Item 7.01 Regulation FD Disclosure On June 26, 2026, Viridian Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (“TED”) regardless of activity or duration.…
Filed Jun 29, 2026Accepted Jun 26, 2026, 6:18 PM EDTCIK 1590750Accession 0001193125-26-286273
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 LumvoaTM, 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.
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Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure
On June 26, 2026, Viridian Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has approved Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (“TED”) regardless of activity or duration. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 7.01 and in Exhibit 99.1 to this Current Report on Form 8-K is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of 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, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events
On June 26, 2026, the Company announced that the FDA has approved Lumvoa™ (veligrotug-vvze) for the treatment of TED regardless of activity or duration. Lumvoa is the first approved treatment for TED with labeling that includes data for both active and chronic TED. Viridian plans to launch Lumvoa immediately.
This Current Report on Form 8-K contains forward-looking statements, including, without limitation, statements regarding the Company’s plans to launch Lumvoa immediately. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations, and assumptions. 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 risks and uncertainties identified in the Company’s filings with the SEC, including those risks set forth under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 5, 2026, and other subsequent disclosure documents filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the Company nor any of 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.
Filed exhibits (1)
EX-99.1 (by filename) d164211dex991.htm
EX-99.1
2
d164211dex991.htm
EX-99.1
EX-99.1
Exhibit 99.1
Viridian Therapeutics Announces U.S. FDA Approval and Launch of Lumvoa ™ (veligrotug-vvze) for the Treatment of Thyroid Eye Disease
- First approved treatment for thyroid
eye disease (TED) with labeling that includes data for both active and chronic TED -
- In two pivotal phase 3 clinical trials,
Lumvoa treatment showed rapid, consistent, and durable reductions of the key signs and symptoms of both active and chronic TED -
-
Lumvoa is the first approved product for TED to show a statistically significant effect in both diplopia response and complete resolution of diplopia in active and chronic disease -
- Viridian plans to launch Lumvoa immediately, a pivotal milestone as the company’s first commercial product in TED with subcutaneous
elegrobart on track for a biologics license application (BLA) submission in Q1 2027 -
- Viridian will host a conference call and
webcast Monday, June 29, at 8:00 a.m. ET -
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 …