RGNX Stock Slumps 25% on FDA Clinical Hold for RGX-121 Gene Therapy
REGENXBIO stock plunges 25% after the FDA places a clinical hold on RGX-121 for MPS II, following asymptomatic spine MRI findings in five participants.
Regenxbio: Sell-Off On Hunter Setback Presents A Risky Buy Opportunity
Regenxbio is rated a 'risky buy' due to high volatility, regulatory setbacks, and significant near-term catalysts. RGNX faces a clinical hold on RGX-121 for Hunter Syndrome, complicating milestone payments and royalty streams, but maintains sufficient cash runway into Q4 2027. Pivotal data for the AbbVie-partnered eye disease program and BLA submission for RGX-202 in DMD represent major binary catalysts by year-end and 2027.
Regenxbio Stock Sinks 22% Following Surprise Finding in Gene Therapy Trial
Regenxbio reports the discovery of nodules and masses on the spines of patients enrolled in a trial for RGX-121, the company's investigational therapy for Hunter syndome.
Regenxbio's Multi-Catalyst Setup Is Hard To Ignore (Rating Upgrade)
Regenxbio Inc. delivered a strong quarter, driven by milestone revenue, with GAAP EPS of $0.43 and revenue up 407% YoY. RGNX now holds $313 million in pro forma cash, funding operations into Q4 2027 and removing near-term financing overhang. Multiple late-stage catalysts—including RGX-202, pivotal wet AMD data, and RGX-121 resubmission—are stacked over the next 12–18 months.
REGENXBIO Q2 Earnings Call Highlights
REGENXBIO NASDAQ: RGNX reported second-quarter 2026 progress across its late-stage gene-therapy pipeline, highlighting completed enrollment in its Duchenne muscular dystrophy confirmatory study, an agreed path to resubmit its Hunter syndrome therapy application, and the start of a pivotal diabetic retinopathy study under its AbbVie collaboration.
REGENXBIO Inc. (RGNX) Q2 2026 Earnings Call Transcript
REGENXBIO Inc. (RGNX) Q2 2026 Earnings Call Transcript
Regenxbio (RGNX) Beats Q2 Earnings and Revenue Estimates
Regenxbio (RGNX) came out with quarterly earnings of $0.43 per share, beating the Zacks Consensus Estimate of $0.12 per share. This compares to a loss of $1.38 per share a year ago.
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
