Viridian Therapeutics Inc. (NASDAQ:VRDN) shares are down during Monday’s premarket session following the announcement of topline results from the REVEAL-1 Phase 3 clinical trial for elegrobart, for thyroid eye disease (TED).

Viridian Therapeutics Trial Meets Primary Endpoint

The REVEAL-1 trial met its primary endpoint, showing a statistically significant treatment effect with elegrobart achieving a proptosis (abnormal protruding eyes) responder rate of 54% and 63% for the Q4W (once in four weeks) and every eight weeks (Q8W) dosing regimens, respectively, compared to 18% for placebo at week 24.

Additionally, the trial reported a complete resolution of diplopia (double vision) in 51% of patients treated with the Q4W regimen versus 16% for placebo.

The trial results indicate that elegrobart was generally well-tolerated, with low rates of hearing impairment observed in both dosing groups.

Competitive Concerns

Citing a Jefferies analyst, Reuters reported that the data lowers the risk for Viridian by giving it two thyroid eye disease candidates. However, elegrobart's weaker efficacy versus peers could trigger investor concerns around commercial viability.

William Blair noted that the placebo-adjusted proptosis responder rates of 36% (Q4W) and 45% (Q8W) came in below the 51%-73% range that investors were looking.

Though analyst Lachlan Hanbury-Brown notes there are several factors contributing to the weaker placebo-adjusted change.

The fall in stock price is an overreaction, and the stock should recover somewhat as investors digest the full dataset, William Blair added.

Cash Position And Pipeline Support Long-Term Strategy

Topline data from the REVEAL-2 study for patients with chronic TED, the second pivotal phase 3 clinical trial of elegrobart, remains on track to read out in the second quarter of 2026.

Viridian anticipates submitting a Biologics License Application (BLA) to the US FDA for elegrobart in the first quarter of 2027.

The company ended the fiscal 2025 with $875 million in cash, which it expects will support its business plans through to profitability, particularly with anticipated revenues from elegrobart and veligrotug if approved.

The veligrotug application is under Priority Review at the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of June 30.

Competitive Landscape

In December 2025, Argenx SE (NASDAQ:ARGX) announced it would discontinue the Phase 3 UplighTED studies evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate to severe TED.

VRDN Stock Price Activity: Viridian Therapeutics shares were down 38.26% at $16.91 during premarket trading on Monday, according to Benzinga Pro data.

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