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ROSEN, TOP RANKED INVESTOR COUNSEL, Encourages REGENXBIO,

https://www.globenewswire.com/news-release/2026/02/20/3242188/673/en/ROSEN-TOP-RANKED-INVESTOR-COUNSEL-Encourages-REGENXBIO-Inc-Investors-to-Secure-Counsel-Before-Important-Deadline-in-Securities-Class-Action-RGNX.html
The Rosen Law Firm announces a class action lawsuit against REGENXBIO, Inc. on behalf of investors who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO made false and misleading statements about the efficacy and safety of its RGX-111 gene therapy trial. Investors are encouraged to secure counsel before the April 14, 2026, deadline to serve as lead plaintiff.

ROSEN, TOP RANKED INVESTOR COUNSEL, Encourages REGENXBIO, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action - RGNX

https://www.globenewswire.com/fr/news-release/2026/02/20/3242188/0/en/ROSEN-TOP-RANKED-INVESTOR-COUNSEL-Encourages-REGENXBIO-Inc-Investors-to-Secure-Counsel-Before-Important-Deadline-in-Securities-Class-Action-RGNX.html
The Rosen Law Firm is encouraging investors of REGENXBIO, Inc. (NASDAQ: RGNX) who purchased securities between February 9, 2022, and January 27, 2026, to secure counsel in a class action lawsuit. Investors have until April 14, 2026, to move the Court to serve as lead plaintiff. The lawsuit alleges that REGENXBIO made false and misleading statements regarding the efficacy and safety of its RGX-111 gene therapy trial.

RGNX Stockholder Alert: Robbins LLP Remind Investors of the Class Action Lawsuit Against REGENXBIO, Inc.

https://www.marketscreener.com/news/rgnx-stockholder-alert-robbins-llp-remind-investors-of-the-class-action-lawsuit-against-regenxbio-ce7e5dddd08ef327
Robbins LLP has reminded investors of a class action lawsuit filed against REGENXBIO, Inc. (NASDAQ: RGNX) on behalf of those who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO misled investors about the viability of its drug candidate RGX-111, which later faced a clinical hold from the FDA due to a serious safety issue, leading to a significant drop in stock price. Investors can submit their papers to the court by April 14, 2026, to potentially serve as lead plaintiff.

Sarepta Hits Fresh Hurdle As Court Revives Patent Lawsuit With Regenxbio Over Muscular Disorder Therapy

https://stocktwits.com/news-articles/markets/equity/sarepta-hits-fresh-hurdle-as-court-revives-patent-lawsuit-with-regenxbio-over-muscular-disorder-therapy/cZRNSgQR4xu/amp
A U.S. appeals court has reinstated a patent lawsuit between Regenxbio and Sarepta Therapeutics concerning Sarepta's Duchenne muscular dystrophy (DMD) treatment, Elevidys. Regenxbio, along with the University of Pennsylvania, is seeking over $900 million in damages, alleging that Elevidys infringes a gene-therapy patent. This development presents a new challenge for Sarepta, which has also faced regulatory scrutiny following patient deaths linked to its gene therapy.

RGNX Investors Have Opportunity to Lead REGENXBIO Inc. Securities Fraud Lawsuit with the Schall Law Firm

https://www.globenewswire.com/de/news-release/2026/02/20/3242121/0/en/RGNX-Investors-Have-Opportunity-to-Lead-REGENXBIO-Inc-Securities-Fraud-Lawsuit-with-the-Schall-Law-Firm.html
The Schall Law Firm is reminding investors of a class action lawsuit against REGENXBIO Inc. (RGNX) for alleged securities fraud. The lawsuit claims that Regenxbio made false and misleading statements about its product candidate RGX-111, concealing negative efficacy and safety data, which led to investor damages when the truth was revealed. Investors who purchased RGNX securities between February 9, 2022, and January 27, 2026, are encouraged to contact the firm.
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RGNX Investors Have Opportunity to Lead REGENXBIO Inc. Securities Fraud Lawsuit with the Schall Law Firm

https://www.globenewswire.com/de/news-release/2026/02/20/3242121/0/en/rgnx-investors-have-opportunity-to-lead-regenxbio-inc-securities-fraud-lawsuit-with-the-schall-law-firm.html
The Schall Law Firm is reminding investors of a class action lawsuit against REGENXBIO Inc. (NASDAQ: RGNX) for alleged securities fraud. The lawsuit claims that Regenxbio made false and misleading statements about the efficacy and safety of its product candidate RGX-111, concealing negative data. Investors who purchased the company's securities between February 9, 2022, and January 27, 2026, are encouraged to contact the firm before April 14, 2026.

