Regenxbio Inc (RGNX)

$11.01 -2.40 (-17.90%)
Market Cap 678.85M
Revenue (ttm) 83.33M
Net Income (ttm) -227.10M
EPS (ttm) N/A
PE Ratio 0.00
Forward PE N/A
Profit Margin -272.53%
Debt to Equity Ratio 0.00
Volume 5,012,300
Avg Vol 808,586
Day's Range N/A - N/A
Shares Out 50.62M
Stochastic %K 22%
Beta 1.07
Analysts Strong Sell
Price Target $32.67

Company Profile

REGENXBIO Inc., a clinical-stage biotechnology company, provides gene therapies that deliver functional genes to cells with genetic defects in the United States. Its gene therapy product candidates are based on NAV Technology Platform, a proprietary adeno-associated virus gene delivery platform. The company's products in pipeline includes ABBV-RGX-314 for the treatment of wet age-related macular degeneration, diabetic retinopathy, and other chronic retinal diseases; and RGX-202, which is in Phas...

Industry: Biotechnology
Sector: Healthcare
Phone: 240 552 8181
Address:
9804 Medical Center Drive, Rockville, United States
topstockalerts
topstockalerts Jan. 29 at 3:07 PM
$RGNX Impressive strength showing today. Price refuses to pull back. Buyers remain aggressive 🔥.
1 · Reply
steven1x
steven1x Jan. 29 at 2:45 PM
$RGNX interesting … https://g.co/gemini/share/b640118b2e41
0 · Reply
Longbuy1
Longbuy1 Jan. 29 at 2:43 PM
$RGNX Clinical hold history for AAV vectors, almost all approved. Hunter syndrome has almost a 100% fatality rate by age 15 for severe cases. That'll weigh in on the FDA decision.
0 · Reply
steven1x
steven1x Jan. 29 at 2:07 PM
$RGNX https://x.com/adamfeuerstein/status/2016489914515198244?s=61
1 · Reply
amessagefromtheodd
amessagefromtheodd Jan. 29 at 11:45 AM
$RGNX 1. Where we are at, if testing shows no vector DNA in the tumor, the FDA will almost certainly lift the hold. That result means the gene therapy did not play a role in causing the cancer. If vector DNA is found but it’s scattered randomly and not tied to a single expanding cell population, the FDA will likely slow things down but not kill the program. They would ask for more analysis and possibly tighter monitoring, but this points away from causation. If the vector is found integrated near a cancer-related gene, that’s a serious problem. That suggests the therapy may have triggered the cancer, and the FDA would likely halt not just the trial but re-evaluate the entire platform. On tumor structure: If the tumor is polyclonal, meaning it arose from many different cells, that strongly argues the cancer developed naturally and was not caused by the therapy.
1 · Reply
Zaens
Zaens Jan. 29 at 9:09 AM
$RGNX So is it now a CRL on feb 8th or there’s a chance of approval?
0 · Reply
TimeForBio
TimeForBio Jan. 29 at 6:37 AM
$ABEO It happens quite often. The RGNX clinical hold triggered algorithmic selling of a “gene therapy” basket. Zevaskyn is ex-vivo gene cell therapy, not in-vivo AAV delivery, and is not exposed to the tumor/integration risk that drove the $RGNX headline. Algos dumped the entire “gene therapy” factor indiscriminately
1 · Reply
rando321456
rando321456 Jan. 29 at 2:12 AM
$RGNX I would say the main hit to this story is the potential of them having to do a 5-10 million share raise now. I personally think 121 will be approved within 12 months.(hopefully 3-4 or even in feb still) However it's a very real risk now that a PRV won't be obtained outside of that they already have front loaded the cash from 121 by both doing the deal with NS Pharma and the HCR financing last year. The big question in my mind now is what do they sell to raise money next? It could be one or a combo of the ROW Rights to the MPS assets, the ROW rights to 202, or just equity.
1 · Reply
thehivemindfund
thehivemindfund Jan. 29 at 12:41 AM
$RGNX Original PDUFA date was November 9. It was extended by the FDA to February 8 to allow review of additional longer-term CAMPSIITE data. I don't see any news of another delay. Feb 8 is still action date for 121.
0 · Reply
mikesterz7
mikesterz7 Jan. 28 at 10:53 PM
$RGNX The company announced earlier on Wednesday that the U.S. Food and Drug Administration placed a clinical hold on its investigational gene therapy, RGX-111, for the treatment of Hurler syndrome.
0 · Reply
Latest News on RGNX
FDA Clinical Hold Knocks REGENXBIO Stock

