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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ROCKVILLE, Md., Feb. 9, 2022 /PRNewswire/ -- RGX-121, a one-time gene therapy for MPS II, continues to be well-tolerated with no drug-related SAEs across three dose levels Dose-dependent reductions in CSF biomarkers observed; Cohort 3 patients approach normal levels of D2S6 biomarker  Measures of neurodevelopmental function from patients in Cohorts 1 and 2 demonstrate continued developmental skill acquisition up to two years after RGX-121 administration  Evidence of systemic enzyme expression and biomarker activity continues to be observed  Cohort 3 expansion using commercial-scale cGMP material is planned to start in 1H 2022 REGENXBIO Inc. (Nasdaq: RGNX) today announced additional positive interim data from Cohorts 1-3 of the ongoing Phase I/II trial of RGX-121 for the treatment of patients up to 5 years old diagnosed with Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome, are being presented at the 18th Annual WORLDSymposium™.

REGENXBIO Presents Additional Positive Interim Data from Phase I/II Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome) at 18th Annual WORLDSymposium™ 2022

ROCKVILLE, Md., Feb. 8, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 16, 2022 at 8:40 a.m.

REGENXBIO Announces Presentations at the 11th Annual SVB Leerink Global Healthcare Conference

ROCKVILLE, Md., Feb. 4, 2022 /PRNewswire/ --  Data for Cohort 1 with six months of follow-up from the Phase II ALTITUDE™ trial of RGX-314 for the treatment of diabetic retinopathy to be presented REGENXBIO Inc. (Nasdaq: RGNX) today announced that three oral presentations, including updated interim data from the ongoing Phase II ALTITUDE™ trial of RGX-314 for the treatment of diabetic retinopathy, will be presented at the Angiogenesis, Exudation, and Degeneration 2022 Conference taking place virtually from February 11 to 12, 2022.

REGENXBIO Announces Presentations at the Angiogenesis, Exudation, and Degeneration 2022 Conference

ROCKVILLE, Md., Jan. 31, 2022 /PRNewswire/ --  Interim data from Phase I/II trials of RGX-121 for the treatment of MPS II and RGX-111 for the treatment of MPS I to be presented REGENXBIO Inc. (Nasdaq: RGNX) today announced that five oral and seven poster presentations will be presented at the 18th Annual WORLDSymposium™, taking place in San Diego, CA from February 7 through 11, 2022.

REGENXBIO Announces Presentations at the 18th Annual WORLDSymposium™ 2022

ROCKVILLE, Md., Jan. 10, 2022 /PRNewswire/ -- ASCENTTM, a Phase III clinical trial conducted in partnership with AbbVie, is expected to enroll patients in the United States and Canada Pivotal trials expected to support BLA submission for RGX-314 in 2024 REGENXBIO Inc. (Nasdaq: RGNX) today announced the initiation of ASCENTTM, the second of two Phase III pivotal trials to evaluate the efficacy and safety of subretinal delivery of RGX-314 in patients with wet age-related macular degeneration (wet AMD).

REGENXBIO Announces Initiation of Second Pivotal Trial in RGX-314 Clinical Program for the Treatment of Wet AMD Using Subretinal Delivery

ROCKVILLE, Md., Jan. 6, 2022 /PRNewswire/ -- Potential one-time gene therapy for the treatment of Duchenne includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector Innovative trial design, including comprehensive immunosuppressive regimen, to evaluate safety and optimal dose cGMP process material made at commercial-scale to be used throughout clinical development of RGX-202 REGENXBIO expects to initiate trial in the first half of 2022 REGENXBIO Inc. (Nasdaq: RGNX) today announced the clearance of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to evaluate RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne) in a first-in-human clinical trial.

REGENXBIO Announces FDA Clearance of IND for Clinical Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy

RGNX announced promising safety and efficacy data from its SCS micro injector trial.

Regenxbio: Accumulating For The Long Haul

REGENXBIO (RGNX) is developing a gene therapy candidate, RGX-202, for treating DMD, which is currently in the pre-clinical stage. An IND application is expected by the end of 2021.

