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REGENXBIO Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for RGX-121 Gene Therapy for Hunter Syndrome - Vimarsana News

REGENXBIO Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for RGX-121 Gene Therapy for Hunter Syndrome

Published: May 23, 2023

RMAT recognizes that the preliminary clinical evidence from RGX-121, a potential one-time AAV Therapeutic, indicates the potential to address unmet medical needs for MPS II RMAT designation is for... | May 23, 2023

Source: marketscreener.com
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Dana CormackJoseph MuenzerTerri KleinSteve PakolaChris BrinzeyTechnology Platform LicenseesTreatment CenterUniversity Of North Carolina At Chapel HillTechnology PlatformCorporate CommunicationsManufacturing Innovation CenterDrug AdministrationInnovation CenterBiologics License ApplicationRegenerative Medicine Advanced TherapyMucopolysaccharidosis TypeChief Medical OfficerCentury Cures ActBryson Distinguished ProfessorPediatrics GeneticsNorth CarolinaChief Executive OfficerHeparin SulfateOrphan Drug ProductRare Pediatric Disease
REGENXBIO Announces Intention to File a Biologics License Application Using the Accelerated Approval Pathway for RGX-121, an AAV Therapeutic for the Treatment of MPS II - Vimarsana News

REGENXBIO Announces Intention to File a Biologics License Application Using the Accelerated Approval Pathway for RGX-121, an AAV Therapeutic for the Treatment of MPS II

Published: August 3, 2022

/PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated...

Source: prnewswire.com
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United StatesDana CormackTerri KleinJoseph MuenzerChris BrinzeyPaul HarmatzTechnology PlatformTechnology Platform LicenseesDrug AdministrationExchange CommissionUniversity Of North Carolina At Chapel HillCorporate CommunicationsPivotal ProgramSecurities ExchangeTreatment ProgramDepartment Of PediatricsBiologics License ApplicationMucopolysaccharidosis TypeChief Executive OfficerHunter SyndromeBryson Distinguished ProfessorPediatrics GeneticsNorth CarolinaInborn ErrorsAnnual Symposium