Jan 28, 2026, 12:31 PM EST - 22 hours ago

FDA Clinical Hold Knocks REGENXBIO Stock

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

Jan 28, 2026, 7:46 AM EST - 1 day ago

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

REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs

Jan 28, 2026, 7:30 AM EST - 1 day ago

REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs

REGENXBIO: Key FDA Decision On Hunter Syndrome Just Weeks Away

Jan 27, 2026, 8:28 AM EST - 2 days ago

REGENXBIO: Key FDA Decision On Hunter Syndrome Just Weeks Away

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

Jan 14, 2026, 4:25 PM EST - 14 days ago

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

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

Jan 11, 2026, 3:00 PM EST - 17 days ago

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

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

Dec 18, 2025, 7:05 AM EST - 6 weeks ago

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

REGENXBIO to Participate in Upcoming Investor Conference

Nov 25, 2025, 7:05 AM EST - 2 months ago

REGENXBIO to Participate in Upcoming Investor Conference

REGENXBIO Inc. (RGNX) Q3 2025 Earnings Call Transcript

Nov 6, 2025, 4:16 PM EST - 2 months ago

REGENXBIO Inc. (RGNX) Q3 2025 Earnings Call Transcript

REGENXBIO Reports Third Quarter 2025 Financial Results and Operational Highlights

Nov 6, 2025, 7:05 AM EST - 3 months ago

REGENXBIO Reports Third Quarter 2025 Financial Results and Operational Highlights

REGENXBIO Announces Completion of Pivotal Enrollment and Initiates Commercial Production in Duchenne Gene Therapy Program

Oct 30, 2025, 7:05 AM EDT - 3 months ago

REGENXBIO Announces Completion of Pivotal Enrollment and Initiates Commercial Production in Duchenne Gene Therapy Program

REGENXBIO to Host Conference Call on November 6 to Discuss Third Quarter 2025 Financial Results and Operational Highlights

Oct 29, 2025, 7:05 AM EDT - 3 months ago

REGENXBIO to Host Conference Call on November 6 to Discuss Third Quarter 2025 Financial Results and Operational Highlights

REGENXBIO to Participate in Upcoming Investor Conferences

Oct 15, 2025, 7:05 AM EDT - 3 months ago

REGENXBIO to Participate in Upcoming Investor Conferences

REGENXBIO Announces Presentation at the American Academy of Ophthalmology 2025 Annual Meeting

Oct 9, 2025, 7:05 AM EDT - 4 months ago

REGENXBIO Announces Presentation at the American Academy of Ophthalmology 2025 Annual Meeting

REGENXBIO Announces Completion of Enrollment in Pivotal Trials of Subretinal Surabgene Lomparvovec for Wet AMD

Oct 6, 2025, 7:05 AM EDT - 4 months ago

REGENXBIO Announces Completion of Enrollment in Pivotal Trials of Subretinal Surabgene Lomparvovec for Wet AMD

REGENXBIO Announces Presentation at the World Muscle Society

Sep 29, 2025, 7:05 AM EDT - 4 months ago

REGENXBIO Announces Presentation at the World Muscle Society

Regenxbio: Poised For Breakthrough With RGX-121 Gene Therapy In Hunter Syndrome

Sep 9, 2025, 6:12 AM EDT - 5 months ago

Regenxbio: Poised For Breakthrough With RGX-121 Gene Therapy In Hunter Syndrome

REGENXBIO Inc. (RGNX) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript

Sep 8, 2025, 2:05 PM EDT - 5 months ago

REGENXBIO Inc. (RGNX) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript

Regenxbio: Remains A "Buy Rating" Despite BLA Review Delay Of RGX-121 For Hunter Syndrome

Sep 6, 2025, 8:29 AM EDT - 5 months ago

Regenxbio: Remains A "Buy Rating" Despite BLA Review Delay Of RGX-121 For Hunter Syndrome

REGENXBIO Presents Positive Twelve-Month Pivotal Data from Phase I/II/III CAMPSIITE® Trial of RGX-121 for Treatment of MPS II

Sep 5, 2025, 7:05 AM EDT - 5 months ago

REGENXBIO Presents Positive Twelve-Month Pivotal Data from Phase I/II/III CAMPSIITE® Trial of RGX-121 for Treatment of MPS II

