Regenxbio Inc. (RGNX)
Regenxbio: 'Strong Buy' On FDA Course Reversal For NAVSUNLI And Potential AA DMD Filing
REGENXBIO upgraded to 'Strong Buy' on FDA's course reversal for rare disease therapies, notably impacting NAVSUNLI [RGX-121] for MPS II. Company expects to resubmit NAVSUNLI BLA in Q3 2026, leveraging robust CAMPSIITE trial data and no new study requirements per FDA alignment. RGX-202 for DMD and sura-vec for wet AMD offer additional catalysts, with pivotal trial data and regulatory submissions anticipated through 2027.
Regenxbio Shares Rise on Plans to Resubmit Navsunli BLA for MPS II
RGNX shares jump after FDA alignment on next steps for Navsunli, paving the way for a planned MPS II BLA resubmission in Q3 2026.
FDA Will Reverse Rejection of Third Rare-Disease Drug, Regenxbio Says
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
REGENXBIO Inc. (RGNX) Presents at RBC Capital Markets Global Healthcare Conference 2026 Transcript
REGENXBIO Inc. (RGNX) Q1 2026 Earnings Call Transcript
REGENXBIO Inc. (RGNX) Q1 2026 Earnings Call Transcript
Regenxbio (RGNX) Reports Q1 Loss, Lags Revenue Estimates
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.
REGENXBIO Inc. (RGNX) Q4 2025 Earnings Call Transcript
REGENXBIO Inc. (RGNX) Q4 2025 Earnings Call Transcript
Regenxbio (RGNX) Reports Q4 Loss, Lags Revenue Estimates
Regenxbio (RGNX) came out with a quarterly loss of $1.3 per share versus the Zacks Consensus Estimate of a loss of $1.01. This compares to a loss of $1.01 per share a year ago.
Regenxbio (RGNX) Expected to Beat Earnings Estimates: Can the Stock Move Higher?
Regenxbio (RGNX) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Regenxbio: Cautiously Bullish After FDA Setbacks
REGENXBIO's NAV AAV platform has given them a diversified pipeline. They have RGX-314 and RGX-202 as primary value drivers with promising 2026 catalysts. RGX-314 is being developed in partnership with AbbVie, targeting wet AMD and diabetic retinopathy. These are sizeable TAMs, which could pay off in the long run. RGX-202 also shows promising early Duchenne data and Phase 3 progress. However, we still need to see the trials' long-term efficacy and safety data.
Regenxbio (RGNX) Soars 5.4%: Is Further Upside Left in the Stock?
Regenxbio (RGNX) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
REGENXBIO: Key FDA Decision On Hunter Syndrome Just Weeks Away
Regenxbio Inc. faces pivotal catalysts in 2026, notably RGX-121's FDA decision and RGX-202 Duchenne data, potentially transforming it into a commercial-stage gene therapy company. RGX-121 offers a unique CNS-targeted approach for Hunter syndrome, with strong biomarker and neurodevelopmental data supporting its accelerated approval case ahead of the February 8 PDUFA date. RGNX's valuation appears modest at a 3.3x forward EV/sales multiple, with late-stage assets, near-term regulatory events, and a healthy cash position providing balance sheet flexibility.
