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RGNX Overview

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0.000(0.000%)Aft-market
ET
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0.000
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0.000(0.000%)Aft-market
ET
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Intellectia

Loading chart...

High
15.710
Open
14.940
VWAP
14.94
Vol
2.76M
Mkt Cap
776.50M
Low
14.100
Amount
41.20M
EV/EBITDA(TTM)
--
Total Shares
51.70M
EV
793.51M
EV/OCF(TTM)
--
P/S(TTM)
8.75
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 an array of 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). It is developing RGX-121 for the treatment of Mucopolysaccharidosis type II (MPS II), and RGX-111 to treat Mucopolysaccharidosis Type I.
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Events Timeline

(ET)
2026-06-24
07:30:00
Regenxbio Completes Dosing in RGX-202 Confirmatory Study
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2026-06-22 (ET)
2026-06-22
16:30:00
Nasdaq Declines Amid Weakness in Tech Stocks
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2026-06-22
09:30:00
S&P 500 Futures Slightly Higher, Markets Cautious Start
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2026-06-22
08:01:00
Regenxbio Aligns with FDA for Accelerated Navsunli Approval
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2026-06-22
07:00:00
Regenxbio CEO: FDA Agrees to Reconsider Gene Therapy Application
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link
2026-06-22
07:00:00
Regenxbio CEO: FDA Agrees to Reconsider Gene Therapy Application
select