FDA Extends Decision Date On Regenxbio's Gene Therapy Into Next Year

Aug 19, 2025, 12:01 PM EDT - 5 months ago

FDA Extends Decision Date On Regenxbio's Gene Therapy Into Next Year

REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II

Aug 18, 2025, 5:00 PM EDT - 5 months ago

REGENXBIO Announces FDA Review Extension of BLA for RGX-121 to Treat Patients with MPS II

REGENXBIO Inc. (RGNX) Q2 2025 Earnings Call Transcript

Aug 8, 2025, 9:11 AM EDT - 6 months ago

REGENXBIO Inc. (RGNX) Q2 2025 Earnings Call Transcript

REGENXBIO Reports Second Quarter 2025 Financial Results and Operational Highlights

Aug 7, 2025, 7:05 AM EDT - 6 months ago

REGENXBIO Reports Second Quarter 2025 Financial Results and Operational Highlights

REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy

Aug 7, 2025, 7:00 AM EDT - 6 months ago

REGENXBIO Announces Pivotal Program for Surabgene Lomparvovec in Diabetic Retinopathy

REGENXBIO to Host Conference Call on August 7 to Discuss Second Quarter 2025 Financial Results and Operational Highlights

Jul 31, 2025, 7:05 AM EDT - 6 months ago

REGENXBIO to Host Conference Call on August 7 to Discuss Second Quarter 2025 Financial Results and Operational Highlights

REGENXBIO Announces Publication of Preclinical Results Demonstrating Functional Benefits of Novel Microdystrophin Construct in RGX-202 Investigational Gene Therapy for Duchenne Muscular Dystrophy

Jul 10, 2025, 11:54 AM EDT - 7 months ago

REGENXBIO Announces Publication of Preclinical Results Demonstrating Functional Benefits of Novel Microdystrophin Construct in RGX-202 Investigational Gene Therapy for Duchenne Muscular Dystrophy

Regenxbio's RGX-121 Could Become The New Standard Of Care In Hunter Syndrome

Jun 6, 2025, 4:02 PM EDT - 8 months ago

Regenxbio's RGX-121 Could Become The New Standard Of Care In Hunter Syndrome

Early Wins: RegenXBio's Gene Therapy Helps Duchenne Patients Walk Stronger, Longer

Jun 5, 2025, 11:43 AM EDT - 8 months ago

Early Wins: RegenXBio's Gene Therapy Helps Duchenne Patients Walk Stronger, Longer

REGENXBIO REPORTS NEW POSITIVE FUNCTIONAL DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202

Jun 5, 2025, 7:05 AM EDT - 8 months ago

REGENXBIO REPORTS NEW POSITIVE FUNCTIONAL DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202

REGENXBIO to Host Webcast Discussing Interim Functional Data from the Phase I/II AFFINITY DUCHENNE® Trial of RGX-202

Jun 2, 2025, 7:05 AM EDT - 8 months ago

REGENXBIO to Host Webcast Discussing Interim Functional Data from the Phase I/II AFFINITY DUCHENNE® Trial of RGX-202

REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million

May 19, 2025, 4:05 PM EDT - 9 months ago

REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million

FDA Accepts Biologics License Application for Mucopolysaccharidosis II Treatment

May 14, 2025, 7:13 AM EDT - 9 months ago

FDA Accepts Biologics License Application for Mucopolysaccharidosis II Treatment

REGENXBIO Inc. (RGNX) Q1 2025 Earnings Call Transcript

May 13, 2025, 7:07 AM EDT - 9 months ago

REGENXBIO Inc. (RGNX) Q1 2025 Earnings Call Transcript

REGENXBIO Announces FDA Acceptance and Priority Review of the BLA for RGX-121 for MPS II

May 13, 2025, 7:05 AM EDT - 9 months ago

REGENXBIO Announces FDA Acceptance and Priority Review of the BLA for RGX-121 for MPS II

REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights

May 12, 2025, 4:05 PM EDT - 9 months ago

REGENXBIO Reports First Quarter 2025 Financial Results and Recent Operational Highlights

REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy 28th Annual Meeting

May 8, 2025, 7:05 AM EDT - 9 months ago

REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy 28th Annual Meeting

REGENXBIO to Host Conference Call on May 12 to Discuss First Quarter 2025 Financial Results and Recent Operational Highlights

Apr 30, 2025, 4:05 PM EDT - 9 months ago

REGENXBIO to Host Conference Call on May 12 to Discuss First Quarter 2025 Financial Results and Recent Operational Highlights

