REGENXBIO (RGNX) completes employee option exchange, grants 775,401 replacement options
REGENXBIO (RGNX) announced the final results of its employee option exchange program, which concluded on July 1, 2026. The company accepted eligible options to purchase 1,940,394 shares from 184 holders and subsequently granted 775,401 replacement options with an exercise price of $13.28 per share, based on the Nasdaq closing price on July 2, 2026. This exchange effectively reduced legacy option counts and reissued fewer replacement options at market-based strikes under the 2025 Equity Incentive Plan.
RGNX SHAREHOLDER ALERT: Bronstein, Gewirtz and Grossman, LLC Announces that REGENXBIO Inc. Shareholders with Losses Have Opportunity to Lead Class Action Lawsuit!
Bronstein, Gewirtz & Grossman, LLC has announced a class action lawsuit against REGENXBIO Inc. (NASDAQ:RGNX) for alleged violations of federal securities laws. The lawsuit claims REGENXBIO made false and misleading statements regarding its RGX‑111 gene therapy, overstating its efficacy and safety. Shareholders who suffered losses between February 9, 2022, and January 27, 2026, are encouraged to join the suit and have until April 14, 2026, to request to be appointed lead plaintiff.
RGNX INVESTOR ALERT: Bronstein, Gewirtz and Grossman, LLC Reminds Stockholders of REGENXBIO Inc. to Contact the Firm Today!
Bronstein, Gewirtz and Grossman, LLC has filed a class action lawsuit against REGENXBIO Inc. (NASDAQ:RGNX) alleging violations of federal securities laws. The lawsuit claims that REGENXBIO made false and misleading statements regarding the development and commercialization of its gene therapy RGX-111, overstating its efficacy and safety. Investors who purchased REGENXBIO securities between February 9, 2022, and January 27, 2026, are encouraged to contact the firm to potentially become a lead plaintiff by April 14, 2026.
REGENXBIO Inc updates pipeline strategy as gene therapy sector evolves
REGENXBIO Inc is a clinical-stage biotechnology company focusing on developing gene therapies for neurological and ophthalmological conditions. The company's strategy involves advancing its pipeline through clinical trials and seeking collaborations, operating within a biotech sector influenced by capital access and clinical data. REGENXBIO aims to address the genetic causes of serious diseases, with its stock performance tied to sector sentiment and trial updates.
RGNX SHAREHOLDER ALERT: Bronstein, Gewirtz and Grossman, LLC Anno
Bronstein, Gewirtz & Grossman, LLC has announced a class action lawsuit against REGENXBIO Inc. (NASDAQ:RGNX) for alleged violations of federal securities laws. The lawsuit seeks to recover damages for investors who purchased REGENXBIO securities between February 9, 2022, and January 27, 2026, claiming that the company made materially false and misleading statements regarding its RGX-111 gene therapy. Investors with substantial losses have an opportunity to lead the class action by April 14, 2026.
Regenxbio CMO Steve Pakola sells $688,755 in company stock.
Steve Pakola, Chief Medical Officer of REGENXBIO Inc. (NASDAQ:RGNX), sold $688,755 worth of company stock in recent transactions, occurring at prices between $11.04 and $12.86 per share. These sales followed an exercise of options and were conducted under a Rule 10b5-1 trading plan. The transactions take place amidst recent positive developments for Regenxbio, including progress in clinical trials for diabetic retinopathy and Duchenne muscular dystrophy, and alignment with the FDA for resubmission of an application for Mucopolysaccharidosis II treatment.
[Form 4] REGENXBIO Inc. Insider Trading Activity
REGENXBIO Inc.'s Chief Medical Officer, Steve Pakola, engaged in an exercise-and-sell transaction. He exercised options to acquire 36,725 common stock shares at $7.86 per share and subsequently sold 56,333 shares on the open market at weighted average prices of $12.86 and $11.04 per share. Following these transactions, Pakola directly holds 249,734 common stock shares and retains 66,973 stock options expiring in 2035.
