Earnings summaries and quarterly performance for REGENXBIO.
Executive leadership at REGENXBIO.
Curran Simpson
Detailed
President and Chief Executive Officer
CEO
CM
Craig Malzahn
Detailed
Executive Vice President, Product Development and Chief Technology Officer
MC
Mitchell Chan
Detailed
Executive Vice President, Chief Financial Officer and Treasurer
PC
Patrick Christmas
Detailed
Executive Vice President, Chief Strategy and Legal Officer
SP
Steve Pakola
Detailed
Executive Vice President, Chief Medical Officer
Board of directors at REGENXBIO.
AG
Alexandra Glucksmann
Detailed
Director
AF
Allan Fox
Detailed
Director
DT
Daniel Tassé
Detailed
Lead Independent Director
DS
David Stump
Detailed
Director
GM
George Migausky
Detailed
Director
JB
Jean Bennett
Detailed
Director
JZ
Jennifer Zachary
Detailed
Director
JK
Jerry Karabelas
Detailed
Director
KM
Kenneth Mills
Detailed
Chairman of the Board
Research analysts who have asked questions during REGENXBIO earnings calls.
Judah Frommer
Morgan Stanley
3 questions for RGNX
Also covers: APLS, ARQT, ATAI +4 more
KC
Kyuwon Choi
Goldman Sachs
3 questions for RGNX
Also covers: AMRN, ASND, BHVN +9 more
Sean McCutcheon
Raymond James
3 questions for RGNX
Also covers: BMY, CMPX, CRIS +6 more
YC
Yi Chen
H.C. Wainwright & Co.
3 questions for RGNX
Also covers: ANGO, APDN, BLFS +22 more
Alec Stranahan
Bank of America
2 questions for RGNX
Also covers: AGIO, ALEC, BTAI +11 more
Annabel Samimy
Stifel Financial Corp.
2 questions for RGNX
Also covers: ALT, APLS, CARA +14 more
Brian Skorney
Robert W. Baird & Co.
2 questions for RGNX
Also covers: ABUS, CRNX, MIRM +6 more
DG
Daniil Gataulin
Chardan
2 questions for RGNX
Also covers: CGTX, CLSD, EYPT +3 more
HW
Huidong Wang
Barclays
2 questions for RGNX
Also covers: ALNY, BCRX, BEAM +15 more
Jack Padovano
Stifel
2 questions for RGNX
Also covers: RVNC, SUPN
LW
Lisa Walter
RBC Capital Markets
2 questions for RGNX
Also covers: APLS, EYPT, OCUL +2 more
MF
Mani Foroohar
Leerink Partners
2 questions for RGNX
Also covers: ADVM, ALNY, ARWR +9 more
Ryan Mcelroy
Leerink Partners
2 questions for RGNX
Also covers: BBIO, MIRM
BM
Bill Maughan
Clear Street
1 question for RGNX
Also covers: DCTH, OCUL
EM
Eliana Merle
UBS
1 question for RGNX
Also covers: ALNY, APLS, ARVN +17 more
EM
Ellie Merle
UBS Group AG
1 question for RGNX
Also covers: ALNY, ALT, ARVN +12 more
GE
Gospel Enyindah-Asonye
Morgan Stanley
1 question for RGNX
Also covers: KYMR, VTYX
LI
Luca Issi
RBC Capital Markets
1 question for RGNX
Also covers: ADVM, ALLO, ALNY +12 more
Luke Lapointe
Robert W. Baird & Co.
1 question for RGNX
PC
Paul Choi
Goldman Sachs
1 question for RGNX
Also covers: AMRN, ARVN, ASND +12 more
Qian Wang
Barclays
1 question for RGNX
ST
Shelby Tucker
RBC Capital Markets
1 question for RGNX
Also covers: ALLO, UTL
Tejas Vyas
UBS
1 question for RGNX
Recent press releases and 8-K filings for RGNX.
Regenxbio under investigation following FDA clinical holds
RGNX
Legal Proceedings
- Levi & Korsinsky, LLP is investigating Regenxbio Inc. (RGNX) for potential gaps between information provided to investors and underlying safety developments in its gene therapy clinical programs.
- On January 28, 2026, Regenxbio disclosed that the FDA placed clinical holds on its RGX-111 and RGX-121 programs after a tumor was identified in a trial participant.
