Teprotumumab-TRBW

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.