Market Cap 564.95M
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 701,800
Avg Vol 848,072
Day's Range N/A - N/A
Shares Out 50.62M
Stochastic %K 20%
Beta 1.07
Analysts Strong Sell
Price Target $32.58

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
rando321456
rando321456 Feb. 4 at 4:44 PM
$RGNX Novartis on sales potential of IT and IV SMA treatment: "Now Itvisma, which we haven’t had as much attention, but it’s something we continue to believe has a significant overall sales potential, total potential for this brand across the IV and IT of $3 billion+. " On sales ramp: "I think over the next 2-3 years, we would expect really Itvisma to penetrate the majority of the kind of relevant patient pool that it has and then come back down, as we saw with Zolgensma, more to a steady state because of the nature of the one-time therapy. So I think relative to other brands, the ramp will be on the faster side."
1 · Reply
Savon13
Savon13 Feb. 4 at 4:26 PM
$RGNX ironically this is one of the few stocks in my portfolio to not take a major shit this morning. I’ll take this sideways action
0 · Reply
HODLHammer
HODLHammer Feb. 4 at 4:07 PM
$RGNX is a clinical-stage gene therapy company (REGENXBIO); its pipeline includes both partnered and proprietary assets, but the gene therapy sector faces technical, manufacturing, and reimbursement challenges.
0 · Reply
thehivemindfund
thehivemindfund Feb. 4 at 3:46 PM
$RGNX why assume a second delay? our pdufa has nothing to do with other drug candidate. does everyone here just mix up data like a whirlpool?
1 · Reply
HamBoneXoXo
HamBoneXoXo Feb. 4 at 3:21 PM
$RGNX $RGNX At these prices, smart money is buying while confused Joe trader circle jerking
0 · Reply
TrialWatcher
TrialWatcher Feb. 4 at 2:37 PM
$RGNX Need one mega bull to sell me more $10P for 2/20 at 45c ea
0 · Reply
Lanikai16
Lanikai16 Feb. 3 at 11:28 PM
$RGNX If your long, this should be the reason…there will likely be no decision now on 121 before Duchenne reports topline data. Duchenne is a multi billion market and wet AMD is even larger. RGNX is currently a 550MM mkt cap & well funded into 2027. Nice risk/reward setup imo Key Catalysts in 2026 - RGX-202 (Duchenne): Pivotal topline data expected early Q2 2026 (e.g., April-May), followed by BLA submission mid-2026 under accelerated approval. Recent Phase I/II updates (Jan 2026) showed durable +7.4 NSAA points vs. natural history at 18 months—strong differentiation as the only next-gen microdystrophin candidate in pivotal stage. - ABBV-RGX-314 (wet AMD): Topline pivotal data from ATMOSPHERE/ASCENT (subretinal) expected Q4 2026 (late year). First patient dosing in sura-vec triggers $100M AbbVie milestone (likely 1H 2026). This could be the first gene therapy for a major non-rare disease (wet AMD market potential multi-billion+), with long-term durability vs. frequent injections.
1 · Reply
Lanikai16
Lanikai16 Feb. 3 at 11:05 PM
$RGNX Most Likely scenario (~70-80% probability): PDUFA date missed (no action by Feb 8), with de facto delay while hold is investigated. Regenxbio would announce this (or any formal extension) via press release/SEC filing shortly after Feb 8 if no decision comes. Hold resolution could take 3-9+ months, potentially leading to: - Hold lift + approval (if investigation clears the signal as unrelated/low risk). - Hold lift + CRL or label discussions requiring more data. - Rare but possible: Approval with post-marketing commitments (e.g., enhanced monitoring), though unlikely given timing. (MPS II affects ~1 in 100,000-170,000 births, with urgent need for better CNS-penetrating treatments beyond ERT). The single-event nature (no pattern in long-term follow-up) and strong RGX-121 safety/efficacy data could support eventual positive resolution, but FDA caution on potential genotoxicity/integration risks in AAV CNS delivery makes near-term approval improbable
0 · Reply
Steve_TheBull_Rogers
Steve_TheBull_Rogers Feb. 3 at 7:55 PM
$RGNX One of the easiest CRL plays in years Here are the facts: 1. They can't delay this FDA result as they've already had 1 delay 2. the FDA a gov medical body will no approve a drug (even with a black box) that has potentially given a patient a tumour! See you under 8 post CRL I have no clue why anyone with an inch of a brain cell would be going long into this!
4 · Reply
rando321456
rando321456 Feb. 3 at 7:44 PM
$RGNX Btw the extension to the PRV program is in the spending bill about to be signed, from an investor standpoint if the FDA does a CRL here solely due to the hold it's now mostly meaningless. We should be able to get a PRV for 202 aswell, will be very interesting to see how sticky the prices are. Though for the kids' sakes I hope the FDA makes the right decision here and lets them begin treatment.
2 · Reply
Latest News on RGNX
FDA Clinical Hold Knocks REGENXBIO Stock

