REGENXBIO Inc., a clinical-stage biotechnology company, provides gene therapy product candidates to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins or antibodies that are intended to impact disease. Its gene therapy product candidates are based on NAV Technology Platform, a proprietary adeno-associated virus gene delivery platform. The company's lead product candidate is RGX-314, which is in Phase I/IIa clinical trial for the treatment of wet age-related macular degeneration. It is also developing RGX-121 that is in Phase I/II clinical trial to treat mucopolysaccharidosis type II; RGX-111, which is in Phase I clinical trial for treating mucopolysaccharidosis type I; RGX-181 for the treatment of late-infantile neuronal ceroid lipofuscinosis type II disease; and RGX-501, which is in Phase I/II clinical trials to treat homozygous familial hypercholesterolemia. REGENXBIO Inc. also licenses its NAV Technology Platform to other biotechnology and pharmaceutical companies; and has a collaboration and license agreement with Neurimmune AG to develop vectorized antibodies for the treatment of neurodegenerative diseases. The company was formerly known as ReGenX Biosciences, LLC and changed its name to REGENXBIO Inc. in September 2014. REGENXBIO Inc. was founded in 2008 and is headquartered in Rockville, Maryland.
IPO Year: 2015
Exchange: NASDAQ
Website: regenxbio.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 1/28/2026 | $37.00 | Overweight | Barclays |
| 2/11/2025 | $38.00 → $14.00 | Buy → Neutral | Goldman |
| 2/7/2025 | $27.00 | Outperform | Raymond James |
| 11/15/2024 | $22.00 | Overweight | Morgan Stanley |
| 10/10/2024 | $18.00 | Outperform | Raymond James |
| 6/7/2024 | $38.00 | Buy | Goldman |
| 3/11/2024 | $36.00 | Buy | H.C. Wainwright |
| 3/8/2024 | $20.00 → $35.00 | Sector Perform → Outperform | RBC Capital Mkts |
| 3/6/2024 | $37.00 | Market Perform → Outperform | Leerink Partners |
| 2/21/2024 | $45.00 | Outperform | Raymond James |
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Barclays resumed coverage of REGENXBIO with a rating of Overweight and set a new price target of $37.00
Goldman downgraded REGENXBIO from Buy to Neutral and set a new price target of $14.00 from $38.00 previously
Raymond James resumed coverage of REGENXBIO with a rating of Outperform and set a new price target of $27.00
Morgan Stanley resumed coverage of REGENXBIO with a rating of Overweight and set a new price target of $22.00
Raymond James resumed coverage of REGENXBIO with a rating of Outperform and set a new price target of $18.00
Goldman initiated coverage of REGENXBIO with a rating of Buy and set a new price target of $38.00
H.C. Wainwright initiated coverage of REGENXBIO with a rating of Buy and set a new price target of $36.00
RBC Capital Mkts upgraded REGENXBIO from Sector Perform to Outperform and set a new price target of $35.00 from $20.00 previously
Leerink Partners upgraded REGENXBIO from Market Perform to Outperform and set a new price target of $37.00
Raymond James resumed coverage of REGENXBIO with a rating of Outperform and set a new price target of $45.00
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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, NYStifel 2026 Virtual Ophthalmology Forum Fireside Chat: Tuesday, May 26 at 9:30am ET Location: VirtualLive webcasts of select events can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com. Archived replays of the webcasts will be available for approximately 30 days following the events.ABOUT REGENXBIO Inc. REGENXBIO is a biotechnology company on a mission to improve lives through the curative poten
Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE® study of RGX-202Primary endpoint achieved with high statistical significanceStatistically 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 2026Subretinal wet AMD topline pivotal data expected in Q4 2026Clinical hold lifted for RGX-121Webcast today at 8:00 a.m. ET to discuss RGX-202 topline pivotal data and Q1 2026 earnings ROCKVILL
Achieved primary endpoint with high statistical significance; 93% of patients achieved microdystrophin expression above 10% (p<0.0001)Statistically significant correlation between RGX-202 microdystrophin expression and functional improvement (NSAA n=9), supporting validity of surrogate endpoint Well-tolerated, differentiated safety profileCompany preparing for potential accelerated approval in 2027Webcast to be held at 8:00 a.m. ET todayROCKVILLE, Md., May 14, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) announced positive topline and interim functional data from the pivotal Phase III portion of the Phase I/II/III AFFINITY DUCHENNE® trial of RGX-202, a potential best-in-class gene thera
