REGENXBIO Inc., a clinical-stage biotechnology company, provides gene therapy product candidates to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins or antibodies that are intended to impact disease. Its gene therapy product candidates are based on NAV Technology Platform, a proprietary adeno-associated virus gene delivery platform. The company's lead product candidate is RGX-314, which is in Phase I/IIa clinical trial for the treatment of wet age-related macular degeneration. It is also developing RGX-121 that is in Phase I/II clinical trial to treat mucopolysaccharidosis type II; RGX-111, which is in Phase I clinical trial for treating mucopolysaccharidosis type I; RGX-181 for the treatment of late-infantile neuronal ceroid lipofuscinosis type II disease; and RGX-501, which is in Phase I/II clinical trials to treat homozygous familial hypercholesterolemia. REGENXBIO Inc. also licenses its NAV Technology Platform to other biotechnology and pharmaceutical companies; and has a collaboration and license agreement with Neurimmune AG to develop vectorized antibodies for the treatment of neurodegenerative diseases. The company was formerly known as ReGenX Biosciences, LLC and changed its name to REGENXBIO Inc. in September 2014. REGENXBIO Inc. was founded in 2008 and is headquartered in Rockville, Maryland.
IPO Year: 2015
Exchange: NASDAQ
Website: regenxbio.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 11/15/2024 | $22.00 | Overweight | Morgan Stanley |
| 10/10/2024 | $18.00 | Outperform | Raymond James |
| 6/7/2024 | $38.00 | Buy | Goldman |
| 3/11/2024 | $36.00 | Buy | H.C. Wainwright |
| 3/8/2024 | $20.00 → $35.00 | Sector Perform → Outperform | RBC Capital Mkts |
| 3/6/2024 | $37.00 | Market Perform → Outperform | Leerink Partners |
| 2/21/2024 | $45.00 | Outperform | Raymond James |
| 11/1/2023 | $35.00 | Buy | Stifel |
| 6/2/2023 | $42.00 | Outperform | Robert W. Baird |
| 6/23/2022 | $61.00 | Buy | Berenberg |
Alignment achieved with FDA on AFFINITY DUCHENNE® pivotal program and access to accelerated approval; BLA expected in 2026Pivotal trial of RGX-202 is enrolling ambulatory patients aged 1 and above with first patient dosedPhase I/II data show RGX-202 recipients exceeding external natural history and established benchmarks for clinical outcomesFunctional improvements seen in all patients treated with dose level 1 and dose level 2 at 12 and 9 months respectivelyNew biomarker data confirms consistent robust expression of differentiated RGX-202 microdystrophin in the muscleFavorable safety profile observed at both dose levels; no serious adverse events or AEs of special interest Webcast to be hel
- Event will feature Aravindhan Veerapandiyan, M.D., principal investigator of the AFFINITY DUCHENNE® trial and Michael Kelly, PhD, Chief Scientific Officer of CureDuchenne ROCKVILLE, Md., Nov. 14, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a webcast to discuss the AFFINITY DUCHENNE® pivotal program and new clinical data, including the first functional data from the ongoing Phase I/II study of RGX-202, the company's next-generation gene therapy for the treatment of Duchenne muscular dystrophy. The webcast will feature AFFINITY DUCHENNE principal investigator Aravindhan Veerapandiyan, M.D., Arkansas Children's Hospital, and Michael Kelly, PhD, Ch
Advancement in Phase I/II AFFINITY DUCHENNE® trial of RGX-202 for Duchenne Muscular Dystrophy; pivotal trial initiation and first functional data expected this monthBLA submission for RGX-121 initiated and expected to complete in Q1 2025Positive Phase II data support bilateral administration of subretinal ABBV-RGX-314; data consistent with that from multiple previous studies demonstrating favorable safety and efficacy profileEnd-of-Phase II meeting for ABBV-RGX-314 in diabetic retinopathy accelerated to Q4 2024 to support global pivotal program initiation in H1 2025Conference call today at 4:30 p.m. ETROCKVILLE, Md., Nov. 6, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today reported fi
ROCKVILLE, Md., Nov. 4, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced it will participate in the following investor conferences: UBS Global Healthcare Conference Fireside Chat: Wednesday, November 13 at 12:30 p.m. PTLocation: Rancho Palos Verdes, CA Stifel 2024 Healthcare Conference Fireside Chat: Tuesday, November 19 at 11:30 a.m. ETLocation: New York, NY Piper Sandler 36th Annual Healthcare Conference Fireside Chat: Thursday, December 5 at 9:30 a.m. ETLocation: New York, NY Live webcasts of the fireside chats can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com. An archived replay of the webcast will be available for approximately 30 days
