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 Inc. (RGNX) CEO Ken Mills on Q1 2021 Results - Earnings Call Transcript

ROCKVILLE, Md., May 5, 2021 /PRNewswire/ -- Enrollment ongoing in ATMOSPHERE™, the first of two planned pivotal trials for the subretinal delivery of RGX-314 for the treatment of wet AMD Continued progress and expansion of Phase II AAVIATE® trial of RGX-314 utilizing in-office suprachoroidal delivery for the treatment of wet AMD Began dosing in Phase I/II trial of RGX-121, a one-time gene therapy for MPS II, in pediatric patients over 5 years old Completed dosing in Cohort 1 of ongoing trial of RGX-111, a one-time gene therapy for MPS I IND filing expected in mid-2021 for RGX-202, a novel, advanced microdystrophin gene therapy for treatment of Duchenne Muscular Dystrophy $657 million in cash, cash equivalents and marketable securities as of March 31, 2021 Conference call Wednesday, May 5 th at 4:30 p.m.

REGENXBIO Reports First Quarter 2021 Financial Results and Operational Highlights

On Wednesday, May 05, Regenxbio (NASDAQ:RGNX) will release its latest earnings report. Check out Benzinga's preview to understand the implications.

Preview: Regenxbio's Earnings

ROCKVILLE, Md., April 28, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, May 5, 2021, at 4:30 p.m.

REGENXBIO to Host Conference Call on May 5 to Discuss First Quarter 2021 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., April 27, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that four oral and nine poster presentations will be presented at the American Society of Gene and Cell Therapy's 24th Annual Meeting taking place from May 11 to 14, 2021, in virtual format.

REGENXBIO Announces Presentations at the American Society of Gene and Cell Therapy's 24th Annual Meeting

ROCKVILLE, Md., April 21, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that Curran M.

REGENXBIO To Present at the Chardan 5th Annual Genetic Medicines Manufacturing Summit

ROCKVILLE, Md., April 14, 2021 /PRNewswire/ -- First patient dosed at third dose level in ongoing trial of RGX-121, a one-time gene therapy for MPS II; total of nine patients have been dosed at four leading clinical centers in the U.S. and Brazil   Previously reported positive interim data from Cohorts 1 and 2 demonstrated consistent reductions in CNS biomarkers, continued neurocognitive development, and evidence of systemic effects REGENXBIO Inc. (Nasdaq: RGNX) today announced that it dosed the first patient in Cohort 3 of the ongoing Phase I/II trial of RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome, in patients up to five years old.

REGENXBIO Announces Dosing of First Patient in Cohort 3 of Phase I/II Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome)

REGENXBIO, Inc. (RGNX) CEO Ken Mills on Q4 2020 Results - Earnings Call Transcript

Shares of Regenxbio (NASDAQ:RGNX) fell in after-market trading after the company reported Q4 results. Quarterly Results Earnings per share fell 72.22% over the past year to ($1.24), which missed the estimate of ($0.43).

Recap: Regenxbio Q4 Earnings

ROCKVILLE, Md., March 1, 2021 /PRNewswire/ -- Pivotal program for subretinal delivery of RGX-314 for the treatment of wet AMD is active and enrolling patients; expected to support BLA filing in 2024 Phase II trials of RGX-314 utilizing in-office suprachoroidal delivery for treatment of...

REGENXBIO Reports Fourth Quarter and Full-Year 2020 Financial Results and Operational Highlights

Regenxbio (RGNX) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Regenxbio (RGNX) Earnings Expected to Grow: What to Know Ahead of Q4 Release

Regenxbio Inc (NASDAQ: RGNX) has reported additional interim data from Cohorts 4 and 5 of its Phase 1/2a trial evaluating RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) and Cohort 3 of its Long-Term Follow-Up (LTFU) study. As of January 22, RGX-314 continued to be generally well-tolerated across all cohorts, with 20 serious adverse events (SAEs) reported in 13 patients, including one possibly drug-related SAE of a significant decrease in vision in Cohort 5.

