Viridian Therapeutics reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2025.

Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2025.

"We enter 2026 with the momentum of our continued execution," said Steve Mahoney, President and Chief Executive Officer of Viridian. "With the veligrotug BLA filing under Priority Review and a PDUFA target date of June 30, 2026, we are well-prepared for our potential first commercial launch, a significant milestone for the company and for patients with TED. The submission of our MAA to the EMA supports the long-term, global opportunity for veligrotug. We are advancing toward reporting pivotal REVEAL-1 topline data for elegrobart next month, which we believe has the potential to be a best-in-class subcutaneous therapy for TED patients. Our goal is to establish veligrotug and elegrobart as foundational therapies for TED, while driving our pipeline forward to address additional indications and unmet needs."

Recent Business Highlights

TED PORTFOLIO

Veligrotug: U.S. Biologics License Application (BLA) Priority Review ongoing; Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026

U.S. Food and Drug Administration (FDA) Priority Review of veligrotug BLA for TED is ongoing with a PDUFA target action date of June 30, 2026. Veligrotug received Breakthrough Therapy designation from the FDA in 2025.

Submitted an MAA to the EMA in January 2026, on schedule.

Positive pivotal results from THRIVE and THRIVE-2 underpin veligrotug's clinical profile in active and chronic TED. Across active and chronic TED, following five infusions, veligrotug demonstrated rapid onset of treatment effect, clinically meaningful improvements in proptosis and diplopia, durable responses, and was generally well-tolerated.

Commercial preparations continue and are on track to support a planned mid-2026 U.S. commercial launch, if approved, including the build-out of field leadership, sales, market access, and patient services.

Medical affairs engagement continues to expand, educating key opinion leaders and healthcare professionals on veligrotug clinical data and profile.

Elegrobart (VRDN-003): REVEAL topline data release on track

REVEAL-1 topline data in active TED on track for Q1 2026 and REVEAL-2 topline data in chronic TED on track for Q2 2026.

Elegrobart is designed to be an infrequent, low-volume, self-administered at-home subcutaneous therapy using a commercially validated autoinjector with either every-4-week or every-8-week dosing.

TSHR program: Investigational New Drug (IND) submission anticipated in Q4 2026

Developing a potential best-in-class, half-life extended, monoclonal anti-TSHR antibody, designed for subcutaneous delivery in an autoinjector with the potential to support extended dosing intervals.

Viridian anticipates clinical potential for this program in TED and Graves' disease and plans to submit an IND in Q4 2026.

FCRN INHIBITOR PORTFOLIO

VRDN-006: Phase 1 proof-of-concept IgG reduction; 2026 development plan update

In a phase 1 clinical trial in healthy volunteers, VRDN-006 showed IgG reductions consistent with the FcRn inhibitor class, spared albumin and LDL, and was generally well-tolerated.

Viridian anticipates communicating development plans in 2026.

VRDN-008: IND cleared and phase 1 clinical trial initiated

VRDN-008 IND cleared in January 2026.

Phase 1 clinical trial in healthy volunteers is now enrolling participants; data expected in 2H 2026.

Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $874.7 million as of December 31, 2025, compared with $717.6 million as of December 31, 2024. Together with anticipated milestone payments from the DRI royalty agreement and anticipated future commercial revenues from veligrotug and elegrobart, if approved, the company expects to fund its current business plans through profitability.

R&D Expenses: Research and development expenses for the year ended December 31, 2025 were $338.9 million, compared with $238.3 million for the year ended December 31, 2024. The increase in research and development expenses was driven by increased costs associated with ongoing clinical trials and manufacturing activities for our TED portfolio, additional investment in advancing our FcRn inhibitor portfolio and TSHR program, as well as increased personnel-related costs as a result of headcount increases.

SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2025 were $95.3 million, compared with $61.1 million for the year ended December 31, 2024. The increase in selling, general and administrative expenses was driven by preparatory commercial activities for veligrotug, including increased personnel-related costs as a result of headcount increases.

Net Loss: Net loss for the year ended December 31, 2025 was $342.6 million, compared with $269.9 million for the same period in 2024.

Shares Outstanding: As of December 31, 2025, Viridian had 116,126,148 shares of common stock outstanding on an as-converted basis, which included 101,826,500 shares of common stock and an aggregate 14,299,648 shares of common stock issuable upon the conversion of 134,864 and 79,620 shares of Series A and Series B preferred stock, respectively.

Upcoming Investor Conferences

Viridian will participate in the following upcoming investor conferences. Live webcasts of the presentation can be accessed under "Events and Presentations" on the Investors section of the Viridian website at viridiantherapeutics.com. Replays of the webcasts will be available following each event.

TD Cowen 46th Annual Health Care Conference: Fireside chat on Wednesday, March 4, 2026, at 10:30 a.m. ET in Boston, MA

Leerink Partners Global Healthcare Conference: Fireside chat on Monday, March 9, 2026, at 8:00 a.m. ET in Miami, FL

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