Jan 28, 2026, 12:31 PM EST - 7 days ago

FDA Clinical Hold Knocks REGENXBIO Stock


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 - 3 months ago

REGENXBIO Inc. (RGNX) Q3 2025 Earnings Call Transcript


REGENXBIO to Participate in Upcoming Investor Conferences

Oct 15, 2025, 7:05 AM EDT - 4 months ago

REGENXBIO to Participate in Upcoming Investor Conferences


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 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 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


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 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


rando321456
rando321456 Feb. 4 at 4:44 PM
$RGNX Novartis on sales potential of IT and IV SMA treatment: "Now Itvisma, which we haven’t had as much attention, but it’s something we continue to believe has a significant overall sales potential, total potential for this brand across the IV and IT of $3 billion+. " On sales ramp: "I think over the next 2-3 years, we would expect really Itvisma to penetrate the majority of the kind of relevant patient pool that it has and then come back down, as we saw with Zolgensma, more to a steady state because of the nature of the one-time therapy. So I think relative to other brands, the ramp will be on the faster side."
1 · Reply
Savon13
Savon13 Feb. 4 at 4:26 PM
$RGNX ironically this is one of the few stocks in my portfolio to not take a major shit this morning. I’ll take this sideways action
0 · Reply
HODLHammer
HODLHammer Feb. 4 at 4:07 PM
$RGNX is a clinical-stage gene therapy company (REGENXBIO); its pipeline includes both partnered and proprietary assets, but the gene therapy sector faces technical, manufacturing, and reimbursement challenges.
0 · Reply
thehivemindfund
thehivemindfund Feb. 4 at 3:46 PM
$RGNX why assume a second delay? our pdufa has nothing to do with other drug candidate. does everyone here just mix up data like a whirlpool?
1 · Reply
HamBoneXoXo
HamBoneXoXo Feb. 4 at 3:21 PM
$RGNX $RGNX At these prices, smart money is buying while confused Joe trader circle jerking
0 · Reply
TrialWatcher
TrialWatcher Feb. 4 at 2:37 PM
$RGNX Need one mega bull to sell me more $10P for 2/20 at 45c ea
0 · Reply
Lanikai16
Lanikai16 Feb. 3 at 11:28 PM
$RGNX If your long, this should be the reason…there will likely be no decision now on 121 before Duchenne reports topline data. Duchenne is a multi billion market and wet AMD is even larger. RGNX is currently a 550MM mkt cap & well funded into 2027. Nice risk/reward setup imo Key Catalysts in 2026 - RGX-202 (Duchenne): Pivotal topline data expected early Q2 2026 (e.g., April-May), followed by BLA submission mid-2026 under accelerated approval. Recent Phase I/II updates (Jan 2026) showed durable +7.4 NSAA points vs. natural history at 18 months—strong differentiation as the only next-gen microdystrophin candidate in pivotal stage. - ABBV-RGX-314 (wet AMD): Topline pivotal data from ATMOSPHERE/ASCENT (subretinal) expected Q4 2026 (late year). First patient dosing in sura-vec triggers $100M AbbVie milestone (likely 1H 2026). This could be the first gene therapy for a major non-rare disease (wet AMD market potential multi-billion+), with long-term durability vs. frequent injections.
1 · Reply
Lanikai16
Lanikai16 Feb. 3 at 11:05 PM
$RGNX Most Likely scenario (~70-80% probability): PDUFA date missed (no action by Feb 8), with de facto delay while hold is investigated. Regenxbio would announce this (or any formal extension) via press release/SEC filing shortly after Feb 8 if no decision comes. Hold resolution could take 3-9+ months, potentially leading to: - Hold lift + approval (if investigation clears the signal as unrelated/low risk). - Hold lift + CRL or label discussions requiring more data. - Rare but possible: Approval with post-marketing commitments (e.g., enhanced monitoring), though unlikely given timing. (MPS II affects ~1 in 100,000-170,000 births, with urgent need for better CNS-penetrating treatments beyond ERT). The single-event nature (no pattern in long-term follow-up) and strong RGX-121 safety/efficacy data could support eventual positive resolution, but FDA caution on potential genotoxicity/integration risks in AAV CNS delivery makes near-term approval improbable