Regenxbio CMO Steve Pakola sells $688,755 in company stock. By Investing.com
Regenxbio's Chief Medical Officer, Steve Pakola, sold company stock totaling $688,755 through pre-arranged trading plans, following a significant rise in the company's stock price. These transactions included selling 19,608 shares at an average of $11.04 and exercising options to acquire and immediately sell 36,725 shares at $12.86. The sales occurred while the stock surged nearly 28% and was deemed "fairly valued" by InvestingPro, though showing overbought conditions.
REGENXBIO (RGNX) amends Schedule TO to update employee option exchange content
REGENXBIO Inc. has filed an Amendment No. 1 to its Schedule TO, updating an Exchange Offer that allows certain non-executive employees to swap eligible outstanding stock options for replacement options. This amendment incorporates new communications, FAQs, and plan documents related to the offer, while other disclosures from the original June 3, 2026 filing remain unchanged. The Exchange Offer is detailed in the company's Offer to Exchange Eligible Options for Replacement Options.
H.C. Wainwright reiterates Regenxbio stock rating on trial milestone
H.C. Wainwright has reiterated a Buy rating and a $26.00 price target for Regenxbio Inc. (NASDAQ:RGNX) after the company announced a clinical trial milestone for its diabetic retinopathy treatment. Regenxbio received a $100 million payment from AbbVie for dosing the first patient in the Phase 2b/3 NAAVIGATE trial, highlighting significant progress in its gene therapy pipeline. The company also has other trials underway and plans to submit a Biologics License Application for another gene therapy in Q3 2026.
REGENXBIO doses first patient in NAAVIGATE, phase 2b/3 sura-vec trial for diabetic retinopathy
REGENXBIO has dosed the first patient in its phase 2b/3 NAAVIGATE clinical trial for surabgene lomparvovec (sura-vec) for diabetic retinopathy, administering the gene therapy via suprachoroidal delivery. This investigational gene therapy, developed in collaboration with AbbVie, aims to provide sustained treatment by inhibiting VEGF, with REGENXBIO receiving a $100 million milestone payment for this first dosing. The trial will evaluate the safety and efficacy of sura-vec in patients with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME), using a 1.0x10^12 GC/eye dose and targeting a >2-step improvement on the diabetic retinopathy severity scale (DRSS) at one year.
REGENXBIO Inc.(NasdaqGS: RGNX) added to Russell Small Cap Comp Growth Benchmark
REGENXBIO Inc. (NasdaqGS: RGNX) has been added to the Russell Small Cap Comp Growth Benchmark. This news follows a period of significant activity for the clinical-stage biotechnology company, including the completion of dosing in a confirmatory study for RGX-202 and alignment with the FDA on the BLA resubmission for RGX-121. The company focuses on gene therapy programs for retinal, neuromuscular, and neurodegenerative diseases.
REGENXBIO doses first patient in DR trial
REGENXBIO has dosed the first patient in its Phase IIb/III NAAVIGATE trial for diabetic retinopathy, triggering a $100 million payment from AbbVie. The study will enroll approximately 135 U.S. patients and evaluate vision improvement over one year. The company also anticipates presenting long-term data at ASRS 2026 and expects pivotal trial topline data in Q4 2026 for its gene therapy pipeline in retinal diseases.
Regenxbio doses first patient in diabetic retinopathy trial
REGENXBIO Inc. has dosed the first patient in its Phase IIb/III NAAVIGATE clinical trial for surabgene lomparvovec (sura-vec) in diabetic retinopathy, triggering a $100 million milestone payment from AbbVie. The company's stock rose over 15% on the news, driven by an InvestingPro fair value assessment suggesting undervaluation. This development, alongside progress in Duchenne muscular dystrophy and Mucopolysaccharidosis II treatments, reinforces a bullish outlook from analysts like H.C. Wainwright, Leerink, and Baird.