RGNX SHAREHOLDER ALERT: Bronstein, Gewirtz and Grossman, LLC Announces that REGENXBIO Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit!

https://www.accessnewswire.com/newsroom/en/business-and-professional-services/rgnx-shareholder-alert-bronstein-gewirtz-and-grossman-llc-announ-1137823
Bronstein, Gewirtz & Grossman, LLC has announced a class action lawsuit against REGENXBIO Inc. (NASDAQ:RGNX) and its officers. The lawsuit alleges that REGENXBIO made false and misleading statements regarding its RGX-111 gene therapy for Hurler syndrome. Investors who purchased REGENXBIO securities between February 9, 2022, and January 27, 2026, have until April 14, 2026, to seek to be appointed as lead plaintiff.

Court Revives RegenxBio, UPenn Patent, Suit Against Sarepta

https://news.bloomberglaw.com/ip-law/tktktktktk-1
The Federal Circuit has reinstated a gene-therapy patent belonging to RegenxBio Inc. and the University of Pennsylvania, overturning a district court's decision that had invalidated it. This ruling revives their infringement lawsuit against Sarepta Therapeutics Inc. RegenxBio is seeking over $900 million in damages if it can prove Sarepta infringed on the patent related to Duchenne muscular dystrophy gene therapies.

Court Revives RegenxBio, UPenn Patent, Suit Against Sarepta

https://news.bloomberglaw.com/business-and-practice/tktktktktk-1
The Federal Circuit Court has reinstated a gene-therapy patent held by RegenxBio Inc. and the University of Pennsylvania, which a district judge had previously invalidated. This decision revives their patent infringement lawsuit against Sarepta Therapeutics Inc. The appeals court reversed a summary judgment ruling that the patent covered natural phenomena and remanded the case to the US District Court for the District of Delaware.

RGNX Investors Have Opportunity to Lead REGENXBIO Inc. Securities Fraud Lawsuit with the Schall Law Firm

https://www.prnewswire.com/news-releases/rgnx-investors-have-opportunity-to-lead-regenxbio-inc-securities-fraud-lawsuit-with-the-schall-law-firm-302693405.html
The Schall Law Firm announced a class action lawsuit against REGENXBIO Inc. (RGNX) for alleged securities fraud. Investors who purchased RGNX securities between February 9, 2022, and January 27, 2026, are encouraged to contact the firm before April 14, 2026. The lawsuit claims that Regenxbio made misleading statements about its product candidate RGX-111, concealing negative efficacy and safety data, particularly after a tumor was discovered in a study participant.
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Levi & Korsinsky Notifies Shareholders of REGENXBIO

https://www.globenewswire.com/news-release/2026/02/19/3241495/0/en/Levi-Korsinsky-Notifies-Shareholders-of-REGENXBIO-Inc-RGNX-of-a-Class-Action-Lawsuit-and-an-Upcoming-Deadline.html
Levi & Korsinsky, LLP has notified shareholders of REGENXBIO Inc. (RGNX) about a class action lawsuit. The lawsuit alleges securities fraud and seeks to recover losses for investors affected between February 9, 2022, and January 27, 2026, due to misleading statements regarding the RGX-111 gene therapy trial. The stock price declined significantly after the FDA placed a clinical hold on RGX-111 following the discovery of a CNS tumor in a study participant.

INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in REGENXBIO Inc. of Class Action Lawsuit and Upcoming Deadlines - RGNX

https://www.prnewswire.com/news-releases/investor-alert-pomerantz-law-firm-reminds-investors-with-losses-on-their-investment-in-regenxbio-inc-of-class-action-lawsuit-and-upcoming-deadlines--rgnx-302693176.html
Pomerantz LLP has announced a class action lawsuit against REGENXBIO Inc. (NASDAQ: RGNX) for alleged securities fraud, following a significant drop in its stock price. This occurred after the FDA placed a clinical hold on two of REGENXBIO's investigational gene therapies, RGX-111 and RGX-121, due to a reported neoplasm in a study participant. Investors who purchased REGENXBIO securities during the Class Period have until April 14, 2026, to apply for lead plaintiff status.

