Waltham, Massachusetts — May 5, 2026 — Leads & Copy — Viridian Therapeutics, Inc. (Nasdaq: VRDN) reported its recent business highlights and financial results for the first quarter ended March 31, 2026.
Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics, stated that the team is ready to launch ahead of veligrotug’s Prescription Drug User Fee Act (PDUFA) target date. Positive topline data was delivered from both of elegrobart’s pivotal REVEAL phase 3 clinical trials, and earlier programs are moving ahead as planned.
With veligrotug’s PDUFA target date next month, the company has hired and deployed its full field teams, readied commercial supply and supply chain infrastructure, and continues to engage physicians, payers, and key opinion leaders. Viridian believes it is well-prepared and well-positioned to deliver a successful launch.
Following positive topline data from REVEAL-1 and REVEAL-2 in active and chronic TED, respectively, Viridian believes that subcutaneous elegrobart has the potential to be the simplest and most convenient treatment for TED.
TED Portfolio Highlights:
Veligrotug:
The veligrotug Biologics License Application (BLA) is under Priority Review at the U.S. Food and Drug Administration (FDA) with a PDUFA target action date of June 30, 2026. Veligrotug received Breakthrough Therapy Designation and Priority Review from the FDA in 2025.
Field team hiring, including sales, market access, and patient services, are complete and ready for launch. Commercial supply and manufacturing, distribution, and supply chain infrastructure are also established and ready for launch.
A Marketing Authorization Application (MAA) was submitted to the EMA in January 2026, which was accepted for review in February 2026.
Veligrotug was designed to offer a differentiated clinical profile compared to the current approved treatment option. Across pivotal trials in 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.
Elegrobart (VRDN-003):
Positive topline data was announced in both REVEAL-1 and REVEAL-2, elegrobart’s two pivotal phase 3 clinical trials for active and chronic TED, respectively.
Elegrobart is the only subcutaneous program to demonstrate positive pivotal phase 3 clinical data in both active and chronic TED.
REVEAL-1 in Active TED: The primary endpoint was met with a statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms showed rapid onset of treatment effect and achieved clinically meaningful 54% and 63% proptosis responder rates, respectively, versus 18% placebo at week 24. The Q4W treatment arm provided meaningful diplopia benefit to patients with active TED.
REVEAL-2 in Chronic TED: The primary endpoint was met with a statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms achieved statistically significant and clinically meaningful 50% and 54% proptosis responder rates, respectively, versus 15% placebo at week 24. The Q4W treatment arm provided meaningful diplopia benefit to patients with chronic TED.
Elegrobart was generally well-tolerated in both pivotal clinical trials, with low rates of hearing impairment. Viridian plans to submit a BLA to the FDA in Q1 2027 and seek approval for both Q4W and Q8W elegrobart dosing regimens. Viridian plans to launch elegrobart as the first simple and convenient autoinjector that patients can administer at home.
Viridian anticipates that the veligrotug commercial and medical affairs infrastructure will support the potential elegrobart launch, if approved.
TSHR program:
Viridian is developing a potential best-in-class, half-life extended, monoclonal anti-thyroid-stimulating hormone receptor (TSHR) antibody, designed for subcutaneous delivery in an autoinjector with the potential to support extended dosing intervals for patient convenience.
Viridian plans to submit an Investigational New Drug (IND) application in Q4 2026. The company expects this program to have clinical potential in TED and Graves’ disease.
FcRn Inhibitor Portfolio
VRDN-006:
Viridian anticipates sharing development plans for VRDN-006 in 2026. VRDN-006 showed IgG reductions consistent with the FcRn inhibitor class in a phase 1 healthy volunteer clinical trial in 2025. VRDN-006 also spared albumin and LDL in the phase 1 clinical trial and was generally well-tolerated.
VRDN-008:
VRDN-008 IND was accepted by the FDA in January 2026, and Viridian initiated a phase 1 clinical trial in healthy volunteers which is ongoing. Data is on track for 2H 2026.
VRDN-008 is a bi-specific half-life extended FcRn inhibitor. After a single, high-dose head-to-head study in non-human primates, VRDN-008 showed a longer half-life and more sustained IgG reduction versus efgartigimod.
Financial Results:
Cash Position: Cash, cash equivalents, and marketable securities were $762.2 million as of March 31, 2026, compared with $874.7 million as of December 31, 2025.
R&D Expenses: Research and development expenses for the three months ended March 31, 2026 were $77.6 million, compared to $76.8 million during the three months ended March 31, 2025. The increase was driven by ongoing manufacturing activities to support preparatory commercial activities for veligrotug, additional investment in advancing the TSHR program, and increased personnel-related costs due to headcount increases, partially offset by a decrease in clinical trial costs for the TED portfolio.
SG&A Expenses: Selling, general and administrative expenses for the three months ended March 31, 2026 were $38.7 million, compared with $17.1 million for the three months ended March 31, 2025. The increase was driven by preparatory commercial activities for veligrotug, including increased personnel-related costs due to headcount increases.
Net Loss: Net loss for the three months ended March 31, 2026 was $104.9 million, compared with $86.9 million for the same period in 2025.
Shares Outstanding: As of March 31, 2026, Viridian had 116,757,742 shares of common stock outstanding on an as-converted basis.
Upcoming Investor Conferences:
Viridian will participate in the Jefferies Global Health Care Conference on June 4, 2026, in New York, NY and the Goldman Sachs 47th Annual Global Healthcare Conference on June 9, 2026, in Miami, FL.
Viridian Therapeutics is a biotechnology company focused on discovering, developing, and commercializing potential medicines for patients with autoimmune and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for validated drug targets and disease-driving mechanisms in autoimmune and rare diseases. Viridian is based in Waltham, Massachusetts.
Source: Viridian Therapeutics
