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) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.

Strength Seen in Regenxbio (RGNX): Can Its 11.7% Jump Turn into More Strength?

Results support BLA submission in 2024 using the accelerated approval pathway Primary endpoint of patients achieving reduction in CSF biomarker of MPS II disease was met with statistical significance (p value of 0.00016) Patients treated with RGX-121 have showed continued improvement in neurodevelopmental skill acquisition up to four years and discontinued intravenous enzyme therapy Company plans to discuss these results as part of a full rare disease program update on its conference call today, Wednesday, February 7, 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Announces Pivotal Trial of RGX-121 for the Treatment of MPS II Achieves Primary Endpoint

Completed enrollment in cohort 2 of the Phase I/II AFFINITY DUCHENNE® trial of RGX-202, a potential one-time AAV Therapeutic for the treatment of Duchenne that includes an optimized transgene for a novel microdystrophin New three-month assessment in third patient at dose level 1 demonstrates largest increase in microdystrophin expression Patient aged 6.6 years old had expression level at 83.4% of control On track to initiate pivotal trial in second half of 2024 Company plans to discuss these new results as part of a full rare disease program update on its conference call today, Wednesday, February 7, 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Announces Completion of Enrollment in Cohort 2 and Additional Positive Interim Data in AFFINITY DUCHENNE® Trial

Pivotal topline results from the CAMPSIITE® trial of RGX-121 for the treatment of MPS II to be presented Conference call Wednesday, February 7, 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Announces Presentations at the 20th Annual WORLDSymposium 2024

REGENXBIO's stock has consistently underperformed, down 26% since May. The company released positive interim data from their Phase II trial for the treatment of wet age-related macular degeneration. The data showed a reduction in treatment burden and no cases of intraocular inflammation with the use of ABBV-RGX-314 gene therapy.

Regenxbio: Robust Data, Decent Cash, Never Ending Trials, Buying At Dips

A single ABBV-RGX-314 gene therapy treatment has the potential to become a new standard-of-care option among anti-VEGF treatments by sustaining vision health long term and overcoming the clinical challenges of managing wet AMD due to the treatment burden of chronic anti-VEGF injections ABBV-RGX-314 continues to be well tolerated in over 100 patients from three dose levels with no drug-related serious adverse events ABBV-RGX-314 in over 50 patients at third dose level demonstrated highest reduction in treatment burden: 80% reduction in annualized injection rate 50% injection-free Zero cases of intraocular inflammation observed in patients that received short-course prophylactic topical steroid eye drops Conference call Tuesday, January 16 at 4:30 p.m. EST ROCKVILLE, Md.

REGENXBIO Announces Positive Interim Data from Phase II AAVIATE® Trial of ABBV-RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery

ROCKVILLE, Md. , Jan. 10, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present data from the Phase II AAVIATE® trial of suprachoroidal ABBV-RGX-314 for the treatment of wet age-related macular degeneration (AMD) at Hawaiian Eye and Retina 2024 Meeting being held January 13-19, 2024 in Maui, HI.

REGENXBIO Announces Presentation at the Hawaiian Eye and Retina 2024 Meeting

Regenxbio (RGNX) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.

Down -25.53% in 4 Weeks, Here's Why You Should You Buy the Dip in Regenxbio (RGNX)

ROCKVILLE, Md. , Jan. 8, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. District Court for the District of Delaware granted Sarepta Therapeutics, Inc. (Sarepta) summary judgment on invalidity in a patent infringement suit arising from Sarepta's manufacture and use of cultured host cell technology covered by a University of Pennsylvania (Penn) patent that Sarepta uses to make clinical and commercial supplies of SRP-9001 (also known as ELEVIDYS in the U.S.), for itself and Roche, for the treatment of Duchenne muscular dystrophy.

U.S. District Court Issues Decision on REGENXBIO and University of Pennsylvania NAV® Technology Patent Infringement Lawsuit

First patient received dose level 2 of RGX-202, a potential one-time AAV Therapeutic for the treatment of Duchenne that includes an optimized transgene for a novel microdystrophin On track for pivotal dose determination and initiation of pivotal program in 2024  ROCKVILLE, Md. , Nov. 29, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the first patient received RGX-202 at dose level 2 in the Phase I/II AFFINITY DUCHENNE® trial.

REGENXBIO Announces Dose Escalation in AFFINITY DUCHENNE® Trial

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It's been all about the biggest of the big S&P 500 stocks all year. But now, investors are starting to look for big gains from small stocks.