Bronstein, Gewirtz & Grossman LLC Urges REGENXBIO Inc. Investors to Act: Class Action Filed Alleging Investor Harm

https://www.globenewswire.com/news-release/2026/02/19/3241378/9788/en/Bronstein-Gewirtz-Grossman-LLC-Urges-REGENXBIO-Inc-Investors-to-Act-Class-Action-Filed-Alleging-Investor-Harm.html
Bronstein, Gewirtz & Grossman LLC has filed a class action lawsuit against REGENXBIO Inc. and certain officers on behalf of investors who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO made false and misleading statements regarding the development and commercialization of its gene therapy RGX-111, particularly concerning its efficacy and safety profile in a Phase I/II clinical trial. Investors are encouraged to join the case, with a lead plaintiff deadline of April 14, 2026.

The Gross Law Firm Notifies REGENXBIO Inc. Investors of a Class Action Lawsuit and Upcoming Deadline - RGNX

https://www.prnewswire.com/news-releases/the-gross-law-firm-notifies-regenxbio-inc-investors-of-a-class-action-lawsuit-and-upcoming-deadline--rgnx-302692455.html
The Gross Law Firm has issued a notice to investors of REGENXBIO Inc. (RGNX) regarding a class action lawsuit. The lawsuit alleges that REGENXBIO made misleading statements about its gene therapy product candidate RGX-111, particularly concerning its efficacy and safety, and concealed material adverse facts. This follows an FDA clinical hold placed on RGX-111 after a CNS tumor was found in a study participant, leading to a significant drop in REGENXBIO's stock price. Shareholders who purchased shares between February 9, 2022, and January 27, 2026, are encouraged to contact the firm to discuss potential lead plaintiff appointment before the April 14, 2026, deadline.

Portnoy Law Firm Announces Class Action on Behalf of REGENXBIO, Inc. Investors

https://www.globenewswire.com/news-release/2026/02/19/3241312/0/en/Portnoy-Law-Firm-Announces-Class-Action-on-Behalf-of-REGENXBIO-Inc-Investors.html
The Portnoy Law Firm has announced a class action lawsuit against REGENXBIO, Inc. on behalf of investors who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO made false and misleading statements regarding its RGX-111 gene therapy trial, which led to an 18% stock drop after the FDA placed a clinical hold due to an adverse event. Investors have until April 14, 2026, to file a lead plaintiff motion.
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RGNX Stockholder Alert: Robbins LLP Remind Investors of the Class Action Lawsuit Against REGENXBIO, Inc.

https://themalaysianreserve.com/2026/02/19/rgnx-stockholder-alert-robbins-llp-remind-investors-of-the-class-action-lawsuit-against-regenxbio-inc/amp/
Robbins LLP has reminded investors of a class action lawsuit against REGENXBIO, Inc. (NASDAQ: RGNX) concerning alleged misleading statements about its drug candidate RGX-111. The lawsuit claims REGENXBIO failed to disclose serious safety issues, including a CNS neoplasm, leading to a significant stock price drop after a clinical hold was placed by the FDA on both RGX-111 and RGX-121. Shareholders have until April 14, 2026, to submit papers to the court to serve as lead plaintiff.

RGNX INVESTOR ALERT: Bronstein, Gewirtz and Grossman, LLC Announces that REGENXBIO Inc. Investors with Losses Have Opportunity to Lead Class Action Lawsuit!

https://www.accessnewswire.com/newsroom/en/business-and-professional-services/rgnx-investor-alert-bronstein-gewirtz-and-grossman-llc-announces-1137821
Bronstein, Gewirtz and Grossman, LLC has announced a class action lawsuit against REGENXBIO Inc. (NASDAQ:RGNX) for alleged violations of federal securities laws. The lawsuit claims that REGENXBIO made materially false and misleading statements regarding its RGX-111 gene therapy for Hurler syndrome. Investors who purchased REGENXBIO securities between February 9, 2022, and January 27, 2026, are encouraged to join the lawsuit and have until April 14, 2026, to request to be appointed as lead plaintiff.

Shareholders that lost money on REGENXBIO Inc. (RGNX) Urged to Join Class Action - Contact Levi & Korsinsky to Learn More

https://www.prnewswire.com/news-releases/shareholders-that-lost-money-on-regenxbio-inc-rgnx-urged-to-join-class-action--contact-levi--korsinsky-to-learn-more-302691417.html
Levi & Korsinsky, LLP has filed a class action securities lawsuit against REGENXBIO Inc. (RGNX) for investors who suffered losses between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO made misleading statements regarding its gene therapy product candidate RGX-111, particularly concerning its efficacy and safety data. The stock price declined significantly after the FDA placed a clinical hold on RGX-111 due to an intraventricular CNS tumor found in a study participant.

