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Regenxbio表示FDA延长了亨特综合症药物的审查日期
2025-08-19 05:33
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- Regenxbio (NASDAQ:RGNX) said that the FDA has postponed the decision date for the marketing application of its experimental candidate, clemidsogene lanparvovec (RGX-121), a treatment for Hunter syndrome.
- The new target action date has been moved from November 9, 2025, to February 8, 2026.
- RGX-121 has received orphan drug product, rare pediatric disease, fast track and regenerative medicine advanced therapy designations from the FDA.
- "We promptly provided the FDA with the information requested and expect the commercial launch plans remain on track," CEO Curran Simpson said in a statement.
More on Regenxbio
- REGENXBIO Inc. (RGNX) Q2 2025 Earnings Call Transcript
- Regenxbio's RGX-121 Could Become The New Standard Of Care In Hunter Syndrome
- Regenxbio accelerates RGX-202 pivotal enrollment to October 2025 as topline data targeted for early 2026
- REGENXBIO registers 268K shares for resale
- Seeking Alpha’s Quant Rating on Regenxbio
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