Research analysts covering 1S1.
Recent press releases and 8-K filings for 1S1.
Viridian Provides Update on Veligrotug Regulatory Status, Elegrobart Clinical Timelines, and Financial Position
1S1
Product Launch
New Projects/Investments
Guidance Update
- Veligrotug (Anti-IGF-1R; Intravenous), for Thyroid Eye Disease (TED), received Priority Review from the US FDA, with a PDUFA target date of June 30, 2026. Its Biologics License Application (BLA) was accepted in December 2025.
- Veligrotug demonstrated robust and consistent clinical activity, meeting all primary and secondary endpoints in its Phase 3 THRIVE (active TED) and THRIVE-2 (chronic TED) studies, with topline results reported in September 2024 and December 2024, respectively.
- Pivotal data readouts for Elegrobart (VRDN-003), a subcutaneous anti-IGF-1R therapy for TED, are anticipated in Q1 2026 for the REVEAL-1 study and Q2 2026 for the REVEAL-2 study.
- The company reported $888 million in cash as of October 31, 2025, and expects this, along with other funding, to support its current business plans through profitability.
- Viridian is expanding its pipeline with an Investigational New Drug (IND) submission for VRDN-008 in December 2025 and an anticipated IND for an anti-TSHR product candidate in Q4 2026. The FcRn market, which includes VRDN-008, is projected to exceed $11 billion by 2030 for MG and CIDP alone.
Jan 6, 2026, 12:00 PM
Viridian Therapeutics Provides Updates on Clinical Programs and Financial Outlook
1S1
New Projects/Investments
Guidance Update
Product Launch
- Viridian Therapeutics anticipates top-line data for its subcutaneous (subcu) program for active Thyroid Eye Disease (TED) in Q1 2026 (REVEAL-1 study) and for chronic TED in Q2 2026 (REVEAL-2 study).
- The company plans to file the Marketing Authorization Application (MAA) in Europe in Q1 2026 for its IV program, targeting a $2 billion U.S. market for TED.
- The subcu program is designed for at-home self-administration via an auto-injector, with PK exposures expected to achieve 50%-70% placebo-adjusted proptosis response for efficacy and potentially improved safety due to lower Cmax compared to the IV formulation.
- Viridian reported a cash position of just under $900 million and expects to reach profitability and break-even, supported by recent financing activities including a Japan deal, a royalty deal, and an equity raise.
Dec 4, 2025, 2:35 PM
Viridian Therapeutics (1S1) Updates on Subcutaneous Program and Financial Position
1S1
Product Launch
Guidance Update
New Projects/Investments
- Viridian Therapeutics (1S1) anticipates top-line data for its subcutaneous (subcu) program for active and chronic thyroid eye disease (TED) in Q1 and Q2 2026, respectively.
- The company plans to file for marketing authorization in Europe in Q1 2026 and has partnered in Japan, targeting a $2 billion U.S. market for its IV and subcu programs.
- Viridian expects to achieve profitability and break even, supported by a recent royalty deal and equity raise, with a cash position of just under $900 million.
- The subcu program is designed for at-home self-administration via an auto-injector, with PK exposures expected to deliver 50%-70% placebo-adjusted proptosis response, similar to the IV program, and potentially an improved safety profile due to lower Cmax.
Dec 4, 2025, 2:35 PM
Viridian Therapeutics Provides Update on TED and FcRn Programs, Anticipates Mid-2026 Veligrotug Launch
1S1
Product Launch
New Projects/Investments
Guidance Update
- Viridian Therapeutics filed a Biologics License Application (BLA) for its intravenous (IV) thyroid eye disease (TED) treatment, Veligrotug, at the end of October 2025, following Breakthrough Therapy Designation, and anticipates a potential commercial launch in mid-2026 if granted priority review.
- The company's subcutaneous (subQ) TED program, an autoinjector version, completed pivotal study enrollment in September 2025, with top-line readouts expected in Q1 2026 for the active study and Q2 2026 for the chronic study.
- Viridian is also progressing its FcRn portfolio, with an Investigational New Drug (IND) filing for VRDN-008 expected by the end of 2025 and healthy volunteer data in 2026.
- The company is well capitalized after a royalty deal and equity raise in October 2025, guiding towards profitability or break-even based on cash.
Nov 19, 2025, 8:00 AM
Viridian Therapeutics Updates on Thyroid Eye Disease and FcRn Pipeline Progress
1S1
Product Launch
New Projects/Investments
Guidance Update
- Viridian Therapeutics has filed its Biologics License Application (BLA) for veligrotug (IV program) for Thyroid Eye Disease (TED) at the end of October, following Breakthrough Therapy Designation, with a potential commercial launch in mid-2026 if granted priority review. The US TED market is currently annualizing at $2 billion.
- The company's subcutaneous (subQ) program (VRDN-003) for TED has completed enrollment in pivotal studies, with top-line readouts anticipated in Q1 2026 for the active study and Q2 2026 for the chronic study. This program aims to expand the market significantly by enabling home self-administration.
