REGENXBIO's RGX-121 BLA Accepted by FDA Under Accelerated Approval Pathway
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 10 2026
0mins
Should l Buy RGNX?
Source: Benzinga
- FDA Approval Update: The FDA has accepted REGENXBIO's RGX-121 BLA under the accelerated approval pathway; however, the PDUFA goal date has been extended from November 9, 2025, to February 8, 2026, indicating the agency's cautious approach to expedited approvals.
- Reasons for CRL: The FDA issued a Complete Response Letter (CRL) for RGX-121, citing concerns regarding study eligibility criteria and the appropriateness of a surrogate endpoint, suggesting that new studies and long-term follow-ups may be necessary, which poses challenges in an ultra-rare disease population.
- Market Reaction: Despite regulatory hurdles, REGENXBIO's stock shows strong momentum in the market, with analysts maintaining a
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Analyst Views on RGNX
Wall Street analysts forecast RGNX stock price to rise
7 Analyst Rating
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 8.360
Low
19.00
Averages
29.71
High
45.00
Current: 8.360
Low
19.00
Averages
29.71
High
45.00
About RGNX
REGENXBIO Inc. is a clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. The Company has developed a pipeline of gene therapy programs using its proprietary adeno-associated virus (AAV) gene therapy delivery platform (NAV Technology Platform) to address genetic diseases. It is focused on its internal development pipeline in three areas: retinal, neuromuscular, and neurodegenerative diseases. Its investigational AAV therapeutics include ABBV-RGX-314, RGX-202, RGX-121, and RGX-111. It is developing ABBV-RGX-314 in collaboration with AbbVie to treat large patient populations impacted by wet age-related macular degeneration, diabetic retinopathy (DR) and other chronic retinal diseases characterized by loss of vision. It is developing RGX-202 to treat Duchenne muscular dystrophy (Duchenne). The Company is developing RGX-121 to treat Mucopolysaccharidosis type II (MPS II), a progressive, neurodegenerative lysosomal storage disorder.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Notice of Class Action Lawsuit for REGENXBIO Securities
- Class Action Initiation: Rosen Law Firm reminds investors who purchased REGENXBIO (NASDAQ: RGNX) securities between February 9, 2022, and January 27, 2026, to apply as lead plaintiffs by April 14, 2026, to potentially receive compensation without any out-of-pocket costs.
- Lawsuit Background: The lawsuit alleges that REGENXBIO misled investors regarding its RGX-111 gene therapy clinical trial, providing false and misleading information that led to investor losses when the truth was revealed, adversely affecting the company's reputation and stock price.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions, having recovered over $438 million for investors in 2019 alone, and was ranked No. 1 by ISS Securities Class Action Services in 2017, demonstrating its expertise and success in this field.
- Investor Guidance: Investors are advised to select qualified counsel with a proven track record to ensure effective legal support in class actions, avoiding firms that merely act as intermediaries, which could negatively impact the outcome of the litigation.
See More
Notice of Class Action Lawsuit for REGENXBIO Securities
- Class Action Deadline: Rosen Law Firm reminds investors who purchased REGENXBIO (NASDAQ:RGNX) securities between February 9, 2022, and January 27, 2026, that they must apply to be lead plaintiff by April 14, 2026, to participate in the class action and potentially receive compensation.
- No Upfront Fees: Investors joining the class action will incur no out-of-pocket fees or costs, as the law firm operates on a contingency fee basis, ensuring that investor rights are protected without financial risk.
- Case Background: The lawsuit alleges that defendants provided false and misleading information regarding REGENXBIO's RGX-111 gene therapy development, resulting in investor losses when the true facts emerged, negatively impacting the company's reputation and stock price.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, being ranked first by ISS Securities Class Action Services in 2017, demonstrating its expertise and success in this legal domain.
See More
Class Action Lawsuits Filed Against PayPal and REGENXBIO
- PayPal Lawsuit Overview: A class action lawsuit has been filed on behalf of PayPal Holdings, Inc. shareholders for the period from February 25, 2025, to February 2, 2026, alleging that the company misrepresented its revenue outlook, resulting in a stock price drop of over 20% following the February 3, 2026 earnings announcement.
- Disappointing Financial Performance: On February 3, 2026, PayPal reported its fiscal year 2025 results, revealing worsening performance in Branded Checkout and retracting its 2027 financial targets, highlighting challenges from macroeconomic factors and competitive pressures.
- REGENXBIO Lawsuit Context: Shareholders of REGENXBIO Inc. have initiated a class action for the period from February 9, 2022, to January 27, 2026, alleging that the company concealed adverse facts regarding the safety and efficacy of its RGX-111 gene therapy trial, misleading investors.
