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ozgurdonmaz/iStock via Getty Images Viridian Therapeutics ( NASDAQ: VRDN ) shares gained after the company detailed its plans to start late-stage trials for VRDN-003, an injectable drug for thyroid eye disease (TED), while Wolfe Research launched its coverage with an Outperform rating. REVEAL-1 and REVEAL-2 Phase 3 trials, designed to test two dosing regimens of subcutaneously delivered VRDN-003, would get underway in August 2024, with their topline data expected in H1 2026, Viridian ( VRDN ) said. While REVEAL-1 will enroll about 84 patients with active TED, REVEAL-2, designed to target chronic TED, will add about 126 patients.

The company plans to file a marketing application for VRDN-003 with the U.S. FDA by the end of 2026.



Meanwhile, Wolfe analyst Andy Chen said Viridian ( VRDN ) shares are expected to move in response to a potential ramp-up in sales for Tepezza, a rival TED therapy from Amgen ( AMGN ). “With AMGN having achieved 50% payer coverage (up from 30% ~7 months ago), we believe a ramp-up may be an inevitability,” Chen wrote. Issuing a $29 price target on VRDN, the analyst expects potential blockbuster status for Viridian’s ( VRDN ) experimental TED therapy, VRDN-001, by 2027–28, despite Amgen’s ( AMGN ) competition.

Viridian ( VRDN ) expects topline Phase 3 data for VRDN-001 in active TED and chronic TED in September 2024 and by the year-end, respectively. More on Viridian Therapeutics Viridian Therapeutics, Inc. (VRDN) Q1 2024 Earnings Call Transcrip.

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