RGNX shares jump after FDA alignment on next steps for Navsunli, paving the way for a planned MPS II BLA resubmission in Q3 2026.
Regenxbio Inc. (NASDAQ:RGNX) on Monday said it aligned with the Food and Drug Administration (FDA) regarding the next steps needed for a potential accelerated approval of Navsunli (RGX-121, clemidsoge
FDA confirmed no additional studies required, existing longer-term data from the CAMPSIITE ® study will be reviewed on an expedited basis for approval via the accelerated approval pathway The Company
The ​U.S. Food ‌and Drug ​Administration ​will reverse ⁠its ​earlier ​rejection of a ​rare-disease ​therapy from Regenxbio , ‌the ⁠Wall Street ​Journal ​reported ⁠on Monday
The company plans to refile its application for its gene therapy for a fatal brain disease after the FDA dropped demands to give a placebo to some study subjects.
REGENXBIO Inc. (RGNX) Presents at RBC Capital Markets Global Healthcare Conference 2026 Transcript
ROCKVILLE, Md., May 18, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conferences: 2026 RBC Capital Markets Global Healthcare Confer
REGENXBIO Inc. (RGNX) Q1 2026 Earnings Call Transcript
REGENXBIO Inc. (NASDAQ:RGNX) on Thursday released topline and interim functional data from the pivotal Phase 1/2/3 AFFINITY DUCHENNE trial evaluating RGX-202, its investigational gene therapy for Duch
Regenxbio (RGNX) came out with a quarterly loss of $1.72 per share versus the Zacks Consensus Estimate of a loss of $1.36. This compares to earnings of $0.12 per share a year ago.
Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE ® study of RGX-202 Primary endpoint achieved with high statistical significance Statistically significant correlati
Regenxbio said on Thursday that ​its experimental therapy to ‌treat a muscle-wasting disorder met the main goal in ​a late-stage study.
Achieved primary endpoint with high statistical significance; 93% of patients achieved microdystrophin expression above 10% (p
ROCKVILLE, Md., May 7, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the 2026 American Society of Gene & Cell Therapy Annual Meeting ("ASGCT 2026") taking place
-- Company will also report first quarter 2026 financial results and operational highlights -- ROCKVILLE, Md., May 6, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will h
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