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REGENXBIO Highlights Key 2026 Catalysts and Announces Positive Long-Term Functional Outcomes in Lead Duchenne Gene Therapy Program
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New Phase I/II RGX-202 functional data demonstrates long-term, durable treatment effect at pivotal dose at 18 months Robust patient enrollment in confirmatory trial continues, expect majority of patients to be dosed by planned BLA filing, mid-yearExpecting FDA PDUFA decision and multiple pivotal top-line data readouts in 2026 to support potential...
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18.12.2025
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REGENXBIO to Present at the 44th Annual J.P. Morgan Healthcare Conference
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ROCKVILLE, Md., Dec. 18, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present at the 44th Annual J.P. Morgan Healthcare Conference.Presentation DetailsDate and Time: Wednesday, January 14, 2026 at 10:30 a.m. PT Location: Westin St. Francis, San Francisco, CAA live webcast of the presentation can be accessed in the Inv...
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25.11.2025
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REGENXBIO to Participate in Upcoming Investor Conference
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ROCKVILLE, Md., Nov. 25, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conference:Piper Sandler 37th Annual Healthcare ConferenceFireside Chat: Tuesday, December 2 at 8:30 a.m. ETLocation: New York, NYA live webcast of the fireside chat can be accessed in the Investors section of R...
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20.10.2025
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06.11.2025
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REGENXBIO Reports Third Quarter 2025 Financial Results and Operational Highlights
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RGX-202 program for Duchenne muscular dystrophy advancing rapidly, topline results expected early Q2 2026 and BLA submission mid-2026
Pivotal trial enrollment completed in October; confirmatory trial open and enrolling ...
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30.10.2025
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REGENXBIO Announces Completion of Pivotal Enrollment and Initiates Commercial Production in Duchenne Gene Therapy Program
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Patients treated with RGX-202 demonstrate consistent, robust microdystrophin expression and functional improvement compared to natural history in Phase I/II portion of AFFINITY DUCHENNE® trial supporting potential approval via the accelerated approval pathway...
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29.10.2025
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REGENXBIO to Host Conference Call on November 6 to Discuss Third Quarter 2025 Financial Results and Operational Highlights
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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 regist...
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15.10.2025
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REGENXBIO to Participate in Upcoming Investor Conferences
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ROCKVILLE, Md., Oct. 15, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conferences:
Chardan's 9th Annual Genetic Medicines Conference
Panel "Battleground States for Muscular Dystrophies": Tuesd...
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09.10.2025
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REGENXBIO Announces Presentation at the American Academy of Ophthalmology 2025 Annual Meeting
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ROCKVILLE, Md., Oct. 9, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present interim data from the Phase II ALTITUDE® trial evaluating suprachoroidal delivery of surabgene lomparvovec (ABBV-RGX-314, sura-vec) for the treatment of diabetic retinopathy (DR) at the American Academy...
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06.10.2025
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REGENXBIO Announces Completion of Enrollment in Pivotal Trials of Subretinal Surabgene Lomparvovec for Wet AMD
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Over 1,200 participants enrolled in ATMOSPHERE® and ASCENT® pivotal trials, representing largest global gene therapy program ever conducted
Subretinal surabgene lomparvovec on track to be first gene therapy for wet AMD...
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29.09.2025
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REGENXBIO Announces Presentation at the World Muscle Society
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ROCKVILLE, Md., Sept. 29, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced Chief Medical Officer, Steve Pakola, M.D., will present at the International Congress of the World Muscle Society taking place in Vienna, Austria, October 7-11, 2025.
The podium presentation will share new...
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05.09.2025
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REGENXBIO Presents Positive Twelve-Month Pivotal Data from Phase I/II/III CAMPSIITE® Trial of RGX-121 for Treatment of MPS II
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12-month pivotal data further demonstrate the ability of one-time RGX-121 treatment to improve outcomes for patients with MPS II>80% reduction in CSF levels of HS D2S6, key biomarker of MPS II brain disease, sustained through 1 yearPivotal patients demonstrate continued skill acquisition or stability, stratified by baseline function, through 1...
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28.08.2025
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REGENXBIO to Participate in Upcoming Investor Conferences
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ROCKVILLE, Md., Aug. 28, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conferences:
2025 Wells Fargo Healthcare Conference 1x1 Investor Meetings: Thursday, September 4 Location: Boston, MA
Morgan Stanley 23rd Annual Global Healthcare Conference Fireside Chat: Monday, September 8,...