Regenxbio Gene Therapy Shows Treatment Benefit In Wet AMD Study

ROCKVILLE, Md., Feb. 16, 2021 /PRNewswire/ -- RGX-314 using subretinal delivery continues to be generally well-tolerated at all dose levels Positive interim update from Cohorts 4 and 5 at 1.5 years after RGX-314 administration Durable treatment effect observed with stable visual acuity,...

REGENXBIO Announces Additional Positive Interim Phase I/IIa and Long-Term Follow-Up Data of RGX-314 for the Treatment of Wet AMD

ROCKVILLE, Md., Feb. 8, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that additional positive interim data from a total of eight patients in Cohorts 1 and 2 of the ongoing Phase I/II trial of RGX-121 for the treatment of patients up to 5 years old diagnosed with...

REGENXBIO Presents Additional Positive Interim Data from Phase I/II Trial of RGX-121 for the Treatment of MPS II (Hunter Syndrome) at 17th Annual WORLDSymposium™ 2021

ROCKVILLE, Md., Feb. 5, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that two oral presentations will be presented at the Angiogenesis, Exudation, and Degeneration 2021 conference taking place virtually from February 12 to 13, 2021. The presentations will be as...

REGENXBIO Announces Presentations at the Angiogenesis, Exudation, and Degeneration 2021 Conference

ROCKVILLE, Md., Feb. 1, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that three oral and nine poster presentations will be presented at the 17th Annual WORLDSymposium™, taking place virtually from February 8 through 12, 2021. The oral presentations include interim...

REGENXBIO Announces Presentations at the 17th Annual WORLDSymposium™ 2021

ROCKVILLE, Md., Jan. 12, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its previously announced underwritten public offering of 4,260,000 shares of its common stock at a price to the public of $47.00 per share, as well as the exercise in full of the...

REGENXBIO Announces Closing Of Public Offering Of Common Stock And Full Exercise Of Underwriters' Option To Purchase Additional Shares

ROCKVILLE, Md., Jan. 11, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 11:40 a.m. ET. The conference will be held in a virtual meeting format. A webcast of the...

REGENXBIO to Present at the 39th Annual J.P. Morgan Healthcare Conference

ROCKVILLE, Md., Jan. 8, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the pricing of an underwritten public offering of 4,260,000 shares of its common stock at the price of $47.00 per share before underwriting discounts and commissions. The gross proceeds to REGENXBIO...

REGENXBIO Announces Pricing Of Public Offering Of Common Stock

Regenxbio launched a key study of its eye disease-targeting gene therapy, prompting RGNX stock to pop on Wednesday. It's also planning to test a gene therapy in muscular dystrophy.

This Small Gene Therapy Stock Is Taking On Giants Regeneron, Roche

ROCKVILLE, Md., Jan. 6, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it intends to offer and...

REGENXBIO Announces Proposed Public Offering Of Common Stock

REGENXBIO (RGNX) provided an update on the RGX-314 programs. Further, the company made an announcement of a new program, RGX-202, for the treatment of Duchenne Muscular Dystrophy

REGENXBIO (RGNX) Provides Update on RGX-314 & Begins New Program

ROCKVILLE, Md., Jan. 5, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today provided an update on the RGX-314 programs, including the announcement that the pivotal program for RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) is now active. In addition,...

REGENXBIO Announces Update on RGX-314 and Pivotal Program for the Treatment of Wet AMD and New Gene Therapy Program for the Treatment of Duchenne Muscular Dystrophy

ROCKVILLE, Md., Dec. 22, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that it has entered into...

REGENXBIO Announces Agreement to Monetize Portion of Zolgensma® Royalties for $200 Million

Back in 2019, the Zolgensma approval validated Regenxbio's NAV technology platform for gene delivery. Despite a slow start, Zolgensma recently hit $1B in cumulative sales. Regenxbio's organic pipeline is advancing rapidly with RGX-314. And, you can expect an early data release in the next few months.

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