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 Q1 2021

Earnings data Q2 2021

Earnings data Q3 2021

Earnings data Q4 2021

Earnings data Q1 2022

Earnings data Q2 2022

Earnings data Q3 2022

Earnings data Q4 2022

Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

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.

Revenue

Cost of revenue

Gross profit

Operating expenses

SG&A

Other

Operating income

EBITDA

Net income

Earnings per share

Total assets

Current assets

Cash & equivalents

Receivables

Inventory

Non-current assets

Net PPE

Intangibles

Total liabilities

Current liabilities

Short term debt

Income tax payable

Non-current liabilities

Long-term debt

Total equity

Stockholders equity

Minority interest

Total liabilities & equity

Total debt

Net debt

Book value per share

Cash from operations

Funds from operations

Change in working capital

Cash from investing

Capital expenditure

Purchase/sale of investments

Purchase/sale of business

Other sources

Cash from financing

Change in stock

Change in debt

Cash dividends paid

Cash from other sources

Net change in cash

Free cash flow

Regenxbio (RGNX) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

Regenxbio (RGNX) Soars 6.4%: Is Further Upside Left in the Stock?

Amphastar Pharma

Collegium Pharmaceutical

Genmab - ADR

Harmony Biosciences Holdings

 Pliant Therapeutics

Royalty Pharma

Fundamentally, the biotechnology sphere enjoys a powerful catalyst: wealth without health means nothing. Yes, it's important to save money and invest for the future.

7 Biotech Stocks to Buy on the Dip: June 2024

Company to begin enrollment of  patients aged 1-3 years Expects data from younger cohort to be part of pivotal plans and BLA filing for broad label End-of-Phase II meeting with FDA scheduled for late July to finalize pivotal  program design Based on recent commercial landscape, confirmed accelerated approval pathway remains available given ongoing unmet need and RGX-202 differentiated design Remains on track to initiate pivotal trial in late Q3 to early Q4 2024 The next potential therapy to become available for Duchenne patients ROCKVILLE, Md., June 24, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it initiated enrollment in a new cohort of patients ages 1-3 in its Phase I/II AFFINITY DUCHENNE® trial to evaluate the safety and efficacy of RGX-202 in boys with Duchenne muscular dystrophy (Duchenne).

REGENXBIO Announces Expansion of AFFINITY DUCHENNE® Trial to Include a New Cohort of Younger Patients

Aligned with FDA on content of BLA and plans for submission: Submission of a rolling BLA using the accelerated approval pathway expected to start in Q3 2024 Confirmatory trial expected to begin in H2 2025 FDA confirmed RGX-121 commercial bulk drug is comparable to clinical material Positive biomarker, neurocognitive and systemic data will be part of BLA submission ROCKVILLE, Md. , June 18, 2024 /PRNewswire/ --  REGENXBIO Inc. (Nasdaq: RGNX) today announced it completed a successful Pre-Biologics License Application (BLA) meeting for RGX-121 for the treatment Mucopolysaccharidosis Type II (MPS II), where it finalized details of its BLA with the U.S. Food and Drug Administration (FDA).

REGENXBIO Announces Successful Pre-BLA Meeting with FDA to Support Accelerated Approval Pathway for RGX-121 for the Treatment of MPS II

Curran Simpson, Chief Operating Officer, Appointed as President and CEO Co-Founder Kenneth T. Mills to Step Down as President and CEO; Named Chairman of the Board ROCKVILLE, Md.

REGENXBIO Announces Leadership Transition

REGENXBIO develops AAV therapies using its proprietary NAV platform, offering one-dose treatments targeting disease root causes. The company's pipeline includes promising candidates for age-related macular degeneration, Duchenne muscular dystrophy, and Hunter syndrome. ABBV-RGX-314, RGX-202, and RGX-121 are key pipeline candidates targeting significant markets with promising clinical data.

Regenxbio: Transforming Gene Therapy With Innovative AAV Treatments, Strong Buy

ROCKVILLE, Md. , June 5, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in the Goldman Sachs 45th Annual Global Healthcare Conference on Wednesday, June 12, 2024.

REGENXBIO to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference

REGENXBIO Inc. (NASDAQ:RGNX ) Q1 2024 Earnings Conference Call May 8, 2024 4:30 PM ET Company Participants Patrick Christmas – Chief Legal Officer Ken Mills – Chief Executive Officer Curran Simpson – Chief Operating Officer Vit Vasista – Chief Financial Officer Conference Call Participants Gena Wang – Barclays Annabel Samimy – Stifel Brian Skorney – Baird Luca Issi – RBC Capital Daniil Gataulin – Chardan Operator Good day and thank you for standing by. Welcome to REGENXBIO's First Quarter 2024 Earnings Conference Call.

REGENXBIO Inc. (RGNX) Q1 2024 Earnings Call Transcript

Regenxbio (RGNX) came out with a quarterly loss of $1.38 per share versus the Zacks Consensus Estimate of a loss of $1.28. This compares to loss of $1.53 per share a year ago.