- Viridian is advancing its FcRn portfolio, with the VRDN-008 program expected to have an Investigational New Drug (IND) filing by the end of 2025 and healthy volunteer data in 2026.
- The company is well-capitalized after a royalty deal and equity raise in October, and expects to be profitable on a break-even basis with current cash and anticipated revenues.
Nov 19, 2025, 8:00 AM
Viridian Therapeutics Provides Updates on Thyroid Eye Disease and FCRN Programs, Targets Mid-2026 Launch for Veligrotug
1S1
Product Launch
New Projects/Investments
Guidance Update
- Viridian Therapeutics filed its Biologics License Application (BLA) for Veligrotug (IV program) for Thyroid Eye Disease (TED) at the end of October 2025, following Breakthrough Therapy Designation, and anticipates a potential commercial launch in mid-2026 if granted priority review.
- The company's subcutaneous (subQ) program for TED completed pivotal study enrollment in September 2025, with top-line readouts expected in Q1 2026 for the active study and Q2 2026 for the chronic study.
- Viridian is advancing its FCRN portfolio, with an Investigational New Drug (IND) filing for VRDN-008 expected by the end of 2025 and healthy volunteer data anticipated in 2026.
- The company is well-capitalized after a recent royalty deal and equity raise in October 2025, and expects to be profitable or at a break-even stage based on its cash position.
Nov 19, 2025, 8:00 AM
Viridian Therapeutics Submits BLA for IV Thyroid Eye Disease Treatment, Anticipates Mid-2026 Launch
1S1
Product Launch
New Projects/Investments
Guidance Update
- Viridian Therapeutics has submitted its Biologics License Application (BLA) for the intravenous (IV) version of its thyroid eye disease (TED) treatment, veligrotug, based on robust Phase 3 data and Breakthrough Therapy Designation. The company anticipates a potential priority review, which could lead to a launch timeframe of mid-2026.
- Enrollment is complete for the subcutaneous (SC) TED program, with top-line readouts expected in Q1 2026 for the active form of the disease and Q2 2026 for the chronic form.
- The company is targeting the sizable and growing $2 billion U.S. TED market, aiming to expand it significantly, and is well-capitalized, expecting to reach profitability following a recent royalty financing deal and equity follow-on.
- Additionally, Viridian is advancing an FCRN portfolio with programs 006 and 008, which are considered "low-cost optionality" in a projected $10 billion+ market by 2030.
Nov 12, 2025, 2:20 PM
Viridian Therapeutics Provides Update on Thyroid Eye Disease Programs, FCRN Portfolio, and Financial Position
1S1
Product Launch
New Projects/Investments
Guidance Update
- Viridian Therapeutics has submitted its Biologics License Application (BLA) for its intravenous (IV) thyroid eye disease (TED) program, veligrotug, based on robust Phase 3 data, and expects a 60-day window for the FDA to decide on priority review, which could lead to a launch timeframe of mid-2026.
- The company has completed enrollment for its subcutaneous (subcu) TED program (003), with top-line readouts for the active form of the disease expected in Q1 2026 and for the chronic form in Q2 2026.
- Viridian is well-capitalized following a recent DRI royalty financing deal and an equity follow-on, and expects to reach profitability regardless of priority or standard FDA review for veligrotug.
- The company highlights its competitive advantages in the $2 billion U.S. TED market, including a shorter dosing regimen (5 infusions over roughly three months vs. 8 infusions over five months for Tepezza), faster onset of action, and anticipated label inclusion of both active and chronic TED data at launch.
- Viridian is also advancing an FCRN portfolio, with its lead program 006 (an FC fragment) showing consistency with IgG suppression and albumin sparing, and a second program 008 (half-life extended approach) on track for an IND filing by the end of 2025.
Nov 12, 2025, 2:20 PM
Viridian Therapeutics Updates on Thyroid Eye Disease Program and Financial Outlook
1S1
Product Launch
New Projects/Investments
Guidance Update
- Viridian Therapeutics recently submitted its Biologics License Application (BLA) for its intravenous (IV) thyroid eye disease (TED) product, veligrotug, and is seeking priority review, which could lead to a mid-2026 launch.
- The company completed enrollment for pivotal studies of its subcutaneous (subcu) TED program, with top-line readouts anticipated in Q1 2026 for active disease and Q2 2026 for chronic disease.
- The US TED market is estimated at $2 billion annually, with 500,000 patients and 200,000 moderate to severe cases, currently dominated by one competitor, Tepezza, which recently annualized $2 billion in sales.
- Viridian's veligrotug offers potential competitive advantages including fewer infusions (5 vs. 8), shorter infusion times (30-45 minutes vs. 60-90 minutes), and faster onset of action compared to the existing therapy.
- The company is well-capitalized following a recent royalty financing deal and an equity follow-on, and expects to reach profitability on this basis, regardless of the FDA's review timeline.
Nov 12, 2025, 2:20 PM
Quarterly earnings call transcripts for 1S1.
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