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. , Aug. 10, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will present at the H.C.

REGENXBIO Announces Presentation at the H.C. Wainwright 2nd Annual Ophthalmology Virtual Conference

REGENXBIO Inc. (NASDAQ:RGNX ) Q2 2022 Earnings Conference Call August 3, 2022 4:30 PM ET Company Participants Vit Vasista - Chief Financial Officer Ken Mills - President & Chief Executive Officer Steve Pakola - Chief Medical Officer Conference Call Participants Dane Leone - Raymond James Ellie Merle - UBS Lisa Walter - RBC Capital Markets Andreas Argyrides - Wedbush Securities Mani Foroohar - SVB Securities Operator Good day, ladies and gentlemen. Thank you for standing by.

REGENXBIO Inc. (RGNX) CEO Ken Mills on Q2 2022 Results - Earnings Call Transcript

RGX-314 program for the treatment of wet AMD and diabetic retinopathy, being developed in collaboration with AbbVie, remains on track for first BLA filing in 2024 Enrollment ongoing in the pivotal ATMOSPHERE® and ASCENT™ clinical trials of RGX-314 for the treatment of wet AMD using subretinal delivery Completed enrollment in Cohort 5 of the AAVIATE® trial of RGX-314 for the treatment of wet AMD using suprachoroidal delivery Completed enrollment in ALTITUDE® trial of RGX-314 for the treatment of diabetic retinopathy using suprachoroidal delivery AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 remains on track for dosing in the first half of 2023 Announced intention to file a BLA in 2024 using the accelerated approval pathway for RGX-121 for the treatment of MPS II; pivotal program is active and enrolling patients $682 million in cash, cash equivalents and marketable securities of as of June 30, 2022; operational runway into 2025 Conference call Wednesday, August 3 rd at 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Reports Second Quarter 2022 Financial Results and Recent Operational Highlights

FDA will consider an accelerated approval pathway for RGX-121; BLA filing expected in 2024 Pivotal program is active and enrolling patients RGX-121 is a potential first-in-class, one-time gene therapy for the treatment of MPS II Internal cGMP manufacturing process expected to support BLA ROCKVILLE, Md. , Aug. 3, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome.

REGENXBIO Announces Intention to File a Biologics License Application Using the Accelerated Approval Pathway for RGX-121, an AAV Therapeutic for the Treatment of MPS II

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.

Earnings Preview: Regenxbio (RGNX) Q2 Earnings Expected to Decline

ROCKVILLE, Md. , Aug. 1, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, August 3, 2022, at 4:30 p.m.

REGENXBIO to Host Conference Call on August 3 to Discuss Second Quarter 2022 Financial Results and Recent Operational Highlights

RGNX is proceeding towards becoming a pillar of the gene therapy space for ocular diseases. However, it will need time to get there.

Regenxbio: Patience And Regular Homework Are Keys

85 subjects dosed across five cohorts in AAVIATE ®  trial evaluating RGX-314 for the treatment of wet AMD using suprachoroidal delivery Company expects to report additional suprachoroidal data later this year ROCKVILLE, Md. , July 8, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it has completed enrollment in Cohort 5 of the Phase II AAVIATE® trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using in-office suprachoroidal delivery.

REGENXBIO Announces Enrollment Complete in Cohort 5 of Phase II AAVIATE® Trial

In-house facility to produce NAV Technology-based AAV gene therapies at 2,000 liters scale $65 million invested in new facility, enabling end-to-end control of gene therapy manufacturing in Montgomery County, Maryland ROCKVILLE, Md. , June 9, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today is celebrating the opening of its new Manufacturing Innovation Center gene therapy manufacturing facility.

REGENXBIO Opens State-of-the-Art Gene Therapy Manufacturing Facility

ROCKVILLE, Md. , June 7, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the appointment of Jennifer Zachary to its Board of Directors, effective June 3, 2022.

Jennifer Zachary Joins REGENXBIO Board of Directors

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REGENXBIO Inc. (NASDAQ:RGNX ) Q1 2022 Earnings Conference Call May 4, 2022 4:30 PM ET Company Participants Patrick Christmas - Chief Legal Officer Ken Mills - President and CEO Steve Pakola - Chief Medical Officer Vit Vasista - CFO Conference Call Participants Andreas Argyrides - Wedbush Securities Operator Good day and thank you for standing by. Welcome to the Q1 2022 REGENXBIO Inc. Earnings Conference Call.

