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Viridian Therapeutics(VRDN) - 2025 Q3 - Quarterly Results
2025-11-05 12:09
Financial Position - Viridian Therapeutics reported a cash position of approximately $887.9 million as of October 31, 2025, following a comprehensive financing package[5] - Cash, cash equivalents, and short-term investments decreased to $490.90 million as of September 30, 2025, down from $717.58 million at the end of 2024[26] - Total assets decreased to $577.14 million as of September 30, 2025, compared to $742.40 million at the end of 2024[26] - Total stockholders' equity fell to $502.97 million as of September 30, 2025, down from $671.64 million at the end of 2024[26] Revenue and Expenses - Total revenue for Q3 2025 was $70.57 million, a significant increase from $86,000 in Q3 2024[24] - License revenue for Q3 2025 was $70 million, while collaboration revenue from related parties was $570,000[24] - Total operating expenses for Q3 2025 were $110.58 million, compared to $83.57 million in Q3 2024, reflecting a 32.3% increase[24] - The net loss for Q3 2025 was $34.60 million, an improvement from a net loss of $76.69 million in Q3 2024[24] - Research and development expenses increased to $86.3 million for the three months ended September 30, 2025, compared to $69.2 million for the same period in 2024, driven by ongoing clinical trials[11] - General and administrative expenses rose to $24.3 million for the three months ended September 30, 2025, up from $14.4 million in the prior year, primarily due to preparatory activities for veligrotug[11] - Research and development expenses for the nine months ended September 30, 2025, were $249.72 million, up from $166.29 million for the same period in 2024[24] - General and administrative expenses for the nine months ended September 30, 2025, were $61.64 million, compared to $45.50 million for the same period in 2024[24] Clinical Trials and Product Development - Enrollment in pivotal clinical trials REVEAL-1 and REVEAL-2 for VRDN-003 exceeded targets, with 132 and 204 patients enrolled, respectively[11] - The Biologics License Application (BLA) for veligrotug was submitted to the FDA in October 2025, with a request for Priority Review and a potential U.S. commercial launch anticipated in mid-2026[5] - VRDN-006 demonstrated proof-of-concept IgG reduction in a phase 1 clinical trial, while VRDN-008 is on track for an Investigational New Drug (IND) filing by year-end 2025[11] - The company anticipates topline data readouts for VRDN-003 from REVEAL-1 in Q1 2026 and REVEAL-2 in Q2 2026, with a BLA submission planned for year-end 2026[11] Financing Activities - The company completed a public equity offering in October 2025, raising total gross proceeds of $289.1 million by selling 13,138,750 shares at $22.00 per share[4] - The company secured a royalty financing agreement with DRI Healthcare for up to $300 million, including $55 million upfront and $115 million in near-term milestones[8] Market Focus - Viridian is focused on a core group of approximately 2,000 prescribers in the $2 billion annual TED market, with strong enthusiasm for veligrotug among key opinion leaders[6]
Viridian Therapeutics Reports Third Quarter 2025 Financial Results and Highlights Recent Progress
Businesswire· 2025-11-05 12:01
Core Insights - Viridian Therapeutics, Inc. reported strong business performance with the successful submission of its Biologics License Application (BLA) for veligrotug [1] - The company completed enrollment in both pivotal clinical trials, indicating progress in its drug development pipeline [1] Financial Results - The financial results for the third quarter ended September 30, 2025, were highlighted, showcasing the company's ongoing commitment to developing treatments for serious and rare diseases [1]
Viridian Therapeutics Announces Successful October Submission of Biologics License Application (BLA) to U.S. FDA for Veligrotug in Thyroid Eye Disease
Businesswire· 2025-11-03 12:01