- FDA Clinical Hold Impact: On January 28, 2026, REGENXBIO announced that the FDA had placed a clinical hold on RGX-111 due to the discovery of an intraventricular CNS tumor in a trial participant, causing the stock price to plummet 17.8% in a single day, from $13.41 to $11.01 per share.
See More
REGENXBIO Faces Class Action Lawsuit Over Securities Violations
- Class Action Filed: Bronstein, Gewirtz & Grossman LLC has initiated a class action lawsuit against REGENXBIO, alleging violations of federal securities laws from February 9, 2022, to January 27, 2026, indicating significant investor concern regarding the company's transparency and accountability.
- False Statements Allegations: The complaint claims that REGENXBIO made materially misleading statements about its RGX-111 gene therapy development, particularly regarding the anticipated success of its clinical trials, which lacked a reasonable basis, potentially undermining investor confidence in the company's future prospects.
- Investor Rights Protection: Affected investors are encouraged to apply to be lead plaintiffs by April 14, 2026, highlighting the law firm's commitment to safeguarding investor rights and reflecting the market's increasing emphasis on corporate governance and transparency.
- No-Cost Legal Services: The law firm offers legal representation on a contingency fee basis, meaning they will only charge fees if successful in recovering damages, thereby reducing the financial burden on investors and encouraging greater participation in the lawsuit.
See More
Regenxbio Faces Class Action Lawsuit Reminder
- Class Action Reminder: The Schall Law Firm alerts investors of a class action lawsuit against Regenxbio for violations of §§10(b) and 20(a) of the Securities Exchange Act, concerning securities purchased between February 9, 2022, and January 27, 2026, with a deadline to contact the firm by April 14, 2026.
- False Statements Exposed: The complaint alleges that Regenxbio made misleading statements regarding its product candidate RGX-111, concealing negative efficacy and safety data, which led to significant investor losses once the truth was revealed.
- Market Reaction: Following the revelation of Regenxbio's misleading statements, investor losses increased significantly, indicating a major failure in the company's disclosure practices that could undermine future investor confidence.
- Legal Consultation Opportunity: The Schall Law Firm offers free legal consultations and encourages affected shareholders to join the lawsuit for compensation, demonstrating the firm's commitment to protecting investor rights.
See More
Regenxbio Faces Class Action Lawsuit Over Securities Fraud Allegations
- Class Action Filed: Pomerantz LLP has initiated a class action lawsuit against Regenxbio, alleging securities fraud and other unlawful business practices by the company and certain officers, with investors needing to apply as Lead Plaintiff by April 14, 2026, which could significantly impact the company's reputation and shareholder confidence.
- FDA Clinical Hold: On January 28, 2026, Regenxbio announced that the FDA placed a clinical hold on its gene therapies RGX-111 and RGX-121 due to a reported case of neoplasm in a trial participant, leading to a 17.9% drop in stock price to $11.01 per share, indicating market concerns over product safety.
- Stock Price Impact: The news of the FDA's clinical hold resulted in a $2.40 decline in Regenxbio's stock price, reflecting investor pessimism about the company's future prospects, which may hinder financing efforts and decrease market trust.
- Legal Firm Background: Pomerantz LLP is a prominent law firm specializing in class action litigation in securities and antitrust, with a long history of recovering multimillion-dollar damages for victims, underscoring its influence and expertise in the legal field.
See More
Notice of Class Action Lawsuit for REGENXBIO Securities
- Class Action Initiation: Rosen Law Firm reminds investors who purchased REGENXBIO (NASDAQ: RGNX) securities between February 9, 2022, and January 27, 2026, to apply as lead plaintiffs by April 14, 2026, to potentially receive compensation without any out-of-pocket costs.
- Lawsuit Background: The lawsuit alleges that REGENXBIO misled investors regarding its RGX-111 gene therapy clinical trial, providing false and misleading information that led to investor losses when the truth was revealed, adversely affecting the company's reputation and stock price.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions, having recovered over $438 million for investors in 2019 alone, and was ranked No. 1 by ISS Securities Class Action Services in 2017, demonstrating its expertise and success in this field.
- Investor Guidance: Investors are advised to select qualified counsel with a proven track record to ensure effective legal support in class actions, avoiding firms that merely act as intermediaries, which could negatively impact the outcome of the litigation.
See More
Notice of Class Action Lawsuit for REGENXBIO Securities
- Class Action Deadline: Rosen Law Firm reminds investors who purchased REGENXBIO (NASDAQ:RGNX) securities between February 9, 2022, and January 27, 2026, that they must apply to be lead plaintiff by April 14, 2026, to participate in the class action and potentially receive compensation.
- No Upfront Fees: Investors joining the class action will incur no out-of-pocket fees or costs, as the law firm operates on a contingency fee basis, ensuring that investor rights are protected without financial risk.
