REGENXBIO Inc. logo RGNX - REGENXBIO Inc.

Price: -- -- | CONSENSUS: Buy DETAILS
STRONG
BUY 1
BUY 13
HOLD 5
SELL 1
STRONG
SELL 0
| PRICE TARGET: $19.14 DETAILS
HIGH: $32.00
LOW: $12.00
MEDIAN: $18.00
CONSENSUS: $19.14
UPSIDE: 25.67%

Stock News

REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million Milestone

REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million Milestone

New long-term data from diabetic retinopathy and wet AMD programs to be presented at American Society of Retina Specialists (ASRS) 2026 ROCKVILLE, Md., June 29, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the first patient has been dosed in the Phase IIb/III NAAVIGATE clinical trial of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy (DR) using suprachoroidal delivery.

Jun 29, 2026 03:05 AM • prnewswire.com
Regenxbio: 'Strong Buy' On FDA Course Reversal For NAVSUNLI And Potential AA DMD Filing

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.

Jun 28, 2026 04:45 AM • seekingalpha.com
REGENXBIO Completes Dosing in Confirmatory Study of RGX-202, Marking Completion of Registrational Development Program and Supporting Planned BLA Submission in Q3 2026

REGENXBIO Completes Dosing in Confirmatory Study of RGX-202, Marking Completion of Registrational Development Program and Supporting Planned BLA Submission in Q3 2026

Confirmatory study completed ahead of schedule due to strong patient demand and robust investigator interest On track to initiate BLA in Q3 2026 under the accelerated approval pathway supporting potential approval in 2H 2027 ROCKVILLE, Md., June 24, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the successful completion of dosing in the confirmatory study of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy.

Jun 24, 2026 03:05 AM • prnewswire.com
REGENXBIO Announces Alignment with FDA on Path Forward for NAVSUNLI™ BLA Resubmission for Accelerated Approval; First Potential Gene Therapy for MPS II

REGENXBIO Announces Alignment with FDA on Path Forward for NAVSUNLI™ BLA Resubmission for Accelerated Approval; First Potential Gene Therapy for MPS II

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 expects to resubmit the BLA in Q3 2026 ROCKVILLE, Md., June 22, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it has aligned with the U.S. Food and Drug Administration (FDA) regarding the next steps needed for a potential accelerated approval of NAVSUNLI™ (clemidsogene lanparvovec-sngl, RGX-121), the only potential one-time treatment and gene therapy for Mucopolysaccharidosis II (MPS II), an ultra-rare neurodegenerative disease also known as Hunter syndrome.

Jun 22, 2026 03:30 AM • prnewswire.com
REGENXBIO to Participate in Upcoming Investor Conferences

REGENXBIO to Participate in Upcoming Investor Conferences

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 Conference Fireside Chat: Wednesday, May 20 at 9:30am ET Location: New York, NY Stifel 2026 Virtual Ophthalmology Forum Fireside Chat: Tuesday, May 26 at 9:30am ET Location: Virtual Live webcasts of select events can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com.

May 18, 2026 12:05 PM • prnewswire.com
REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights

REGENXBIO Reports First Quarter 2026 Financial Results and Operational Highlights

Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE ® study of RGX-202 Primary endpoint achieved with high statistical significance Statistically significant correlation between RGX-202 microdystrophin expression and functional improvement (NSAA, n=9), supporting validity of surrogate endpoint Surabgene lomparvovec (sura-vec, ABBV-RGX-314) on track toward key catalysts Sites activated in pivotal Phase IIb/III study for diabetic retinopathy; first patient dosed expected Q2 2026 Subretinal wet AMD topline pivotal data expected in Q4 2026 Clinical hold lifted for RGX-121 Webcast today at 8:00 a.m. ET to discuss RGX-202 topline pivotal data and Q1 2026 earnings ROCKVILLE, Md.

May 14, 2026 03:10 AM • prnewswire.com
REGENXBIO Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - RGNX

REGENXBIO Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - RGNX

LOS ANGELES, April 14, 2026 /PRNewswire/ -- The DJS Law Group reminds investors of a class action lawsuit against REGENXBIO Inc. ("Regenxbio" or "the Company") (NASDAQ: RGNX) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Shareholders who purchased shares of RGNX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments.

Apr 14, 2026 04:05 PM • prnewswire.com (Hide legal announcements)
RGNX Deadline Today: RGRX Investors Have Opportunity to Lead REGENXBIO, Inc. Securities Fraud Lawsuit

RGNX Deadline Today: RGRX Investors Have Opportunity to Lead REGENXBIO, Inc. Securities Fraud Lawsuit

NEW YORK, April 14, 2026 /PRNewswire/ -- Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of REGENXBIO, Inc. (NASDAQ: RGNX) between February 9, 2022 and January 27, 2026, inclusive (the "Class Period"), of the important April 14, 2026 lead plaintiff deadline. So what: If you purchased REGENXBIO securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

Apr 14, 2026 10:00 AM • prnewswire.com (Hide legal announcements)

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