Viridian Q2 2026 results and Lumvoa FDA approval

Viridian Therapeutics reported second-quarter 2026 results and significant milestones.

Rhea-AI Filing Summary

Viridian Therapeutics reported second-quarter 2026 results and significant milestones. Lumvoa (veligrotug-vvze) was approved by the FDA for thyroid eye disease on June 26, 2026, ahead of its target PDUFA date, and was immediately launched in the U.S. Elegrobart remains on track for a planned BLA submission in the first quarter of 2027, while FcRn and TSHR programs are expected to meet 2026 development milestones. The company also completed a May 2026 convertible debt and equity financing with gross proceeds of $394 million.

For the three months ended June 30, 2026, Viridian generated $284 thousand in total revenues and incurred $126,552 thousand of operating expenses, resulting in a net loss of $127,119 thousand, compared with $100,735 thousand a year earlier. Cash, cash equivalents, and marketable securities were $981,530 thousand as of June 30, 2026, supporting total assets of $1,097,233 thousand, liabilities of $435,136 thousand, and stockholders’ equity of $662,097 thousand.

Positive

• Lumvoa received FDA approval for thyroid eye disease on June 26, 2026 and was immediately launched in the U.S., marking Viridian’s transition to a commercial-stage company.
• $394 million of gross proceeds from a May 2026 convertible debt and equity financing contributed to cash, cash equivalents, and marketable securities of $981,530 thousand as of June 30, 2026.

Negative

• Net loss increased to $127,119 thousand for the three months ended June 30, 2026, from $100,735 thousand a year earlier, as total operating expenses rose to $126,552 thousand.

Filing Explained

Viridian’s second-quarter report is complete: its common-stock loss was allocated across a weighted-average 107,884,104 shares, versus 81,593,463 a year earlier, producing a $1.05 per-share loss.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Total revenues: $284 thousand Net loss: $127,119 thousand Research and development expense: $71,577 thousand +5 more

8 metrics

Total revenues $284 thousand Three months ended June 30, 2026

Net loss $127,119 thousand Three months ended June 30, 2026

Research and development expense $71,577 thousand Three months ended June 30, 2026

Selling, general and administrative expense $54,975 thousand Three months ended June 30, 2026

Cash, cash equivalents and marketable securities $981,530 thousand As of June 30, 2026

Gross proceeds from financing $394 million Convertible debt and equity financing completed in May 2026

Total liabilities $435,136 thousand As of June 30, 2026

Total stockholders’ equity $662,097 thousand As of June 30, 2026

Key Terms

thyroid eye disease (TED), BLA, FcRn, TSHR, +2 more

6 terms

thyroid eye disease (TED) medical

"Lumvoa™ (veligrotug-vvze) approved by the FDA for thyroid eye disease (TED)"

An inflammatory condition in which the immune system attacks the tissues and muscles around the eyes, causing swelling, bulging, double vision, pain and, in severe cases, loss of sight. It matters to investors because its severity and prevalence drive demand for drugs, surgeries and diagnostics, influence healthcare spending and regulatory decisions, and can meaningfully affect revenue and valuations for companies developing or selling treatments—like a busted pipe creating urgent repair needs.

BLA regulatory

"Elegrobart ... on track for BLA submission Q1 2027"

FcRn medical

"Pipeline progress continues, with FcRn and TSHR program development milestones"

The neonatal Fc receptor (FCRN or FcRn) is a protein that controls how long antibodies and the blood protein albumin stay in circulation by protecting them from being broken down. For investors, therapies that block or harness FcRn can change a drug’s dosing, effectiveness and market appeal—either by lengthening beneficial antibodies for longer-lasting treatments or by reducing harmful antibodies in autoimmune disease—so progress in FcRn-targeted programs can materially affect a biotech’s commercial value.

TSHR medical

"Pipeline progress continues, with FcRn and TSHR program development milestones"

TSHR is the thyroid‑stimulating hormone receptor, a protein on thyroid cells that acts like a thermostat sensor: it detects the circulating hormone that tells the gland to make thyroid hormones and controls how strongly the gland responds. Investors watch TSHR because it is a common target for drugs and diagnostic tests, and changes involving the receptor — from new therapies to safety or regulatory findings — can affect the value of companies working on thyroid disease.

convertible debt and equity financing financial

"Completed convertible debt and equity financing in May 2026 with gross proceeds"

forward-looking statements regulatory

"This press release contains forward-looking statements."

