Latest News on MGTX

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(MGTX) and the Role of Price-Sensitive Allocations

https://news.stocktradersdaily.com/news_release/20/MGTX_and_the_Role_of_Price-Sensitive_Allocations_021926014402_1771526642.html
This article analyzes Meiragtx Holdings Plc (NASDAQ: MGTX), noting a divergent sentiment across all time horizons and suggesting choppy conditions. It highlights an exceptional 60.5:1 risk-reward short setup and provides institutional trading strategies tailored to different risk profiles, including position, momentum breakout, and risk hedging strategies. The analysis also includes multi-timeframe signal analysis with support and resistance levels.

MeiraGTx Holdings PLC (NASDAQ:MGTX) Receives Average Rating of "Moderate Buy" from Analysts

https://www.marketbeat.com/instant-alerts/meiragtx-holdings-plc-nasdaqmgtx-receives-average-rating-of-moderate-buy-from-analysts-2026-02-19/
MeiraGTx Holdings PLC (NASDAQ:MGTX) has received a consensus "Moderate Buy" rating from analysts, with an average 12-month price target of $26.00. While some analysts have issued "sell" ratings, the majority have given "buy" or "strong buy" recommendations. The company's stock currently trades at $7.51, with a market capitalization of $604.48 million, and institutional investors hold 67.48% of the shares.

MeiraGTx (NASDAQ:MGTX) Trading Up 1.7% - Should You Buy?

https://www.marketbeat.com/instant-alerts/meiragtx-nasdaqmgtx-trading-up-17-should-you-buy-2026-02-18/
MeiraGTx (NASDAQ:MGTX) recently traded up 1.7% to $7.58, though with lower-than-average volume, and currently holds a "Moderate Buy" consensus from analysts with an average price target of $26.00. The clinical-stage gene therapy company has a market cap of $610.11 million, but also faces weak liquidity and a high debt-to-equity ratio. While hedge funds have adjusted their positions, MarketBeat suggests that top analysts recommend other stocks over MGTX.

Responsive Playbooks and the MGTX Inflection

https://news.stocktradersdaily.com/news_release/8/Responsive_Playbooks_and_the_MGTX_Inflection_020826123601_1770572161.html
This article from Stock Traders Daily discusses Meiragtx Holdings Plc (NASDAQ: MGTX), highlighting a weak near-term sentiment despite long-term strength. It outlines three AI-generated trading strategies—Position, Momentum Breakout, and Risk Hedging—with specific entry, target, and stop-loss levels, and provides multi-timeframe signal analysis for different horizons.

MeiraGTx Licenses complement-targeted geographic atrophy program from ZipBio

https://www.ophthalmologytimes.com/view/meiragtx-licenses-complement-targeted-geographic-atrophy-program-from-zipbio
MeiraGTx has licensed a complement-targeted geographic atrophy program from ZipBio, focusing on AI-designed protein therapeutics for this severe form of age-related macular degeneration. While current FDA-approved therapies show modest benefits, this deal highlights ongoing efforts to find more durable treatments for GA, though no clinical data for ZipBio's therapies are yet available. The agreement underscores the potential of gene therapy and novel protein therapeutics in addressing the significant unmet need in GA treatment.
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MeiraGTx licenses ZipBio’s AI-designed therapies for geographic atrophy

https://www.investing.com/news/company-news/meiragtx-licenses-zipbios-aidesigned-therapies-for-geographic-atrophy-93CH-4481687
MeiraGTx has licensed exclusive rights to ZipBio’s AI-designed therapies for geographic atrophy, targeting the complement pathway. This agreement combines MeiraGTx’s expertise in genetic medicines with ZipBio’s AI platform for creating compact, multifunctional proteins. Financial terms were not disclosed, but the deal includes upfront and potential milestone/royalty payments, allowing ZipBio to focus on its internal pipeline while MeiraGTx advances the geographic atrophy program.

MeiraGTx stock rises on exclusive licensing deal with ZipBio for eye disease therapy

https://ng.investing.com/news/stock-market-news/meiragtx-stock-rises-on-exclusive-licensing-deal-with-zipbio-for-eye-disease-therapy-93CH-2320278
MeiraGTx Holdings plc's stock rose 1% following an exclusive licensing agreement with ZipBio for gene therapy treatments targeting Geographic Atrophy. This collaboration combines MeiraGTx's expertise in genetic medicines with ZipBio's AI-driven protein therapeutics to address significant unmet medical needs in eye disease. The deal involves upfront payments and potential milestone and royalty payments.

ZipBio and MeiraGTx Enter into Exclusive License Agreement to Advance First-in-Class AAV Gene Therapy for Geographic Atrophy

https://investingnews.com/zipbio-and-meiragtx-enter-into-exclusive-license-agreement-to-advance-first-in-class-aav-gene-therapy-for-geographic-atrophy/
ZipBio and MeiraGTx have signed an exclusive licensing agreement to develop first-in-class AAV gene therapy for Geographic Atrophy, targeting the complement pathway. This partnership combines ZipBio's AI-driven protein therapeutics expertise with MeiraGTx's leadership in genetic medicines, vector design, and manufacturing. The deal includes upfront, milestone, and royalty payments, and allows ZipBio to focus on its internal pipeline while advancing AI-designed therapies for unmet medical needs.

Understanding the Setup: (MGTX) and Scalable Risk

https://news.stocktradersdaily.com/news_release/98/Understanding_the_Setup:_MGTX_and_Scalable_Risk_012826112802_1769617682.html
This article analyzes Meiragtx Holdings Plc (NASDAQ: MGTX), identifying strong sentiment and an overweight bias across all horizons. It highlights an exceptional 61.5:1 risk-reward short setup and provides three distinct AI-generated trading strategies (Position, Momentum Breakout, Risk Hedging) tailored for different risk profiles and holding periods. The analysis includes multi-timeframe signals, support, and resistance levels for MGTX.

