NEW YORK, July 13, 2026 (GLOBE NEWSWIRE) -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of  Regenxbio, Inc. (NASDAQ: RGNX) breached their fiduciary duties to shareholders.

globenewswire.com - 2026-07-13 15:32:00

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.

prnewswire.com - 2026-06-29 07:05:00

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.

seekingalpha.com - 2026-06-28 08:45:00

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.

prnewswire.com - 2026-06-24 07:05:00

RGNX shares jump after FDA alignment on next steps for Navsunli, paving the way for a planned MPS II BLA resubmission in Q3 2026.

zacks.com - 2026-06-23 11:51:08

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, clemidsogene lanparvovec).

benzinga.com - 2026-06-22 09:23:14

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.

prnewswire.com - 2026-06-22 07:30:00

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.

reuters.com - 2026-06-22 07:01:40

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.

wsj.com - 2026-06-22 06:30:00

REGENXBIO Inc. (RGNX) Presents at RBC Capital Markets Global Healthcare Conference 2026 Transcript

seekingalpha.com - 2026-05-22 16:20:43

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.

prnewswire.com - 2026-05-18 16:05:00

REGENXBIO Inc. (RGNX) Q1 2026 Earnings Call Transcript

seekingalpha.com - 2026-05-14 20:30:46

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 Duchenne muscular dystrophy.

benzinga.com - 2026-05-14 12:03:30

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.

zacks.com - 2026-05-14 09:30:42

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.

prnewswire.com - 2026-05-14 07:10:00

Regenxbio said on Thursday that ​its experimental therapy to ‌treat a muscle-wasting disorder met the main goal in ​a late-stage study.

reuters.com - 2026-05-14 07:04:48

Achieved primary endpoint with high statistical significance; 93% of patients achieved microdystrophin expression above 10% (p

prnewswire.com - 2026-05-14 07:00:00

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 May 11-15, 2026, in Boston, Massachusetts.

prnewswire.com - 2026-05-07 07:05:00

-- 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 host a webcast on Thursday, May 14, 2026, at 8:00 a.m.

prnewswire.com - 2026-05-06 07:05:00

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.

prnewswire.com - 2026-04-14 20:05:00

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.

prnewswire.com - 2026-04-14 14:00:00

New York, New York--(Newsfile Corp. - April 14, 2026) - Bronstein, Gewirtz & Grossman, LLC, a nationally recognized investor-rights law firm, announces that a class action lawsuit has been filed against REGENXBIO Inc. (NASDAQ: RGNX) and certain of its officers. This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired REGENXBIO securities between February 9, 2022 and January 27, 2026, both dates inclusive (the "Class Period").

newsfilecorp.com - 2026-04-14 12:00:00

NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of securities of REGENXBIO, Inc. (NASDAQ: RGNX) between February 9, 2022 and January 27, 2026, inclusive (the “Class Period”). REGENXBIO is a clinical-stage biotechnology company. For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653. The Allegations: Rosen Law Firm is Investigating the Allegations that REGENXBIO, Inc.

businesswire.com - 2026-04-14 11:45:00

NEW YORK--(BUSINESS WIRE)---- $RGNX #ClassAction--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against REGENXBIO Inc. (“REGENXBIO” or the “Company”) (NASDAQ: RGNX) and reminds investors of the April 14, 2026 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has.

businesswire.com - 2026-04-14 09:34:00

LOS ANGELES, April 14, 2026 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises REGENXBIO, Inc., (“REGENXBIO” or the "Company") (NASDAQ: RGNX) investors of a class action on behalf of investors that bought securities between February 9, 2022 and January 27, 2026, inclusive (the “Class Period”). REGENXBIO investors have until April 14, 2026 to file a lead plaintiff motion.

globenewswire.com - 2026-04-14 09:00:00

NEW YORK, April 14, 2026 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of REGENXBIO Inc. (NASDAQ: RGNX). Shareholders who purchased shares of RGNX during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment.

prnewswire.com - 2026-04-14 09:00:00