REGENXBIO Announces Successful Pre-BLA Meeting with FDA to Support Accelerated Approval Pathway for RGX-121 for the Treatment of MPS II [Yahoo! Finance]
REGENXBIO Inc. (RGNX)
Last regenxbio inc. earnings: 2/26 04:05 pm
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Source: Yahoo! Finance
Confirmatory trial expected to begin in H2 2025 FDA confirmed RGX-121 commercial bulk drug is comparable to clinical material Positive biomarker, neurocognitive and systemic data will be part of BLA submission ROCKVILLE, Md. June 18, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it completed a successful Pre-Biologics License Application (BLA) meeting for RGX-121 for the treatment Mucopolysaccharidosis Type II (MPS II), where it finalized details of its BLA with the U.S. Food and Drug Administration (FDA). The FDA continues to be aligned with REGENXBIO's plan to use cerebrospinal fluid (CSF) levels of heparan sulfate (HS) D2S6, a key biomarker of brain disease activity, as a surrogate endpoint reasonably likely to predict clinical benefit to support accelerated approval of RGX-121. Additionally, REGENXBIO and the FDA discussed manufacturing, non-clinical, device delivery system and other critical elements of the BLA, including a confirmatory study designe
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News
- Regenxbio (RGNX) Soars 6.4%: Is Further Upside Left in the Stock? [Yahoo! Finance]Yahoo! Finance
- REGENXBIO Announces Expansion of AFFINITY DUCHENNE® Trial to Include a New Cohort of Younger Patients [Yahoo! Finance]Yahoo! Finance
- REGENXBIO Announces Expansion of AFFINITY DUCHENNE® Trial to Include a New Cohort of Younger PatientsPR Newswire
- REGENXBIO Inc. (NASDAQ: RGNX) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $38.00 price target on the stock.MarketBeat
- REGENXBIO Announces Successful Pre-BLA Meeting with FDA to Support Accelerated Approval Pathway for RGX-121 for the Treatment of MPS IIPR Newswire
RGNX
Earnings
- 5/8/24 - Miss
RGNX
Sec Filings
- 6/13/24 - Form 8-K
- 6/4/24 - Form 4
- 6/4/24 - Form 4
- RGNX's page on the SEC website