REGENXBIO Investors Urged to Join Securities Fraud Lawsuit

https://nationaltoday.com/us/ca/los-angeles/news/2026/02/17/regenxbio-investors-urged-to-join-securities-fraud-lawsuit/
The Schall Law Firm has reminded investors of a class action lawsuit against REGENXBIO Inc. The lawsuit alleges that REGENXBIO made false and misleading statements about the efficacy and safety of its product candidate RGX-111 between February 9, 2022, and January 27, 2026. Investors have until April 14, 2026, to join the lawsuit, which emphasizes the importance of corporate transparency and accurate disclosures.

RGNX DEADLINE ALERT: Faruqi & Faruqi, LLP Reminds REGENXBIO (RGNX) Investors of Securities Class Action Deadline on April 14, 2026

https://www.marketscreener.com/news/rgnx-deadline-alert-faruqi-faruqi-llp-reminds-regenxbio-rgnx-investors-of-securities-class-act-ce7e5dd9dd81f727
Faruqi & Faruqi, LLP is reminding REGENXBIO (RGNX) investors of the securities class action deadline on April 14, 2026. The lawsuit alleges that REGENXBIO made false or misleading statements regarding the efficacy and safety of its RGX-111 trial study. The stock price fell 17.9% after the FDA placed a clinical hold on RGX-111 and RGX-121 due to a reported neoplasm in a participant.
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Bronstein, Gewirtz & Grossman LLC Urges REGENXBIO Inc. Investors to Act: Class Action Filed Alleging Investor Harm

https://www.globenewswire.com/news-release/2026/02/17/3239585/9788/en/Bronstein-Gewirtz-Grossman-LLC-Urges-REGENXBIO-Inc-Investors-to-Act-Class-Action-Filed-Alleging-Investor-Harm.html
Bronstein, Gewirtz & Grossman LLC has filed a class action lawsuit against REGENXBIO Inc. (NASDAQ: RGNX) and its officers, alleging violations of federal securities laws. The lawsuit claims that REGENXBIO made materially false and misleading statements regarding the development and commercialization of RGX‑111 for Hurler syndrome, overstating its efficacy and safety profile. Investors who purchased REGENXBIO securities between February 9, 2022, and January 27, 2026, are encouraged to join the case, with a lead plaintiff deadline of April 14, 2026.

REGENXBIO Inc. Sued for Securities Law Violations – Contact the DJS Law Group to Discuss Your Rights – RGNX

https://markets.financialcontent.com/wral/article/bizwire-2026-2-17-regenxbio-inc-sued-for-securities-law-violations-contact-the-djs-law-group-to-discuss-your-rights-rgnx
REGENXBIO Inc. (RGNX) is facing a class action lawsuit for alleged securities law violations, with a class period from February 9, 2022, to January 27, 2026. The lawsuit claims the company made false and misleading statements about its RGX-111 product candidate, concealing adverse safety and efficacy information, which was revealed when the FDA placed a clinical hold after a clinical trial participant developed a tumor. The DJS Law Group is encouraging affected shareholders to contact them to discuss their rights and participate in the case, with a lead plaintiff deadline of April 14, 2026.

REGENXBIO Faces Class Action Lawsuit for Misleading Statements

https://intellectia.ai/news/stock/regenxbio-faces-class-action-lawsuit-for-misleading-statements
REGENXBIO is facing a class-action lawsuit for allegedly making misleading statements about its product candidate RGX-111, concealing negative efficacy and safety data. The lawsuit stems from the discovery of an intraventricular CNS tumor in a participant during the RGX-111 study, which led to significant investor losses. Affected investors are encouraged to join the lawsuit, with a deadline to contact the Schall Law Firm by April 14, 2026.

RGNX Investors Have Opportunity to Lead REGENXBIO Inc. Securities Fraud Lawsuit with the Schall Law Firm

https://www.businesswire.com/news/home/20260216184394/en/RGNX-Investors-Have-Opportunity-to-Lead-REGENXBIO-Inc.-Securities-Fraud-Lawsuit-with-the-Schall-Law-Firm
The Schall Law Firm is encouraging investors of REGENXBIO Inc. (RGNX) to participate in a class-action lawsuit alleging securities fraud. The lawsuit claims that Regenxbio made misleading statements about its product candidate RGX-111, concealing negative data regarding its efficacy and safety, and that investors suffered losses when this information came to light. The class period for affected investors is from February 9, 2022, to January 27, 2026, with a deadline to contact the firm before April 14, 2026.