0 · Reply
Steve_TheBull_Rogers
Steve_TheBull_Rogers Feb. 3 at 7:55 PM
$RGNX One of the easiest CRL plays in years Here are the facts: 1. They can't delay this FDA result as they've already had 1 delay 2. the FDA a gov medical body will no approve a drug (even with a black box) that has potentially given a patient a tumour! See you under 8 post CRL I have no clue why anyone with an inch of a brain cell would be going long into this!
4 · Reply
rando321456
rando321456 Feb. 3 at 7:44 PM
$RGNX Btw the extension to the PRV program is in the spending bill about to be signed, from an investor standpoint if the FDA does a CRL here solely due to the hold it's now mostly meaningless. We should be able to get a PRV for 202 aswell, will be very interesting to see how sticky the prices are. Though for the kids' sakes I hope the FDA makes the right decision here and lets them begin treatment.
2 · Reply
Steve_TheBull_Rogers
Steve_TheBull_Rogers Feb. 3 at 5:35 PM
$RGNX FYI The 10P are mis-priced here to market/PDUFA move So took 20 more at the ask at .45c Avg up now 38c avg I take the put sellers are retail as they didn't add in the vega to the contract here By 8-9$ even these will be up 100-200%
2 · Reply
Steve_TheBull_Rogers
Steve_TheBull_Rogers Feb. 3 at 4:16 PM
$RGNX Sitting on the bid at 40c for 10P FEB 20s if any you longs want to sell me some puts?
2 · Reply
WaveRB77
WaveRB77 Feb. 3 at 3:18 PM
$RGNX why is this stock holding its position with the FDA delay.
2 · Reply
Brian_CC
Brian_CC Feb. 3 at 6:08 AM
$RGNX The biggest mob is the FDA with Prasad at it's helm. He wasn't a fan of SRPT and CAPR.
0 · Reply
OfficialStocktwitsUser
OfficialStocktwitsUser Feb. 3 at 12:56 AM
$RGNX RSI: 29.19, MACD: -0.6100 Vol: 1.53, MA20: 13.78, MA50: 13.49 ⚪ HOLD - Sideways 👉 https://quantumstockalerts.com Disclaimer: I am not a financial advisor. This post reflects personal analysis and opinions only. Please do your own research before investing or trading.
0 · Reply
Savon13
Savon13 Feb. 2 at 9:52 PM
$RGNX this is a coin flip plain and simple. My bet is on approval with post marketing requirements 😎. 🤷‍♂️ I’ll see you on the other side
5 · Reply
TrialWatcher
TrialWatcher Feb. 2 at 6:33 PM
$RGNX clinical hold 11 days before PDUFA = nearly guaranteed CRL response. CRL would likely be FDA requesting more info on brain tumor found in patient and if other patients are at risk across the trials. FDA guidance will be very important on Feb 8th.
1 · Reply
TrialWatcher
TrialWatcher Feb. 2 at 5:21 PM
$RGNX some fund wants out at $12
1 · Reply
rando321456
rando321456 Feb. 2 at 3:04 PM
$RGNX How much do you guys think the deprioritization of SCS Wet AMD treatment and Abbvie doubling down on SR delivery by sole funding a phase 3b signal that what they are seeing out of the SR pivotals is very strong? From what I understand Abbvie should have a pretty decent understanding of what the pivotal readouts will look like due to the trial being partially masked. I just don't see how they could justify setting up an 8 year trial a year before primary readout otherwise.
2 · Reply
Steve_TheBull_Rogers
Steve_TheBull_Rogers Feb. 1 at 7:45 PM
$RGNX FDA isn't going to approve a pipeline that potentially gave a patient a tumour! Grow up longs. The trade here is the downside. See you under 8 next week post CRL. Don't say I didn't warn you.
4 · Reply
rando321456
rando321456 Feb. 1 at 6:57 AM
$RGNX What's so horrible about what the FDA did here is that it will have a pretty broad chilling effect on R&D in general. For instance why would Regenx even run a pivotal in MPS I now if they're gonna pull this crap? Furthermore why would companies with advanced therapies with good safety profiles risk running different therapies in new indications on the chance the FDA would put in such a hold on an SAE?
1 · Reply
rando321456
rando321456 Jan. 31 at 10:58 PM
$RGNX What's interesting about their NPDR effort is that we effectively already have 200+ SCS injections of 314 already performed and years of corresponding data at this point. It's likely that the safety aspect of this upcoming trial is largely derisked. The big question imo is if they can get a breakthrough in efficacy by upping the dose 50%.
0 · Reply