Regenxbio (RGNX) Reports Q1 Loss, Lags Revenue Estimates

Company remains on track for its first BLA filing in 2024 and is accelerating progress toward pivotal trial initiation for Duchenne (H2 2024) and diabetic retinopathy (H1 2025) Dose level 2 selected as pivotal dose for RGX-202 treatment of Duchenne New positive interim efficacy and safety data announced for second boy at DL2 AFFINITY DUCHENNE® trial expansion phase is underway with third and fourth boys dosed at DL2 End-of-Phase II meeting with FDA planned for early Q3 and pivotal trial initiation anticipated in late Q3 to early Q4 2024 Positive interim results from ALTITUDE® trial for diabetic retinopathy support plans for anticipated End-of-Phase II meeting with FDA in Q1 2025 $381 million in cash, cash equivalents and marketable securities as of March 31, 2024, expected to fund operational runway into 2026 Conference call Wednesday, May 8, at 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Reports First Quarter 2024 Financial Results and Recent Operational Highlights

ROCKVILLE, Md. , May 1, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Wednesday, May 8, 2024, at 4:30 p.m.

REGENXBIO to Host Conference Call on May 8 to Discuss First Quarter 2024 Financial Results and Recent Operational Highlights

ROCKVILLE, Md. , April 24, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in Chardan's 8th Annual Genetic Medicines and Cell Therapy Manufacturing Summit on Monday, April 29, 2024.

REGENXBIO to Participate in Chardan's 8th Annual Genetic Medicines and Cell Therapy Manufacturing Summit

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 Patients who received therapeutic doses resulted in stable or improved vision and retinal anatomy up to 2 years Additional long-term follow-up data has demonstrated durable treatment effect, with stable or improved vision, up to 4 years Enrollment is on track in pivotal trials of ABBV-RGX-314 in wet AMD that are expected to support global regulatory submissions in late 2025 through the first half of 2026 ROCKVILLE, Md. , March 28, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the publication of results from the Phase I/IIa trial evaluating the safety and tolerability of a single dose of subretinal ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).

REGENXBIO Announces Lancet Publication of Phase I/IIa Study Evaluating ABBV-RGX-314 as a One-Time Gene Therapy for Wet AMD

ROCKVILLE, Md. , March 27, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will participate in Cantor Fitzgerald's Virtual DMD and Other Dystrophy Days on Wednesday, April 3, 2024.

REGENXBIO to Participate in Cantor Fitzgerald's Virtual DMD and Other Dystrophy Days

Positive interim results released from phase 1/2 AFFINITY study, using RGX-202 for the treatment of patients with Duchenne Muscular Dystrophy. Functional and strength data from the phase 1/2 AFFINITY study, using RGX-202 for the treatment of patients with Duchenne Muscular Dystrophy, expected in the 2nd half of 2024. The Duchenne Muscular Dystrophy Treatment Market size is estimated to reach $4.32 billion by 2029.

Regenxbio: DMD Program Lends Additional Credibility To NAV Technology Platform

ROCKVILLE, Md. , March 6, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy, today announced the pricing of an underwritten upsized public offering of 4,565,260 shares of its common stock at the price of $23.00 per share and 1,521,740 pre-funded warrants at a price of $22.9999 per warrant, in each case before underwriting discounts and commissions.

REGENXBIO Announces Pricing of Upsized Public Offering of Common Stock and Pre-funded Warrants

ROCKVILLE, Md. , March 6, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it intends to offer and sell, subject to market conditions, $125,000,000 of its common stock in an underwritten public offering.

REGENXBIO Announces Proposed Public Offering of Common Stock

Data from an early-stage study shows that treatment with REGENXBIO's (RGNX) investigational Duchenne therapy RGX-202 demonstrates early evidence of strength and motor function improvement.

REGENXBIO (RGNX) Soars 15% on Interim Data From DMD Study

New three-month assessment in first patient at dose level 2 demonstrates robust microdystrophin expression Patient aged 12 years at dosing had expression level at 75.7% of control Early evidence of strength and motor function improvement observed On track to initiate pivotal trial in second half of 2024 Webcast this morning, Tuesday, March 5, 8:30 a.m. ET, with principal investigator ROCKVILLE, Md.

REGENXBIO ANNOUNCES NEW POSITIVE INITIAL EFFICACY DATA FROM AFFINITY DUCHENNE® TRIAL

Company to host webcast on Tuesday, March 5, 2024 at 8:30 a.m. EST Interim clinical data will be presented by Aravindhan Veerapandiyan, M.D.

REGENXBIO to Host Webcast Event to Discuss New Interim Clinical Data from the Phase I/II AFFINITY DUCHENNE® Trial

REGENXBIO Inc. (RGNX) Q4 2023 Earnings Call Transcript

Regenxbio (RGNX) came out with a quarterly loss of $1.43 per share versus the Zacks Consensus Estimate of a loss of $1.27. This compares to loss of $1.38 per share a year ago.

Regenxbio (RGNX) Reports Q4 Loss, Lags Revenue Estimates

Focus on clinical stage AAV Therapeutic product candidates addressing large commercial opportunities and value generation Prioritized pipeline is expected to further progress to pivotal stage and first BLA filing in 2024 New updates planned for Duchenne and in-office delivery retinal disease programs starting in March $314 million in cash, cash equivalents and marketable securities as of December 31, 2023, expected to fund operational runway into the second half of 2025 Conference call Tuesday, February 27, at 4:30 p.m. ET ROCKVILLE, Md.

REGENXBIO Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights

ROCKVILLE, Md. , Feb. 21, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that it will host a conference call on Tuesday, February 27, 2024, at 4:30 p.m.

REGENXBIO to Host Conference Call on February 27 to Discuss Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights

REGENXBIO (RGNX) gains 12% on positive top-line results from the phase I/II/III study of its investigational one-time gene therapy candidate, RGX-121, to treat pediatric patients with Hunter syndrome.

News for REGENXBIO Stock (RGNX)