REGENXBIO

REGENXBIO, Inc. is a clinical-stage biotechnology company, which engages in the development, commercialization, and licensing of recombinant adeno-associated virus gene therapy. Its product candidates include the NAV Technology Platform, which consists of exclusive rights to novel adeno-associated viral vectors, and therapeutic programs such as RGX-314, RGX-202, RGX-121, RGX-111, RGX-181, and RGX-381. The company was founded by Kenneth T. Mills and James M. Wilson on July 16, 2008 and is headquartered in Rockville, MD.

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REGENXBIO reports robust earnings, eyes gene therapy market expansion

REGENXBIO's Q4 2022 earnings call highlighted strong financial performance, progress in gene therapy development, and strategic collaborations with AbbVie.
While challenges like precise dosing and program validation exist, the company's focus on innovation and market potential present significant growth opportunities.
With a robust pipeline, efficient development processes, and a commitment to addressing unmet medical needs, REGENXBIO is well-positioned for continued success in the gene therapy market.
Investors can look forward to potential revenue growth from royalty recognition and license agreements, supported by the company's solid financial foundation and strategic initiatives.

REGENXBIO reports solid Q1 earnings, advances gene therapy initiatives

REGENXBIO's Q1 2023 earnings call showcased strong financial performance, progress in gene therapy, and strategic partnerships, positioning the company for future growth.
Challenges such as patient exclusions in clinical trials and decision-making on pivotal studies require careful navigation and operational focus.
Opportunities in partnership milestones, regulatory paths, and market differentiation present avenues for continued success and innovation in the gene therapy space.

REGENXBIO advances AAV therapeutics with strong Q2 performance

REGENXBIO's Q2 performance reflects progress in AAV therapeutics and positive clinical outcomes, supported by a strong financial position and strategic focus on urgent medical needs.
While facing challenges related to competitive pressures and program timelines, the company's commitment to innovation and regulatory compliance positions it well for future growth.
Opportunities lie in differentiated treatment approaches, improved product efficacy, and expedited regulatory pathways, signaling potential for market leadership and patient impact.

REGENXBIO reports robust Q3 results, eyes sustainable growth post-2025

REGENXBIO's Q3 2023 earnings call highlighted strong financial performance, clinical progress, and strategic initiatives, showcasing a promising outlook for the company.
While facing challenges in aligning financial expectations and operational performance, REGENXBIO's focus on cost-saving measures and program advancements presents growth opportunities.
The company's commitment to patient impact, regulatory excellence, and shareholder value creation underpin its position as a key player in the biopharmaceutical industry.

REGENXBIO reports robust earnings, focuses on AAV innovation and growth

REGENXBIO's Q4 2023 earnings call highlighted strong financials, exciting program progress, and a focus on innovation in AAV therapeutics for long-term value creation.
While challenges exist in navigating AAV development complexity and operational demands, the company's proactive approach and financial strength position it well for growth.
Opportunities lie in leveraging cash reserves for accelerated development, engaging stakeholders for strategic insights, and exploring enhancements in therapeutic benefits.

REGENXBIO reports strong Q2 results, poised for program advancements

REGENXBIO's Q2 performance showcased advancements in key programs, bolstered by a strong financial position and positive clinical data.
While challenges exist in patient recruitment and regulatory strategies, opportunities for market approvals and portfolio expansion are on the horizon.
Strategic planning and successful execution will be crucial for REGENXBIO to capitalize on its strengths and navigate potential obstacles.

REGENXBIO reports robust Q3 results and advances gene therapy programs

REGENXBIO's strong financial position and progress in key programs demonstrate a promising outlook for the company's growth and innovation.
The company's focus on rare diseases and ophthalmology positions it as a leader in gene therapy treatments with significant market potential.
Addressing challenges related to program durability, market competition, and regulatory complexities will be crucial for sustaining growth and success.

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Regenxbio (RGNX) came out with a quarterly loss of $1.66 per share versus the Zacks Consensus Estimate of a loss of $1.26. This compares to loss of $1.58 per share a year ago.