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. Oral Presentations:The oral presentations include an overview of recent advancements in production titer and product quality achieved through REGENXBIO's NAVXpress® manufacturing platform and an encore presentation of topline pivotal data from RGX-202, the company's next generation gene therapy program for Duchenne muscular dystrophy.Title: Advancing AAV manufacturability toolbox for early programs and beyondPresenter: Metewo Selase Kosi Enuameh, Ph.D., A
-- 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. ET to discuss topline results from the pivotal trial of RGX-202, the company's next-generation investigational gene therapy for the treatment of Duchenne muscular dystrophy.The webcast will feature leading Duchenne physicians including Aravindhan Veerapandiyan, M.D., Director of the Comprehensive Neuromuscular Program and Co-Director of the Muscular Dystrophy Association Care Center at Arkansas Children's Hospital, Carolina Tesi-Rocha, M.D., Cli
Investigational RGX-202 continues to demonstrate evidence of positively changing disease trajectory for Duchenne Pivotal dose participants exceeded external controls across functional measures at 1 year, including participants aged 8+Cardiac MRI data for pivotal dose patients demonstrated stability at 1 yearFavorable safety profile continued with no serious adverse events or adverse events of special interest observed in Phase I/II studyNew data from multiple measures supported liver safety in pivotal patientsPivotal topline data expected Q2 2026ROCKVILLE, Md., March 11, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced new positive interim data from the Phase I/II AFFINITY D
Late-stage gene therapy pipeline for rare and retinal diseases advancing toward key catalysts RGX-202 for Duchenne muscular dystrophy: New Phase I/II data at MDA, topline pivotal results expected early Q2 2026Robust patient enrollment continues in confirmatory trialSurabgene lomparvovec (sura-vec, ABBV-RGX-314) subretinal wet AMD topline pivotal data expected in Q4 2026; first patient dosed in pivotal Phase IIb/III trial in diabetic retinopathy expected in Q2 2026Company to engage FDA on potential path forward for RGX-121Conference call today at 8:00 a.m. ETROCKVILLE, Md., March 5, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today reported financial results and operational highlights f
ROCKVILLE, Md., March 4, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced presentations on its RGX-202 investigational gene therapy for Duchenne muscular dystrophy at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, taking place in Orlando, FL March 8-11, 2026.Presentations include preclinical and Phase I/II clinical safety, biomarker, and functional data.Podium Presentation:Title: RGX-202, An Investigational Gene Therapy for the Treatment of Duchenne Muscular Dystrophy: Interim Phase I/II Clinical Data (P432 O)Session: Clinical Trial UpdatesDate/Time: March 11, 2026; 11:45 a.m. ETPresenter: Carolina Tesi Rocha, M.D., Clinical Professor, Neurol
ROCKVILLE, Md., March 2, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced it will participate in the following investor conferences:Leerink Partners Global Healthcare ConferenceFireside Chat: Monday, March 9 at 9:20am ETLocation: Miami, FLBarclays 28th Annual Global Healthcare ConferenceFireside Chat: Tuesday, March 10 at 1:30pm ETLocation: Miami, FLRBC Inaugural Virtual Ophthalmology Conference Fireside Chat: Tuesday, March 24 at 8:45am ETLocation: VirtualLive webcasts of select events can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com. Archived replays of the webcasts will be available for approximately 30 days following the events.ABOUT R
ROCKVILLE, Md., Feb. 25, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, March 5, at 8:00 a.m. ET to discuss its financial results for the fourth quarter and full year ended December 31, 2025, and operational highlights.Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.ABOUT REGENXBIO Inc.REGENXBIO is a biotechnology comp
