RGNX
NASDAQREGENXBIO Inc.
Price$8.98+0.10 (+1.07%)
01:30 PM07:45 PM
News · 26 weeks40-60%
2025-11-022026-04-26
Mix1890d
- SEC Filings8(44%)
- Other5(28%)
- Insider3(17%)
- Earnings2(11%)
Latest news
25 items- SECSEC Form DEFA14A filed by REGENXBIO Inc.DEFA14A - REGENXBIO Inc. (0001590877) (Filer)
- SECSEC Form DEF 14A filed by REGENXBIO Inc.DEF 14A - REGENXBIO Inc. (0001590877) (Filer)
- SECSEC Form PRE 14A filed by REGENXBIO Inc.PRE 14A - REGENXBIO Inc. (0001590877) (Filer)
- SECAmendment: SEC Form SCHEDULE 13G/A filed by REGENXBIO Inc.SCHEDULE 13G/A - REGENXBIO Inc. (0001590877) (Subject)
- SECREGENXBIO Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement8-K - REGENXBIO Inc. (0001590877) (Filer)
- INSIDERChief Medical Officer Pakola Steve sold $53,033 worth of shares (5,124 units at $10.35), decreasing direct ownership by 2% to 247,926 units (SEC Form 4)4 - REGENXBIO Inc. (0001590877) (Issuer)
- PRREGENXBIO REPORTS NEW POSITIVE INTERIM DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202Investigational 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
- SECSEC Form 10-K filed by REGENXBIO Inc.10-K - REGENXBIO Inc. (0001590877) (Filer)
- SECREGENXBIO Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits8-K - REGENXBIO Inc. (0001590877) (Filer)
- PRREGENXBIO Reports Fourth Quarter and Full Year 2025 Financial Results and Operational HighlightsLate-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
- PRREGENXBIO Announces Presentations at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific ConferenceROCKVILLE, 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
- PRREGENXBIO to Participate in Upcoming Investor ConferencesROCKVILLE, 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
- PRREGENXBIO to Host Conference Call on March 5 to Discuss Fourth Quarter and Full Year 2025 Financial Results and Operational HighlightsROCKVILLE, 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
- SECSEC Form 424B5 filed by REGENXBIO Inc.424B5 - REGENXBIO Inc. (0001590877) (Filer)
- SECREGENXBIO Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits8-K - REGENXBIO Inc. (0001590877) (Filer)
- PRREGENXBIO Announces Regulatory Update on RGX-121 BLA for MPS IIFDA issues Complete Response Letter for RGX-121 (clemidsogene lanparvovec) for treatment of Mucopolysaccharidosis II (MPS II) REGENXBIO plans to work with FDA on a path forward with the goal of resubmitting the BLAROCKVILLE, Md., Feb. 9, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for RGX-121 (clemidsogene lanparvovec) for the treatment of Mucopolysaccharidosis II (MPS II), an ultra-rare neurodegenerative disease also known as Hunter syndrome. In May 2025, the FDA accepted the RGX-121 BLA under the accelerated approval pathway. I
- INSIDERChief Strategy & Legal Officer Christmas Patrick J. covered exercise/tax liability with 4,700 shares, decreasing direct ownership by 2% to 210,667 units (SEC Form 4)4 - REGENXBIO Inc. (0001590877) (Issuer)
- INSIDERChief Medical Officer Pakola Steve covered exercise/tax liability with 5,267 shares, decreasing direct ownership by 2% to 253,050 units (SEC Form 4)4 - REGENXBIO Inc. (0001590877) (Issuer)
- INSIDERDirector Mills Kenneth T. exercised 225,000 shares at a strike of $13.09 and covered exercise/tax liability with 221,753 shares, increasing direct ownership by 0.67% to 486,118 units (SEC Form 4)4 - REGENXBIO Inc. (0001590877) (Issuer)
- SECREGENXBIO Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits8-K - REGENXBIO Inc. (0001590877) (Filer)
- PRREGENXBIO Announces Regulatory Update on Ultra Rare MPS ProgramsROCKVILLE, Md., Jan. 28, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that the U.S. Food and Drug Administration (FDA) placed a clinical hold on its investigational gene therapy, RGX-111, for the treatment of MPS I, also known as Hurler syndrome, following preliminary analysis of a single case of neoplasm (intraventricular CNS tumor) in a participant treated in its Phase I/II study. The FDA also placed a clinical hold on RGX-121, for the treatment of MPS II, also known as Hunter Syndrome, citing the similarities in products, study populations, and shared risk between the clinical studies. The case was identified during a routine brain MRI of an asymptomatic five-year-old
- ANALYSTBarclays resumed coverage on REGENXBIO with a new price targetBarclays resumed coverage of REGENXBIO with a rating of Overweight and set a new price target of $37.00
- SECAmendment: SEC Form SCHEDULE 13G/A filed by REGENXBIO Inc.SCHEDULE 13G/A - REGENXBIO Inc. (0001590877) (Subject)
- PRREGENXBIO Highlights Key 2026 Catalysts and Announces Positive Long-Term Functional Outcomes in Lead Duchenne Gene Therapy ProgramNew 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 commercial launches 2026-2028 In-house manufacturing and strategic global partnerships driving commercial readinessPresentation at 44th Annual J.P. Morgan Healthcare Conference Wednesday, January 14ROCKVILLE, Md., Jan. 11, 2026 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) highlighted progress and upcoming anticipated milestones across its pipeline
- INSIDERChief Medical Officer Pakola Steve was granted 65,847 shares, increasing direct ownership by 34% to 258,317 units (SEC Form 4)4 - REGENXBIO Inc. (0001590877) (Issuer)
RGNX FAQ
7 questionsWhat does REGENXBIO Inc. do?
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...Where does RGNX stock trade?
REGENXBIO Inc. (RGNX) is listed on NASDAQ.What sector and industry is RGNX in?
REGENXBIO Inc. operates in the Health Care sector, Biotechnology: Biological Products (No Diagnostic Substances) industry.When did REGENXBIO Inc. go public?
REGENXBIO Inc. (RGNX) completed its IPO in 2015.What are analysts saying about RGNX?
REGENXBIO Inc. has had 8 recent analyst actions on file. The most recent action was from Barclays: Overweight with a $3700.00 price target on 2026-01-28. Recent price targets range from $1400.00 to $3800.00.What companies are similar to RGNX?
Notable peers in the same industry include QURE (uniQure N.V.), MGTX (MeiraGTx Holdings plc), RCKT (Rocket Pharmaceuticals Inc.), VYGR (Voyager Therapeutics Inc.). Compare RGNX side-by-side with any of them on Quantisnow.How can I track RGNX on Quantisnow?
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