ROCKVILLE, Md., Oct. 30, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Wednesday, November 6, at 4:30 p.m. ET to discuss its financial results for the third quarter ended September 30, 2024, and recent operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. ABOUT REGENXBIO Inc. REGENXBIO is a leading clinical-s
97% reduction in treatment burden at nine months after treatment with ABBV-RGX-314Data consistent with that from multiple previous studies demonstrating favorable safety and efficacy profile Well tolerated with zero cases of intraocular inflammation in a setting of no prophylactic steroids Data highlight the potential of ABBV-RGX-314 to treat both eyes in wet AMD ROCKVILLE, Md., Oct. 21, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced positive data from the Phase II fellow eye sub-study evaluating the subretinal delivery of ABBV-RGX-314 in patients with bilateral wet age-related macular degeneration (wet AMD). The new data were presented at the American Academy of Ophthalmo
ROCKVILLE, Md., Oct. 18, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will present new interim data evaluating subretinal delivery of ABBV-RGX-314 in patients with bilateral wet age-related macular degeneration (wet AMD) at the American Academy of Ophthalmology 2024 annual meeting. ABBV-RGX-314 is an investigational one-time AAV Therapeutic being developed in collaboration with AbbVie for the treatment of wet AMD, diabetic retinopathy and other additional chronic retinal conditions. New data will be presented as follows: Title: Subretinal Delivery of Investigational ABBV-RGX-314 as a Gene Therapy for nAMD: First Time Results of a Fellow Eye Bilateral Dosing Study
ROCKVILLE, Md., Sept. 23, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced it will participate in Chardan's 8th Annual Genetic Medicines Conference on Monday, September 30, 2024. Chardan's 8th Annual Genetic Medicines Conference Fireside Chat: Monday, September 30, 2024 at 8:30 a.m. ET Location: New York, NY A live webcast of the fireside chat can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com. An archived replay of the webcast will be available for approximately 30 days following the presentation. ABOUT REGENXBIO Inc. REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene
Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programsVit Vasista steps down following more than 15 years at the CompanyROCKVILLE, Md., Sept. 17, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that Mitchell Chan has been appointed as Executive Vice President and Chief Financial Officer, effective today. A veteran finance executive and operating partner in the biotechnology industry, Mr. Chan has held key roles in raising capital, business development transactions and operations for nearly 20 years. "We are excited to welcome Mitchell at this exciting time for REGENXBIO," said Curran Simpson, President and
- Data from pivotal dose level demonstrates long-term, sustained reductions in CSF levels of HS D2S6, a key biomarker of brain disease in MPS II- 80% of patients who received the pivotal dose discontinued intravenous enzyme replacement therapy or remained treatment-naïve- Submission of a rolling BLA using the accelerated approval pathway on track for Q3 2024 ROCKVILLE, Md., Sept. 3, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced positive results from the Phase I/II/III CAMPSIITE® trial of RGX-121 for the treatment of patients with Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome. The results were presented at the Society for the Study of Inborn Erro
Morgan Stanley resumed coverage of REGENXBIO with a rating of Overweight and set a new price target of $22.00
Raymond James resumed coverage of REGENXBIO with a rating of Outperform and set a new price target of $18.00
Goldman initiated coverage of REGENXBIO with a rating of Buy and set a new price target of $38.00
H.C. Wainwright initiated coverage of REGENXBIO with a rating of Buy and set a new price target of $36.00
RBC Capital Mkts upgraded REGENXBIO from Sector Perform to Outperform and set a new price target of $35.00 from $20.00 previously
Leerink Partners upgraded REGENXBIO from Market Perform to Outperform and set a new price target of $37.00
Raymond James resumed coverage of REGENXBIO with a rating of Outperform and set a new price target of $45.00
Stifel initiated coverage of REGENXBIO with a rating of Buy and set a new price target of $35.00
Robert W. Baird initiated coverage of REGENXBIO with a rating of Outperform and set a new price target of $42.00