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

Earnings Snapshot

Total revenues: $284 thousand · Guidance included

Three months ended June 30, 2026

Total revenues $284 thousand vs $75 thousand for the three months ended June 30, 2025

Net loss $127,119 thousand vs $100,735 thousand for the three months ended June 30, 2025

Research and development expense $71,577 thousand vs $86,626 thousand for the three months ended June 30, 2025

Selling, general and administrative expense $54,975 thousand vs $20,216 thousand for the three months ended June 30, 2025

Cash, cash equivalents and marketable securities $981,530 thousand vs $874,652 thousand as of December 31, 2025

Guidance

Viridian states that its cash and anticipated commercial revenues from Lumvoa and, if approved, elegrobart, are expected to fund its business plans through profitability, subject to the risks and uncertainties described in its risk disclosures.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What FDA approval did Viridian Therapeutics (VRDN) secure in 2026?

Viridian’s drug Lumvoa (veligrotug-vvze) received FDA approval for thyroid eye disease on June 26, 2026 and was immediately launched in the U.S. This represents the company’s first approved product and supports its move into commercial operations.

How did Viridian Therapeutics (VRDN) perform financially in Q2 2026?

For Q2 2026, Viridian reported total revenues of $284 thousand and a net loss of $127,119 thousand. Operating expenses were $126,552 thousand, reflecting ongoing R&D and commercial build-out, compared with a net loss of $100,735 thousand in the prior-year quarter.

What is the status of elegrobart at Viridian Therapeutics (VRDN)?

Elegrobart, a late-stage investigational therapy for TED, is on track for a planned BLA submission in Q1 2027. It is described as a potential first subcutaneous autoinjector treatment for thyroid eye disease designed for at-home self-administration.

What was Viridian Therapeutics’ (VRDN) cash position as of June 30, 2026?

As of June 30, 2026, Viridian reported cash, cash equivalents, and marketable securities of $981,530 thousand. This follows a May 2026 convertible debt and equity financing that generated $394 million in gross proceeds, strengthening the company’s liquidity profile.

How did Viridian Therapeutics’ (VRDN) operating expenses change year over year in Q2 2026?

In Q2 2026, research and development expense was $71,577 thousand, down from $86,626 thousand a year earlier, while selling, general and administrative expense rose to $54,975 thousand from $20,216 thousand, bringing total operating expenses to $126,552 thousand.

What funding outlook does Viridian Therapeutics (VRDN) describe?

Viridian states that its cash and anticipated commercial revenues from Lumvoa and, if approved, elegrobart are expected to be sufficient to fund its business plans through profitability, although this expectation is subject to numerous risks and uncertainties detailed in its risk disclosures.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 08/06/2026 - 07:05 AM Accepted by SEC EDGAR 08/06/2026 - 07:05 AM Learn about SEC filing dates

Viridian Therapeutics, Inc.\DE false 0001590750 0001590750 2026-08-06 2026-08-06

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 6, 2026

VIRIDIAN THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-36483		47-1187261
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

221 Crescent Street, Suite 103A Waltham, MA		02453
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (617) 272-4600

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value		VRDN		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition

On August 6, 2026, Viridian Therapeutics, Inc. issued a press release reporting financial results for the quarter ended June 30, 2026.

The press release is attached hereto as Exhibit 99.1, which is furnished under Item 2.02 of this Current Report on Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

99.1		Press Release, dated August 6, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

				Viridian Therapeutics, Inc.
Date: August 6, 2026				By:		/s/ Stephen Mahoney
						Stephen Mahoney
						President and Chief Executive Officer

Exhibit 99.1

Viridian Therapeutics Highlights Recent Business Progress and Reports Second

Quarter 2026 Financial Results

- Lumvoa^™ (veligrotug-vvze) approved by the FDA for thyroid eye disease (TED) on June 26, 2026, ahead of

target PDUFA date and immediately launched in the U.S. -

- Elegrobart, potentially the first subcutaneous autoinjector for the treatment of TED, on track for BLA

submission Q1 2027 -

- Pipeline progress continues, with FcRn and TSHR program development milestones on track in 2026 -

- Completed convertible debt and equity financing in May 2026 with gross proceeds of $394 million; cash,

cash equivalents, and marketable securities of $982 million as of June 30, 2026 -

WALTHAM, Mass. – August 6, 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 recent business highlights and financial results for the second quarter ended June 30, 2026.