REGENXBIO Announces First Patient Dosed in Phase IIb/III NAAVIGATE Trial of Surabgene Lomparvovec in Diabetic Retinopathy; Company to Receive $100 Million Milestone
REGENXBIO Inc. has announced the dosing of the first patient in its Phase IIb/III NAAVIGATE clinical trial for surabgene lomparvovec (sura-vec) in diabetic retinopathy (DR), triggering a $100 million milestone payment from AbbVie. The investigational gene therapy aims to provide a one-time treatment for chronic retinal diseases, with two-year data from the ALTITUDE trial reinforcing its durable efficacy. REGENXBIO will present further long-term data at the upcoming American Society of Retina Specialists (ASRS) 2026 meeting.
REGENXBIO Inc.(NasdaqGS: RGNX) added to Russell 3000E Growth Benchmark
REGENXBIO Inc. (NasdaqGS:RGNX) has been added to the Russell 3000E Growth Benchmark. This news comes amidst other recent updates for the clinical-stage biotechnology company, including the completion of dosing in a confirmatory study for RGX-202 and alignment with the FDA on the path forward for RGX-121 BLA resubmission. REGENXBIO focuses on gene therapy programs using its proprietary NAV Technology Platform to address retinal, neuromuscular, and neurodegenerative diseases.
Enterprise value to revenue forward of REGENXBIO Inc. – NASDAQ:RGNX
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Enterprise value to EBITDA forward of REGENXBIO, Inc. – MUN:RB0
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Enterprise value to EBITDA forward of REGENXBIO Inc. – NASDAQ:RGNX
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Enterprise value to revenue forward of REGENXBIO, Inc. – MUN:RB0
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Price to sales forward of REGENXBIO Inc. – NASDAQ:RGNX
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FDA’s uniQure, REGENXBIO reversals could bolster other near-term rare disease applications
The FDA's recent reversal of prior decisions for uniQure and REGENXBIO, now allowing them to file or re-file for approval of their gene therapies based on existing data and external controls, signals a new, more flexible approach to rare disease drug approvals. This shift, attributed by some to changes in FDA leadership, could significantly benefit other companies with near-term rare disease applications currently using similar innovative trial designs, such as Skyhawk Therapeutics, Capricor Therapeutics, Biohaven, and Stoke Therapeutics. The agency's renewed openness to externally controlled studies will likely streamline regulatory pathways for several late-stage development programs.
REGENXBIO Announces Alignment with FDA on Path Forward for NAVSUNLI™ BLA Resubmission for Accelerated Approval; First Potential Gene Therapy for MPS II
REGENXBIO has aligned with the FDA on resubmitting its Biologics License Application (BLA) for NAVSUNLI™ for the accelerated approval pathway. The FDA has confirmed no additional studies or patient enrollment are required, and the resubmission, expected in Q3 2026, will be reviewed on an expedited basis. NAVSUNLI™ is a one-time gene therapy for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome, an ultra-rare neurodegenerative disease.
REGENXBIO Completes Dosing in Confirmatory Study of RGX-202, Marking Completion of Registrational Development Program and Supporting Planned BLA Submission in Q3 2026
REGENXBIO Inc. has completed dosing in the confirmatory study of RGX-202, a gene therapy for Duchenne muscular dystrophy, ahead of schedule. This achievement sets the company on track to submit a Biologics License Application (BLA) in Q3 2026 under the accelerated approval pathway, aiming for potential FDA approval by the second half of 2027. The successful completion is attributed to strong patient demand and positive pivotal data showing RGX-202 met its primary endpoint for microdystrophin expression and demonstrated functional improvement.
Feeling bullish over FDA changes, Regenxbio solidifies filing plans for Duchenne gene therapy
Regenxbio is moving forward with its Duchenne gene therapy filing plans, feeling optimistic about recent changes at the FDA. The company is preparing to submit its therapy, highlighting a strategic step in its development pipeline.
