REGENXBIO Inc.RGNXNASDAQ

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newsfilecorp.com

Lost Money on REGENXBIO Inc. (RGNX)? Possible Fraud - Contact Levi & Korsinsky Today

New York, New York--(Newsfile Corp. - February 2, 2026) - Levi & Korsinsky notifies investors that it has commenced an investigation into REGENXBIO Inc. ("REGENXBIO Inc.") (NASDAQ: RGNX) concerning potential violations of the federal securities laws. On January 28, 2026, Regenxbio disclosed via Form 8-K that the FDA placed clinical holds on its RGX-111 and RGX-121 programs following the identification of a tumor in a trial participant.

zacks.com

Regenxbio (RGNX) Soars 5.4%: Is Further Upside Left in the Stock?

Regenxbio (RGNX) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.

prnewswire.com

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of REGENXBIO Inc. - RGNX

NEW YORK, Jan. 29, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of REGENXBIO Inc. ("Regenxbio" or the "Company") (NASDAQ: RGNX). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

prnewswire.com

Investigation into Regenxbio: Questions Arise Over Disclosure Completeness Prior to FDA Action

(NASDAQ: RGNX) NEW YORK, Jan. 29, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP is investigating Regenxbio Inc. (NASDAQ: RGNX) regarding potential gaps between information provided to investors and underlying safety developments in the company's gene therapy clinical programs. Shareholders who purchased RGNX shares and lost money may click here to learn about their legal rights.

newsfilecorp.com

RGNX ALERT: Levi & Korsinsky Investigates REGENXBIO Inc. for Possible Securities Fraud Violations

New York, New York--(Newsfile Corp. - January 29, 2026) - Levi & Korsinsky notifies investors that it has commenced an investigation into REGENXBIO Inc. ("REGENXBIO Inc.") (NASDAQ: RGNX) concerning potential violations of the federal securities laws. On January 28, 2026, Regenxbio disclosed via Form 8-K that the FDA placed clinical holds on its RGX-111 and RGX-121 programs following the identification of a tumor in a trial participant.

globenewswire.com

INVESTOR ALERT: Investigation of REGENXBIO Inc. (RGNX) by Holzer & Holzer, LLC

ATLANTA, Jan. 28, 2026 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether REGENXBIO Inc. (“REGENXBIO” or the “Company”) (NASDAQ: RGNX) complied with federal securities laws. On January 28, 2026, REGENXBIO announced it “received communication from the U.S. Food and Drug Administration (“FDA”) that the Company's Investigational New Drug applications for both its Phase I/II trial evaluating RGX-111 for Mucopolysaccharidosis type I and its Phase I/II/III trial of RGX-121 for Mucopolysaccharidosis type II were placed on clinical hold.” Following this news, the price of the Company's stock dropped.

benzinga.com

FDA Clinical Hold Knocks REGENXBIO Stock

REGENXBIO Inc. (NASDAQ: RGNX) shares are tumbling on Wednesday with a session volume of 3.83 million versus an average volume of 684.271 thousand.

reuters.com

US FDA places clinical hold on Regenxbio's gene therapy trials

Regenxbio said on Wednesday the U.S. Food and Drug Administration has placed a clinical hold on two of its experimental gene therapy programs for rare childhood diseases after a brain tumor was found in one treated patient.

prnewswire.com

REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs

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.

seekingalpha.com

REGENXBIO: Key FDA Decision On Hunter Syndrome Just Weeks Away

Regenxbio Inc. faces pivotal catalysts in 2026, notably RGX-121's FDA decision and RGX-202 Duchenne data, potentially transforming it into a commercial-stage gene therapy company. RGX-121 offers a unique CNS-targeted approach for Hunter syndrome, with strong biomarker and neurodevelopmental data supporting its accelerated approval case ahead of the February 8 PDUFA date. RGNX's valuation appears modest at a 3.3x forward EV/sales multiple, with late-stage assets, near-term regulatory events, and a healthy cash position providing balance sheet flexibility.