“We are very encouraged by the early indications from our recent launch of Lumvoa as we start a new chapter for Viridian as a commercial-stage company,” said Steve Mahoney, President and Chief Executive Officer of Viridian Therapeutics. “Our team’s focus on execution continues in the commercial setting and we are happy with the early launch feedback from physicians and patients, positive payer engagement, and our progress in building enthusiasm for Lumvoa as a new treatment option. In parallel, we continue to advance our R&D pipeline toward a planned BLA submission for elegrobart in the first quarter of 2027, and are on track to deliver on clinical development milestones for our FcRn and TSHR programs in the second half of this year. With a strong balance sheet, we are well positioned to continue executing across our commercial and development priorities.”

Recent Business Highlights

TED PORTFOLIO

• Lumvoa: commercial launch in the U.S. with strong early momentum

• The U.S. Food and Drug Administration (FDA) approved Lumvoa for the treatment of TED on June 26, 2026.

• In the early stages of launch, the Viridian commercial team is focused on physician engagement, advancement of payer policy adoption, and generation of market demand. As of July 31, 2026:

• The field sales team achieved engagement with 95% of the 2,000 core prescribing physicians with strong and positive early feedback.

• Market access efforts to gain payer coverage are on track.

• The first doses of Lumvoa were administered in July, and patient enrollment forms to-date indicate broad and strong physician demand.

• ViridianCares^™, Viridian’s comprehensive patient support program, was activated at the time of approval to help patients, physician offices, and infusion centers navigate insurance coverage and provide personalized assistance along the Lumvoa treatment journey.

• Elegrobart (VRDN-003): BLA submission on track for Q1 2027

• Viridian is on track to submit a Biologics License Application (BLA) to the FDA for elegrobart in Q1 2027.

• Reported positive topline results from REVEAL-1 and REVEAL-2, two pivotal phase 3 clinical trials of subcutaneous elegrobart in active and chronic TED, respectively. At week 24 in both REVEAL-1 and REVEAL-2, Q4W and Q8W elegrobart demonstrated rapid and robust reductions in proptosis, and Q4W elegrobart additionally showed meaningful benefits for patients with diplopia. Elegrobart was generally well tolerated with a safety profile consistent with the anti-IGF-1R class.

• Elegrobart has the potential to be the first low-volume, subcutaneous autoinjector for the treatment of TED that patients can self-administer at home, if approved.

• Viridian anticipates that its current commercial and medical affairs infrastructure will support and accelerate a potential elegrobart launch with limited incremental investment.

• TSHR program: IND submission anticipated in Q4 2026

• 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 and expects to develop this program in TED and Graves’ disease.

FCRN PORTFOLIO

• VRDN-008: phase 1 healthy volunteer data expected in 2H 2026

• VRDN-008 phase 1 clinical trial in healthy volunteers is ongoing. Data remains on track for 2H 2026.

• VRDN-008 is a bi-specific, half-life extended FcRn inhibitor. As previously disclosed, 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.

• VRDN-006: development plan on track for disclosure in 2026

• 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.

• Viridian anticipates sharing development plans for VRDN-006 in 2026.

Financial Results

• Cash Position: Cash, cash equivalents, and marketable securities were $981.5 million as of June 30, 2026, compared with $762.2 million as of March 31, 2026. Existing cash and anticipated future commercial revenues from Lumvoa and elegrobart, if approved, are expected to fund Viridian’s current business plans through profitability.

• R&D Expenses: Research and development expenses were $71.6 million for the three months ended June 30, 2026, compared to $86.6 million for the three months ended June 30, 2025. The decrease in research and development expenses was driven by reduced expenses related to veligrotug and elegrobart studies, partially offset by additional investment in advancing our 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 three months ended June 30, 2026 were $55.0 million, compared with $20.2 million for the three months ended June 30, 2025. The increase in selling, general and administrative expenses was driven by increased personnel-related costs and build-out of commercial infrastructure for Lumvoa.

• Net Loss: Net loss for the three months ended June 30, 2026, was $127.1 million, compared with $100.7 million for the three months ended June 30, 2025.

• Shares Outstanding: As of June 30, 2026, Viridian had 125,349,092 shares of common stock outstanding on an as-converted basis, which included 113,238,218 shares of common stock and an aggregate 12,110,874 shares of common stock issuable upon the conversion of 181,654 total shares of preferred stock.

About Viridian Therapeutics

Viridian Therapeutics is a biotechnology company dedicated to developing better medicines for patients with autoimmune and rare diseases. Utilizing our expertise in antibody discovery and protein engineering, we aim to build on proven science to develop innovative medicines that address unmet needs and improve patient outcomes.