Live Leadership Updates
NEW YORK, Dec. 6, 2024 /PRNewswire/ -- S&P Dow Jones Indices ("S&P DJI") will make the following changes to the S&P 500, S&P MidCap 400, and S&P SmallCap 600 indices effective prior to the open of trading on Monday, December 23, to coincide with the quarterly rebalance. The changes ensure each index is more representative of its market capitalization range. All companies being added to the S&P 500 are more representative of the large-cap market space, all companies being added to the S&P MidCap 400 are more representative of the mid-cap market space, and all companies being added to the S&P SmallCap 600 are more representative of the small-cap market space. The companies being removed from t
Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programsVit Vasista steps down following more than 15 years at the CompanyROCKVILLE, Md., Sept. 17, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that Mitchell Chan has been appointed as Executive Vice President and Chief Financial Officer, effective today. A veteran finance executive and operating partner in the biotechnology industry, Mr. Chan has held key roles in raising capital, business development transactions and operations for nearly 20 years. "We are excited to welcome Mitchell at this exciting time for REGENXBIO," said Curran Simpson, President and
Curran Simpson, Chief Operating Officer, Appointed as President and CEOCo-Founder Kenneth T. Mills to Step Down as President and CEO; Named Chairman of the Board ROCKVILLE, Md., June 12, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that Curran Simpson, Chief Operating Officer, has been appointed as President, Chief Executive Officer and a member of the Board of Directors, effective July 1, 2024. Co-Founder Kenneth T. Mills will step down as President and Chief Executive Officer following 15 years of leadership at the Company, and he is taking on an expanded role on the Board as Chairman. In connection with these changes, Board member Daniel Tassé has been appointed as RE
NEW YORK, July 07, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, today announced that it has appointed Dr. Ellen Strahlman and Dr. Ram Palanki as new and independent members of its Board of Directors. With these appointments, the Eyenovia Board will expand to eight seats, from six currently. "I could not be more pleased to welcome Drs. Strahlman and Palanki to our Board and look forward to their immediate contributions," stated Dr. Sean Ianchulev, chief executive officer and chief medical officer of Eyenovia. "Each brings decades of medical technology, cl
ROCKVILLE, Md., June 7, 2022 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced the appointment of Jennifer Zachary to its Board of Directors, effective June 3, 2022. Ms. Zachary will serve as a member of REGENXBIO's Audit Committee and brings 20 years of legal and regulatory experience working in the pharmaceutical and medical device industries. "We are pleased to welcome Jennifer to our Board of Directors," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "Jennifer is an accomplished pharmaceutical executive with a wealth of knowledge and
ROCKVILLE, Md., Sept. 7, 2021 /PRNewswire/ -- Renowned gene therapy pioneer and biotechnology executive bring extensive R&D leadership and financial and operational expertise to the BoardREGENXBIO Inc. (NASDAQ:RGNX) today announced the appointment of Jean Bennett, M.D., Ph.D., and George Migausky to its Board of Directors, effective September 3, 2021. Dr. Bennett, a leading molecular genetics researcher, is the F.M. Kirby Emeritus Professor of Ophthalmology at the Perelman School of Medicine and previously served as director of the Center for Advanced Retinal and Ocular Therapeutics (CAROT) at the University of Pennsylvania. She will serve as a member of REGENXBIO's Nominating and Corporate
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Company announced positive topline results from pivotal Phase III AFFINITY DUCHENNE® study of RGX-202Primary endpoint achieved with high statistical significanceStatistically 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 2026Subretinal wet AMD topline pivotal data expected in Q4 2026Clinical hold lifted for RGX-121Webcast today at 8:00 a.m. ET to discuss RGX-202 topline pivotal data and Q1 2026 earnings ROCKVILL