Berenberg initiated coverage of REGENXBIO with a rating of Buy and set a new price target of $61.00
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Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programsVit Vasista steps down following more than 15 years at the CompanyROCKVILLE, Md., Sept. 17, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that Mitchell Chan has been appointed as Executive Vice President and Chief Financial Officer, effective today. A veteran finance executive and operating partner in the biotechnology industry, Mr. Chan has held key roles in raising capital, business development transactions and operations for nearly 20 years. "We are excited to welcome Mitchell at this exciting time for REGENXBIO," said Curran Simpson, President and
Curran Simpson, Chief Operating Officer, Appointed as President and CEOCo-Founder Kenneth T. Mills to Step Down as President and CEO; Named Chairman of the Board ROCKVILLE, Md., June 12, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that Curran Simpson, Chief Operating Officer, has been appointed as President, Chief Executive Officer and a member of the Board of Directors, effective July 1, 2024. Co-Founder Kenneth T. Mills will step down as President and Chief Executive Officer following 15 years of leadership at the Company, and he is taking on an expanded role on the Board as Chairman. In connection with these changes, Board member Daniel Tassé has been appointed as RE
NEW YORK, July 07, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, today announced that it has appointed Dr. Ellen Strahlman and Dr. Ram Palanki as new and independent members of its Board of Directors. With these appointments, the Eyenovia Board will expand to eight seats, from six currently. "I could not be more pleased to welcome Drs. Strahlman and Palanki to our Board and look forward to their immediate contributions," stated Dr. Sean Ianchulev, chief executive officer and chief medical officer of Eyenovia. "Each brings decades of medical technology, cl
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. Ms. Zachary will serve as a member of REGENXBIO's Audit Committee and brings 20 years of legal and regulatory experience working in the pharmaceutical and medical device industries. "We are pleased to welcome Jennifer to our Board of Directors," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "Jennifer is an accomplished pharmaceutical executive with a wealth of knowledge and
ROCKVILLE, Md., Sept. 7, 2021 /PRNewswire/ -- Renowned gene therapy pioneer and biotechnology executive bring extensive R&D leadership and financial and operational expertise to the BoardREGENXBIO Inc. (NASDAQ:RGNX) today announced the appointment of Jean Bennett, M.D., Ph.D., and George Migausky to its Board of Directors, effective September 3, 2021. Dr. Bennett, a leading molecular genetics researcher, is the F.M. Kirby Emeritus Professor of Ophthalmology at the Perelman School of Medicine and previously served as director of the Center for Advanced Retinal and Ocular Therapeutics (CAROT) at the University of Pennsylvania. She will serve as a member of REGENXBIO's Nominating and Corporate
Oppenheimer initiated coverage on Clearside Biomedical Inc (NASDAQ:CLSD), a biopharmaceutical company focused on delivering therapies to the back of the eye through the suprachoroidal (SCS) space. Oppenheimer writes, “We consider Clearside a pioneer in suprachoroidal delivery via its suprachoroidal Microinjector that improves delivery of therapies for retinal diseases.” Suprachoroidal drug delivery is an ocular route of drug administration. The analyst writes that intravitreal injections have traditionally been the standard for delivering retinal treatments, but they can cause issues like uncontrolled dispersion. Meanwhile, SCS injections provide a more targeted and compartmental
Thursday, the FDA approved labeled indication for Sarepta Therapeutics Inc’s (NASDAQ:SRPT) Elevidys (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least 4 years of age. Confirming the functional benefits, the FDA granted traditional approval for ambulatory patients (patients who can walk) and accelerated approval for non-ambulatory patients (patients who cannot walk). Related: Sarepta Downgraded As FDA Decision Date Approaches, Shares Up 50% Over Last Six Months. Continued approval for non-ambulatory Duchenne patients may be contingent upon verification of clinical benefit in a co
HC Wainwright & Co. analyst Yi Chen reiterates Regenxbio (NASDAQ:RGNX) with a Buy and maintains $38 price target.