Investor Notice: Shareholder Rights Law Firm Robbins LLP Informs Investors of the REGENXBIO, Inc. Securities Class Action Lawsuit

https://aijourn.com/investor-notice-shareholder-rights-law-firm-robbins-llp-informs-investors-of-the-regenxbio-inc-securities-class-action-lawsuit/
Robbins LLP is informing investors of REGENXBIO, Inc. (NASDAQ: RGNX) about a class action lawsuit filed on behalf of shareholders who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO misled investors regarding the viability of its drug candidate RGX-111, which was later placed on clinical hold by the FDA due to safety concerns. Shareholders are encouraged to contact Robbins LLP to learn more about participating in the class action.
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RGNX Investors Have Opportunity to Lead REGENXBIO, Inc. Securities Fraud Lawsuit

https://www.prnewswire.com/news-releases/rgnx-investors-have-opportunity-to-lead-regenxbio-inc-securities-fraud-lawsuit-302688808.html
The Rosen Law Firm has announced a class action lawsuit against REGENXBIO, Inc. (NASDAQ: RGNX) on behalf of investors who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO made false and misleading statements regarding the efficacy and safety of its RGX-111 gene therapy trial. Investors have until April 14, 2026, to move for lead plaintiff status.

Rosen Law Firm Urges REGENXBIO, Inc. (NASDAQ: RGNX) Stockholders with Large Losses to Contact the Firm for Information About Their Rights

https://www.joplinglobe.com/region/national_business/rosen-law-firm-urges-regenxbio-inc-nasdaq-rgnx-stockholders-with-large-losses-to-contact-the/article_11c0d0a5-5145-559c-ba87-52eb7967f63e.html
Rosen Law Firm has announced a class action lawsuit against REGENXBIO, Inc. (NASDAQ: RGNX) on behalf of investors who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO misled investors about the development and commercialization of its product candidate RGX-111, a gene therapy for Hurler syndrome, by disseminating false and misleading statements regarding its efficacy and safety. Stockholders with significant losses are urged to contact the firm by April 13, 2026, to learn about their rights.

Rosen Law Firm Urges REGENXBIO, Inc. (NASDAQ: RGNX) Stockholders with Large Losses to Contact the Firm for Information About Their Rights

https://www.businesswire.com/news/home/20260216615459/en/Rosen-Law-Firm-Urges-REGENXBIO-Inc.-NASDAQ-RGNX-Stockholders-with-Large-Losses-to-Contact-the-Firm-for-Information-About-Their-Rights
The Rosen Law Firm has announced a class action lawsuit against REGENXBIO, Inc. (NASDAQ: RGNX) on behalf of investors who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO misled investors regarding the development and commercialization of its product candidate RGX-111, specifically concerning the efficacy and safety of its trial study. Shareholders who suffered losses are encouraged to contact the firm by April 14, 2026, to potentially serve as lead plaintiff.

Rosen Law Firm Urges REGENXBIO, Inc. (NASDAQ: RGNX) Stockholders with Large Losses to Contact the Firm for Information About Their Rights

https://www.marketscreener.com/news/rosen-law-firm-urges-regenxbio-inc-nasdaq-rgnx-stockholders-with-large-losses-to-contact-the-fi-ce7e5dd8db8bf523
The Rosen Law Firm has announced a class action lawsuit against REGENXBIO, Inc. (NASDAQ: RGNX) on behalf of investors who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO misled investors regarding the development and commercialization of its product candidate RGX-111, a gene therapy for Hunter syndrome. Stockholders with significant losses are encouraged to contact the firm to learn about their rights and the opportunity to act as lead plaintiff by April 14, 2026.

