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MeiraGTx, an emerging leader in genetic medicine, boasts Johnson & Johnson and Sanofi as shareholders, a partnership with Hologen AI – an Eric Schmidt (former Google CEO) company – and has a number of late-stage drugs in its clinical pipeline using its first-gen gene technology. MeiraGTx is pioneering future genetic medicines with its next-gen Riboswitch technology that broadens the application of genetic medicine to a wider range of disease areas.

The company has received two FDA RMAT designations, for its Parkinson’s and Xerostomia programs, further strengthening its regulatory momentum.

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Major pharmaceuticals, J&J and Sanofi, have made strategic investments into MeiraGTx, validating its unique pipeline and technology. Plus, the company recently entered a JV with Hologen AI - a venture co-founded by highly regarded individuals including former Google CEO, Eric Schmidt.

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MeiraGTx has multiple clinical-stage programs focused on diseases with limited or no treatment options. These include conditions such as X-linked Retinitis Pigmentosa, Inherited Retinal Diseases, Salivary Gland Disorders, and Parkinson’s Disease.

Its gene therapy for Parkinson’s (AAV-GAD), now supported by FDA RMAT designation, aims to slow or stop disease progression — a potential breakthrough. Separately, J&J’s bota-vec gene therapy for vision loss missed its main trial goal but showed meaningful improvements on several secondary measures, and may still advance toward approval.

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Phase 3 initiation for AAV-GAD (Parkinson’s) – 2025:
A pivotal trial supported by RMAT status and full funding through Hologen AI.
BLA filing for AAV-AQP1 (Xerostomia) – 2026:
RMAT-designated therapy with promising Phase 2 data addresses a significant unmet need in radiation-induced dry mouth.
Expansion of Riboswitch platform into new indications:
Progress in metabolic disease and autoimmune applications could lead to new preclinical partnerships or INDs.

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BLA submission for AAV-GAD (Parkinson’s) – 2027:
If successful, could be the first disease-modifying gene therapy for Parkinson’s.
Pre-IND progress across core pipeline:
ALS, Stargardt’s Disease, AMD, and Glaucoma programs represent diversified opportunities in high-need areas.
Next-generation cell and gene therapy innovation:
Advances in in vivo CAR-T and Riboswitch-controlled therapies targeting cancer and autoimmune disease.

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Marketing authorization for AAV-AIPL1 (LCA4):
Planned submission to the UK’s MHRA under exceptional circumstances based on vision gains in 11 legally blind children. No further trials required.
Regulatory engagement for AAV-GAD (Parkinson’s):
Following RMAT designation and strong clinical data, FDA interactions may fast-track development and approval discussions.
Manufacturing expansion and monetization:
Ongoing scale-up of MeiraGTx’s GMP viral vector and plasmid production may unlock near-term efficiencies and potential third-party revenue.

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The path to approval for gene therapies can be long and fraught with regulatory challenges, including the risk of trial delays or rejections that could significantly impact the company’s timeline and financial standing.

With gene therapies still in the clinical phase, there are inherent risks related to trial outcomes. Negative results or adverse events could delay or derail progress.

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In 2019, MeiraGTx and Janssen, a subsidiary of Johnson & Johnson, entered an agreement for the clinical development of MeiraGTx’s leading IRD pipeline. MeiraGTx received an upfront payment of $100 million and the potential of additional milestone payments of up to $340 million, along with untiered royalties.

In 2023, MeiraGTx sold full rights to bota-vec to J&J for $130 million upfront, with the potential for $285 million in milestone payments. However, J&J’s recent Phase 3 data missed the primary endpoint, casting uncertainty over future payments. That said, MeiraGTx is not reliant on bota-vec revenues, with its Parkinson’s candidate fully financed by a separate $430 million deal with Hologen AI.