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
Goldman Sachs has initiated coverage on Regenxbio Inc (NASDAQ:RGNX), citing the potential for the company’s gene therapy platform. The company’s pipeline includes gene therapy candidates for ophthalmology (wet AMD and diabetic retinopathy), Duchenne muscular dystrophy (DMD), and Hunter syndrome. The analyst predicts that RGX-314 for wet AMD and diabetic retinopathy will have limited market penetration, primarily serving specific patient subgroups due to the high standards of efficacy and safety set by newer anti-VEGF treatments that require fewer injections, e.g., high dose Regeneron Pharmaceutical Inc’s (NASDAQ:REGN) Eylea, Roche Holdings AG’s (OTC:RHHBY) Vabysmo. Also Read: This G
In the latest quarter, 4 analysts provided ratings for Regenxbio (NASDAQ:RGNX), showcasing a mix of bullish and bearish perspectives. The following table provides a quick overview of their recent ratings, highlighting the changing sentiments over the past 30 days and comparing them to the preceding months. Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 4 0 0 0 0 Last 30D 1 0 0 0 0 1M Ago 1 0 0 0 0 2M Ago 1 0 0 0 0 3M Ago 1 0 0 0 0 Analysts' evaluations of 12-month price targets offer additional insights, showcasing an average target of $38.0, with a high estimate of $40.00 and a low estimate of $36.00. Observing a 5.56% increase, the current a
Goldman Sachs analyst Paul Choi initiates coverage on Regenxbio (NASDAQ:RGNX) with a Buy rating and announces Price Target of $38.
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ROCKVILLE, Md., Oct. 30, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Wednesday, November 6, at 4:30 p.m. ET to discuss its financial results for the third quarter ended September 30, 2024, and recent operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. ABOUT REGENXBIO Inc. REGENXBIO is a leading clinical-s
ROCKVILLE, Md., July 25, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, August 1, 2024, at 4:30 p.m. ET to discuss its financial results for the second quarter ended June 30, 2024, and recent operational highlights. To access the live call by phone, dial (646) 307-1963 (domestic) or (800) 715-9871 (international) and enter the passcode 4849384. To access a live or recorded webcast of the call, please visit the Investors section of the REGENXBIO website at www.regenxbio.com. The recorded webcast will be available for approximately 30 days following the call. Those who plan on participating are advised to join 15 minutes prior
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. ET to discuss its financial results for the first quarter ended March 31, 2024, and recent operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. ABOUT REGENXBIO Inc. REGENXBIO is a leading clinical-stage
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 controlEarly evidence of strength and motor function improvement observedOn track to initiate pivotal trial in second half of 2024 Webcast this morning, Tuesday, March 5, 8:30 a.m. ET, with principal investigatorROCKVILLE, Md., March 5, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today reported additional interim safety and efficacy data in the Phase I/II AFFINITY DUCHENNE® trial of RGX-202 in patients with Duchenne muscular dystrophy (Duchenne) ages 4 to11 years old, including RGX-202 microdystrophin expression from
Focus on clinical stage AAV Therapeutic product candidates addressing large commercial opportunities and value generationPrioritized pipeline is expected to further progress to pivotal stage and first BLA filing in 2024New 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 2025Conference call Tuesday, February 27, at 4:30 p.m. ETROCKVILLE, Md., Feb. 27, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced financial results for the fourth quarter and full year ended December 31, 2023, and r
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. ET to discuss its financial results for the fourth quarter and full year ended December 31, 2023, and recent operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. About REGENXBIO Inc. REGENXBIO is
Results support BLA submission in 2024 using the accelerated approval pathwayPrimary 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 therapyCompany 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. ETROCKVILLE, Md., Feb. 7, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced topline results from the Phase I/II/III CAMPSIITE® trial of RGX-121 for the
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 microdystrophinNew 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 controlOn 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. ETROCKVILLE, Md., Feb. 7, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today an
Pivotal topline results from the CAMPSIITE® trial of RGX-121 for the treatment of MPS II to be presentedConference call Wednesday, February 7, 4:30 p.m. ETROCKVILLE, Md., Jan. 31, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced presentations on its program for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, will be shared at the 20th Annual WORLDSymposium™ 2024, taking place in San Diego, CA February 3-9, 2024. The presentations include the topline results from the pivotal phase of the Phase I/II/III CAMPSIITE® trial of RGX-121 for the treatment of MPS II. The oral presentations will be presented as follows: Abstract Title: CAMPSIITE®
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 eventsABBV-RGX-314 in over 50 patients at third dose level demonstrated highest reduction in treatment burden:80% reduction in annualized injection rate50% injection-freeZero cases of intraocular inflammation observed in patients that received short-course prophylactic topical steroid ey