REGENXBIO Inc. (RGNX) CEO Ken Mills on Q1 2022 Results - Earnings Call Transcript

ROCKVILLE, Md. , May 4, 2022 /PRNewswire/ -- Continues to advance RGX-314 program for the treatment of wet AMD and diabetic retinopathy; remains on track for first BLA filing in 2024 Enrollment ongoing in the pivotal ATMOSPHERE™ and ASCENT™ clinical trials of RGX-314 for the treatment of wet AMD using subretinal delivery Enrollment ongoing in AAVIATE® trial of RGX-314 for the treatment of wet AMD using suprachoroidal delivery Enrollment complete in ALTITUDE™ trial of RGX-314 for the treatment of diabetic retinopathy using suprachoroidal delivery Today announced update on initiation of AFFINITY DUCHENNE™ trial of RGX-202 for the treatment of Duchenne Continues plans for expanded enrollment of RGX-121 and RGX-111 clinical trials for the treatment of MPS II and MPS I, respectively In-house cGMP manufacturing facility is operational, allowing for high-yield manufacturing of AAV Therapeutics up to 2,000L scale $765 million in cash, cash equivalents and marketable securities as of March 31, 2022; operational runway into 2025 Conference call Wednesday, May 4 th at 4:30 p.m.

REGENXBIO Reports First Quarter 2022 Financial Results and Recent Operational Highlights

ROCKVILLE, Md. , May 3, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting, taking place virtually and in Washington, D.C.

REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting

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ROCKVILLE, Md. , April 27, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, May 4, 2022, at 4:30 p.m.

REGENXBIO to Host Conference Call on May 4 to Discuss First Quarter 2022 Financial Results and Recent Operational Highlights

Regenxbio holds the most powerful gene delivery platform on the planet. The company recently closed a $1.3B deal with AbbVie for the development of RGX314 for wet AMD.

Regenxbio: Is The Ultimate Catalyst Coming?

ROCKVILLE, Md. , April 20, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present in a fireside chat at Chardan's 6th Annual Genetic Medicines and Cell Therapy Manufacturing Summit on Tuesday, April 26, 2022 at 8:30 a.m.

REGENXBIO Announces Presentation at Chardan's 6th Annual Genetic Medicines and Cell Therapy Manufacturing Summit

Regenxbio (RGNX) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Regenxbio (RGNX) Moves to Buy: Rationale Behind the Upgrade

The consensus price target hints at a 101.7% upside potential for Regenxbio (RGNX). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Wall Street Analysts Believe Regenxbio (RGNX) Could Rally 102%: Here's is How to Trade

REGENXBIO's (RGNX) CEO Ken Mills on Q4 2021 Results - Earnings Call Transcript

Regenxbio (RGNX) delivered earnings and revenue surprises of 55.84% and 29.98%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?

Regenxbio (RGNX) Q4 Earnings and Revenues Beat Estimates

ROCKVILLE, Md., March 1, 2022 /PRNewswire/ -- Closed eye care collaboration agreement with AbbVie to develop and commercialize RGX-314 Received upfront payment of $370 million and eligible to receive up to $1.38 billion in additional development, regulatory and commercial milestones Continue to advance RGX-314 program for the treatment of wet AMD and diabetic retinopathy Two pivotal trials active for the treatment of wet AMD using subretinal delivery Today announced Cohort 4 enrollment complete in RGX-314 Phase II trial for the treatment of wet AMD using in-office suprachoroidal delivery; presented positive six-month data Presented positive six-month data from RGX-314 Phase II trial for the treatment of diabetic retinopathy using in-office suprachoroidal delivery Received IND clearance and Orphan Drug Designation for RGX-202 for the treatment of Duchenne Today announced that FDA has granted Rare Pediatric Disease Designation for RGX-202 AFFINITY DUCHENNETM Phase I/II clinical trial on-track to be initiated in the first half of 2022 Presented positive data from RGX-121 and RGX-111 clinical trials for the treatment of MPS II and MPS I $849 million current cash and cash equivalents of as of December 31, 2021; including upfront payment from closing of the AbbVie eye care collaboration agreement; operational runway into 2025 Conference call Tuesday, March 1 st at 4:30 p.m.

REGENXBIO Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Feb. 22, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Tuesday, March 1, 2022, at 4:30 p.m.

REGENXBIO to Host Conference Call on March 1 to Discuss Fourth Quarter and Full-Year 2021 Financial Results and Recent Operational Highlights

ROCKVILLE, Md., Feb. 12, 2022 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced additional positive interim 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 Interim Data from Phase II ALTITUDE™ Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery

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