VRDN

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Viridian Therapeutics Reports Third Quarter 2026 Financial Results and Highlights Recent Business Progress

- $24.7 million in Lumvoa™ (veligrotug-vvze) net product revenue with more than 100 patients on therapy at the end of Q3 2026 -

- Elegrobart Biologics License Application (BLA) submission on track for Q1 2027 -

- VRDN-008 phase 1 data disclosure on track for Q4 2026 -

- VRDN-292, a potential best-in-class TSHR inhibitor, expected to initiate a phase 1 clinical trial in patients in Q4 2026 -

- Cash, cash equivalents, and marketable securities of $955.2 million as of September 30, 2026 -

- Company to host webcast today, November 4, at 8:00 a.m. ET -

WALTHAM, Mass. – Nov. 4, 2026—Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today reported financial results and recent business updates for the third quarter ended September 30, 2026.

“We are highly encouraged by the strength of Lumvoa’s early launch in TED, which has exceeded expectations,” said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. “These strong early results are a testament to Lumvoa’s compelling clinical profile, the extraordinary execution of our Commercial and Medical teams, and the incredible support of our broader organization. We are excited about this early momentum and look forward to building on it as we continue to execute our launch strategy and strive to bring Lumvoa to more patients with TED. Our pipeline also continues to move forward as we advance elegrobart, our subcutaneously administered anti-IGF-1R, toward a planned BLA submission for TED in the first quarter of 2027. In addition, we look forward to several important milestones for the remainder of this year, including sharing clinical data for VRDN-008, development plans for our FcRn portfolio, and initiating a first-in-human clinical trial in patients for our TSHR program VRDN-292.”

Recent Business Highlights

THYROID EYE DISEASE

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Lumvoa: strong first quarter of launch, as of September 30, 2026:

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Lumvoa generated $24.7 million in net product revenue;

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More than 100 patients on therapy with Lumvoa;

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Significant market access progress made during the quarter;

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CMS has assigned Lumvoa a permanent J-code J3242, effective

January 1, 2027; and

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Continued execution across field sales, medical, market access, and patient services to drive Lumvoa adoption.

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Elegrobart: BLA submission on track for Q1 2027

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Viridian expects to submit a BLA to the U.S. FDA for elegrobart in TED in Q1 2027.

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Viridian anticipates launching elegrobart, if approved, in a commercially available autoinjector with at-home, subcutaneous Q4W and Q8W dosing.

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The Lumvoa Commercial and Medical infrastructure is expected to support a potential elegrobart launch with limited incremental investment.

TSHR PROGRAM

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VRDN-292: IND on track to initiate a phase 1 clinical trial in

patients in Q4 2026

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VRDN-292 IND on track to support phase 1 clinical trial initiation in Q4

2026, starting in patients with Graves’ disease.

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VRDN-292 is a potential best-in-class, half-life extended, monoclonal antibody targeting the thyroid-stimulating hormone receptor (TSHR), designed for subcutaneous delivery in an autoinjector with the potential to support extended dosing intervals for patient convenience.

FCRN PORTFOLIO

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VRDN-006: VRDN-006 is an

Fc fragment that inhibits the neonatal Fc receptor (FcRn). In a phase 1 healthy volunteer clinical trial, VRDN-006 showed IgG reductions consistent with the FcRn inhibitor class, spared albumin and LDL, and was generally well-tolerated.

•

VRDN-008: VRDN-008 is a

bispecific, half-life extended FcRn inhibitor. In non-human primates, a single, high-dose of VRDN-008 showed a longer half-life and more sustained IgG reduction versus efgartigimod in a head-to-head study.

•

FcRn update on track for Q4 2026: Viridian expects to announce VRDN-008 phase 1 healthy volunteer data and development plans for the FcRn portfolio in Q4 2026.

Financial Results

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Cash Position: Cash, cash equivalents, and marketable securities were $955.2 million as of September 30, 2026. Existing cash and anticipated future commercial revenues from Lumvoa and elegrobart, if approved, are expected to be able to fund Viridian’s current business plans through profitability.

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Net Product Revenue: Net product revenue for Lumvoa was $24.7 million during the three months ended September 30, 2026. Viridian did not record net product revenue for the same period in 2025.

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R&D Expenses: Research and development expenses were $70.1 million during the three months ended September 30, 2026, compared to $86.3 million during the three months ended September 30, 2025. The decrease in research and development expenses was driven by reduced expenses rel

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EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Viridian Therapeutics Reports First Quarter 2026 Financial Results and Highlights Recent Progress

- PDUFA target action date of June 30, 2026 for veligrotug in thyroid eye disease (TED); organization is launch-ready -

- Marketing Authorization Application (MAA) for veligrotug in TED submitted to the European Medicines Agency (EMA) in January 2026 and accepted for review in February 2026 -

- Subcutaneous elegrobart showed positive topline data in REVEAL-1 and REVEAL-2 phase 3 clinical trials in active and chronic TED, respectively; Biologics License Application (BLA) submission anticipated in Q1 2027 with the potential to be the first subcutaneous autoinjector treatment for TED -

- FcRn portfolio on track to share VRDN-006 development plan in 2026, and for VRDN-008 phase 1 healthy volunteer data 2H 2026 -

- Cash, cash equivalents, and short-term investments of $762M as of March 31, 2026 –

WALTHAM, Mass. – (BUSINESS WIRE) – Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare diseases, today reported recent business highlights and financial results for the first quarter ended March 31, 2026.

“Our team continues its strong execution across our portfolio as we are launch ready ahead of veligrotug’s PDUFA target date. We delivered positive topline data from both of elegrobart’s pivotal REVEAL phase 3 clinical trials, and earlier programs are moving ahead as planned,” said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. “With veligrotug’s PDUFA target date next month, we have hired and deployed our full field teams, readied commercial supply and supply chain infrastructure, and continue to engage physicians, payers, and key opinion leaders. We believe we are well-prepared and well-positioned to deliver a successful launch. With the positive topline data from REVEAL-1 and REVEAL-2, in active and chronic TED, respectively, we believe that subcutaneous elegrobart has the potential to be the simplest and most convenient treatment for TED.”

Recent Business Highlights

TED PORTFOLIO

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Veligrotug: PDUFA target action date of June 30, 2026; ready to launch

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The veligrotug BLA is under Priority Review at the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026. Veligrotug received Breakthrough Therapy Designation and Priority Review from the FDA in 2025.

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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.

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Submitted an MAA to the EMA in January 2026, which was accepted for review in February 2026.

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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.

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Elegrobart (VRDN-003): positive pivotal phase 3 data and potential to be first subcutaneous autoinjector treatment in TED

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Announced positive topline data in both REVEAL-1 and REVEAL-2, elegrobart’s two pivotal phase 3 clinical trials for active and chronic TED, respectively.

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Elegrobart is the only subcutaneous program to demonstrate positive pivotal phase 3 clinical data in both active and chronic TED.

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REVEAL-1 in Active TED: met its primary endpoint with a highly

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 additionally provided meaningful diplopia benefit to patients with active TED.

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REVEAL-2 in Chronic TED: met its primary endpoint with a highly

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 additionally provided meaningful diplopia benefit to patients with chronic TED.

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Generally Well-Tolerated: Elegrobart was generally well-tolerated in both pivotal clinical trials, with

low rates of hearing impairment.

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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.

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Viridian anticipates that the veligrotug commercial and medical affairs infrastructure w