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Jun 30, 2024
Viridian Therapeutics Q2 2024 Earnings Report
Reported progress in TED portfolio and FcRn portfolio with key milestones achieved.
Key Takeaways
Viridian Therapeutics reported solid progress in its TED portfolio, with VRDN-001 phase 3 trials exceeding enrollment targets and VRDN-003 trials planned to initiate this month. All timelines within the FcRn portfolio remain on track, and the company anticipates submitting an IND for VRDN-006 by year-end and reporting NHP data for VRDN-008 in the second half of the year. Cash, cash equivalents, and short-term investments were $571.4 million as of June 30, 2024, providing a cash runway into the second half of 2026.
THRIVE VRDN-001 global phase 3 clinical trial in active thyroid eye disease (TED) remains on track for topline readout in September 2024.
THRIVE-2 VRDN-001 global phase 3 clinical trial in chronic TED topline readout expected year-end 2024; enrollment completed in July and exceeded its target.
REVEAL-1 and REVEAL-2, global phase 3 clinical trials for subcutaneous VRDN-003 in patients with active and chronic TED, on track to initiate in August 2024.
Cash, cash equivalents, and short-term investments of $571.4 million as of June 30, 2024, provides cash runway into the second half of 2026.
Viridian Therapeutics
Viridian Therapeutics
Forward Guidance
Viridian is on track with its clinical development programs and anticipates key milestones in the near term.
Positive Outlook
- THRIVE VRDN-001 global phase 3 clinical trial remains on track for topline readout in September 2024.
- THRIVE-2 VRDN-001 global phase 3 clinical trial topline readout expected by year-end 2024.
- REVEAL-1 and REVEAL-2 trials for subcutaneous VRDN-003 on track to initiate in August 2024.
- IND submission for VRDN-006 planned by year-end 2024.
- NHP data anticipated for VRDN-008 in the second half of 2024.
Challenges Ahead
- Uncertainty and potential delays related to clinical drug development.
- The duration and impact of regulatory delays in clinical programs.
- Manufacturing risks could impact timelines.
- Competition from other therapies or products.
- Changes to trial protocols for ongoing or new clinical trials.