Institutional shareholders may be less affected by REGENXBIO Inc.'s (NASDAQ:RGNX) pullback last week after a year of 9.5% returns

https://finance.yahoo.com/news/institutional-shareholders-may-less-affected-125016190.html
Institutional investors, owning 71% of REGENXBIO Inc. (NASDAQ:RGNX), likely felt less impact from last week's market cap drop due to a solid 9.5% return over the past year. The top 8 shareholders account for over half of the company's stock, giving institutions significant influence over board decisions. While insider ownership is present, the general public also holds a notable 11% stake in the company.
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Regenxbio Receives CRL from FDA, NDA for Takeda’s Overporextin Accepted, ACP Abandons use of “Provider”

https://www.neurologylive.com/view/regenxbio-receives-crl-fda-nda-takeda-overporextin-accepted-acp-abandons-provider-
This Neurology News Network update covers three key stories. Regenxbio received a Complete Response Letter from the FDA for its Hunter syndrome gene therapy, RGX-121, raising concerns from the company about the FDA's evaluation. Takeda's new drug application for oveporexton, an oral treatment for narcolepsy type 1, has been accepted with priority review, supported by positive phase 3 trial data. Finally, the American College of Physicians released a policy paper advocating against the use of the term "provider" for physicians, arguing it erodes professional identity and ethical practice.

SHAREHOLDER ALERT: Levi & Korsinsky, LLP Notifies Investors

https://www.globenewswire.com/news-release/2026/02/13/3238366/0/en/SHAREHOLDER-ALERT-Levi-Korsinsky-LLP-Notifies-Investors-It-Has-Filed-a-Complaint-to-Recover-Losses-Suffered-by-Purchasers-of-REGENXBIO-Inc-Securities-and-Sets-a-Lead-Plaintiff-Dead.html
Levi & Korsinsky, LLP has filed a class action lawsuit against REGENXBIO Inc. (NASDAQ: RGNX) on behalf of investors who purchased securities between February 9, 2022, and January 27, 2026. The lawsuit alleges that REGENXBIO made false and misleading statements regarding its RGX-111 gene therapy trial, which saw an FDA clinical hold after a CNS tumor was found in a participant, causing a significant stock price drop. Investors have until April 14, 2026, to request to be appointed lead plaintiff.

US FDA’s Rare Pediatric Disease Flexibility Rhetoric Undermined By Regenxbio’s CRL

https://insights.citeline.com/pink-sheet/rare-diseases/us-fdas-rare-pediatric-disease-flexibility-rhetoric-undermined-by-regenxbios-crl-SBTWTAORFVF4NBQBKA44UNJA24/
Regenxbio's Complete Response Letter (CRL) from the FDA highlights the challenges and uncertainties faced by developers of rare pediatric disease drugs. Despite the FDA's stated flexibility for such conditions, the CRL suggests a potential gap between rhetoric and outcomes. This event adds to a series of recent FDA decisions raising questions about the agency's stance on flexibility in rare disease drug approvals.

Regenxbio stock drops on FDA setback for RGX-121 gene therapy

https://www.msn.com/en-us/health/other/regenxbio-stock-drops-on-fda-setback-for-rgx-121-gene-therapy/ar-AA1W2Y1Y
Regenxbio's stock fell due to the FDA's decision to delay the Biologics License Application (BLA) submission for its RGX-121 gene therapy. The FDA requested additional manufacturing information, preventing the application from proceeding as planned. This setback impacts the company's timeline for bringing the treatment for Sanfilippo syndrome Type A to market.

Regenxbio stock price target lowered to $32 at H.C. Wainwright after FDA rejection

https://www.investing.com/news/analyst-ratings/regenxbio-stock-price-target-lowered-to-32-at-hc-wainwright-after-fda-rejection-93CH-4499731
H.C. Wainwright has lowered its price target for Regenxbio Inc. (NASDAQ:RGNX) to $32 from $34, while maintaining a Buy rating. This adjustment follows the FDA's rejection of the company's gene therapy RGX-121 for Hunter syndrome, citing concerns with study criteria. Despite the setback, the firm believes the delay does not impact Regenxbio's RGX-202 program, and the stock is considered undervalued by InvestingPro Fair Value metrics.
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REGENXBIO Inc. (NASDAQ:RGNX) Given Average Recommendation of "Moderate Buy" by Brokerages

https://www.marketbeat.com/instant-alerts/regenxbio-inc-nasdaqrgnx-given-average-recommendation-of-moderate-buy-by-brokerages-2026-02-10/
REGENXBIO Inc. (NASDAQ:RGNX) has received an average "Moderate Buy" rating from nine brokerages, with an average 12-month price target of $30.38, and some analysts raising their targets to as high as $52.00. Institutional investors hold approximately 88.08% of the stock, with several hedge funds recently increasing their stakes. The company's shares are currently trading around $10.31, reflecting both volatility and the inherent risks of a clinical-stage biotechnology company.