REGENXBIO clears key Duchenne study step, aims for BLA filing in Q3
REGENXBIO announced the completion of dosing in the confirmatory study of RGX-202 for Duchenne muscular dystrophy, a critical step that finalizes its registrational development program. This achievement supports the company's plan to submit a Biologics License Application (BLA) in Q3 2026 under an accelerated approval pathway, targeting potential FDA approval in the second half of 2027. The BLA will be backed by comprehensive safety data from 63 patients and pivotal efficacy data from 30 patients, with RGX-202 showing a favorable safety profile and meeting its primary endpoint of microdystrophin expression.
REGENXBIO Inc. Stock 12‑Month Price Target Raised to $26.08, Implies 234% Upside
The average 12-month price target for REGENXBIO Inc. (RGNX) stock has increased from $25.58 to $26.08, according to estimates from 12 analysts. This new target implies a potential upside of approximately 234% from its June 18 closing price. The consensus rating for RGNX remains a "Buy" from these analysts.
Regenxbio reaches FDA deal on accelerated approval for Hunter syndrome drug
Regenxbio has secured an agreement with the FDA for accelerated approval of its gene therapy, Navsunli, for Hunter syndrome. The FDA reversed its earlier rejection, confirming existing clinical data are sufficient and not requiring new studies. This decision signals a broader softening of the FDA's stance on rare disease therapies.
Regenxbio Shares Rise on Plans to Resubmit Navsunli BLA for MPS II
Regenxbio announced plans to resubmit its Biologics License Application (BLA) for Navsunli, a gene therapy for Hunter syndrome, after reaching an agreement with the FDA. The FDA acknowledged existing clinical data are sufficient for accelerated approval and requested a Type A meeting to review longer-term data. This news led to a rise in Regenxbio's shares, with the resubmission planned for Q3 2026.
RGNX Stock Price and Chart — NASDAQ:RGNX
This page provides a detailed overview of REGENXBIO Inc. (RGNX) stock performance, financials, news, and technical analysis from TradingView. It includes current stock prices, market capitalization, key financial figures, upcoming earnings dates, and analyst ratings. The article also lists ETFs holding RGNX and answers frequently asked questions about the stock.
Regenxbio’s gene therapy latest example of FDA’s reversion to the mean
Regenxbio's gene therapy, Navsunli clemidsogene lanparvovec for MPS II, is highlighted as the latest instance of the FDA reversing previous regulatory obstacles. This trend suggests that many products initially derailed under the leadership of former Commissioner Marty Makary, CBER Director Vinay Prasad, and acting CDER Director Tracy Beth Høeg are now back on track for approval. At least 11 products have either been approved or had their development hurdles removed, indicating a "reversion to the mean" in FDA regulatory decisions.
Regenxbio’s gene therapy latest example of FDA’s reversion to the mean
Regenxbio's gene therapy, Navsunli clemidsogene lanparvovec, for MPS II has received a pathway to accelerated approval from the FDA, marking a significant reversal of previous regulatory obstacles. This decision is one of at least eleven instances where products, initially derailed under the former FDA leadership, are now back on track, suggesting a shift in the agency's approval stance. The article highlights a pattern of the FDA undoing decisions made during the tenure of former Commissioner Marty Makary, CBER Director Vinay Prasad, and acting CDER Director Tracy Beth Høeg.
Regenxbio Gets Breath Of Fresh Air From US FDA For Navsunli In MPS II
Regenxbio has received positive news from the US FDA regarding its gene therapy, Navsunli, for Mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The company announced its intention to resubmit its Biologics License Application (BLA) for the treatment. This development offers a "breath of fresh air" for Regenxbio and patients affected by this rare genetic disorder.