5 Reasons To Buy Regenxbio Right Now

Mar 26, 2025, 12:31 PM EDT - 11 months ago

5 Reasons To Buy Regenxbio Right Now

REGENXBIO REPORTS POSITIVE BIOMARKER DATA FROM AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY

Mar 19, 2025, 9:15 AM EDT - 11 months ago

REGENXBIO REPORTS POSITIVE BIOMARKER DATA FROM AFFINITY DUCHENNE® TRIAL OF RGX-202 GENE THERAPY

REGENXBIO Inc. (RGNX) Q4 2024 Earnings Call Transcript

Mar 13, 2025, 6:44 PM EDT - 11 months ago

REGENXBIO Inc. (RGNX) Q4 2024 Earnings Call Transcript

REGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates

Mar 13, 2025, 4:05 PM EDT - 11 months ago

REGENXBIO Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Updates

REGENXBIO Announces Presentations at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference

Mar 10, 2025, 7:05 AM EDT - 11 months ago

REGENXBIO Announces Presentations at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference

REGENXBIO Announces Closing of Strategic Partnership with Nippon Shinyaku for MPS Diseases

Mar 4, 2025, 7:31 AM EST - 11 months ago

REGENXBIO Announces Closing of Strategic Partnership with Nippon Shinyaku for MPS Diseases

REGENXBIO to Host Conference Call on March 13 to Discuss Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Highlights

Feb 26, 2025, 4:05 PM EST - 1 year ago

REGENXBIO to Host Conference Call on March 13 to Discuss Fourth Quarter and Full Year 2024 Financial Results and Recent Operational Highlights

Regenxbio's Gene Therapy Outlook Dims As Rival Treatments Gain Ground, Goldman Sachs Warns

Feb 11, 2025, 3:20 PM EST - 1 year ago

Regenxbio's Gene Therapy Outlook Dims As Rival Treatments Gain Ground, Goldman Sachs Warns

REGENXBIO Announces Presentations of RGX-121 at the 21st Annual WORLDSymposium 2025

Jan 30, 2025, 7:05 AM EST - 1 year ago

REGENXBIO Announces Presentations of RGX-121 at the 21st Annual WORLDSymposium 2025

