Viridian Therapeutics Poised for Growth with Strong Clinical Pipeline and Market Potential in TED Treatment
PorAinvest
jueves, 7 de agosto de 2025, 2:00 pm ET1 min de lectura
VRDN--
Key Highlights:
- Veligrotug Progress: Veligrotug, an intravenously delivered anti-IGF-1R antibody, has demonstrated robust clinical activity and a generally well-tolerated safety profile in its pivotal phase 3 clinical trials, THRIVE and THRIVE-2. The drug candidate received a Breakthrough Therapy Designation (BTD) from the FDA for the treatment of thyroid eye disease (TED). Veligrotug is on track to submit a BLA to the U.S. FDA in the second half of 2025 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2026. The company plans to launch veligrotug commercially in 2026 if approved.
- VRDN-003 Topline Data: The company anticipates topline data from both REVEAL-1 and REVEAL-2 in the first half of 2026, with a BLA submission planned for year-end 2026. VRDN-003 is a subcutaneously delivered, half-life extended, anti-IGF-1R antibody designed for active and chronic TED patients.
- Japan Licensing Agreement: Viridian entered into an exclusive license agreement with Kissei Pharmaceutical to develop and commercialize veligrotug and VRDN-003 in Japan. The agreement includes an upfront cash payment of $70 million and potential future milestones up to $315 million, along with tiered royalties on net sales in Japan.
- Financial Performance: As of June 30, 2025, Viridian's cash position was $563.4 million, supporting its cash runway into the second half of 2027. Research and development expenses were $86.6 million during the quarter, up from $56.2 million in the same period last year, reflecting increased clinical trial costs and personnel-related expenses. General and administrative expenses were $20.2 million, up from $16.1 million in the same period last year.
Analyst Outlook:
Analyst Douglas Tsao from H.C. Wainwright reiterated a Buy rating on Viridian Therapeutics with a price target of $34.00. Tsao is optimistic about the company's prospects due to its potential to submit a BLA for veligrotug, capture a significant portion of the chronic TED market, and strengthen its position with strategic partnerships and advancements in FcRn technology [1].
References:
[1] https://investors.viridiantherapeutics.com/news/news-details/2025/Viridian-Therapeutics-Highlights-Recent-Progress-and-Reports-Second-Quarter-2025-Financial-Results/default.aspx
Analyst Douglas Tsao from H.C. Wainwright reiterated a Buy rating on Viridian Therapeutics with a price target of $34.00. Tsao is optimistic about the company's prospects due to its potential to submit a Biologics License Application for veligrotug, capture a significant portion of the chronic thyroid eye disease market, and strengthen its position with strategic partnerships and advancements in FcRn technology.
WALTHAM, Mass. — July 2, 2025 — Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases, reported its second-quarter 2025 financial results today. The company highlighted recent progress and milestones achieved, including the submission of a Biologics License Application (BLA) for veligrotug and the announcement of an exclusive license agreement with Kissei Pharmaceutical.Key Highlights:
- Veligrotug Progress: Veligrotug, an intravenously delivered anti-IGF-1R antibody, has demonstrated robust clinical activity and a generally well-tolerated safety profile in its pivotal phase 3 clinical trials, THRIVE and THRIVE-2. The drug candidate received a Breakthrough Therapy Designation (BTD) from the FDA for the treatment of thyroid eye disease (TED). Veligrotug is on track to submit a BLA to the U.S. FDA in the second half of 2025 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first half of 2026. The company plans to launch veligrotug commercially in 2026 if approved.
- VRDN-003 Topline Data: The company anticipates topline data from both REVEAL-1 and REVEAL-2 in the first half of 2026, with a BLA submission planned for year-end 2026. VRDN-003 is a subcutaneously delivered, half-life extended, anti-IGF-1R antibody designed for active and chronic TED patients.
- Japan Licensing Agreement: Viridian entered into an exclusive license agreement with Kissei Pharmaceutical to develop and commercialize veligrotug and VRDN-003 in Japan. The agreement includes an upfront cash payment of $70 million and potential future milestones up to $315 million, along with tiered royalties on net sales in Japan.
- Financial Performance: As of June 30, 2025, Viridian's cash position was $563.4 million, supporting its cash runway into the second half of 2027. Research and development expenses were $86.6 million during the quarter, up from $56.2 million in the same period last year, reflecting increased clinical trial costs and personnel-related expenses. General and administrative expenses were $20.2 million, up from $16.1 million in the same period last year.
Analyst Outlook:
Analyst Douglas Tsao from H.C. Wainwright reiterated a Buy rating on Viridian Therapeutics with a price target of $34.00. Tsao is optimistic about the company's prospects due to its potential to submit a BLA for veligrotug, capture a significant portion of the chronic TED market, and strengthen its position with strategic partnerships and advancements in FcRn technology [1].
References:
[1] https://investors.viridiantherapeutics.com/news/news-details/2025/Viridian-Therapeutics-Highlights-Recent-Progress-and-Reports-Second-Quarter-2025-Financial-Results/default.aspx
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