It's Small Stocks' Time To Rally — Analysts Like These 11 Best

The average of price targets set by Wall Street analysts indicates a potential upside of 95.6% 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.

Wall Street Analysts Believe Regenxbio (RGNX) Could Rally 95.61%: Here's is How to Trade

REGENXBIO Inc. (NASDAQ:RGNX ) Q3 2023 Earnings Conference Call November 8, 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 Gena Wang - Barclays Dane Leone - Raymond James Alec Stranahan - Bank of America Lisa Walter - RBC Capital Markets Brian Skorney - Baird Mani Foroohar - Leerink Partners Operator Good day, and thank you for standing by. Welcome to REGENXBIO's Third Quarter 2023 Earnings Conference Call.

REGENXBIO Inc. (RGNX) Q3 2023 Earnings Call Transcript

Announces pipeline prioritization and corporate restructuring to focus on clinical stage AAV Therapeutic product candidates addressing large commercial opportunities and value generation Highest priority programs are ABBV-RGX-314 for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, RGX-202 for the treatment of Duchenne, and RGX-121 for the treatment MPS II Restructuring plan, including a 15% reduction in workforce, expected to result in total savings of at least $100 million Anticipated cost savings from corporate restructuring, along with $365 million in cash, cash equivalents and marketable securities as of September 30, 2023, expected to fund operational runway into the second half of 2025 Conference call Wednesday, November 8, 2023, at 4:30 p.m. (EST) ROCKVILLE, Md.

REGENXBIO Announces Updated Strategic Plans and Third Quarter 2023 Financial Results

ABBV-RGX-314 continues to be well tolerated in 50 patients from dose levels 1 and 2 (Cohorts 1-3) with no drug-related serious adverse events Dose level 2 prevented disease progression and reduced vision-threatening events in non-proliferative diabetic retinopathy patients at 1 Year  70.8% of patients achieved Diabetic Retinopathy Severity Scale improvement vs. 25.0 % in control  0% of patients worsened ≥2 steps vs.

REGENXBIO Presents Positive One Year Data from Phase II ALTITUDE® Trial of ABBV-RGX-314 for Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery

Regenxbio Inc. is making progress in its pipeline, aiming to have five gene therapies in late-stage testing or approved by 2025. The company's lead candidate, ABBV-RGX-314, is being developed for the treatment of wet age-related macular degeneration; collaboration with AbbVie in place. Two other programs, RGX-202 for Duchenne Muscular Dystrophy and RGX-121 for mucopolysaccharidosis Type II, have the potential for Accelerated Approval, which could generate significant shareholder value.

Regenxbio: Biotech To Watch With 2 Possible Accelerated Approval Pathways

ROCKVILLE, Md. , Nov. 1, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, November 8, 2023, at 4:30 p.m.

REGENXBIO to Host Conference Call on November 8 to Discuss Third Quarter 2023 Financial Results and Recent Operational Highlights

ROCKVILLE, Md. , Oct. 30, 2023 /PRNewswire/ --  REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting being held November 3-6, 2023 in San Francisco, CA.

REGENXBIO Announces Presentations at the American Academy of Ophthalmology 2023 Annual Meeting

ROCKVILLE, Md. , Oct. 5, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the Jefferies CNS/Neuro Summit on Thursday, October 12, 2023.

REGENXBIO to Participate in the Jefferies CNS/Neuro Summit

RGX-202, a potential one-time AAV Therapeutic for the treatment of Duchenne that includes an optimized transgene for a novel microdystrophin, continues to be well-tolerated in three patients from dose level 1 (1x1014 GC/kg) Initial biomarker data in two patients who completed three-month assessment demonstrate robust microdystrophin expression with localization to the muscle cell membrane Patient aged 4.4 years old had expression level at 38.8% of control Trial dose escalation expected by end of 2023 Pivotal dose determination and initiation of pivotal program anticipated in 2024 Plan to use RGX-202 microdystrophin as a surrogate endpoint to support a Biologics License Application filing using the accelerated approval pathway RGX-202 development program uses commercial-ready cGMP material from the REGENXBIO Manufacturing Innovation Center Conference call today, Tuesday, October 3, 2023, at 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Presents Interim Clinical Data from Phase I/II AFFINITY DUCHENNE™ Trial of RGX-202 at 28th Annual International Congress of the World Muscle Society

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

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.

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