"}}]}]]}],["$","details","6757",{"className":"group bg-[#1B1A1F] border border-[#FFFFFF15] rounded-lg overflow-hidden","children":[["$","summary",null,{"className":"flex items-center justify-between p-4 cursor-pointer hover:bg-[#2A2930] transition-colors duration-200","children":[["$","h3",null,{"className":"text-white font-medium pr-4","children":"What is the agreement with Sanofi?"}],["$","svg",null,{"className":"w-5 h-5 text-gray-400 transform transition-transform duration-200 group-open:rotate-180 flex-shrink-0","fill":"none","stroke":"currentColor","viewBox":"0 0 24 24","aria-hidden":"true","children":["$","path",null,{"strokeLinecap":"round","strokeLinejoin":"round","strokeWidth":2,"d":"M19 9l-7 7-7-7"}]}]]}],["$","div",null,{"className":"px-4 pb-4","children":["$","div",null,{"className":"text-[#D9D7DB] prose prose-invert max-w-none prose-sm","dangerouslySetInnerHTML":{"__html":"In October 2023, MeiraGTx received a $30 million strategic investment from pharma giant Sanofi that reinforces MeiraGTx's financial position but also validates the company's potential in the genetic medicine landscape. This type of investment is a rare occurrence for a young company involved in early-stage biotech.

In exchange for the $30 million, Sanofi received a Right of First Negotiation for MeiraGTx's phase 2 Xerostomia program, which treats salivary glands damaged by radiotherapy treatments. In addition to this, Sanofi will get the first look at MeiraGTx's Riboswitch gene regulation technology in certain targets.

Subsequently, after the 24Q2 earnings release, MeiraGTx offered $50mn in Ordinary Shares at $4/sh. The financing was led by Sanofi, which made a $30mn equity investment, making them the #1 shareholder, further strengthening the relationship between the two companies."}}]}]]}],["$","details","6758",{"className":"group bg-[#1B1A1F] border border-[#FFFFFF15] rounded-lg overflow-hidden","children":[["$","summary",null,{"className":"flex items-center justify-between p-4 cursor-pointer hover:bg-[#2A2930] transition-colors duration-200","children":[["$","h3",null,{"className":"text-white font-medium pr-4","children":"What are RPDDs and PRVs and why are they relevant for MeiraGTx?"}],["$","svg",null,{"className":"w-5 h-5 text-gray-400 transform transition-transform duration-200 group-open:rotate-180 flex-shrink-0","fill":"none","stroke":"currentColor","viewBox":"0 0 24 24","aria-hidden":"true","children":["$","path",null,{"strokeLinecap":"round","strokeLinejoin":"round","strokeWidth":2,"d":"M19 9l-7 7-7-7"}]}]]}],["$","div",null,{"className":"px-4 pb-4","children":["$","div",null,{"className":"text-[#D9D7DB] prose prose-invert max-w-none prose-sm","dangerouslySetInnerHTML":{"__html":"

Rare Pediatric Disease Designations (RPDDs) are special designations granted by the FDA to drugs intended to treat serious or life-threatening rare diseases that primarily affect children. MeiraGTx has four RPDDs (Two for Retinal Dystrophy, one for Bardet-Biedl syndrome (BBS) and one for Leber congenital amaurosis).

If a therapy has an RPDD then it can qualify for the FDA's Rare Pediatric Disease Priority Review Voucher (PRV) program which incentivizes the development of treatments for serious or life-threatening rare pediatric diseases .These vouchers can significantly accelerate regulatory review (from 10 months to 6 months), helping to reduce development costs and expedite market entry. PRVs are also a valuable financial asset, as they can be sold for hundreds of millions of dollars, further bolstering MeiraGTx’s cash reserves.

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This is initiated by the patient simply taking a pill that activates the specific genetic medicine to produce the required proteins at the precise time and the precise dosage needed for that particular condition.