Regenxbio to resubmit gene therapy as FDA backtracks on another drug rejection
Regenxbio plans to resubmit its gene therapy, Navsunli, for FDA review after the agency reversed its stance on requiring a placebo-controlled trial. The FDA now deems Regenxbio's existing clinical data sufficient for potential accelerated approval, signaling a shift from previous decisions made under former commissioner Marty Makary's leadership. This move follows appeals from several other drugmakers who faced rejections based on criteria that seemingly contradicted earlier agreements with the FDA.
RGNX Retail Investors See Hope As FDA Reopens Door For Regenxbio’s Hunter Syndrome Therapy
The FDA has agreed to re-evaluate Regenxbio's gene therapy, Navsunli, for Hunter syndrome, leading to a 12% jump in RGNX shares. Regenxbio plans to resubmit its application in Q3, with the FDA indicating a potentially faster review process. This development follows a previous rejection and a formal dispute resolution meeting, offering new hope for the rare disease treatment.
FDA to reverse rejection of Regenxbio's rare-disease drug, WSJ reports
The Wall Street Journal has reported that the FDA plans to reverse its rejection of Regenxbio's rare-disease drug. This news, initially shared by Refinitiv and then picked up by TradingView, suggests a positive development for Regenxbio (RGNX). The article is concise, indicating this is a significant report regarding the drug's regulatory status.
Exclusive | FDA Gives Third Rare-Disease Drug Another Shot, Regenxbio Says
The FDA has reversed its rejection of Regenxbio's experimental gene therapy for a rare and fatal brain disease, marking the third such reversal recently. This change indicates a broader retreat from previous FDA demands for placebo-controlled trials for rare-disease drugs, which companies argued were impractical for small patient populations. Regenxbio plans to refile its application after the FDA dropped the requirement for a placebo group in its study.
REGENXBIO Announces Alignment with FDA on Path Forward for NAVSUNLI™ BLA Resubmission for Accelerated Approval; First Potential Gene Therapy for MPS II
REGENXBIO announced alignment with the FDA on the resubmission path for NAVSUNLI™ (RGX-121), a potential gene therapy for MPS II (Hunter syndrome). The FDA has confirmed that no additional studies are required and will review existing long-term data for accelerated approval. REGENXBIO plans to have a Type A meeting in July and resubmit the Biologics License Application (BLA) in Q3 2026, aiming to expedite access to this one-time treatment for patients.
Regenxbio Inc (RGNX) Earnings Forecast: Future EPS & Revenue Growth Estimates
This article provides an earnings forecast for Regenxbio Inc (RGNX), detailing its current earnings forecast score, average price target from analysts, and a breakdown of analyst ratings. It also includes expected revenue for the next quarter, historical EPS performance, and future EPS predictions. The data indicates that most analysts recommend a "Buy" for RGNX stock with a significant upside potential.
Why (RGNX) Price Action Is Critical for Tactical Trading
This article analyzes Regenxbio Inc. (NASDAQ: RGNX) using AI models to provide tactical trading insights. It identifies a strong risk-reward short setup, divergent sentiment across time horizons, and outlines three institutional trading strategies: Position Trading, Momentum Breakout, and Risk Hedging. The analysis also includes multi-timeframe signal analysis with support and resistance levels.
Are Options Traders Betting on a Big Move in REGENXBIO Stock?
Options traders are showing significant interest in REGENXBIO Inc. (RGNX), with high implied volatility for its June 18, 2026 $14.00 Call, suggesting expectations of a large price movement. Despite this, REGENXBIO is currently a Zacks Rank #4 (Sell) stock, with recent analyst earnings estimate revisions indicating a less favorable fundamental outlook. The article suggests that option traders might be selling premium, anticipating the stock will not move as much as implied volatility suggests.
Are Options Traders Betting on a Big Move in REGENXBIO Stock?
Options traders are showing significant interest in REGENXBIO (RGNX) stock, as indicated by the high implied volatility of its June 18, 2026 $14.00 Call options. High implied volatility suggests expectations of a large price movement, potentially due to an upcoming event. However, analysts currently rate REGENXBIO as a Zacks Rank #4 (Sell), with recent earnings estimate reductions, indicating a mixed fundamental picture despite the options market activity.