- This disclosure led to a 30-35% decline in the company's share price.
- The investigation questions the completeness of information provided, noting that during the Q3 2025 earnings call on November 6, 2025, CEO Curran Simpson highlighted positive regulatory interactions without disclosing safety concerns, and the RGX-111 program was not discussed.
Jan 29, 2026, 11:06 PM
REGENXBIO Gene Therapy Trials Placed on Clinical Hold by FDA
RGNX
New Projects/Investments
Profit Warning
- The U.S. Food and Drug Administration (FDA) has placed clinical holds on REGENXBIO’s investigational gene therapies RGX-111 (for MPS I/Hurler) and RGX-121 (for MPS II/Hunter).
- This action followed the identification of an intraventricular CNS neoplasm in a five-year-old participant in the RGX-111 Phase I/II study, though causality to the therapy has not been established and the participant remains asymptomatic.
- RGNX shares experienced a steep sell-off, closing down 17.75% at $11.03 with volume around 3.88 million shares, significantly above the average.
- The FDA cited similarities in products, study populations, and shared risk for the hold, despite no additional neoplasms reported among other trial participants and RGX-121's prior safety record in over 30 patients.
Jan 28, 2026, 1:59 PM
REGENXBIO Announces FDA Clinical Holds on MPS Programs
RGNX
- On January 28, 2026, REGENXBIO Inc. announced that the U.S. Food and Drug Administration (FDA) placed a clinical hold on its investigational gene therapy, RGX-111, for the treatment of MPS I.
- The FDA also placed a clinical hold on RGX-121 for the treatment of MPS II, citing similarities in products, study populations, and shared risk between the clinical studies.
- The hold on RGX-111 was initiated following the preliminary analysis of a single case of neoplasm (intraventricular CNS tumor) in a participant, where an AAV vector genome integration event was detected, although causality has not been established.
Jan 28, 2026, 1:30 PM
REGENXBIO announces FDA clinical hold on RGX-111 and RGX-121 programs
RGNX
Legal Proceedings
New Projects/Investments
- The U.S. Food and Drug Administration (FDA) has placed a clinical hold on REGENXBIO's investigational gene therapy, RGX-111, for the treatment of MPS I, following preliminary analysis of a single case of neoplasm (intraventricular CNS tumor) in a participant.
- The FDA also placed a clinical hold on RGX-121, for the treatment of MPS II, citing similarities in products, study populations, and shared risk between the clinical studies.
- Preliminary genetic analysis of the resected tumor in the RGX-111 participant detected an AAV vector genome integration event associated with overexpression of a proto-oncogene, though the investigation to determine if this event is drug related is ongoing and causality has not been established.
- REGENXBIO's President and CEO, Curran Simpson, expressed surprise at the RGX-121 hold, noting it is a separate therapy with a positive safety profile in over 30 patients, and no evidence of neoplasm has been reported in other RGX-111 or RGX-121 participants.
Jan 28, 2026, 12:30 PM
REGENXBIO: Gene Therapy Market Outlook Highlights Growth and Challenges
RGNX
New Projects/Investments
Product Launch
Revenue Acceleration/Inflection
- The Global Gene Therapy Market is projected for significant expansion, with an estimated value of $7.54 Billion in 2025 growing to $13.02 Billion by 2031, reflecting a Compound Annual Growth Rate (CAGR) of 9.53%.
- This market growth is supported by a pro-innovation regulatory environment, including the FDA's approval of a record nine new cell and gene therapies in 2024, and substantial investment, with the sector attracting $15.2 billion in global investment in 2024.
- Despite the positive outlook, the market faces considerable challenges, primarily the high complexity and cost of manufacturing gene therapies, which leads to high Cost of Goods Sold (COGS) and significant capital requirements for Good Manufacturing Practice (GMP) facilities.
- Key trends emerging to address these manufacturing hurdles include the adoption of strategic partnerships with Contract Development and Manufacturing Organizations (CDMOs) and a shift towards direct in vivo administration routes for therapies.
- REGENXBIO Inc. is identified as a key player within this dynamic and expanding Global Gene Therapy Market.