It improves the potency, safety and specificity of genetic medicines.
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Investigators found that 13% of a recent study's participants had a genetic form of PD.","cta_label":"See more","cta_link":"https://x.com/ChEnected/status/1818320651926597851","title":null}]},{"id":5886,"name":"Genpharm","image":"https://curation-api-production-assets.s3.eu-west-2.amazonaws.com/5/1722432669.jpeg","expertise":"Specialises in Rare Disease","audience":"29k","x_link":null,"linkedin":"https://www.linkedin.com/company/genpharm-services/posts/?feedView=all","website":null,"quotes":[{"id":7877,"showcase_expert_id":5886,"platform":"linkedin","type":"text","content":"Genetic Medicine allows doctors to treat a disorder by altering a person's genetic makeup instead of using drugs or surgery","cta_label":"See more","cta_link":"https://www.linkedin.com/posts/genpharm-services_gene-therapy-the-future-of-medicine-activity-7161660007812325377-BkS1/?utm_source=share&utm_medium=member_desktop","title":null}]},{"id":5887,"name":"Michael Mulraney","image":"https://curation-api-production-assets.s3.eu-west-2.amazonaws.com/5/1722432819.jpeg","expertise":"Genetic Therapy commentator","audience":"574","x_link":null,"linkedin":"https://www.linkedin.com/in/mmulraney/","website":null,"quotes":[{"id":7878,"showcase_expert_id":5887,"platform":"linkedin","type":"text","content":"Genetic medicine is pushing the boundaries of what we believed to be possible in the fights against viral infections","cta_label":"See more","cta_link":"https://www.linkedin.com/posts/mmulraney_how-solving-a-problem-with-genetic-medicines-activity-7199138175837970432-lSXf?utm_source=share&utm_medium=member_desktop","title":null}]}],"catalysts":[{"id":5827,"showcase_id":3316,"type":"medium","description":"

Phase 3 initiation for AAV-GAD (Parkinson’s) – 2025:
A pivotal trial supported by RMAT status and full funding through Hologen AI.
BLA filing for AAV-AQP1 (Xerostomia) – 2026:
RMAT-designated therapy with promising Phase 2 data addresses a significant unmet need in radiation-induced dry mouth.
Expansion of Riboswitch platform into new indications:
Progress in metabolic disease and autoimmune applications could lead to new preclinical partnerships or INDs.

","cta_name":null,"cta_link":null,"video":null,"video_iframe_url":null},{"id":5828,"showcase_id":3316,"type":"long","description":"

BLA submission for AAV-GAD (Parkinson’s) – 2027:
If successful, could be the first disease-modifying gene therapy for Parkinson’s.
Pre-IND progress across core pipeline:
ALS, Stargardt’s Disease, AMD, and Glaucoma programs represent diversified opportunities in high-need areas.
Next-generation cell and gene therapy innovation:
Advances in in vivo CAR-T and Riboswitch-controlled therapies targeting cancer and autoimmune disease.

","cta_name":null,"cta_link":null,"video":null,"video_iframe_url":null},{"id":5829,"showcase_id":3316,"type":"short","description":"

Marketing authorization for AAV-AIPL1 (LCA4):
Planned submission to the UK’s MHRA under exceptional circumstances based on vision gains in 11 legally blind children. No further trials required.
Regulatory engagement for AAV-GAD (Parkinson’s):
Following RMAT designation and strong clinical data, FDA interactions may fast-track development and approval discussions.
Manufacturing expansion and monetization:
Ongoing scale-up of MeiraGTx’s GMP viral vector and plasmid production may unlock near-term efficiencies and potential third-party revenue.

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In 2019, MeiraGTx and Janssen, a subsidiary of Johnson & Johnson, entered an agreement for the clinical development of MeiraGTx’s leading IRD pipeline. MeiraGTx received an upfront payment of $100 million and the potential of additional milestone payments of up to $340 million, along with untiered royalties.\n\nIn 2023, MeiraGTx sold full rights to bota-vec to J&J for $130 million upfront, with the potential for $285 million in milestone payments. However, J&J’s recent Phase 3 data missed the primary endpoint, casting uncertainty over future payments. That said, MeiraGTx is not reliant on bota-vec revenues, with its Parkinson’s candidate fully financed by a separate $430 million deal with Hologen AI.

