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 |
|---|---|---|---|
| 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 |
| 11/1/2023 | $35.00 | Buy | Stifel |
Positive biomarker data in patient aged 1-3 add to consistent, robust microdystrophin and transduction levels across all treated ages Patient aged 3 years at dosing had expression level at 122.3% compared to controlWith a differentiated novel construct and proactive short course immune modulation regimen, RGX-202 continues to demonstrate encouraging safety profile with no SAEs or AESIs Phase III portion of AFFINITY DUCHENNE® trial enrolling ambulatory patients aged 1 and above, on track for BLA submission mid-2026ROCKVILLE, Md., March 19, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today reported new, positive interim data from two additional patients in the Phase I/II portion of the A
Biologics Licensing Application (BLA) for clemidsogene lanparvovec (RGX-121) submitted and on track for potential FDA approval 2H 2025; strategic partnership with Nippon Shinyaku aims to expand potential access and commercial opportunity in MPS II and MPS IPivotal trial of RGX-202 for Duchenne Muscular Dystrophy progressing rapidly; enrollment completion expected in 2025 with BLA filing in mid-2026 AbbVie-partnered retinal franchise continues advancing; pivotal data evaluating the safety and efficacy of the subretinal delivery of surabgene lomparvovec (ABBV-RGX-314) in patients with wet age-related macular degeneration are expected in 2026 and planning of diabetic retinopathy pivotal study c
ROCKVILLE, Md., March 10, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced new interim biomarker data from the Phase I/II portion of the AFFINITY DUCHENNE® trial of RGX-202 for the treatment of Duchenne muscular dystrophy will be presented at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, taking place in Dallas, TX, March 16-19, 2025. Title: RGX-202, an investigational gene therapy for the treatment of Duchenne Muscular Dystrophy: Interim clinical data (O75)Session: Clinical TrialsDate/Time: Wednesday, March 19, 2025; 8:15 a.m. CTPresenter: Carolina Tesi Rocha, M.D., Clinical Professor, Neurology, Stanford School of Medicine, Stanford Childre
ROCKVILLE, Md., March 4, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced the closing of its previously announced strategic partnership with Nippon Shinyaku. Under the terms of the agreement, REGENXBIO and Nippon Shinyaku will develop and commercialize RGX-121 (clemidsogene lanparvovec) for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome and RGX-111 for Mucopolysaccharidosis I (MPS I), also known as Hurler syndrome in the United States and Asia. "RGX-121 and RGX-111 represent potentially transformative new medicines for patient populations in great need of new options," said Curran M. Simpson, President and CEO of REGENXBIO. "This partnership bolsters our ab
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
ROCKVILLE, Md., Feb. 25, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced it will participate in the following investor conferences: TD Cowen's 45th Annual Health Care ConferenceFireside Chat: Wednesday, March 5 at 1:10pm ETLocation: Boston, MA Leerink Partners Global Healthcare ConferenceFireside Chat: Tuesday, March 11 at 9:20am ETLocation: Miami, FL Barclays 27th Annual Global Healthcare Conference Fireside Chat: Wednesday, March 12 at 3:30pm ETLocation: Miami, FL UBS Virtual CNS DayFireside Chat: Monday, March 17 at 10:00am ETLocation: Virtual RBC Inaugural Virtual Ophthalmology Conference Fireside Chat: April 3 at 8:15am ETLocation: Virtual Live webcasts of select fires
ROCKVILLE, Md., Jan. 30, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced data from its RGX-121 (clemidsogene lanparvovec) program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, will be shared at the 21st Annual WORLDSymposium™ 2025, taking place in San Diego, CA February 3-7, 2025. The following presentations include an encore of the topline results from the pivotal phase of the Phase I/II/III CAMPSIITE® trial of RGX-121. Abstract Title: Audiology assessment of participants in CAMPSIITE®, a phase I/II/III study of RGX-121 in neuronopathic MPS II (poster 35)Presenter: Nidal Boulos, Ph.D., Director, Clinical Science, REGENXBIODate/
REGENXBIO to receive $110 million upfront, potential milestone payments of up to $700 million and meaningful double-digit royalties on net sales, and lead manufacturingNippon Shinyaku to lead commercialization of first potential gene therapies for Mucopolysaccharidosis II (MPS II) and Mucopolysaccharidosis I (MPS I) in U.S. and AsiaREGENXBIO retains rights to RGX-121 Priority Review Voucher (PRV) with potential accelerated approval expected in 2025; rolling BLA submission underwayROCKVILLE, Md., Jan. 14, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) and Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) today announced a strategic partnership for the development and commercialization of RGX-121
Pivotal data evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet age-related macular degeneration (wet AMD) are expected in 2026AbbVie and REGENXBIO will plan the Phase 3 clinical program of investigational ABBV-RGX-314 in diabetic retinopathy (DR)NORTH CHICAGO, Ill. and ROCKVILLE, Md., Jan. 13, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) and REGENXBIO Inc. (NASDAQ:RGNX) today announced updates to the ABBV-RGX-314 clinical program. ABBV-RGX-314 in Wet Age-Related Macular Degeneration (wet AMD), Subretinal DeliveryData from the ATMOSPHERE® and ASCENT™ pivotal trials evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in pati
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
3 - REGENXBIO Inc. (0001590877) (Issuer)