Regenxbio (RGNX) Reports Q2 Loss, Lags Revenue Estimates

Continued progress on '5x'25' strategy to advance five AAV Therapeutics from REGENXBIO's internal pipeline and licensed programs into pivotal-stage or commercial products by 2025 ABBV-RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie Interim results from Phase II AAVIATE® and ALTITUDE® trials of dose level 3 cohorts with short-course prophylactic steroid eye drops resulted in zero cases of intraocular inflammation Additional interim efficacy data from the Phase II AAVIATE and ALTITUDE trials expected at upcoming medical conferences in second half 2023 and first half 2024 Interim data from Phase II Bridging Study evaluating subretinal delivery of ABBV-RGX-314 produced by the NAVXpress™ platform process demonstrated the anticipated clinical profile in the low dose cohort: well-tolerated and with the majority of subjects (11/15, 73%) injection-free through six months Initial safety results from Cohort 1 of the Phase I/II AFFINITY DUCHENNE TM trial of RGX-202 support well-tolerated profile; initial microdystrophin protein expression levels from Cohort 1 to be presented at World Muscle Society meeting in October Completed enrollment of the Phase III part of CAMPSIITE™ clinical trial of RGX-121 for treatment of MPS II; remains on track to file BLA in 2024 using the accelerated approval pathway $415 million in cash, cash equivalents and marketable securities as of June 30, 2023; operational runway into 2025 Conference call Wednesday, August 2, 2023, at 4:30 PM (EDT) ROCKVILLE, Md. , Aug. 2, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced financial results for the second quarter ended June 30, 2023, and recent operational highlights.

REGENXBIO Reports Second Quarter 2023 Financial Results and Recent Operational Highlights

ROCKVILLE, Md. , Aug. 1, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host one-on-one investor meetings at the 2023 Wedbush PacGrow Healthcare Conference on Tuesday, June 8, 2023.

REGENXBIO Announces Participation at the 2023 Wedbush PacGrow Healthcare Conference

ROCKVILLE, Md. , July 26, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, August 2, 2023, at 4:30 p.m.

REGENXBIO to Host Conference Call on August 2 to Discuss Second Quarter 2023 Financial Results and Recent Operational Highlights

ROCKVILLE, Md. , July 24, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced three presentations at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting, taking place in Seattle, Washington from July 28 through August 1, 2023.

REGENXBIO Announces Upcoming Presentations at the American Society of Retina Specialists Annual Scientific Meeting

-Interim results from Phase II AAVIATE and ALTITUDE trials of dose level 3 cohorts with short-course prophylactic steroid eye drops resulted in zero cases of intraocular inflammation - Initial safety results from Cohort 1 of the AFFINITY DUCHENNE study support well-tolerated profile to date; initial efficacy data to be presented at World Muscle Society meeting in October -A new program in Duchenne with preclinical data using innovative science to produce near full-length wild-type dystrophin; expects to file IND to the FDA in the first half of 2025 -Detailed updates will be presented at its Virtual Investor Day, today at 8:30 a.m. ET ROCKVILLE, Md.

REGENXBIO Highlights AAV Pipeline with Interim Results from Retinal and Duchenne Programs at its Virtual Investor Day on July 11, 2023

-REGENXBIO AAV Therapeutics pipeline to be discussed by management and external experts -Focus on programs for Wet AMD, Diabetic Retinopathy, and Duchenne Muscular Dystrophy ROCKVILLE, Md. , June 27, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a virtual investor day on July 11, 2023.

REGENXBIO to Host Virtual Investor Day Highlighting AAV Pipeline Programs with Upcoming Interim Trial Updates

ROCKVILLE, Md. , June 20, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it has filed a second complaint for patent infringement against Sarepta Therapeutics, Inc. (Sarepta) arising from Sarepta's manufacture, use and imminent commercial launch of SRP-9001 for the treatment of Duchenne muscular dystrophy.

REGENXBIO and University of Pennsylvania File NAV® Technology Patent Infringement Lawsuit

Regenxbio (NASDAQ:RGNX) Inc has one of the most-broad based approaches to adeno-associated virus (AAV)-based gene therapy (GT), utilizing their intellectual property (IP) to develop proprietary in-house programs, partner with large pharma for larger, late-stage indications and outlicensing their technology for economic interest in a number of other programs, Baird Equity Research analysts wrote in a note published on Friday.   The analysts initiated coverage of clinical-stage biotechnology company with an ‘Outperform' rating and a $42 per share price target, given what they call Regenxbio's “down to earth” valuation and multiple ways to win over the next year as AAV sees a resurgence.