Core Points - Viridian Therapeutics has successfully submitted a Biologics License Application (BLA) for its investigational therapy, veligrotug, to the U.S. FDA for the treatment of thyroid eye disease (TED) [1][2] - The BLA submission is supported by data from two pivotal phase 3 clinical trials, THRIVE and THRIVE-2, which met all primary and secondary endpoints [2][5] - Veligrotug has received Breakthrough Therapy Designation, which may support eligibility for Priority Review by the FDA [1][3] Company Overview - Viridian Therapeutics is a biotechnology company focused on developing potentially best-in-class medicines for serious and rare diseases [1][6] - The company is advancing multiple candidates for TED, including veligrotug and VRDN-003, with ongoing global phase 3 clinical trials [7] - Viridian's expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates [6][8] Clinical Development - Veligrotug is an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for TED [4] - The pivotal trials THRIVE and THRIVE-2 demonstrated a rapid onset of clinical benefit and statistically significant effects on multiple diplopia endpoints [5][7] - The BLA submission aims for a potential commercial launch of veligrotug in mid-2026, contingent on FDA approval [3]
Viridian Therapeutics Announces Pricing of $251 Million Public Offering of Shares of Common Stock
Businesswire· 2025-10-22 03:24
Core Viewpoint - Viridian Therapeutics, Inc. has announced the pricing of an underwritten public offering of its common stock, indicating a strategic move to raise capital for its operations in the biotechnology sector [1] Company Summary - Viridian is offering a total of 11,425,000 shares of common stock at a public offering price of $22.00 per share, which reflects the company's efforts to secure funding for the development of medicines targeting serious and rare diseases [1] - The company has granted underwriters a 30-day option to purchase additional shares, which could further enhance the capital raised through this offering [1]
Viridian Therapeutics announces inducement grants under Nasdaq listing rule 5635(c)(4) (VRDN:NASDAQ)
Seeking Alpha· 2025-10-02 20:11
Group 1 - The article does not provide any specific content or key points related to a company or industry [1]
Viridian Therapeutics: De-Risked Leadership In Thyroid Eye Disease (NASDAQ:VRDN)
Seeking Alpha· 2025-09-26 14:56
Core Insights - The individual has a B.Tech degree in Mechanical Engineering and nearly twenty-five years of experience in the oil and gas sector, primarily in the Middle East [1] - The investment strategy is informed by traits of efficiency, carefulness, and discipline, developed through extensive industry experience [1] - There is a sustained interest in U.S. equity markets, focusing on technology, energy, and healthcare sectors [1] - The investment approach has evolved from growth investing to a blend of value and growth, emphasizing the understanding of business economics and competitive advantages [1] - The individual believes in the importance of allowing time and compounding to enhance investment returns, particularly in high-quality businesses [1] - A moderately conservative orientation is adopted, with a focus on minimizing downside risk as retirement approaches [1] - Recent rebalancing towards income-generating assets such as dividend-paying equities and REITs reflects a shift in investment priorities [1] - Investing is viewed as a means to achieve peace of mind, not just high returns [1] - The individual aims to engage with a community of investors interested in the intersection of business fundamentals and intelligent investing [1] - There is a commitment to investing in ecologically sensitive businesses, as represented by the chosen icon [1]
Viridian Therapeutics: De-Risked Leadership In Thyroid Eye Disease
Seeking Alpha· 2025-09-26 14:56
Core Insights - The individual has extensive experience in the oil and gas sector, particularly in the Middle East, which informs their investment strategy [1] - The investment approach has evolved from growth investing to a blend of value and growth, focusing on business fundamentals and competitive advantages [1] - There is a shift towards income-generating assets as retirement approaches, emphasizing the importance of peace of mind in investing [1] Investment Strategy - The investment strategy is characterized by efficiency, carefulness, and discipline, reflecting the high-stakes nature of the oil and gas industry [1] - The focus is on understanding the underlying economics of businesses and their ability to generate consistent free cash flow [1] - The approach is moderately conservative, seeking to minimize downside risk while looking for upside potential [1] Market Focus - The primary sectors of interest include technology, energy, and healthcare, indicating a diversified investment portfolio [1] - There is a commitment to investing in ecologically sensitive businesses, highlighting a focus on sustainable investing practices [1] Community Engagement - The individual joined Seeking Alpha to engage with a community of investors who value real-world business fundamentals and intelligent investing [1]