seekingalpha.com

REGENXBIO Inc. (RGNX) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript

prnewswire.com

REGENXBIO Highlights Key 2026 Catalysts and Announces Positive Long-Term Functional Outcomes in Lead Duchenne Gene Therapy Program

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-year Expecting 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 readiness Presentation at 44th Annual J.P. Morgan Healthcare Conference Wednesday, January 14 ROCKVILLE, Md.

defenseworld.net

Assenagon Asset Management S.A. Purchases 132,942 Shares of REGENXBIO Inc. $RGNX

Assenagon Asset Management S.A. increased its position in REGENXBIO Inc. (NASDAQ: RGNX) by 23.2% in the third quarter, according to the company in its most recent Form 13F filing with the Securities and Exchange Commission. The firm owned 705,403 shares of the biotechnology company's stock after purchasing an additional 132,942 shares during the

defenseworld.net

REGENXBIO Inc. (NASDAQ:RGNX) Receives Average Rating of “Moderate Buy” from Brokerages

REGENXBIO Inc. (NASDAQ: RGNX - Get Free Report) has been assigned a consensus recommendation of "Moderate Buy" from the nine research firms that are covering the firm, Marketbeat Ratings reports. One investment analyst has rated the stock with a sell rating, one has given a hold rating and seven have assigned a buy rating to the

prnewswire.com

REGENXBIO to Present at the 44th Annual J.P. Morgan Healthcare Conference

ROCKVILLE, Md. , Dec. 18, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present at the 44th Annual J.P.

prnewswire.com

REGENXBIO to Participate in Upcoming Investor Conference

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 Conference Fireside Chat: Tuesday, December 2 at 8:30 a.m.

seekingalpha.com

REGENXBIO Inc. (RGNX) Q3 2025 Earnings Call Transcript

REGENXBIO Inc. ( RGNX ) Q3 2025 Earnings Call November 6, 2025 8:00 AM EST Company Participants Patrick Christmas - Executive VP & Chief Strategy and Legal Officer Curran Simpson - President, CEO & Director Steve Pakola - Executive VP & Chief Medical Officer Mitchell Chan - Executive VP & CFO Conference Call Participants Judah Frommer - Morgan Stanley, Research Division Lili Nsongo - Leerink Partners LLC, Research Division Huidong Wang - Barclays Bank PLC, Research Division Luca Issi - RBC Capital Markets, Research Division Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division Alec Stranahan - BofA Securities, Research Division Brian Skorney - Robert W. Baird & Co. Incorporated, Research Division Sean McCutcheon - CGS International Daniil Gataulin - Chardan Capital Markets, LLC, Research Division Bill Man Yi Chen - H.C.

zacks.com

Regenxbio (RGNX) Reports Q3 Loss, Beats Revenue Estimates

Regenxbio (RGNX) came out with a quarterly loss of $1.2 per share versus the Zacks Consensus Estimate of a loss of $1.38. This compares to a loss of $1.17 per share a year ago.

prnewswire.com

REGENXBIO Reports Third Quarter 2025 Financial Results and Operational Highlights

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 New 12-month analysis shows all participants demonstrate improved functional outcomes across multiple natural history methods of measurement, when decline is expected Clemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; PDUFA date February 8, 2026 Surabgene lomparvovec (sura-vec, ABBV-RGX-314) on track to be first gene therapy for chronic retinal disease Enrollment completed in pivotal trials evaluating subretinal delivery of sura-vec in wet AMD; topline data expected Q4 2026 Sura-vec for diabetic retinopathy using suprachoroidal delivery advancing to global pivotal program, supported by positive 2-year Phase II trial data Conference call today at 8:00 a.m. ET ROCKVILLE, Md.

defenseworld.net

Y Intercept Hong Kong Ltd Invests $1.45 Million in REGENXBIO Inc. $RGNX

Y Intercept Hong Kong Ltd purchased a new position in shares of REGENXBIO Inc. (NASDAQ: RGNX) during the undefined quarter, according to the company in its most recent disclosure with the Securities and Exchange Commission (SEC). The firm purchased 176,999 shares of the biotechnology company's stock, valued at approximately $1,453,000. Y Intercept Hong

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