Are Options Traders Betting on a Big Move in REGENXBIO Stock?
Options traders are showing significant interest in REGENXBIO Inc. (RGNX), with the June 18, 2026 $14.00 Call exhibiting high implied volatility, suggesting expectations of a large price movement. Despite this, analysts currently rate REGENXBIO as a Zacks Rank #4 (Sell), with recent earnings estimate revisions trending downwards. This discrepancy between options market activity and analyst sentiment could indicate a potential trading opportunity for seasoned options traders looking to sell premium.
Regenxbio (RGNX) Expected to Beat Earnings Estimates: Can the Stock Move Higher?
Regenxbio (RGNX) is projected to report flat earnings but significantly higher revenues for the quarter ending December 2025. The company has a positive Earnings ESP of +115.84% and a Zacks Rank of #3, indicating a high probability of beating consensus EPS estimates. Investors are advised to consider other factors beyond earnings surprise when evaluating the stock.
REGENXBIO to Host Webcast on May 14 to Discuss Topline Results from Pivotal Trial of RGX-202 for Duchenne Muscular Dystrophy
REGENXBIO Inc. announced it will host a webcast on May 14, 2026, to discuss topline results from the pivotal trial of RGX-202 for Duchenne muscular dystrophy. The webcast will feature leading Duchenne physicians and include the company's first quarter 2026 financial results and operational highlights. RGX-202 is REGENXBIO's next-generation investigational gene therapy.
H.C. Wainwright lowers Regenxbio stock price target on trial data By Investing.com
H.C. Wainwright lowered its price target for Regenxbio Inc. (NASDAQ:RGNX) to $26 from $30, while maintaining a Buy rating, following positive Phase 3 trial data for RGX-202 in Duchenne muscular dystrophy. Despite the positive trial results and an increased probability of approval, the price target was reduced due to increased projected shares outstanding. The company expects to complete dosing in all trial patients by mid-2026 and aims for accelerated approval for a potential commercial launch in 2027.
Understanding Momentum Shifts in (RGNX)
This article analyzes Regenxbio Inc. (NASDAQ: RGNX), indicating weak near and mid-term sentiment but a neutral long-term outlook. It highlights elevated downside risk due to a lack of additional long-term support signals. The analysis provides specific trading strategies—Position Trading, Momentum Breakout, and Risk Hedging—with entry, target, and stop-loss prices, along with multi-timeframe signal analysis for different horizons.
H.C. Wainwright Maintains Regenxbio(RGNX.US) With Buy Rating, Cuts Target Price to $26
H.C. Wainwright has reiterated its Buy rating on Regenxbio (RGNX.US) but cut its price target to $26. This adjustment reflects a continued positive outlook on the company's prospects despite a revised valuation. Investors should note the maintained "Buy" recommendation alongside the lowered price target.
RGNX Maintains Rating by HC Wainwright & Co. -- Price Target Lowered to $26
HC Wainwright & Co. has maintained a 'Buy' rating for Regenxbio (RGNX) but lowered its price target from $30 to $26, reflecting a cautious outlook amidst market challenges. Despite being considered 52% undervalued by GuruFocus, RGNX has a low GF Score™ of 58 and concerning financial strength and profitability ratings. Insider selling activity also indicates potential concerns about near-term performance.
JPMorgan affiliates report 4.4% stake in REGENXBIO (RGNX) in 13G/A
JPMorgan Chase & Co. and its affiliates have reported a 4.4% beneficial ownership stake in REGENXBIO Inc. (NCUSIP 75901B107), amounting to 2,279,362 shares. This disclosure was made in an amended Schedule 13G/A filing, indicating passive investment intent. The filing details specific voting and dispositive powers held by multiple JPMorgan entities.