","video":null,"video_iframe_url":null},{"id":6757,"showcase_id":3316,"question":"What is the agreement with Sanofi?","answer":"In October 2023, MeiraGTx received a $30 million strategic investment from pharma giant Sanofi that reinforces MeiraGTx's financial position but also validates the company's potential in the genetic medicine landscape. This type of investment is a rare occurrence for a young company involved in early-stage biotech.\n\nIn exchange for the $30 million, Sanofi received a Right of First Negotiation for MeiraGTx's phase 2 Xerostomia program, which treats salivary glands damaged by radiotherapy treatments. In addition to this, Sanofi will get the first look at MeiraGTx's Riboswitch gene regulation technology in certain targets.\n\nSubsequently, after the 24Q2 earnings release, MeiraGTx offered $50mn in Ordinary Shares at $4/sh. The financing was led by Sanofi, which made a $30mn equity investment, making them the #1 shareholder, further strengthening the relationship between the two companies.","video":null,"video_iframe_url":null},{"id":6758,"showcase_id":3316,"question":"What are RPDDs and PRVs and why are they relevant for MeiraGTx?","answer":"

","video":null,"video_iframe_url":null},{"id":6759,"showcase_id":3316,"question":"What does 'vertically integrated end-to-end manufacturing' mean?","answer":"With more than 180,000 sqft of combined dedicated manufacturing facilities in the UK and Ireland, MeiraGTx has brought all aspects of manufacturing and process development of its genetic medicines in-house. \n\nMeiraGTx’s facilities support the supply of its own innovative genetic medicines at all stages of the product development cycle, from pre-clinical stages through clinical trials and commercialization, whilst offering the scale to support drug development for other companies.","video":null,"video_iframe_url":null},{"id":6760,"showcase_id":3316,"question":"What is Riboswitch technology?","answer":"The proprietary Riboswitch technology involves the precise control of genetic medicines via a sort of ‘molecular switch’, or a regulator.\n\nThis is initiated by the patient simply taking a pill that activates the specific genetic medicine to produce the required proteins at the precise time and the precise dosage needed for that particular condition.\n\nIt improves the potency, safety and specificity of genetic medicines.\nThis technology can activate a combination of drugs, making it versatile for genetic medicine, cell therapy, and gene editing.","video":null,"video_iframe_url":null}],"researches":[],"articles":[{"id":3922,"showcase_id":3316,"title":"Operational risks with gene therapies should improve with time, exec says - Pharmaceutical Technology","description":"Making therapies feasible from biological, regulatory, and commercial standpoints drives scalable genetic medicine.","link":"https://www.pharmaceutical-technology.com/news/operational-risks-with-gene-therapies-should-improve-with-time-exec-says/","date":null},{"id":3923,"showcase_id":3316,"title":"Operational risks with gene therapies should improve with time, exec says - Pharmaceutical Technology","description":"Making therapies feasible from biological, regulatory, and commercial standpoints drives scalable genetic medicine.","link":"https://www.pharmaceutical-technology.com/news/operational-risks-with-gene-therapies-should-improve-with-time-exec-says/","date":null},{"id":3924,"showcase_id":3316,"title":"MeiraGTx’s Industry-Leading Gene Therapy Manufacturing Facility in Shannon, Ireland Formally Introduced by Head of Irish Government | MeiraGTx","description":"-- Manufacturing facilities built to accelerate development and delivery of advanced medicines to patients using state-of-the-art technology at scale, with quality appropriate for commercialization -- Site reflects MeiraGTx’s unique, end-to-end approach to gene therapy manufacturing to expedite","link":"https://investors.meiragtx.com/news-releases/news-release-details/meiragtxs-industry-leading-gene-therapy-manufacturing-facility","date":null},{"id":3925,"showcase_id":3316,"title":"'It could change lives': Inside London lab testing gene therapy for cancer & obesity","description":"Meira GTx, in Shoreditch, is working on potentially revolutionary treatments for a wide array of illnesses","link":"https://www.standard.co.uk/news/health/meira-gtx-gene-therapy-london-lab-cancer-obesity-b1128580.html","date":null},{"id":3917,"showcase_id":3316,"title":"MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV-GAD for the Treatment of Parkinson’s Disease | MeiraGTx","description":"- This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD as a one-time treatment for Parkinson’s disease - RMAT designation includes the benefits of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions","link":"https://investors.meiragtx.com/news-releases/news-release-details/meiragtx-granted-fda-regenerative-medicine-advanced-therapy-0","date":null},{"id":3918,"showcase_id":3316,"title":"MeiraGTx Enters into a Strategic Collaboration with Hologen AI to Expedite Phase 3 Development of AAV-GAD for Parkinson’s Disease and Industrialize MeiraGTx’s Proprietary Manufacturing Process | MeiraGTx","description":"- MeiraGTx to receive $200 million in upfront cash consideration - MeiraGTx and Hologen will form a joint venture, Hologen Neuro AI Ltd, with an additional $230 million committed capital from