4/A - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
3 - REGENXBIO Inc. (0001590877) (Issuer)
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
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
Stifel initiated coverage of REGENXBIO with a rating of Buy and set a new price target of $35.00
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
S-8 - REGENXBIO Inc. (0001590877) (Filer)
POS AM - REGENXBIO Inc. (0001590877) (Filer)
10-K - REGENXBIO Inc. (0001590877) (Filer)
POSASR - REGENXBIO Inc. (0001590877) (Filer)
8-K - REGENXBIO Inc. (0001590877) (Filer)
8-K - REGENXBIO Inc. (0001590877) (Filer)
SCHEDULE 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SCHEDULE 13G - REGENXBIO Inc. (0001590877) (Subject)
SCHEDULE 13G/A - REGENXBIO Inc. (0001590877) (Subject)
8-K - REGENXBIO Inc. (0001590877) (Filer)
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
ROCKVILLE, Md., Oct. 30, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Wednesday, November 6, at 4:30 p.m. ET to discuss its financial results for the third quarter ended September 30, 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 clinical-s
ROCKVILLE, Md., July 25, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, August 1, 2024, at 4:30 p.m. ET to discuss its financial results for the second quarter ended June 30, 2024, and recent operational highlights. To access the live call by phone, dial (646) 307-1963 (domestic) or (800) 715-9871 (international) and enter the passcode 4849384. To access a live or recorded webcast of the call, please visit the Investors section of the REGENXBIO website at www.regenxbio.com. The recorded webcast will be available for approximately 30 days following the call. Those who plan on participating are advised to join 15 minutes prior
ROCKVILLE, Md., May 1, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Wednesday, May 8, 2024, at 4:30 p.m. ET to discuss its financial results for the first quarter ended March 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 clinical-stage
New three-month assessment in first patient at dose level 2 demonstrates robust microdystrophin expression Patient aged 12 years at dosing had expression level at 75.7% of controlEarly evidence of strength and motor function improvement observedOn track to initiate pivotal trial in second half of 2024 Webcast this morning, Tuesday, March 5, 8:30 a.m. ET, with principal investigatorROCKVILLE, Md., March 5, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today reported additional interim safety and efficacy data in the Phase I/II AFFINITY DUCHENNE® trial of RGX-202 in patients with Duchenne muscular dystrophy (Duchenne) ages 4 to11 years old, including RGX-202 microdystrophin expression from
Focus on clinical stage AAV Therapeutic product candidates addressing large commercial opportunities and value generationPrioritized pipeline is expected to further progress to pivotal stage and first BLA filing in 2024New updates planned for Duchenne and in-office delivery retinal disease programs starting in March$314 million in cash, cash equivalents and marketable securities as of December 31, 2023, expected to fund operational runway into the second half of 2025Conference call Tuesday, February 27, at 4:30 p.m. ETROCKVILLE, Md., Feb. 27, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced financial results for the fourth quarter and full year ended December 31, 2023, and r
ROCKVILLE, Md., Feb. 21, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Tuesday, February 27, 2024, at 4:30 p.m. ET to discuss its financial results for the fourth quarter and full year ended December 31, 2023, 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
Results support BLA submission in 2024 using the accelerated approval pathwayPrimary endpoint of patients achieving reduction in CSF biomarker of MPS II disease was met with statistical significance (p value of 0.00016) Patients treated with RGX-121 have showed continued improvement in neurodevelopmental skill acquisition up to four years and discontinued intravenous enzyme therapyCompany plans to discuss these results as part of a full rare disease program update on its conference call today, Wednesday, February 7, 4:30 p.m. ETROCKVILLE, Md., Feb. 7, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced topline results from the Phase I/II/III CAMPSIITE® trial of RGX-121 for the
Completed enrollment in cohort 2 of the Phase I/II AFFINITY DUCHENNE® trial of RGX-202, a potential one-time AAV Therapeutic for the treatment of Duchenne that includes an optimized transgene for a novel microdystrophinNew three-month assessment in third patient at dose level 1 demonstrates largest increase in microdystrophin expression Patient aged 6.6 years old had expression level at 83.4% of controlOn track to initiate pivotal trial in second half of 2024 Company plans to discuss these new results as part of a full rare disease program update on its conference call today, Wednesday, February 7, 4:30 p.m. ETROCKVILLE, Md., Feb. 7, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today an
Pivotal topline results from the CAMPSIITE® trial of RGX-121 for the treatment of MPS II to be presentedConference call Wednesday, February 7, 4:30 p.m. ETROCKVILLE, Md., Jan. 31, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced presentations on its program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, will be shared at the 20th Annual WORLDSymposium™ 2024, taking place in San Diego, CA February 3-9, 2024. The presentations include the topline results from the pivotal phase of the Phase I/II/III CAMPSIITE® trial of RGX-121 for the treatment of MPS II. The oral presentations will be presented as follows: Abstract Title: CAMPSIITE®