SEC Form SC 13G/A filed by REGENXBIO Inc. (Amendment)
$RGNX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
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| 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 |
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
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
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
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
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
8-K - REGENXBIO Inc. (0001590877) (Filer)
8-K - REGENXBIO Inc. (0001590877) (Filer)
SCHEDULE 13G/A - REGENXBIO Inc. (0001590877) (Subject)
FDA 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
ROCKVILLE, 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
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 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