Hologen to fund 100% of the development of AAV-GAD for Parkinson’s disease through to commercialization, as","link":"https://investors.meiragtx.com/news-releases/news-release-details/meiragtx-enters-strategic-collaboration-hologen-ai-expedite","date":null},{"id":3919,"showcase_id":3316,"title":"MeiraGTx Announces The Lancet Publication of Data Demonstrating the Efficacy of rAAV8.hRKp.AIPL1 for the Treatment of Leber Congenital Amaurosis 4 (LCA4) Retinal Dystrophy | MeiraGTx","description":"As disclosed in the paper, 4 out of 4 young children with the AIPL1-related retinal dystrophy, LCA4, benefited substantially from unilateral subretinal administration of rAAV8 .hRKp.AIPL1 with improved visual acuity, functional vision, and protection against progressive retinal degeneration","link":"https://investors.meiragtx.com/news-releases/news-release-details/meiragtx-announces-lancet-publication-data-demonstrating","date":null},{"id":3920,"showcase_id":3316,"title":"MeiraGTx Receives Rare Pediatric Disease Designation from FDA for AAV8-RK-RetGC for the Treatment of Patients with Leber Congenital Amaurosis due to GUCY2D Mutations | MeiraGTx","description":"MeiraGTx has recently received Rare Pediatric Disease Designation (RPDD) for four inherited retinal diseases (IRDs) reflecting the transformative therapeutic potential of the Company’s proprietary technology platforms LONDON and NEW YORK, Jan. 22, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings Plc","link":"https://investors.meiragtx.com/news-releases/news-release-details/meiragtx-receives-rare-pediatric-disease-designation-fda-aav8-rk","date":null},{"id":3921,"showcase_id":3316,"title":"Why Is Eye Disease Related Gene Therapy Focused MeiraGTx Stock Soaring Today?","description":"MeiraGTx Holdings plc (NASDAQ: MGTX) on Thursday announced an asset purchase agreement with Janssen Pharmaceuticals Inc, a Johnson & Johnson (NYSE: JNJ) compan","link":"https://markets.businessinsider.com/news/stocks/why-is-eye-disease-related-gene-therapy-focused-meiragtx-stock-soaring-today-1032920039","date":null},{"id":3926,"showcase_id":3316,"title":"MeiraGTx and Hologen launch AI-backed gene therapy venture - 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Alexandria holds an M.A. in Natural Sciences and a Ph.D. in Molecular Genetics."},{"id":5443,"showcase_id":3316,"name":"Richard Giroux","role":"COO & CFO","image":"https://curation-api-production-assets.s3.eu-west-2.amazonaws.com/5/1716387128.jpeg","linkedin":"https://www.linkedin.com/in/richard-giroux-b67749122/","x_link":"https://theorg.com/org/meiragtx/org-chart/richard-giroux","description":"MeiraGTx's COO since 2015 and later assumed the CFO role in 2019. Previously at Sarissa Capital Management, He brings extensive experience in healthcare hedge funds and investment banks. He holds a B.A. in Economics from Yale University."},{"id":5444,"showcase_id":3316,"name":"Stuart Naylor, Ph.D","role":"CDO","image":"https://curation-api-production-assets.s3.eu-west-2.amazonaws.com/5/1716387163.jpeg","linkedin":"https://meiragtx.com/company/our-team/","x_link":"https://meiragtx.com/company/our-team/","description":"Dr. Stuart Naylor has served as CDO since 2015. 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Dr. Naylor holds a BSC in microbiology and virology, an M.S in Immunology and a Phd"}],"showcase_stocks":{"id":3206,"showcase_id":3316,"exchange":"NASDAQ","symbol":"MGTX","price":6.58,"change_percent":-0.75,"average_volume":601305,"marketcap":528803996,"pe_ratio":0,"raise_amount":null,"equity_offered":null,"valuation":null,"revenue":null,"market_opportunity":null,"raise_amount_currency":null,"valuation_currency":null,"revenue_currency":null,"market_opportunity_currency":null,"target_price":null,"price_target_disclaimer":null},"stock_symbol":"NASDAQ:MGTX","exchange":"NASDAQ","symbol":"MGTX","price":6.58,"change_percent":-0.75,"average_volume":601305,"marketcap":528803996,"pe_ratio":0,"raise_amount":null,"equity_offered":null,"valuation":null,"revenue":null,"market_opportunity":null,"raise_amount_currency":null,"valuation_currency":null,"revenue_currency":null,"market_opportunity_currency":null,"target_price":null,"price_target_disclaimer":null,"target_price_change_percentage":null,"buy":[{"id":5288,"showcase_id":3316,"type":"buy","title":"Strong Partnerships","caption":"Strategic investments from J&J & Sanofi and a partnership with Hologen AI, validate MeiraGTx's integrated approach and financial strength."},{"id":5289,"showcase_id":3316,"type":"buy","title":"Innovative Technology","caption":"Proprietary Riboswitch technology offers precise, controlled gene therapy delivery."},{"id":5290,"showcase_id":3316,"type":"buy","title":"Promising Pipeline","caption":"Advanced clinical programs targeting high unmet needs in retinal and neurodegenerative diseases like Parkinson's."}],"sell":[{"id":5291,"showcase_id":3316,"type":"sell","title":"Regulatory Risks","caption":"Long, uncertain approval process could delay or block therapies."},{"id":5292,"showcase_id":3316,"type":"sell","title":"Clinical Risks","caption":"Trial failures or adverse events could derail progress."},{"id":5293,"showcase_id":3316,"type":"sell","title":"Financial Risks","caption":"High development costs may strain finances without additional funding or revenue."}],"key_risks":[{"id":2664,"showcase_id":3316,"title":"Regulatory Hurdles","description":"