FDA Delivers Regenxbio Another Blow, This Time for RGX-121

https://insights.citeline.com/scrip/advanced-therapies/gene-therapies/fda-delivers-regenxbio-another-blow-this-time-for-rgx-121-DCC7E23EGZCLLMBTFELEWZNQPE/
The FDA has issued a Complete Response Letter (CRL) to Regenxbio for its gene therapy RGX-121, intended for the treatment of MPS II. This marks another setback for the company with its gene therapy candidates. The article also touches on various related topics within the pharmaceutical industry.

Regenxbio stock drops on FDA setback for RGX-121 gene therapy (RGNX:NASDAQ)

https://seekingalpha.com/news/4549257-regenxbio-stock-drops-on-fda-setback-for-rgx-121-gene-therapy
Regenxbio (RGNX) shares fell after the U.S. Food and Drug Administration issued a complete response letter for its gene therapy candidate RGX-121, intended for the treatment of Mucopolysaccharidosis II (MPS II). The company plans to work with the FDA to address the issues raised in the letter.

Regenxbio Stock Still Has Over 300% Upside Despite FDA Pushback On Hunter Syndrome Drug: Clear Street

https://stocktwits.com/news-articles/markets/equity/regenxbio-stock-still-has-upside-despite-fda-pushback-hunter-syndrome-drug/cZbxYO6R4oM
Clear Street maintained a 'Buy' rating on Regenxbio (RGNX) despite the FDA issuing a Complete Response Letter for its Hunter syndrome gene therapy, RGX-121. The firm, while lowering its price target to $45, still sees over 300% upside and believes its core thesis remains intact, citing other strong pipeline data. Regenxbio plans to meet with the FDA to discuss a resubmission strategy for RGX-121.

FDA Slams REGENXBIO's MPS II Gene Therapy RGX-121 With CRL

https://www.cgtlive.com/view/fda-slams-regenxbio-mps-ii-gene-therapy-rgx-121-crl
The FDA has issued a complete response letter (CRL) to REGENXBIO for its gene therapy RGX-121 for Hunter syndrome (MPS II), citing concerns about study population classification, external control validity, and the surrogate endpoint's predictive power. REGENXBIO plans to request a Type A meeting with the FDA to discuss a potential resubmission, addressing these concerns with additional data and expert input. This decision follows a clinical hold placed on the RGX-121 trial due to a serious adverse event in a separate gene therapy trial (RGX-111).
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REGENXBIO's MPS II Gene Therapy RGX-121 Hit With CRL

https://www.neurologylive.com/view/regenxbio-mps-ii-gene-therapy-rgx-121-crl
REGENXBIO received a Complete Response Letter (CRL) from the FDA for its gene therapy RGX-121, intended for mucopolysaccharidosis type 2 (MPS II), also known as Hunter syndrome. The FDA cited concerns regarding patient classification, the validity of the external natural history control, and the evidentiary strength of the surrogate endpoint. REGENXBIO plans a Type A meeting with the FDA to discuss a resubmission, which may include longer-term data and expert consensus to address these issues, emphasizing the urgent need for treatment in this ultra-rare disease.

FDA rejects Regenxbio’s rare-disease gene therapy

https://www.statnews.com/2026/02/09/fda-rejects-regenxbio-rare-disease-gene-therapy/
The FDA has rejected Regenxbio's gene therapy, RGX-121, for Hunter syndrome, a rare genetic disorder. The decision was based on concerns about the surrogate biomarker used to predict clinical benefit for accelerated approval. This conditional market clearance was sought based on the therapy's ability to reduce a specific biomarker in cerebrospinal fluid, which was believed to correlate with longer-term cognitive improvements.

FDA Denies Regenxbio Therapy in Latest Rare Disease Setback

https://www.bloomberg.com/news/articles/2026-02-09/fda-denies-regenxbio-gene-therapy-in-latest-rare-disease-setback
The FDA rejected Regenxbio Inc.'s gene therapy for Hunter syndrome, causing the company's shares to tumble. The agency found the clinical trial data insufficient to support approval for the rare disease that causes brain damage in boys. This decision highlights a tough stance on drug approvals for rare diseases by the current administration.