Late-stage gene therapy pipeline for rare and retinal diseases advancing toward key catalysts RGX-202 for Duchenne muscular dystrophy: New Phase I/II data at MDA, topline pivotal results expected early Q2 2026Robust patient enrollment continues in confirmatory trialSurabgene lomparvovec (sura-vec, ABBV-RGX-314) subretinal wet AMD topline pivotal data expected in Q4 2026; first patient dosed in pivotal Phase IIb/III trial in diabetic retinopathy expected in Q2 2026Company to engage FDA on potential path forward for RGX-121Conference call today at 8:00 a.m. ETROCKVILLE, Md., March 5, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today reported financial results and operational highlights f
ROCKVILLE, Md., Feb. 25, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, March 5, at 8:00 a.m. ET to discuss its financial results for the fourth quarter and full year ended December 31, 2025, and operational highlights.Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.ABOUT REGENXBIO Inc.REGENXBIO is a biotechnology comp
RGX-202 program for Duchenne muscular dystrophy advancing rapidly, topline results expected early Q2 2026 and BLA submission mid-2026Pivotal trial enrollment completed in October; confirmatory trial open and enrolling New 12-month analysis shows all participants demonstrate improved functional outcomes across multiple natural history methods of measurement, when decline is expectedClemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; PDUFA date February 8, 2026Surabgene lomparvovec (sura-vec, ABBV-RGX-314) on track to be first gene therapy for chronic retinal diseaseEnrollment completed in pivotal trials evaluating subretinal delivery of sura
ROCKVILLE, Md., Oct. 29, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, November 6, at 8:00 a.m. ET to discuss its financial results for the third quarter ended September 30, 2025, and operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. ABOUT REGENXBIO Inc. REGENXBIO is a biotechnology company on a
RGX-202 in Duchenne muscular dystrophy on track for topline results 1H 2026 and BLA submission mid-2026Pivotal trial enrollment accelerated, expected to complete in October 2025 ahead of previous guidanceClemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; FDA inspections completed successfullyPre-license inspection (PLI) of in-house manufacturing facility, quality systems and processes completed with no observationsBioresearch monitoring information (BIMO) inspection of laboratory and clinical data practices completed with no observationsSurabgene lomparvovec (sura-vec, ABBV-RGX-314) on track to be first gene therapy in chronic retinal dise
ROCKVILLE, Md., July 31, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, August 7, at 8:00 a.m. ET to discuss its financial results for the second quarter ended June 30, 2025, and operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should access the live call by dialing (646) 307-1963 (domestic) or (800) 715-9871 (international) and enter the passcode 9571992. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to
RGX-202 in Duchenne muscular dystrophy on track for BLA submission mid-2026Pivotal trial more than half enrolled, with completion expected in 2025 Additional Phase I/II functional data expected 1H 2025 Initiating commercial supply manufacturing in Q3 2025FDA acceptance of Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121, partnered with Nippon Shinyaku) expected in May 2025 Pivotal data evaluating the safety and efficacy of the subretinal delivery of surabgene lomparvovec (ABBV-RGX-314, partnered with AbbVie) in patients with wet age-related macular degeneration are expected in 2026 and planning of diabetic retinopathy pivotal study continuesConference call today at 4
ROCKVILLE, Md., April 30, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Monday, May 12, at 4:30 p.m. ET to discuss its financial results for the first quarter ended March 31, 2025, and recent operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. ABOUT REGENXBIO Inc.REGENXBIO is a biotechnology company on a mi
ROCKVILLE, Md., Feb. 26, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, March 13, at 4:30 p.m. ET to discuss its financial results for the fourth quarter and full year ended December 31, 2024, and recent operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. ABOUT REGENXBIO Inc.REGENXBIO is a leading