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निर्णायकविनिर्माण निरीक्षण
REGENXBIO: FDA ने RGX-121 की BLA पर क्लिनिकल होल्ड लगाई
FDA placed a clinical hold on the RGX-121 BLA after asymptomatic spine MRI findings were found in five CAMPSIITE participants. The company does not expect to resubmit the BLA in the near term and will incorporate FDA feedback and longer-term data before next steps.
मुख्य तथ्य
- फाइल किया गया
- 24 अग॰ 2026, 09:20 pm
- घटना
- विनिर्माण निरीक्षण
- दिशा
- नकारात्मक
- कंपनी
RGNXREGENXBIO- संपत्ति
- clemidsogene lanparvovec
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
स्रोत का अंश
EX-99.1 2 rgnx-ex99_1.htm EX-99.1 EX-99.1 EXHIBIT 99.1 REGENXBIO Announces Regulatory Update on RGX-121 for MPS II ROCKVILLE, Md., August 24, 2026 – REGENXBIO Inc. (Nasdaq: RGNX) today provided an update on its investigational gene therapy, RGX-121 (clemidsogene lanparvovec), for the treatment of Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome. The U.S. Food and Drug Administration (FDA) placed a clinical hold on RGX-121 following the discovery of asymptomatic spine MRI findings in five participants in the CAMPSIITE ® study; REGENXBIO does not expect to resubmit the RGX-121 Biologics License Application (BLA) in the near term. “We believe these findings are unique and limited to our Hunter Syndrome program, and require longer-term follow-up and additional data an
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निर्णायक
10 फ़र॰ 2026
02:44 am
RGNXREGENXBIO