Regenxbio: Wet AMD ABBV-RGX-314 Results Remain On Track For 2026

Jan 16, 2025, 4:01 AM EST - 1 year ago

Regenxbio: Wet AMD ABBV-RGX-314 Results Remain On Track For 2026

AMD

Regenxbio Inc.: Why It Is Down, And When It Will Go Up Again

Jan 15, 2025, 3:27 PM EST - 1 year ago

Regenxbio Inc.: Why It Is Down, And When It Will Go Up Again

topstockalerts
topstockalerts Jan. 29 at 3:07 PM
$RGNX Impressive strength showing today. Price refuses to pull back. Buyers remain aggressive 🔥.
1 · Reply
steven1x
steven1x Jan. 29 at 2:45 PM
$RGNX interesting … https://g.co/gemini/share/b640118b2e41
0 · Reply
Longbuy1
Longbuy1 Jan. 29 at 2:43 PM
$RGNX Clinical hold history for AAV vectors, almost all approved. Hunter syndrome has almost a 100% fatality rate by age 15 for severe cases. That'll weigh in on the FDA decision.
0 · Reply
steven1x
steven1x Jan. 29 at 2:07 PM
$RGNX https://x.com/adamfeuerstein/status/2016489914515198244?s=61
1 · Reply
amessagefromtheodd
amessagefromtheodd Jan. 29 at 11:45 AM
$RGNX 1. Where we are at, if testing shows no vector DNA in the tumor, the FDA will almost certainly lift the hold. That result means the gene therapy did not play a role in causing the cancer. If vector DNA is found but it’s scattered randomly and not tied to a single expanding cell population, the FDA will likely slow things down but not kill the program. They would ask for more analysis and possibly tighter monitoring, but this points away from causation. If the vector is found integrated near a cancer-related gene, that’s a serious problem. That suggests the therapy may have triggered the cancer, and the FDA would likely halt not just the trial but re-evaluate the entire platform. On tumor structure: If the tumor is polyclonal, meaning it arose from many different cells, that strongly argues the cancer developed naturally and was not caused by the therapy.
1 · Reply
Zaens
Zaens Jan. 29 at 9:09 AM
$RGNX So is it now a CRL on feb 8th or there’s a chance of approval?
0 · Reply
TimeForBio
TimeForBio Jan. 29 at 6:37 AM
$ABEO It happens quite often. The RGNX clinical hold triggered algorithmic selling of a “gene therapy” basket. Zevaskyn is ex-vivo gene cell therapy, not in-vivo AAV delivery, and is not exposed to the tumor/integration risk that drove the $RGNX headline. Algos dumped the entire “gene therapy” factor indiscriminately
1 · Reply
rando321456
rando321456 Jan. 29 at 2:12 AM
$RGNX I would say the main hit to this story is the potential of them having to do a 5-10 million share raise now. I personally think 121 will be approved within 12 months.(hopefully 3-4 or even in feb still) However it's a very real risk now that a PRV won't be obtained outside of that they already have front loaded the cash from 121 by both doing the deal with NS Pharma and the HCR financing last year. The big question in my mind now is what do they sell to raise money next? It could be one or a combo of the ROW Rights to the MPS assets, the ROW rights to 202, or just equity.
1 · Reply
thehivemindfund
thehivemindfund Jan. 29 at 12:41 AM
$RGNX Original PDUFA date was November 9. It was extended by the FDA to February 8 to allow review of additional longer-term CAMPSIITE data. I don't see any news of another delay. Feb 8 is still action date for 121.
0 · Reply
mikesterz7
mikesterz7 Jan. 28 at 10:53 PM
$RGNX The company announced earlier on Wednesday that the U.S. Food and Drug Administration placed a clinical hold on its investigational gene therapy, RGX-111, for the treatment of Hurler syndrome.
0 · Reply
JFais
JFais Jan. 28 at 9:15 PM
Mid-week in Chat, some great discussions ongoing: $RGNX noteworthy today, including concerns on AAV9 vector for protooncogene expression, implications for $QURE and other gene therapy peers In non-biotech channel, focus is on how to optimally diversify away from US-based assets (also plays on tokenization, megatrend in financial sector with $4T to $19T TAM depending on who you ask) $XLF
1 · Reply
StocktwitsNews
StocktwitsNews Jan. 28 at 8:30 PM
RGNX Shares Pare Losses As Wall Street Dismisses Gene Therapy Clinical Hold Spurred Selloff As An Overreaction $RGNX $IWMW $AVUS https://stocktwits.com/news/equity/markets/rgnx-shares-pare-losses-as-wall-street-dismisses-gene-therapy-clinical-hold-spurred-selloff-as-an-overreaction/cmygL8VR40Y
0 · Reply
TrialWatcher
TrialWatcher Jan. 28 at 8:27 PM
$RGNX PDUFA delayed 3 months, FDA clinical hold due to brain tumor in a TINY trial.. what good news is expected on Feb 8?
1 · Reply
Longbuy1
Longbuy1 Jan. 28 at 8:05 PM
$RGNX AAVs almost never migrate into the host genome. Wouldn't be surprised to see ABBV take a swing at a BO is there was a delay. They know the science.
1 · Reply
kenny91655
kenny91655 Jan. 28 at 7:30 PM
$RGNX I think the news is worse than the price action. I don't see the approval on the 8th if it is in a clinical hold
3 · Reply
TrialWatcher
TrialWatcher Jan. 28 at 7:27 PM
$RGNX did you mean BlackRock dumped 2m shares?
1 · Reply
Longbuy1
Longbuy1 Jan. 28 at 7:00 PM
$RGNX Blackrock went from 6M to 8M shares today.
1 · Reply
Longbuy1
Longbuy1 Jan. 28 at 6:58 PM
$RGNX Blackrock is going to close this at 12, and inch it's way back to 13. Like they give a shit if 121 is delayed.
1 · Reply
TrialWatcher
TrialWatcher Jan. 28 at 6:54 PM
$RGNX retail investors hold through clinical trial halts? That’s new to me. I don’t think FDA is trying to steal your tendies with this one.
1 · Reply
Longbuy1
Longbuy1 Jan. 28 at 6:29 PM
$DNLI $RGNX it's saying that retail is stupid and sell your shares cheap,.
0 · Reply
Smellmahass
Smellmahass Jan. 28 at 6:27 PM
$RGNX What is this saying? Is it talking about pdufa delay?
0 · Reply
Lorianyj
Lorianyj Jan. 28 at 6:16 PM
$RGNX gene therapy biotech; asymmetry on catalysts with volume confirm needed
0 · Reply