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Viridian Therapeutics Highlights Recent Progress and Reports Fourth Quarter and Full Year 2025 Financial Results Veligrotug: U.S. Biologics License Application Priority Review ongoing; Prescription Drug User Fee Act target action date of June 30, 2026 U.S. Food and Drug Administration Priority Review of veligrotug BLA for TED is ongoing with a PDUFA target action date of June 30, 2026. Across active and chronic TED, following five infusions, veligrotug demonstrated...

#VRDN Viridian Therapeutics Highlights Recent Progress and Reports Fourth Quarter and Full Year 2025 Financial Results

www.stocktitan.net/news/VRDN/viridian-thera...

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Viridian Therapeutics Prepares for Transformational 2026 Viridian Therapeutics (NASDAQ: VRDN) outlined 2026 priorities including a PDUFA target date of June 30, 2026 for the veligrotug BLA under Priority Review and ongoing commercial launch preparations. Topline phase 3 results for subcutaneous elegrobart (VRDN-003) are expected in Q1 2026 (REVEAL-1) and Q2 2026 (REVEAL-2). An IND for half-life extended FcRn-inhibitor VRDN-008 was submitted in December 2025 with healthy volunteer data expected in 2H 2026. A new TSHR inhibitor IND is expected in Q4 2026. Cash and investments were approximately $888 million as of October 31, 2025, and the company expects to fund current plans through profitability.

#VRDN Viridian Therapeutics Prepares for Transformational 2026

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Viridian Therapeutics Announces BLA Acceptance and Priority Review for Veligrotug for the Treatment of Thyroid Eye Disease Viridian Therapeutics, Inc., a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases, today announced that the U.S. Food and Drug Administration has accepted the Biologics License Application for veligrotug for the treatment of thyroid eye disease.

#VRDN Viridian Therapeutics Announces BLA Acceptance and Priority Review for Veligrotug for the Treatment of Thyroid Eye Disease

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BREAKING NEWS: ( NASDAQ: #VRDN ) Viridian Therapeutics Inc. (NASDAQ: VRDN) Sets New 52-Week High in Friday Session

Viridian Therapeutics Reports Third Quarter 2025 Financial Results and Highlights Recent Progress Viridian Therapeutics (NASDAQ: VRDN) reported Q3 2025 results and progress including an October 2025 BLA submission for veligrotug to the FDA with a Priority Review request and a potential U.S. launch in mid-2026 if approved. The company completed a comprehensive financing package in October providing up to $889 million of potential capital, including a $289.1 million equity offering, a royalty financing with DRI (up to $300 million, including $55 million upfront and $115 million near-term milestones) and an amended Hercules credit facility (up to $300 million).Cash was approximately $887.9 million as of October 31, 2025. VRDN-003 pivotal trials (REVEAL-1/REVEAL-2) completed enrollment and topline readouts are expected in Q1 2026 and Q2 2026. VRDN-006 showed phase 1 IgG reduction proof-of-concept; VRDN-008 IND remains on track with healthy volunteer data expected in 2H 2026. Q3 R&D was $86.3M and G&A $24.3M.

#VRDN Viridian Therapeutics Reports Third Quarter 2025 Financial Results and Highlights Recent Progress

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Viridian Therapeutics Announces Successful October Submission of Biologics License Application (BLA) to U.S. FDA for Veligrotug in Thyroid Eye Disease Viridian Therapeutics (Nasdaq: VRDN) announced a successful late‑October 2025 submission of a Biologics License Application (BLA) to the U.S. FDA for veligrotug, an IV anti‑IGF‑1R monoclonal antibody for thyroid eye disease (TED).The BLA is supported by two pivotal phase 3 trials, THRIVE and THRIVE‑2, which met all primary and secondary endpoints and showed rapid clinical benefit, including statistically significant diplopia response and resolution. Veligrotug has Breakthrough Therapy designation and Viridian requested Priority Review; FDA will decide on BLA acceptance within 60 days.

#VRDN Viridian Therapeutics Announces Successful October Submission of Biologics License Application (BLA) to U.S. FDA for Veligrotug in Thyroid Eye Disease

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Viridian Therapeutics Announces Pricing of $251 Million Public Offering of Shares of Common Stock Viridian Therapeutics (NASDAQ: VRDN) priced an underwritten public offering of 11,425,000 shares of common stock at $22.00 per share, with a 30-day underwriter option for an additional 1,713,750 shares. Gross proceeds are expected to be approximately $251,350,000 before underwriting discounts, commissions and offering expenses. The offering is expected to close on or about October 23, 2025. Viridian intends to use proceeds, together with existing cash and short-term investments, to fund commercial launch activities for veligrotug and VRDN-003, plus R&D, working capital and general corporate purposes.Jefferies, Leerink Partners, Evercore ISI and Stifel are joint book-running managers; Wedbush PacGrow is co-manager. A registration statement became effective on September 5, 2025.

#VRDN Viridian Therapeutics Announces Pricing of $251 Million Public Offering of Shares of Common Stock

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Viridian Therapeutics Announces Proposed Underwritten Public Offering Viridian Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for serious and rare diseases, today announced that it has commenced an underwritten public offering of shares of its common stock and Series B non-voting convertible preferred stock. All of the securities to be...