REGENXBIO (RGNX) DMD Gene Therapy Gets Orphan Drug Status

The FDA has granted Orphan Drug Designation to RegenXbio Inc's (NASDAQ: RGNX) RGX-202, potential one-time gene therapy for Duchenne muscular dystrophy (Duchenne).  Duchenne is a genetic disorder characterized by progressive muscle degeneration and weakness due to the alterations of a protein called dystrophin that helps keep muscle cells intact.

RegenXbio's Duchenne Gene Therapy Secures FDA Orphan Drug Tag

ROCKVILLE, Md., Nov. 22, 2021 /PRNewswire/ -- Potential one-time gene therapy for the treatment of Duchenne, includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector Commercial-scale cGMP material to be used in clinical development Company on track to submit IND by end of 2021 REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne).

REGENXBIO Announces Orphan Drug Designation Granted to RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

ROCKVILLE, Md., Nov. 12, 2021 /PRNewswire/ -- Suprachoroidal delivery of RGX-314 in Phase II AAVIATE® trial for the treatment of wet AMD continues to be well tolerated in 50 patients from Cohorts 1-3 with no drug-related serious adverse events Positive initial data from Cohort 2 in AAVIATE trial at six months after one-time treatment of RGX-314 Treatment effect observed with stable visual acuity and retinal thickness Demonstrated meaningful reduction (>70%) in anti-VEGF treatment burden; 40% of patients in Cohort 2 were anti-VEGF injection-free Additional data from Cohort 1 in Phase II ALTITUDE™ trial for the treatment of DR demonstrated stable visual acuity at three months after one-time treatment of RGX-314 REGENXBIO Inc. (Nasdaq: RGNX) today announced additional positive interim data from the ongoing Phase II AAVIATE® trial and the ongoing Phase II ALTITUDE™ trial of RGX-314 using in-office suprachoroidal delivery for the treatment of wet age-related macular degeneration (wet AMD) and diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME), respectively.

REGENXBIO Presents Additional Positive Interim Data from Trials of RGX-314 in Wet AMD and Diabetic Retinopathy Using Suprachoroidal Delivery at AAO 2021

ROCKVILLE, Md., Nov. 9, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its Collaboration and License Agreement with AbbVie to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases.

REGENXBIO Announces Closing of Eye Care Collaboration Agreement with AbbVie

ROCKVILLE, Md., Nov. 5, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that data from the RGX-314 clinical trials will be presented in an oral presentation at the American Academy of Ophthalmology 2021 Annual Meeting taking place in New Orleans, LA from November 12 to 15, 2021.

REGENXBIO Announces RGX-314 Data Presentation at the American Academy of Ophthalmology 2021 Annual Meeting

Should investors be excited or worried when a stock's 50 -day simple moving average crosses above the 200-day simple moving average?

Regenxbio (RGNX)'s Technical Outlook is Bright After Key Golden Cross

REGENXBIO's (RGNX) CEO Ken Mills on Q3 2021 Results - Earnings Call Transcript

Regenxbio (RGNX) delivered earnings and revenue surprises of -57.47% and -37.64%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?

Regenxbio (RGNX) Reports Q3 Loss, Misses Revenue Estimates

ROCKVILLE, Md., Nov. 2, 2021 /PRNewswire/ -- Announced eye care collaboration with AbbVie to develop and commercialize RGX-314 AbbVie and REGENXBIO form a strategic partnership combining eye care and gene therapy expertise REGENXBIO to receive $370 million upfront payment Transaction expected to close by end of 2021, subject to satisfaction of customary closing conditions, including applicable regulatory approvals Presented positive initial data from RGX-314 Phase II trials for the treatment of wet AMD and diabetic retinopathy using in-office suprachoroidal delivery   In AAVIATE® trial for the treatment of wet AMD, observed treatment effect with stable visual acuity and retinal thickness and meaningful reduction in anti-VEGF treatment burden 33% of patients in ALTITUDE™ trial for the treatment of DR demonstrated a ≥2 step improvement from baseline on the ETDRS-DRSS On track to file IND for RGX-202 for the treatment of Duchenne by end of 2021 Cohort 3 of the ongoing Phase I/II trial of RGX-121 for the treatment of patients up to 5 years old diagnosed with MPS II has been expanded to enroll up to 6 additional patients $533.5  million in cash, cash equivalents and marketable securities as of September 30, 2021 Conference call Tuesday, November 2 nd at 4:30 p.m.