News

PRnewswire
9.0
06-29PRnewswire
REGENXBIO Initiates Phase IIb/III Trial for Diabetic Retinopathy
  • Trial Launch: REGENXBIO announced the dosing of the first patient in the Phase IIb/III NAAVIGATE clinical trial for diabetic retinopathy (DR), marking a significant milestone in its collaboration with AbbVie, which is expected to advance the clinical application of gene therapy.
  • Funding Support: REGENXBIO will receive $100 million from AbbVie as a milestone payment, which not only strengthens the company's financial position but also provides funding for subsequent research, facilitating innovation in retinal disease treatment.
  • Therapeutic Potential: Sura-vec, a one-time gene therapy, aims to improve long-term outcomes for DR patients by inhibiting vascular endothelial growth factor (VEGF), potentially transforming the current treatment paradigm that requires frequent interventions, thereby enhancing patient quality of life.
  • Study Scale: The NAAVIGATE trial plans to enroll approximately 135 participants in the U.S. to primarily assess the safety and efficacy of sura-vec, and if successful, it will offer a new solution for DR treatment with significant market potential.
Newsfilter
9.0
06-29Newsfilter
REGENXBIO Initiates Phase IIb/III Trial for Diabetic Retinopathy
  • Trial Initiation: REGENXBIO announced the dosing of the first patient in the Phase IIb/III NAAVIGATE clinical trial for diabetic retinopathy (DR), marking a significant milestone in its collaboration with AbbVie, which will yield a $100 million milestone payment, further advancing gene therapy clinical progress.
  • Therapeutic Potential: Sura-vec demonstrated durable efficacy in the ALTITUDE trial with no intraocular inflammation observed in 15 patients, indicating its feasibility as a one-time treatment that could transform DR management and improve long-term visual outcomes for patients.
  • Study Design: The NAAVIGATE trial aims to enroll approximately 135 participants in the U.S. to evaluate the safety and efficacy of sura-vec in non-proliferative DR patients without center-involved diabetic macular edema, with the primary endpoint being a greater than 2-step improvement on the diabetic retinopathy severity scale (DRSS) at one year.
  • Future Outlook: REGENXBIO plans to present two-and-a-half-year data from the ALTITUDE trial at the 2026 ASRS Annual Meeting to further validate sura-vec's long-term efficacy, while also expecting to announce topline data from the ATMOSPHERE and ASCENT trials with AbbVie in Q4 2026, promoting its application in chronic retinal disease treatment.
seekingalpha
8.5
06-24seekingalpha
FDA's Regulatory Reversal Boosts Biotech Sector
  • Regulatory Impact: Under the leadership of new acting commissioner Kyle Diamantas, the FDA has rapidly reversed decisions made by former commissioner Marty Makary, particularly those affecting rare disease therapies, benefiting biotech firms like UniQure (QURE) and Regenxbio (RGNX) with significant stock price increases.
  • Gene Therapy Opportunities: UniQure's AMT-130 gene therapy has received a regulatory path forward from the FDA after a reassessment, which previously faced uncertainty under Makary, paving the way for potential market application and future growth for the company.
  • Accelerated Approval Outlook: Regenxbio's RGX-121 gene therapy saw a substantial stock surge after the FDA agreed to its accelerated approval plan, indicating strong support from the new leadership for rare disease treatments, which may attract more investor interest.
  • Positive Market Reaction: Since Diamantas took over, biotech stocks, as represented by the SPDR S&P Biotech ETF, have surged approximately 15%, while the S&P 500 remained flat, reflecting market optimism about the new policies and potentially encouraging more biotech firms to seek regulatory support.
PRnewswire
9.0
06-24PRnewswire
REGENXBIO Completes Dosing in RGX-202 Confirmatory Study
  • Milestone Achieved: REGENXBIO has successfully completed dosing in the confirmatory study of RGX-202, positioning the company to initiate a Biologics License Application (BLA) in Q3 2026, with potential FDA approval in the second half of 2027, advancing treatment options for Duchenne muscular dystrophy.
  • Data Supporting Application: The BLA submission will include safety data from 63 participants and efficacy data from 30 participants in the AFFINITY DUCHENNE® study, ensuring compliance with FDA accelerated approval criteria, highlighting RGX-202's advantages in clinical efficacy and safety profile.
  • Market Readiness Accelerated: The company has initiated commercial supply production at its Manufacturing Innovation Center in Rockville, ensuring a rapid launch of RGX-202 post-FDA approval to meet the urgent market demand for Duchenne treatments, thereby enhancing its competitive position in the gene therapy sector.
  • Innovative Therapeutic Mechanism: RGX-202 features a novel microdystrophin construct, combined with a proactive immune suppression regimen and high-purity manufacturing processes, aiming to provide maximum functional benefit and durability while maintaining a favorable safety profile, offering new hope for Duchenne patients.
Newsfilter
9.0
06-24Newsfilter
REGENXBIO Completes Confirmatory Study for RGX-202 Ahead of Schedule
  • Study Completion Ahead of Schedule: REGENXBIO has successfully completed the confirmatory study for RGX-202 ahead of schedule, reflecting strong patient demand and investigator interest, positioning the company to submit a Biologics License Application (BLA) in Q3 2026, with potential FDA approval expected in H2 2027.
  • Clinical Data Support: The BLA submission will include safety data from 63 participants and efficacy data from 30 participants, with RGX-202 achieving over 93% of patients reaching 10% microdystrophin expression at Week 12, demonstrating significant clinical effects.
  • Significant Functional Improvement: Functional data from 9 patients at the 12-month assessment showed substantial improvements in multiple timed function tests and the North Star Ambulatory Assessment (NSAA), supporting RGX-202 as a potential new gene therapy option.
  • Market Readiness: The company has initiated commercial supply production at its Manufacturing Innovation Center in Rockville, Maryland, ensuring a swift market launch post-FDA approval, further solidifying its leading position in the treatment of Duchenne muscular dystrophy.
NASDAQ.COM
8.5
06-23NASDAQ.COM
Tenon Files S-1, Stock Surges 77.57%
  • Tenon Stock Offering: Tenon Medical Inc. (TNON) filed a Form S-1 to offer up to 1.81 million shares and 6.98 million warrants at a public offering price of $0.6021 per unit, with potential proceeds aimed at bolstering future growth, especially if a reverse stock split occurs, increasing warrant exercise shares to 8.72 million.
  • Azitra's Strategic Shift: Azitra Inc. (AZTR) outlined its 2026 roadmap in a shareholder letter, focusing on the ATR-COSF program for the cosmetic market, with clinical studies expected to start by late 2026, positioning the company for potential commercialization by 2027, enhancing its competitive edge in precision dermatology.
  • Nuvectis Licensing Deal: Nuvectis Pharma Inc. (NVCT) announced a strategic licensing agreement with Haisco Pharmaceutical Group for exclusive ex-China rights to two clinical-stage compounds, NXP100 and NXP200, which could open new market opportunities in treating complement-mediated diseases and BRAF mutations.
  • REGENXBIO's FDA Alignment: REGENXBIO Inc. (RGNX) has aligned with the FDA for the resubmission of its Biologics License Application for NAVSUNLI, with the FDA acknowledging existing clinical data sufficiency for accelerated approval, anticipating resubmission in Q3 2026, which could significantly impact the company's market position in gene therapy for Hunter syndrome.
Wall Street analysts forecast RGNX stock price to rise
7 Analyst Rating
Wall Street analysts forecast RGNX stock price to rise
7 Buy
0 Hold
0 Sell
Strong Buy
Current: 0.000
sliders
Low
19.00
Averages
29.71
High
45.00
Current: 0.000
sliders
Low
19.00
Averages
29.71
High
45.00
Baird
Baird
Outperform
maintain
$27 -> $32
AI Analysis
2026-06-23
Reason
Baird
Baird
Price Target
$27 -> $32
AI Analysis
2026-06-23
maintain
Outperform
Reason
Baird raised the firm's price target on Regenxbio to $32 from $27 and keeps an Outperform rating on the shares. The firm updated its model the reflect the FDA-aligned Hunter resubmission and favorable DMD read-through.
H.C. Wainwright
H.C. Wainwright
Buy
maintain
$26
2026-06-22
Reason
H.C. Wainwright
H.C. Wainwright
Price Target
$26
2026-06-22
maintain
Buy
Reason
After Regenxbio announced that it has aligned with the FDA regarding the resubmission of the Biologics License Application for Navsunli for Mucopolysaccharidosis II or Hunter syndrome, H.C. Wainwright noted that the company does not need to enroll additional patients or conduct additional studies. In the wake of this \"positive update,\" the firm reiterates its Buy rating and $26 price target on Regenxbio shares.
Unlock Full Analyst Thesis, Get the complete breakdown of rating reason for RGNX
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Valuation Metrics