Regenxbio could be a gene therapy pioneer with multiple ways to win in 2023

ROCKVILLE, Md. , June 1, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present and host one-on-one investor meetings at the Jefferies Global Healthcare Conference on Thursday, June 8, 2023.

REGENXBIO Announces Presentation at the Jefferies Global Healthcare Conference

RMAT recognizes that the preliminary clinical evidence from RGX-121, a potential one-time AAV Therapeutic, indicates the potential to address unmet medical needs for MPS II RMAT designation is for gene therapies intended to treat or cure serious condition in order to expedite the drug development and review processes CAMPSIITE™ trial is enrolling MPS II patients as part of a pivotal program that incorporates material from the NAVXpress™ platform process manufactured at the REGENXBIO Manufacturing Innovation Center and continues to support plan to file Biologics License Application in 2024 using the accelerated approval pathway ROCKVILLE, Md. , May 23, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for RGX-121, an investigational one-time AAV Therapeutic for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome.

REGENXBIO Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for RGX-121 Gene Therapy for Hunter Syndrome

ROCKVILLE, Md. , May 22, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present in a fireside chat and panel as well as host one-on-one investor meetings at the Barclays Gene Editing & Therapy Summit 2023 on Wednesday, May 24, 2023.

REGENXBIO Announces Presentation at the Barclays Gene Editing & Therapy Summit 2023

Research in MPS IVA led by REGENXBIO scientists moving into clinic Donation of NAV® Technology licenses will support development of gene therapies for rare diseases ROCKVILLE, Md. , May 16, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that preclinical research in Mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio syndrome, was selected for inclusion in the Foundation for the National Institutes of Health Accelerating Medicines Partnership® Bespoke Gene Therapy Consortium (AMP® BGTC), clinical trial portfolio.

REGENXBIO Announces NAV® Technology Platform Will Support Bespoke Gene Therapy Consortium's First Rare Disease Clinical Portfolio

Regenxbio Inc. has solid cash, a great partnership, and a pipeline with a lot of potential. Their only problem is lack of near-term catalysts.

Regenxbio: Buy, High-Potential Stock Stagnant Due To No Near-Term Catalysts

REGENXBIO Inc. (NASDAQ:RGNX ) Q1 2023 Results Conference Call May 3, 2023 4:30 PM ET Company Participants Patrick Christmas - EVP and Chief Legal Officer Ken Mills - CEO Steve Pakola - Chief Medical Officer Vit Vasista - CFO Conference Call Participants Gena Wang - Barclays Dane Leone - Raymond James Gospel Enyindah-Asonye - Morgan Stanley Alec Stranahan - Bank of America Ellie Merle - UBS Lisa Walter - RBC Capital Markets Caroline Palomeque - Berenberg Capital Markets Operator Good day, and thank you for standing by. Welcome to the REGENXBIO Inc. First Quarter 2023 Conference Call.

REGENXBIO Inc. (RGNX) Q1 2023 Earnings Call Transcript

Regenxbio (RGNX) came out with a quarterly loss of $1.53 per share versus the Zacks Consensus Estimate of a loss of $1.52. This compares to loss of $1.62 per share a year ago.

Regenxbio (RGNX) Reports Q1 Loss, Misses Revenue Estimates

Continued progress on '5x'25' strategy to advance five AAV Therapeutics from REGENXBIO's internal pipeline and licensed programs into pivotal-stage or commercial products by 2025 Announced Updates to Eye Care Collaboration with AbbVie Investigational gene therapy renamed ABBV-RGX-314 IND sponsorship recently transferred to AbbVie for all ongoing clinical trials Expanding sites and enrollment in ATMOSPHERE® and ASCENT™ pivotal trials using subretinal delivery; now expected to support U.S. and European regulatory submissions in late 2025 through the first half of 2026 Completed enrollment in expansion cohorts in both Phase II AAVIATE® and ALTITUDE® trials of ABBV-RGX-314 using in-office suprachoroidal delivery, expect interim trial updates in the second half of 2023 AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 continues to be on track to report initial trial data in the second half of 2023 CAMPSIITE™ clinical trial of RGX-121 for the treatment of MPS II remains on track to file BLA in 2024 using the accelerated approval pathway $474 million in cash, cash equivalents and marketable securities as of March 31, 2023; operational runway into 2025 Conference call Wednesday, May 3 rd at 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Reports First Quarter 2023 Financial Results and Recent Operational Highlights

ROCKVILLE, Md. , May 2, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting, taking place in Los Angeles, California from May 16 through 20, 2023.

REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy 26th Annual Meeting

ROCKVILLE, Md. , April 26, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, May 3, 2023, at 4:30 p.m.

REGENXBIO to Host Conference Call on May 3 to Discuss First Quarter 2023 Financial Results and Recent Operational Highlights

ROCKVILLE, Md. , April 18, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present in a fireside chat at Chardan's 7th Annual Genetic Medicines and Cell Therapy Manufacturing Summit on Tuesday, April 25, 2023 at 9:30 a.m.

REGENXBIO Announces Presentation at Chardan's 7th Annual Genetic Medicines and Cell Therapy Manufacturing Summit

RegenxBio has several collaborations with other pharmaceutical companies. The company doesn't have its own wholly owned product but receives plenty of royalty revenue.

Does an FDA Fast Track Designation Make Regenxbio Stock a Buy Now?

ROCKVILLE, Md. , April 11, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne).

REGENXBIO Receives FDA Fast Track Designation for RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

REGENXBIO Inc. (NASDAQ:RGNX ) Q4 2022 Earnings Conference Call February 28, 2023 4:30 PM ET Company Participants Patrick Christmas - Chief Legal Officer Ken Mills - Chief Executive Officer Steve Pakola - Chief Medical Officer Vit Vasista - Chief Financial Officer Conference Call Participants Dane Leone - Raymond James Lisa Walter - RBC Capital Markets Andreas Argyrides - Wedbush Securities Caroline Palomeque - Berenberg Operator Hello, and thank you for standing by. Welcome to the Q4 and Full Year 2022 REGENXBIO Earnings Call.

REGENXBIO Inc. (RGNX) Q4 2022 Earnings Call Transcript

Continued progress on '5x'25' strategy to advance five AAV Therapeutics from REGENXBIO's internal pipeline and licensed programs into pivotal-stage or commercial products by 2025 RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie Enrollment ongoing in the pivotal ATMOSPHERE® and ASCENT™ clinical trials using subretinal delivery, expected to support BLA filing in 2024 Recently announced interim data from the Phase II pharmacodynamic study supports use of NAVXpress™ platform process in future commercialization plans Recently announced cohort expansions in AAVIATE® and ALTITUDE® suprachoroidal clinical trials on track to be completed in the first half of 2023; expected interim trial updates in the second half of 2023 AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 is active and recruiting patients; anticipated to report initial trial data in the second half of 2023 CAMPSIITE™ clinical trial of RGX-121 for the treatment of MPS II on track to complete pivotal program enrollment in the first half of 2023; recent updates continue to support plan to file BLA in 2024 using the accelerated approval pathway $565 million in cash, cash equivalents and marketable securities as of December 31, 2022; operational runway into 2025 Conference call Tuesday, February 28 th at 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Reports Fourth Quarter 2022 and Full-Year 2022 Financial Results and Recent Operational Highlights

RGX-111 is an investigational AAV Therapeutic for the treatment of severe MPS I that is part of REGENXBIO's clinical-stage pipeline of neurodegenerative disease programs RGX-111, a potential one-time gene therapy for MPS I, continues to be well-tolerated across two dose levels, with no drug-related serious adverse events New biomarker and neurodevelopmental data continue to indicate encouraging CNS profile in patients dosed with RGX-111 Company is on track to manufacture commercial-scale cGMP material to support the continued development of RGX-111 ROCKVILLE, Md. , Feb. 24, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced positive interim data from the Phase I/II trial of RGX-111 for the treatment of severe Mucopolysaccharidosis Type I (MPS I).

News for REGENXBIO Stock (RGNX)