Jan 23, 2026, 11:01 AM
REGENXBIO Outlines Key 2026 Milestones for Hunter, Duchenne, and Retinal Programs
RGNX
New Projects/Investments
Product Launch
Guidance Update
- REGENXBIO anticipates a PDUFA date of February 8, 2026, for its Hunter program and expects top-line pivotal data for its RGX-202 Duchenne program in Q2 2026, followed by a BLA submission mid-2026.
- The company also expects top-line data for its RGX-314 wet AMD program, partnered with AbbVie, in late 2026.
- A $100 million milestone is associated with the start of a Phase II-B/III study for diabetic retinopathy in the first half of 2026.
- REGENXBIO highlights its industry-leading manufacturing capabilities, with a Rockville facility able to produce up to 2,500 doses per year for RGX-202 and 350,000 doses for Surovec, and a recent FDA inspection with no observations.
Jan 14, 2026, 6:30 PM
REGENXBIO Outlines Key Milestones and Pipeline Progress for 2026
RGNX
Guidance Update
New Projects/Investments
- REGENXBIO anticipates a PDUFA date of February 8th for its Hunter program (RGX-111) BLA review.
- The company expects top-line data in Q2 2026 for its Duchenne program (RGX-202), with a BLA submission planned for mid-2026, and late 2026 for its wet AMD program (RGX-314) partnered with AbbVie.
- REGENXBIO plans to initiate a Phase II-B/III study for diabetic retinopathy in the first half of this year, which includes a $100 million milestone upon dosing the first patient.
- The company highlights its manufacturing capabilities, with its Rockville facility able to produce up to 2,500 doses per year for RGX-202 and 350,000 doses for Surovec, and a recent FDA inspection resulting in no observations.
Jan 14, 2026, 6:30 PM
REGENXBIO Provides Updates on Clinical Pipeline and Regulatory Milestones
RGNX
Product Launch
New Projects/Investments
Guidance Update
- REGENXBIO anticipates a PDUFA date of February 8th, 2026, for its Hunter program (MPS II), which is currently under BLA review.
- The company expects top-line data for its RGX-202 Duchenne program in Q2 2026 and for its RGX-314 wet AMD program (partnered with AbbVie) late in 2026.
- A BLA submission for the RGX-202 Duchenne program is planned for mid-2026.
- REGENXBIO will initiate a Phase 2B/3 study for diabetic retinopathy in the first half of 2026, with a $100 million milestone payment expected upon dosing the first patient.
Jan 14, 2026, 6:30 PM
REGENXBIO Highlights 2026 Catalysts and Positive Duchenne Gene Therapy Data
RGNX
New Projects/Investments
Product Launch
Guidance Update
- REGENXBIO announced positive 18-month functional data for its RGX-202 Duchenne Muscular Dystrophy program, with all patients exceeding expected disease trajectory.
- The company anticipates a transformative 2026 with several key catalysts, including pivotal topline data for RGX-202 in early Q2 2026 and a Biologics License Application (BLA) submission in mid-2026.
- An FDA PDUFA decision for clemidsogene lanparvovec (RGX-121) is expected by February 8, 2026, and top-line data for surabgene lomparvovec (ABBV-RGX-314) is anticipated in Q4 2026.
- REGENXBIO expects a $100 million milestone payment from AbbVie in 1H 2026 upon the first patient dosed in a Phase IIb/III trial for surabgene lomparvovec for diabetic retinopathy.
Jan 11, 2026, 8:00 PM
REGENXBIO Outlines Key 2026 Milestones and Financial Outlook
RGNX
Product Launch
New Projects/Investments
Guidance Update
- REGENXBIO anticipates several key milestones in 2026, including a PDUFA date in February for its Hunter program (RGX-121), top-line data for its Duchenne program (RGX-202) in early Q2, and top-line data for its subretinal Wet AMD program (RGX-314) in late 2026.
- The company expects to dose the first patient in the diabetic retinopathy (RGX-314) 2B study in early 2026, which will trigger a $100 million milestone.
- REGENXBIO's current cash balance is projected to fund operations until early 2027, with potential non-dilutive financing extending the runway to late 2027 or early 2028.
- The company highlights its in-house manufacturing facility, which received no observations during FDA inspection, as a de-risked and differentiating asset for its gene therapy pipeline.
Dec 2, 2025, 1:30 PM
Quarterly earnings call transcripts for REGENXBIO.
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more