With an immediate focus in thyroid eye disease (TED), we developed Lumvoa, a full IGF-1R antagonist approved by the U.S. FDA for the treatment of thyroid eye disease. We are also advancing elegrobart, a late-stage investigational subcutaneous therapy designed to further address unmet needs in TED and improve patient convenience. Beyond TED, we are advancing a pipeline of potential best-in-class medicines to address multiple serious autoimmune diseases.

Viridian is headquartered in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X.

Forward Looking Statements

This press release contains forward-looking statements. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “become,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: the commercialization of Lumvoa, including early indications of launch; that the company’s current commercial and medical affairs infrastructure will support and accelerate an elegrobart launch; preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates, elegrobart, VRDN-006, and VRDN-008, including the company’s intention to communicate development plans for VRDN-006 in 2026; anticipated data results and timing of their disclosure, including VRDN-008 phase 1 healthy volunteer data expected in the second half of 2026; Viridian’s expectations regarding the anticipated timing or likelihood of regulatory submissions and approvals, including a BLA submission for elegrobart in the first quarter of 2027 and an IND submission for the company’s TSHR program in the fourth quarter of 2026; elegrobart’s potential to be the first subcutaneous therapy for the treatment of TED with a planned low-volume autoinjector that patients can self-administer at home; Viridian’s product candidates potentially being best-in-class; Viridian’s expectations regarding the potential commercialization, market size, and market opportunities of veligrotug and elegrobart, if approved; and that Viridian’s cash and anticipated commercial revenues from Lumvoa and, if approved, elegrobart, will be sufficient to fund its business plans through profitability.

New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: that the company has historically incurred losses and may not be able to secure additional capital when needed; that prior to marketing approval of veligrotug, the company had not generated revenue from product sales; that the company may be unable to maintain commercial manufacturing, sales and marketing capabilities or enter into agreements with third parties to commercially manufacture, market and sell veligrotug; market acceptance of veligrotug; potential utility, efficacy, potency, safety, clinical benefits, clinical response, and convenience of veligrotug and Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing,

progress and plans for our ongoing or future research, preclinical, and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions; expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; manufacturing risks; competition from other therapies or products; estimates of market size and market opportunity; other matters that could affect the sufficiency of existing cash, cash equivalents, and short-term investments to fund operations; our financial position; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the “Risk Factors” section of our filings with the Securities and Exchange Commission, including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof.

Viridian Therapeutics, Inc.

Condensed Consolidated Statements Of Operations

(In thousands, except share and per share data)

(Unaudited)

		Three Months Ended June 30,
		2026				2025
Revenues:
License revenue		$	233			$	—
Collaboration revenue - related parties			51				75
Total revenues			284				75
Operating expenses:
Research and development			71,577				86,626
Selling, general and administrative			54,975				20,216
Total operating expenses			126,552				106,842
Loss from operations			(126,268	)			(106,767	)
Total other income (expense), net			(851	)			6,032
Net loss		$	(127,119	)		$	(100,735	)
Net loss allocated to common stock		$	(112,824	)		$	(81,978	)
Net loss per share, basic and diluted, common stock		$	(1.05	)		$	(1.00	)
Weighted-average common shares outstanding, basic and diluted			107,884,104				81,593,463
Net loss allocated to Series A convertible preferred stock		$	(9,395	)		$	(9,034	)
Net loss per share, basic and diluted, Series A convertible preferred stock		$	(69.72	)		$	(66.99	)
Weighted-average Series A convertible preferred stock outstanding, basic and diluted			134,754				134,864
Net loss allocated to Series B convertible preferred stock		$	(4,899	)		$	(9,723	)
Net loss per share, basic and diluted, Series B convertible preferred stock		$	(69.72	)		$	(66.98	)
Weighted-average Series B convertible preferred stock outstanding, basic and diluted			70,270				145,160

Viridian Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)

		June 30, 2026				December 31, 2025
Cash, cash equivalents and marketable securities		$	981,530			$	874,652
Other receivable			75,000				—
Other assets			40,703				24,766
Total assets		$	1,097,233			$	899,418
Total liabilities			435,136				177,251
Total stockholders’ equity			662,097				722,167
Total liabilities and stockholders’ equity		$	1,097,233			$	899,418

Contacts

Investors

Greg Rossino

grossino@viridiantherapeutics.com

Media

Lisa Lopez

llopez@viridiantherapeutics.com

Source: Viridian Therapeutics, Inc.

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 63.5 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.1 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 17.6 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.0 KB