","video":"https://google.com","video_iframe_url":null},{"id":2665,"showcase_id":3316,"title":"Clinical Trial Risks","description":"

With gene therapies still in the clinical phase, there are inherent risks related to trial outcomes. Negative results or adverse events could delay or derail progress.

","video":"https://google.com","video_iframe_url":null},{"id":2666,"showcase_id":3316,"title":"Financial Sustainability","description":"

","video":"https://google.com","video_iframe_url":null}],"industries":[{"id":1665,"industry_id":6,"name":"Healthcare"}],"tag":{"id":826,"showcase_id":3316,"company_size":"small","region":"usa","type_of_stock":"gowth","revenue_stage":"post_revenue","mag7":false,"buy_back":false,"income":false,"debt":false,"management_ownership_more_than_5_percent":true},"prompts":[{"id":1204,"showcase_id":3316,"sequence":1,"question":"What is in the pipeline?"},{"id":1205,"showcase_id":3316,"sequence":2,"question":"Explain the relationship with Hologen AI?"},{"id":1206,"showcase_id":3316,"sequence":3,"question":"What stakes do J&J and Sanofi own?"},{"id":1207,"showcase_id":3316,"sequence":4,"question":"What is the cash runway?"},{"id":1208,"showcase_id":3316,"sequence":5,"question":"What is the Riboswitch technology?"}]},"slug":"a9191020-153d-46bc-a89c-4c17fc3af31c"}]}]]}]