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.

Earnings data Q4 2023

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ROCKVILLE, Md. , Sept. 26, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the 28th Annual Congress of the World Muscle Society, taking place in Charleston, SC from October 3-7, 2023.

REGENXBIO Announces Presentations at the 28th Annual Congress of the World Muscle Society

ROCKVILLE, Md. , Sept. 5, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the following upcoming investor conferences: Morgan Stanley 21st Annual Global Healthcare Conference Fireside Chat Date: Tuesday, September 12, 2023 Fireside Chat Time: 10:10 a.m.

REGENXBIO to Participate in Upcoming Investor Conferences

Six-month data from single-patient, investigator-initiated trial showed that one-time administration of RGX-181 was well tolerated, achieved sustained gene expression and demonstrated clinically meaningful improvements across multiple measures including reduced (86%) seizure frequency. Investigators observed encouraging neurodevelopmental skill acquisition at 6 months ROCKVILLE, Md.

Initial Clinical Data of First Pediatric CLN2 Patient Dosed with RGX-181 Presented at SSIEM Annual Symposium

ROCKVILLE, Md. , Aug. 23, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the Society for the Study of Inborn Errors of Metabolism Annual Symposium 2023 in Jerusalem, Israel (August 29 – September 1).

REGENXBIO Announces Presentations at the Society for the Study of Inborn Errors of Metabolism Annual Symposium 2023

REGENXBIO is a biotech company specializing in gene therapy, with a focus on addressing unmet medical needs in genetic disorders. The company's cash position decreased to $415.4 million, but it is projected to sustain operations until 2025. Revenues have dipped, but strategic collaborations and a robust pipeline offer potential for future growth.

Regenxbio: RGX-314 Continues Advancing With Solid Financials

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.

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