Veligrotug

Viridian Therapeutics’ stock jumped Monday after the company unveiled another Phase 3 look at its potential competitor to Amgen’s Tepezza in thyroid eye disease. Veligrotug met all its primary and secondary endpoints in chronic thyroid eye disease patients, Viridian announced. TED occurs in two phases : an active phase when symptoms tend to worsen, and a chronic phase when symptoms stabilize but patients may still experience some eye changes. Of chronic patients who received veligrotug in the Phase 3 THRIVE-2 study, 56% had a reduction in proptosis, or bulging of the eyes — a hallmark of the disease. In the placebo group, 8% of patients saw a response. The results on this measure — the trial’s primary endpoint — were statistically significant, the company said in its announcement . Veligrotug also met the secondary endpoint of improvement in diplopia, or double vision. In the veligrotug arm, 56% of patients had a diplopia response and 32% achieved complete resolution of diplopia, compared to 14% of placebo patients who saw a complete resolution. TD Cowen analysts highlighted the diplopia response as a “potential upside surprise,” as Tepezza did not meet statistical significance on diplopia in a Phase 4 trial in chronic patients. However, the analysts noted that the Tepezza study had fewer diplopia patients at baseline. “Physicians and patients tell us diplopia is one of the hardest parts about living with this disease,” Viridian CEO Steve Mahoney said on the Monday call with investors, according to an AlphaSense transcript. “We look forward to including these data in our BLA submission for potential inclusion in veli’s labeling.” Viridian’s stock $VRDN was up more than 20% on Monday afternoon. Viridian announced plans to file for FDA approval in the second half of 2025, with a potential launch in 2026. The company read out Phase 3 results in active TED patients in September. Questions persist, however, about the risk of hearing impairment, a concern in Tepezza and veligrotug’s class of drugs. In THRIVE-2, hearing impairment occurred in 12.8% of veligrotug patients, compared with 3.2% of placebo patients. The company told investors on Monday that a majority of hearing events were tinnitus, and all but one were mild. Veligrotug is given in five infusions compared to Tepezza’s eight infusions, which Mahoney has previously touted as a potential commercial benefit. “This is no longer simply about shorter infusion times in course of therapy. We now believe that we have a differentiated profile based on the efficacy and safety data that we have seen from THRIVE and THRIVE-2,” he said on the Monday call.

WALTHAM, Mass.--( BUSINESS WIRE )--Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced plans to host a conference call and webcast to report topline data for the THRIVE-2 phase 3 clinical trial, evaluating veligrotug in chronic TED, on Monday, December 16, 2024 at 8:00am ET. Conference call and webcast information The webcast can be accessed under “Events and Presentations” on the Investors section of the Viridian website at viridiantherapeutics.com . To participate in the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference code 9934051. A replay of the webcast will be available following the completion of the event. About Viridian Therapeutics Viridian is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas. Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED. In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases. Viridian is based 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 within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “design,” “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: preclinical and clinical development of Viridian’s product candidates veligrotug (formerly VRDN-001), VRDN-003, VRDN-006 and VRDN-008; Viridian’s product candidates potentially being best-in-class; and the potential for Viridian’s product candidates to be developed in multiple autoimmune diseases. 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 the potential utility, efficacy, potency, safety, clinical benefits, clinical response and convenience of Viridian’s product candidates and those risks set forth under the caption “Risk Factors” in our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2024 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 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.