The current forward P/E ratio for Regenxbio Inc (RGNX.O) is 0.00, compared to its 5-year average forward P/E of 2.03. For a more detailed relative valuation and DCF analysis to assess Regenxbio Inc's fair value, Click here.

Forward PE

The forward P/E ratio is a valuation metric that divides a company's current stock price by its estimated future earnings per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average PE
2.03
Current PE
0.00
Overvalued PE
22.41
Undervalued PE
-18.35

Forward EV/EBITDA

The forward EV/EBITDA ratio is a valuation metric that divides a company's enterprise value (EV) by its estimated future earnings before interest, taxes, depreciation, and amortization (EBITDA) over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average EV/EBITDA
-1.21
Current EV/EBITDA
-0.23
Overvalued EV/EBITDA
13.36
Undervalued EV/EBITDA
-15.79

Forward PS

The forward P/S ratio is a valuation metric that divides a company's current stock price by its estimated future sales (or revenue) per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
5Y Average PS
4.99
Current PS
2.77
Overvalued PS
7.95
Undervalued PS
2.03

Financials

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Whales Holding RGNX

V
Voss Capital, LP
Holding
RGNX
+26.67%
3M Return
R
Redmile Group, LLC
Holding
RGNX
+22.75%
3M Return

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Frequently Asked Questions

What is Regenxbio Inc (RGNX) stock price today?

The current price of RGNX is 15.02 USD — it has increased 1.28

What is Regenxbio Inc (RGNX)'s business?

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 an array of 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). It is developing RGX-121 for the treatment of Mucopolysaccharidosis type II (MPS II), and RGX-111 to treat Mucopolysaccharidosis Type I.

What is the price predicton of RGNX Stock?

Wall Street analysts forecast RGNX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for RGNX is29.71 USD with a low forecast of 19.00 USD and a high forecast of 45.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.

What is Regenxbio Inc (RGNX)'s revenue for the last quarter?

Regenxbio Inc revenue for the last quarter amounts to 6.39M USD, decreased -92.82

What is Regenxbio Inc (RGNX)'s earnings per share (EPS) for the last quarter?

Regenxbio Inc. EPS for the last quarter amounts to -1.72 USD, decreased -1533.33

How many employees does Regenxbio Inc (RGNX). have?

Regenxbio Inc (RGNX) has 371 emplpoyees as of July 08 2026.

What is Regenxbio Inc (RGNX) market cap?

Today RGNX has the market capitalization of 776.50M USD.