#VRDN Viridian Therapeutics Announces Proposed Underwritten Public Offering

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Viridian Therapeutics Announces Royalty Financing with DRI Healthcare for up to $300 Million Viridian Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing potentially best-in-class medicines for serious and rare diseases, today announced it entered into a royalty financing agreement with DRI Healthcare Acquisitions LP and accelerated its timelines for the submission of the veligrotug BLA and...

#VRDN Viridian Therapeutics Announces Royalty Financing with DRI Healthcare for up to $300 Million

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Largest-Ever TED Trial: Viridian Enrolls 330+ Patients in Phase 3 REVEAL Studies, BLA Filing Coming Viridian's REVEAL-1 and REVEAL-2 trials exceed targets with 132 and 204 patients respectively. Veligrotug BLA submission planned for November 2025, with potential launch mid-2026 under Priority Review.

#VRDN Viridian Therapeutics Announces Completion of Enrollment in both REVEAL Clinical Trials and Positive Portfolio Updates

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Viridian's TED Drug Gets FDA Breakthrough Status as Company Lands $385M Japanese Deal FDA grants breakthrough status for veligrotug as Viridian secures $70M upfront Japanese partnership. Strong Q2 financials support 2025 BLA submission. See details.

#VRDN Viridian Therapeutics Highlights Recent Progress and Reports Second Quarter 2025 Financial Results

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Breakthrough Success: Viridian's TED Treatment Maintains 70% Efficacy After One Year in Phase 3 Trial New Phase 3 data reveals long-term efficacy for thyroid eye disease treatment. Breakthrough Therapy designation secured, BLA submission planned. See full results.

#VRDN Viridian Therapeutics Announces Positive Long-Term Durability Data from the Veligrotug Phase 3 THRIVE Clinical Trial in Patients with Active Thyroid Eye Disease (TED)

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Viridian Therapeutics Receives FDA Breakthrough Therapy Designation for Veligrotug for the Treatment of Thyroid Eye Disease (TED) Viridian Therapeutics (NASDAQ: VRDN) has received FDA Breakthrough Therapy Designation for veligrotug, its lead drug candidate for treating Thyroid Eye Disease (TED). The designation was granted based on veligrotug's consistent improvement in diplopia and rapid proptosis response in clinical trials. The drug successfully met all primary and secondary endpoints in the THRIVE and THRIVE-2 phase 3 clinical trials for both active and chronic TED.Notably, veligrotug is the first and only drug candidate in chronic TED to show statistically significant improvement in diplopia in a global phase 3 trial. The company plans to submit a Biologics License Application (BLA) in H2 2025, with a targeted U.S. launch in 2026. The breakthrough designation supports eligibility for Priority Review. The TED market represents significant commercial potential, with U.S. revenues of approximately $2 billion in 2024.

#VRDN Viridian Therapeutics Receives FDA Breakthrough Therapy Designation for Veligrotug for the Treatment of Thyroid Eye Disease (TED)

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Viridian Reports Q1 Earnings: Multiple Phase 3 Programs Advance with $636M War Chest Through 2027 Viridian advances TED portfolio with BLA submission planned, reveals strong $636M cash position. Multiple phase 3 trials progressing toward key milestones. Get full details.

#VRDN Viridian Therapeutics Highlights Recent Progress and Reports First Quarter 2025 Financial Results

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Viridian Therapeutics Highlights Recent Progress and Reports Fourth Quarter and Full Year 2024 Financial Results Viridian Therapeutics (NASDAQ: VRDN) reported significant progress in Q4 and full year 2024, highlighting positive phase 3 data for veligrotug in thyroid eye disease (TED) treatment. The company maintains a strong financial position with $717.6 million in cash as of December 31, 2024, providing runway into H2 2027.Key developments include:Veligrotug BLA submission planned for H2 2025REVEAL-1 and REVEAL-2 phase 3 trials for VRDN-003 progressing with topline data expected in H1 2026VRDN-006 proof-of-concept data anticipated in Q3 2025VRDN-008 IND submission planned for year-end 2025Financial results show R&D expenses increased to $238.3 million in 2024 (from $159.8M in 2023), while G&A expenses decreased to $61.1 million (from $95.0M in 2023). Net loss widened to $269.9 million for 2024 compared to $237.7M in 2023.

#VRDN Viridian Therapeutics Highlights Recent Progress and Reports Fourth Quarter and Full Year 2024 Financial Results

www.stocktitan.net/news/VRDN/viridian-thera...

Viridian Therapeutics Advances Thyroid Eye Disease Drug After Breakthrough Phase 3 Results Viridian plans BLA submission for veligrotug following positive Phase 3 trials in thyroid eye disease, backed by $753M cash runway through 2027. Pipeline expansion continues with VRDN-003.

#VRDN Viridian Therapeutics Highlights 2025 Corporate Priorities Following Positive Phase 3 Topline Data in Thyroid Eye Disease

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