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18.08.2025
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REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II
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RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlying genetic cause of Hunter syndrome, if approvedCommercial launch plans remain on track REGENXBIO plans to present updated pivotal data during the ICIEM meeting in September 2025ROCKVILLE, Md., Aug. 18, 2025 /PRNewswire/...
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10.07.2025
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REGENXBIO Announces Publication of Preclinical Results Demonstrating Functional Benefits of Novel Microdystrophin Construct in RGX-202 Investigational Gene Therapy for Duchenne Muscular Dystrophy
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Construct including CT domain demonstrated higher levels of microdystrophin protein, increased muscle force, and improved resistance to damage in mice lacking dystrophin REGENXBIO's next-generation investigational gene therapy, RGX-202, is the only microdystrophin construct that includes the CT domain Findings support the positive functional data...
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05.06.2025
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REGENXBIO REPORTS NEW POSITIVE FUNCTIONAL DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202
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RGX-202 demonstrating consistent evidence of positively changing disease trajectory for Duchenne All dose level 2 participants exceeded external natural history controls on all functional measuresBiomarker data demonstrate consistent, robust microdystrophin expression and transduction levels across all treated ages One new participant aged 2 year...
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02.06.2025
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REGENXBIO to Host Webcast Discussing Interim Functional Data from the Phase I/II AFFINITY DUCHENNE® Trial of RGX-202
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Event will feature Aravindhan Veerapandiyan, M.D., principal investigator of the AFFINITY DUCHENNE® trialROCKVILLE, Md., June 2, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a webcast to discuss new interim functional data from the Phase I/II AFFINITY DUCHENNE® trial of RGX-202, the company's next-generatio...
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19.05.2025
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REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million
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$150 million secured at closing extends cash runway into early 2027REGENXBIO retains additional potential non-dilutive funding opportunities, including monetization of Priority Review Voucher (PRV) and milestones from AbbVie ROCKVILLE, Md., May 19, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the closure of a non-dilutive, l...
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14.05.2025
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FDA Accepts Biologics License Application for Mucopolysaccharidosis II Treatment
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PARAMUS, N.J., May 14, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced today that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) submission by REGENXBIO Inc. (REGENXBIO; Headquarters: Rockville, Maryland, USA; CEO: Curran...
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13.05.2025
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REGENXBIO Announces FDA Acceptance and Priority Review of the BLA for RGX-121 for MPS II
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FDA assigns PDUFA target action date of November 9, 2025 RGX-121 on track to be the first gene therapy and one-time treatment for MPS IIPartner Nippon Shinyaku to lead commercialization upon potential approval REGENXBIO to lead commercial manufacturing and supply chainROCKVILLE, Md., May 13, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) toda...
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12.05.2025
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REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights
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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,...
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08.05.2025
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REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy 28th Annual Meeting
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ROCKVILLE, Md., May 8, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting, taking place in New Orleans, May 13 through 17, 2025. The presentations highlight REGENXBIO's leading end-to-end capabilities across research and early development,...
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06.05.2025
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REGENXBIO to Participate in Upcoming Investor Conferences
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ROCKVILLE, Md., May 6, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conferences:
BofA Securities Health Care Conference 2025Presentation: Tuesday, May 13, 2025 at 5:00 p.m. PTLocation: Las Vegas, NV
RBC Global Healthcare ConferenceFireside Chat: Tuesday, May 20, 2025 at 11:30 a.m...
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19.03.2025
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REGENXBIO REPORTS POSITIVE BIOMARKER DATA FROM AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY
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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 encourag...
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13.03.2025
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REGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates
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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 co...
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10.03.2025
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REGENXBIO Announces Presentations at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference
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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, tak...
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04.03.2025
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REGENXBIO Announces Closing of Strategic Partnership with Nippon Shinyaku for MPS Diseases
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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), als...
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26.02.2025
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REGENXBIO to Host Conference Call on March 13 to Discuss Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Highlights
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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 lin...
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25.02.2025
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REGENXBIO to Participate in Upcoming Investor Conferences
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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 9:20...
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14.01.2025
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REGENXBIO and Nippon Shinyaku Announce Exclusive Partnership to Develop and Commercialize RGX-121 and RGX-111 for MPS Diseases
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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 reta...
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13.01.2025
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AbbVie and REGENXBIO Announce Updates on the ABBV-RGX-314 Clinical Program
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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...
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18.11.2024
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REGENXBIO INITIATES PIVOTAL PHASE OF AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY AND REPORTS POSITIVE FUNCTIONAL DATA
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Alignment achieved with FDA on AFFINITY DUCHENNE® pivotal program and access to accelerated approval; BLA expected in 2026Pivotal trial of RGX-202 is enrolling ambulatory patients aged 1 and above with first patient dosedPhase I/II data show RGX-202 recipients exceeding external natural history and established benchmarks for clinical outcomesFunc...
