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Viridian Therapeutics stock plummets after Amgen Tepezza data is released
Investing.com – Viridian Therapeutics Inc (NASDAQ:VRDN) shares fell 25.2% on Monday after Amgen (NASDAQ:AMGN) reported positive Phase 3 clinical trial results for TEPEZZA administered for moderate to severe active thyroid eye disease via subcutaneous injection using a syringe on the body.
Amgen’s TEPEZZA OBI trial reached its primary endpoint, showing an exophthalmos response rate of 77% over a 24-week period, versus 19.6% in the placebo group. The trial also demonstrated statistically significant improvements on other secondary endpoints, including overall response rate and clinical activity score.
The results from TEPEZZA OBI appear numerically stronger than Viridian’s elegrobart subcutaneous injection results reported a week earlier. TEPEZZA OBI showed an absolute exophthalmos response rate of 76.7%, while elegrobart Q4W was 54% and elegrobart Q8W was 63%. Adjusted for the placebo response, TEPEZZA OBI reached 57%, while elegrobart Q4W was 36% and elegrobart Q8W was 45%.
Overall safety results were broadly consistent with the known safety profile of TEPEZZA administered intravenously. Mild to moderate injection-site reactions were observed in some patients when administered subcutaneously, but did not lead to treatment interruption or discontinuation. The most common adverse events included muscle spasms, tinnitus, weight loss, ear discomfort, nausea, and diarrhea.
Analysts noted that although TEPEZZA OBI showed stronger efficacy data, Viridian’s elegrobart, administered via an auto-injector with Q4W or Q8W dosing regimens, offers greater convenience, requiring only 4 subcutaneous injections over 24 weeks. By comparison, Amgen’s OBI requires subcutaneous infusion via a pump once every two weeks for 24 weeks, for a total of 12 injections.
Stifel analyst Alex Thompson reiterated a Buy rating on Viridian and a $48.00 price target. RBC Capital analyst Lisa Walter reiterated an Outperform rating and a $42.00 price target. Leerink Partners analyst Thomas Smith reiterated an Outperform rating and a $50.00 price target.
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