on track for topline data in the first half of 2026....VRDN-008, a bispecific neonatal Fc receptor (FcRn) inhibitor with an extended half-life, on track for an Investigational New Drug (IND) submission for year-end 2025."

FDA filing • IND • Launch US • P3 data: top line • Ophthalmology • Thyroid Eye Disease

REVEAL-2: An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=195 | Recruiting | Sponsor: Viridian Therapeutics, Inc. | N=126 ➔ 195

Enrollment change • Ophthalmology • Thyroid Eye Disease

REVEAL-1: An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Active Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=117 | Recruiting | Sponsor: Viridian Therapeutics, Inc. | N=84 ➔ 117

Enrollment change • Ophthalmology • Thyroid Eye Disease

A Safety and Tolerability Study of VRDN-003 in Participants with Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=284 | Recruiting | Sponsor: Viridian Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology • Thyroid Eye Disease

A Safety and Tolerability Study of VRDN-003 in Participants with Thyroid Eye Disease (TED) (clinicaltrials.gov) - P3 | N=284 | Not yet recruiting | Sponsor: Viridian Therapeutics, Inc.

New P3 trial • Ophthalmology • Thyroid Eye Disease

Viridian Therapeutics Highlights 2025 Corporate Priorities Following Positive Phase 3 Topline Data in Thyroid Eye Disease (Businesswire) - "Our BLA and early commercial preparations are well underway, and we are on track to submit the BLA in the second half of this year. The results of THRIVE and THRIVE-2 give us even higher conviction that our subcutaneous VRDN-003 program will deliver positive topline data in the first half of 2026, which would enable a BLA submission for VRDN-003 in the second half of 2026...Topline data for both REVEAL-1 and REVEAL-2 remains on track for the first half of 2026, which would enable a BLA submission by year-end 2026."

FDA filing • P3 data: top line • Thyroid Eye Disease