Viridian Therapeutics Announces Completion of Enrollment in both REVEAL Clinical Trials and Positive Portfolio Updates
Businesswire· 2025-09-15 11:01
Core Insights - Viridian Therapeutics, Inc. has completed enrollment in its phase 3 clinical trials REVEAL-1 and REVEAL-2 for VRDN-003, targeting patients with active and chronic Thyroid Eye Disease (TED) respectively [1] Company Overview - Viridian Therapeutics is a biotechnology company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases [1] Product Details - VRDN-003 is a subcutaneously delivered, half-life extended monoclonal antibody that targets the insulin-like growth factor [1]
These Analysts Revise Their Forecasts On Viridian Therapeutics Following Q2 Results
Benzinga· 2025-08-07 18:37
Financial Performance - Viridian Therapeutics reported quarterly losses of $(1.00) per share, beating the analyst consensus estimate of $(1.02) per share [1] - The company reported quarterly sales of $75.000 million, exceeding the analyst consensus estimate of $43.643 million [1] Product Development and Market Position - Veligrotug received Breakthrough Therapy Designation, indicating strong momentum as the company approaches its planned Biologics License Application (BLA) filing and expected commercial launch [2] - The company is making significant progress in commercial preparation and aims to be launch-ready on a Priority Review designation timeline [2] - A recent license agreement with Kissei to develop and commercialize veligrotug and VRDN-003 in Japan further validates the value of the company's programs and potential global opportunities [2] Analyst Ratings and Price Targets - Oppenheimer analyst Leland Gershell maintained an Outperform rating and raised the price target from $28 to $32 [8] - Goldman Sachs analyst Richard Law maintained a Buy rating and raised the price target from $27 to $30 [8] - RBC Capital analyst Lisa Walter maintained an Outperform rating but lowered the price target from $45 to $41 [8] - Wells Fargo analyst Derek Archila maintained an Equal-Weight rating and lowered the price target from $27 to $26 [8] Stock Performance - Following the earnings announcement, Viridian Therapeutics shares fell 4.1% to $16.50 [2]
Viridian Therapeutics(VRDN) - 2025 Q2 - Earnings Call Presentation
2025-08-06 20:00
Thyroid Eye Disease (TED) Portfolio - Veligrotug's BLA submission is planned for the second half of 2025, with a potential U S launch in the second half of 2026, and the EU MAA submission is planned for the first half of 2026[13] - Topline data for VRDN-003's REVEAL-1 and REVEAL-2 trials are expected in the first half of 2026, with a BLA submission planned by year-end 2026[13] - In the THRIVE trial for active TED, the proptosis responder rate at week 15 was 70% for patients receiving veligrotug compared to 5% on placebo (p < 0 0001)[56, 58] - In the THRIVE-2 trial for chronic TED, the proptosis responder rate at week 15 was 56% for patients receiving veligrotug compared to 8% on placebo (p < 0 0001)[79] - 70% of proptosis responders in the THRIVE trial maintained their response at Week 52[69] FcRn Inhibitor Portfolio - VRDN-006 proof-of-concept Phase 1 clinical trial healthy volunteer data is expected in Q3 2025[13] - VRDN-008 is on track for IND submission by year-end 2025[13] - A single dose of VRDN-008 demonstrated a longer half-life and a ~20% deeper and more sustained reduction of IgG compared to efgartigimod in NHPs[149] - The market size of MG and CIDP alone are projected to be over $11 2 billion by 2030[133, 134] Corporate/Financial - Viridian had $563 million in cash as of June 30, 2025, providing a runway into the second half of 2027[13]