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VRDN FDA decision: Jun 26, 2026

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
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Veligrotug (VRDN-001) was approved by the FDA on June 26, 2026 for thyroid Eye Disease (TED).

Viridian Therapeutics Inc., Lumvoa (veligrotug-vvze) · Active Thyroid Eye Disease (TED).

Run-up into the decision (T-120 → T+5)

PDUFA 6/26/26$33.78$13.31/9/26
Daily close, T-120 (1/9/26) through T+5. Run-up high $33.78 on 1/21/26, low $13.3 on 5/1/26 (T-120 to T-1). FDA decision 6/26/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-06-26
OutcomeApproved
Drug / candidateLumvoa (veligrotug-vvze) - (THRIVE)
CompanyViridian Therapeutics Inc.
120-day run-up (T-120→T-1)-43.3%

FDA record of the action: the FDA approved on June 26, 2026, per BLA 761530 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.

Specialist biotech funds holding VRDN, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
Avoro Capital Advisors2,500,000$45.9 millionfiled August 14, 2026
Baker Bros. Advisors2,383,025$43.8 millionfiled August 14, 2026
Perceptive Advisors581,980$10.7 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

Was Lumvoa (veligrotug-vvze) approved by the FDA?

Yes. The FDA approved the application for Lumvoa (veligrotug-vvze) on June 26, 2026, per the FDA's own record. The primary source is linked on this page.

Which company is behind Lumvoa (veligrotug-vvze)?

Lumvoa (veligrotug-vvze) is a Viridian Therapeutics Inc. (VRDN) program. The FDA decision came on June 26, 2026; the FDA's own record of the decision is linked on this page.

How did VRDN stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), VRDN moved -43.3%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.