FDA rejects Regenxbio's Hunter syndrome gene therapy

https://firstwordpharma.com/story/7099009
The FDA has rejected Regenxbio's gene therapy candidate for Hunter syndrome, known as RGX-121. Despite the setback, the company stated it intends to continue discussions with the FDA regarding a path forward for the treatment. Hunter syndrome is a rare genetic disorder that can cause severe health problems and developmental delays.

FDA rejects Regenxbio's gene therapy in Hunter syndrome, leaving CEO 'concerned'

https://www.fiercebiotech.com/biotech/fda-rejects-regenxbio-hunter-syndrome-gene-therapy-recently-hit-hold-unrelated-brain-tumor
The FDA has rejected Regenxbio's gene therapy, RGX-121, for Hunter syndrome, citing concerns about its clinical trial design, the use of a natural history control arm, and the reliance on a biomarker as a surrogate endpoint. This decision followed a delayed PDUFA date and a clinical hold on both RGX-121 and a related gene therapy, RGX-111, after a patient in the RGX-111 trial developed a brain tumor. Regenxbio plans to resubmit for approval with longer-term data, while the CEO expressed concern over the FDA's feedback given the urgent need for treatment for this rare, life-threatening disease.
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REGENXBIO Inc. (NASDAQ:RGNX) Looks Inexpensive After Falling 28% But Perhaps Not Attractive Enough

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-rgnx/regenxbio/news/regenxbio-inc-nasdaqrgnx-looks-inexpensive-after-falling-28
REGENXBIO Inc.'s shares have dropped 28% in the last month, making its price-to-sales (P/S) ratio of 3.2x appear inexpensive compared to the biotech industry average. However, the company's past revenue growth has been inconsistent, and future projections of 41% annual growth for the next three years fall significantly short of the industry's predicted 134%. This gap in expected growth explains the low P/S ratio, suggesting that despite the recent price fall, the stock may not be an attractive buying opportunity without an improvement in its revenue outlook.

REGENXBIO Inc. (NASDAQ:RGNX) Looks Inexpensive After Falling 28% But Perhaps Not Attractive Enough

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-rgnx/regenxbio/news/regenxbio-inc-nasdaqrgnx-looks-inexpensive-after-falling-28/amp
REGENXBIO Inc.'s shares have dropped 28% in the last month, despite a 22% gain over the past year. The company's price-to-sales (P/S) ratio of 3.2x is low compared to the biotech industry average, but its revenue growth has been weak, experiencing a 66% drop over the last three years. Analysts project 41% annual revenue growth for REGENXBIO over the next three years, significantly trailing the industry's predicted 134% growth, which explains its lower valuation.

The Technical Signals Behind (RGNX) That Institutions Follow

https://news.stocktradersdaily.com/news_release/81/The_Technical_Signals_Behind_RGNX_That_Institutions_Follow_020426110001_1770264001.html
This article analyzes the technical signals for Regenxbio Inc. (NASDAQ: RGNX), indicating weak near and mid-term sentiment but a strong long-term outlook. It presents AI-generated institutional trading strategies including position trading, momentum breakout, and risk hedging, along with multi-timeframe signal analysis for support and resistance levels. The analysis highlights an elevated downside risk with no remaining long-term support signals.

REGENXBIO Inc. (RGNX) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Stockholders to Contact the Firm to Learn More About the Investigation

https://www.accessnewswire.com/newsroom/en/business-and-professional-services/regenxbio-inc.-rgnx-investigation-bronstein-gewirtz-and-grossman-1133550
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims against REGENXBIO Inc. (NASDAQ:RGNX) after the FDA placed a clinical hold on its investigational gene therapies RGX-111 and RGX-121 due to an reported neoplasm in a participant. This news led to a 17.9% drop in REGENXBIO's stock price. The law firm is encouraging affected investors to contact them to learn more about the investigation.

Pfizer’s Metsera Data, 2025 Earnings, the FDA and REGENXBIO, Psychedelics and IPOs

https://www.biospace.com/business/pfizers-metsera-data-2025-earnings-the-fda-and-regenxbio-psychedelics-and-ipos
Pfizer unveiled initial data from its Metsera-acquired obesity pipeline, which analysts deemed competitive but sought more details on during its earnings call. Other pharmaceutical giants including Merck and Roche also reported earnings, with Eli Lilly and Novo Nordisk on deck. The article also highlights REGENXBIO's regulatory setback with the FDA, the launch of the FDA's PreCheck pilot program, and the resurgence of the psychedelics space, with two companies potentially submitting FDA applications this year.
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