Viridian Therapeutics(VRDN) Goldman Sachs·2024-08-15 02:27Investment Rating - The investment rating for Viridian Therapeutics Inc. (VRDN) is "Buy" with a 12-month price target of 14.70 [9]. Core Insights - Viridian Therapeutics Inc. (VRDN) is well-positioned with its VRDN-003 product, which is expected to have best-in-class potential in the subcutaneous (SC) treatment of thyroid eye disease (TED) due to its dosing regimens and autoinjector properties [5][8]. - SLRN has refocused its pipeline strategy to prioritize lonigutamab for TED, moving directly to Phase 3 development by Q1 2025, which increases competitive pressure on VRDN-003 [2][3]. - VRDN plans to initiate Phase 3 trials for VRDN-003 in August 2024, with topline data expected in the first half of 2026, ahead of SLRN's timelines [3][5]. Summary by Sections Pipeline Strategy - SLRN has discontinued investments in HS/PsA and reduced its workforce by 33% to extend its cash runway to mid-2027, focusing solely on lonigutamab for TED [2]. - Early Phase 1/2 data for lonigutamab showed promising results, but VRDN-003's half-life extension and autoinjector features are seen as significant commercial advantages [2][5]. Clinical Development - VRDN-003's Phase 3 REVEAL-1/REVEAL-2 trials are set to begin in August 2024, with topline data expected in 1H26 and a BLA filing by the end of 2026 [3][5]. - SLRN's decision to skip Phase 2b/3 studies and move directly to Phase 3 could intensify competition, but VRDN-003 is anticipated to deliver data from its primary endpoints before SLRN [3][5]. Safety and Efficacy - Updates on tinnitus effects from SLRN's trials indicate that hearing adverse events are mostly transient and manageable, aligning with VRDN's observations [4][5]. - The Phase 3 studies for both VRDN and SLRN may reveal different occurrences of hearing adverse events due to their varying study durations [4].