- Case Background: The lawsuit alleges that defendants provided false and misleading information regarding REGENXBIO's RGX-111 gene therapy development, resulting in investor losses when the true facts emerged, negatively impacting the company's reputation and stock price.
- Law Firm Credentials: Rosen Law Firm specializes in securities class actions and has recovered over $438 million for investors in 2019 alone, being ranked first by ISS Securities Class Action Services in 2017, demonstrating its expertise and success in this legal domain.
See More
Class Action Lawsuits Filed Against PayPal and REGENXBIO
- PayPal Lawsuit Overview: A class action lawsuit has been filed on behalf of PayPal Holdings, Inc. shareholders for the period from February 25, 2025, to February 2, 2026, alleging that the company misrepresented its revenue outlook, resulting in a stock price drop of over 20% following the February 3, 2026 earnings announcement.
- Disappointing Financial Performance: On February 3, 2026, PayPal reported its fiscal year 2025 results, revealing worsening performance in Branded Checkout and retracting its 2027 financial targets, highlighting challenges from macroeconomic factors and competitive pressures.
- REGENXBIO Lawsuit Context: Shareholders of REGENXBIO Inc. have initiated a class action for the period from February 9, 2022, to January 27, 2026, alleging that the company concealed adverse facts regarding the safety and efficacy of its RGX-111 gene therapy trial, misleading investors.
- FDA Clinical Hold Impact: On January 28, 2026, REGENXBIO announced that the FDA had placed a clinical hold on RGX-111 due to the discovery of an intraventricular CNS tumor in a trial participant, causing the stock price to plummet 17.8% in a single day, from $13.41 to $11.01 per share.
See More
REGENXBIO Faces Class Action Lawsuit Over Securities Violations
- Class Action Filed: Bronstein, Gewirtz & Grossman LLC has initiated a class action lawsuit against REGENXBIO, alleging violations of federal securities laws from February 9, 2022, to January 27, 2026, indicating significant investor concern regarding the company's transparency and accountability.
- False Statements Allegations: The complaint claims that REGENXBIO made materially misleading statements about its RGX-111 gene therapy development, particularly regarding the anticipated success of its clinical trials, which lacked a reasonable basis, potentially undermining investor confidence in the company's future prospects.
- Investor Rights Protection: Affected investors are encouraged to apply to be lead plaintiffs by April 14, 2026, highlighting the law firm's commitment to safeguarding investor rights and reflecting the market's increasing emphasis on corporate governance and transparency.
- No-Cost Legal Services: The law firm offers legal representation on a contingency fee basis, meaning they will only charge fees if successful in recovering damages, thereby reducing the financial burden on investors and encouraging greater participation in the lawsuit.
See More
Regenxbio Faces Class Action Lawsuit Reminder
- Class Action Reminder: The Schall Law Firm alerts investors of a class action lawsuit against Regenxbio for violations of §§10(b) and 20(a) of the Securities Exchange Act, concerning securities purchased between February 9, 2022, and January 27, 2026, with a deadline to contact the firm by April 14, 2026.
- False Statements Exposed: The complaint alleges that Regenxbio made misleading statements regarding its product candidate RGX-111, concealing negative efficacy and safety data, which led to significant investor losses once the truth was revealed.
- Market Reaction: Following the revelation of Regenxbio's misleading statements, investor losses increased significantly, indicating a major failure in the company's disclosure practices that could undermine future investor confidence.
- Legal Consultation Opportunity: The Schall Law Firm offers free legal consultations and encourages affected shareholders to join the lawsuit for compensation, demonstrating the firm's commitment to protecting investor rights.
See More
Regenxbio Faces Class Action Lawsuit Over Securities Fraud Allegations
- Class Action Filed: Pomerantz LLP has initiated a class action lawsuit against Regenxbio, alleging securities fraud and other unlawful business practices by the company and certain officers, with investors needing to apply as Lead Plaintiff by April 14, 2026, which could significantly impact the company's reputation and shareholder confidence.
- FDA Clinical Hold: On January 28, 2026, Regenxbio announced that the FDA placed a clinical hold on its gene therapies RGX-111 and RGX-121 due to a reported case of neoplasm in a trial participant, leading to a 17.9% drop in stock price to $11.01 per share, indicating market concerns over product safety.
- Stock Price Impact: The news of the FDA's clinical hold resulted in a $2.40 decline in Regenxbio's stock price, reflecting investor pessimism about the company's future prospects, which may hinder financing efforts and decrease market trust.
- Legal Firm Background: Pomerantz LLP is a prominent law firm specializing in class action litigation in securities and antitrust, with a long history of recovering multimillion-dollar damages for victims, underscoring its influence and expertise in the legal field.
See More