REGENXBIO Reports Third Quarter 2021 Financial Results and Operational Highlights

The average of price targets set by Wall Street analysts indicates a potential upside of 77.4% in Regenxbio (RGNX). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Can Regenxbio (RGNX) Climb 77% to Reach the Level Wall Street Analysts Expect?

ROCKVILLE, Md., Oct. 26, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Tuesday, November 2, 2021, at 4:30 p.m.

REGENXBIO to Host Conference Call on November 2 to Discuss Third Quarter 2021 Financial Results and Recent Operational Highlights

Regenxbio Inc (NASDAQ: RGNX) announced initial data from the Phase 2 ALTITUDE trial of RGX-314 for diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME).  The data were presented at the American Society of Retina Specialists Annual Meeting.

Regenxbio Reveals Interim Data From Diabetic Retinopathy Gene Therapy Trial

ROCKVILLE, Md., Oct. 9, 2021 /PRNewswire/ -- Suprachoroidal delivery of RGX-314 well tolerated in 15 patients in Cohort 1 with no drug-related serious adverse events No intraocular inflammation observed Positive interim data update from Cohort 1 at three months after one-time treatment of RGX-314 33% of patients demonstrated a ≥2 step improvement from baseline on the ETDRS-DRSS compared to 0% of patients in observational control Cohorts 2 and 3 continue to enroll patients at a dose level of 5x1011 GC/eye REGENXBIO Inc. (Nasdaq: RGNX) today announced initial data from the ongoing Phase II ALTITUDE™ trial of RGX-314 for the treatment of diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME) using in-office suprachoroidal delivery.

REGENXBIO Presents Positive Initial Data from Phase II ALTITUDE™ Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery at American Society of Retina Specialists Annual Meeting

REGENXBIO stock declined by 20% yesterday, while it is down 26% in the last ten trading days. In comparison, the broader S&P500 index declined by 1.4% over the same period.

What's Next For REGENXBIO Stock After A 20% Fall Yesterday?

ROCKVILLE, Md., Oct. 1, 2021 /PRNewswire/ -- Suprachoroidal delivery of RGX-314 well tolerated in 50 patients in Cohorts 1-3 with no drug-related serious adverse events Positive initial data from Cohort 1 at six months after one-time treatment of RGX-314 Treatment effect observed with stable visual acuity and retinal thickness Demonstrated meaningful reduction in anti-VEGF treatment burden Phase II trial expanded to include third dose level of RGX-314 (1x1012 GC/eye) Company to host conference call and webcast on Friday, October 1 at 5:00 p.m.

REGENXBIO Presents Positive Initial Data from Phase II AAVIATE® Trial of RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery and Provides Trial Update at Retina Society 54th Annual Scientific Meeting

ROCKVILLE, Md., Oct. 1, 2021 /PRNewswire/ -- Data for Cohort 1 with three months of follow-up from the RGX-314 Phase II trial for the treatment of diabetic retinopathy (ALTITUDE®) to be presented REGENXBIO Inc. (Nasdaq: RGNX) today announced that data from the RGX-314 clinical trials will be presented in three oral presentations at the American Society of Retina Specialists Annual Meeting taking place in San Antonio, TX, from October 8 to 12, 2021.

REGENXBIO Announces RGX-314 Data Presentations at American Society of Retina Specialists Annual Meeting

The company recently inked a $1.7B deal with AbbVie for the development and commercialization of a potential mega-blockbuster, i.e., RGX-314. Under highly favorable deal terms, REGENXBIO will enjoy 50% of the sales potential from RGX-314.

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