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14.11.2024
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REGENXBIO to Host Webcast Discussing Pivotal Program and First Functional Data from the AFFINITY DUCHENNE® Trial of RGX-202
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- Event will feature Aravindhan Veerapandiyan, M.D., principal investigator of the AFFINITY DUCHENNE® trial and Michael Kelly, PhD, Chief Scientific Officer of CureDuchenne
ROCKVILLE, Md., Nov. 14, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a webcast to discuss the AFFINITY DUCHENNE® pivotal program...
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06.11.2024
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REGENXBIO Reports Third Quarter 2024 Financial Results and Recent Operational Updates
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Advancement in Phase I/II AFFINITY DUCHENNE® trial of RGX-202 for Duchenne Muscular Dystrophy; pivotal trial initiation and first functional data expected this monthBLA submission for RGX-121 initiated and expected to complete in Q1 2025Positive Phase II data support bilateral administration of subretinal ABBV-RGX-314; data consistent with that f...
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04.11.2024
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REGENXBIO to Participate in Upcoming Investor Conferences
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ROCKVILLE, Md., Nov. 4, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following investor conferences:
UBS Global Healthcare Conference Fireside Chat: Wednesday, November 13 at 12:30 p.m. PTLocation: Rancho Palos Verdes, CA
Stifel 2024 Healthcare Conference Fireside Chat: Tuesday, November 19 at 11:3...
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21.10.2024
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REGENXBIO Presents Positive Data from the Phase II Study of Subretinal ABBV-RGX-314 in Patients with Bilateral Wet AMD at AAO 2024
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97% reduction in treatment burden at nine months after treatment with ABBV-RGX-314Data consistent with that from multiple previous studies demonstrating favorable safety and efficacy profile Well tolerated with zero cases of intraocular inflammation in a setting of no prophylactic steroids Data highlight the potential of ABBV-RGX-314 to treat bot...
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18.10.2024
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REGENXBIO Announces Presentations at the American Academy of Ophthalmology 2024 Annual Meeting
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ROCKVILLE, Md., Oct. 18, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present new interim data evaluating subretinal delivery of ABBV-RGX-314 in patients with bilateral wet age-related macular degeneration (wet AMD) at the American Academy of Ophthalmology 2024 annual meeting. ABBV-RGX-314 is an investigational...
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23.09.2024
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REGENXBIO to Participate in Chardan's 8th Annual Genetic Medicines Conference
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ROCKVILLE, Md., Sept. 23, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in Chardan's 8th Annual Genetic Medicines Conference on Monday, September 30, 2024.
Chardan's 8th Annual Genetic Medicines Conference Fireside Chat: Monday, September 30, 2024 at 8:30 a.m. ET Location: New York, NY
A live webcast of th...
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17.09.2024
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REGENXBIO Appoints Mitchell Chan as Chief Financial Officer
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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 an...
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03.09.2024
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REGENXBIO Announces Positive Data from Pivotal Dose Level of RGX-121 Demonstrating Long-Term Systemic Effect
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- Data from pivotal dose level demonstrates long-term, sustained reductions in CSF levels of HS D2S6, a key biomarker of brain disease in MPS II- 80% of patients who received the pivotal dose discontinued intravenous enzyme replacement therapy or remained treatment-naïve- Submission of a rolling BLA using the accelerated approval pathway on tr...
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29.08.2024
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REGENXBIO to Participate in Upcoming Investor Conferences
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ROCKVILLE, Md., Aug. 29, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate the following upcoming investor conferences:
Morgan Stanley 22nd Annual Global Healthcare ConferenceFireside Chat: Thursday, September 5, 2024 at 5:35 p.m. ETLocation: New York, NY
Baird 2024 Global Healthcare Conference Fireside Chat:...
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27.08.2024
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REGENXBIO Announces Presentation at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium
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ROCKVILLE, Md., Aug. 27, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced data from its RGX-121 program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, will be shared at the SSIEM 2024 Annual Symposium, taking place in Porto, Portugal from September 3-6, 2024.
Abstract Title: CAMPSIITE...
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08.08.2024
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REGENXBIO to Participate in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference
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ROCKVILLE, Md., Aug. 8, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on Thursday, August 15, 2024.
H.C. Wainwright 4th Annual Ophthalmology Virtual ConferencePanel: The Evolving Therapeutic Landscape of AMDDate/Time: Thursday, August 15, 2...
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