MeiraGTx Holdings PLC (NASDAQ:MGTX) Given Consensus Rating of "Moderate Buy" by Brokerages

https://www.marketbeat.com/instant-alerts/meiragtx-holdings-plc-nasdaqmgtx-given-consensus-rating-of-moderate-buy-by-brokerages-2026-01-25/
MeiraGTx Holdings PLC (NASDAQ:MGTX) has received a consensus "Moderate Buy" rating from brokerages, with an average 12-month price target of $26.00. While analysts have varied price targets, ranging from $20 to $35, fundamental concerns remain as the company, a small-cap biotech, missed quarterly EPS and revenue estimates, and is currently trading around $8 with a market cap of approximately $652 million. Institutional investors hold about 67.48% of the stock, with several increasing their positions in recent quarters despite the company's financial performance.
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The Technical Signals Behind (MGTX) That Institutions Follow

https://news.stocktradersdaily.com/news_release/39/The_Technical_Signals_Behind_MGTX_That_Institutions_Follow_011726102001_1768663201.html
This article analyzes Meiragtx Holdings Plc (NASDAQ: MGTX) through the lens of AI-generated technical signals, highlighting a positive near-term sentiment within a strong long-term context, despite a weak mid-term bias. It outlines distinct trading strategies for various risk profiles, including position trading, momentum breakout, and risk hedging, based on signal strength across different time horizons. The analysis emphasizes a favorable 63.5:1 risk-reward setup targeting a 17.7% gain against a minimal 0.3% risk.

MeiraGTx Holdings plc (MGTX) Stock Analysis: A Biotech Gem with a 247.85% Upside Potential

https://www.directorstalkinterviews.com/meiragtx-holdings-plc-mgtx-stock-analysis-a-biotech-gem-with-a-247-85-upside-potential/4121235275
MeiraGTx Holdings plc (MGTX) is a clinical-stage gene therapy company with a market capitalization of approximately $619 million, showing a potential upside of 247.85% according to analyst projections. Despite current financial challenges including a 96.20% revenue plummet and significant net losses, the company boasts a robust pipeline targeting ocular, neurodegenerative, and genetic disorders, along with strategic collaborations with Johnson & Johnson and Hologen Limited. Market sentiment is overwhelmingly positive, with all eight analysts issuing buy ratings and an average price target of $26.75, reflecting confidence in its long-term growth potential.

Precision Trading with Meiragtx Holdings Plc (MGTX) Risk Zones

https://news.stocktradersdaily.com/news_release/17/Precision_Trading_with_Meiragtx_Holdings_Plc_MGTX_Risk_Zones_010626091201_1767708721.html
This article provides a detailed analysis of Meiragtx Holdings Plc (MGTX), highlighting a weak near and mid-term sentiment but a strong long-term outlook. It outlines specific AI-generated trading strategies for different risk profiles, including long entry zones, breakout triggers, and short hedging strategies, alongside multi-timeframe signal analysis. The report identifies a significant 63.0:1 risk-reward setup targeting a 17.4% gain against a 0.3% risk.

MeiraGTx Announces Share Repurchase and Investor Lock-Up

https://www.theglobeandmail.com/investing/markets/stocks/MGTX-Q/pressreleases/36870740/meiragtx-announces-share-repurchase-and-investor-lock-up/
MeiraGTx Holdings announced it repurchased 2.3 million ordinary shares from Perceptive Life Sciences Master Fund for $18.2 million, facilitated by Perceptive for tax optimization. As part of the agreement, Perceptive Advisors and its affiliates, significant shareholders, committed to a 12-month lock-up on further share sales, reinforcing a stable shareholder base and the close ties with MeiraGTx. An analyst maintains a Buy rating on MGTX with a $20.00 price target, despite Spark's AI Analyst rating the stock as Neutral due to financial challenges, though a collaboration with Eli Lilly offers a positive outlook.

MeiraGTx Holdings enters agreement to repurchase 2.3 million shares from Perceptive

https://www.investing.com/news/sec-filings/meiragtx-holdings-enters-agreement-to-repurchase-23-million-shares-from-perceptive-93CH-4427690
MeiraGTx Holdings (NASDAQ:MGTX) has agreed to repurchase 2.3 million shares from Perceptive Life Sciences Master Fund for $18.193 million, executed on December 31, 2025, at $7.91 per share. This transaction accounts for approximately 2.8% of the company's market capitalization. Perceptive Master Fund, which owns over 10% of MeiraGTx, engaged in this sale for year-end portfolio tax optimization and has agreed to a 12-month lock-up period on remaining shares.
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MeiraGTx Holdings enters agreement to repurchase 2.3 million shares from Perceptive

https://in.investing.com/news/sec-filings/meiragtx-holdings-enters-agreement-to-repurchase-23-million-shares-from-perceptive-93CH-5170142
MeiraGTx Holdings has agreed to repurchase 2.3 million shares from Perceptive Life Sciences Master Fund for $18.19 million. This transaction, executed on December 31, 2025, involved a price of $7.91 per share and represents about 2.8% of the company's market capitalization. The sale is part of Perceptive Master Fund's year-end tax optimization, and they have agreed to a 12-month lock-up period for their remaining shares.

MeiraGTx Announces Share Repurchase and Investor Lock-Up

https://www.tipranks.com/news/company-announcements/meiragtx-announces-share-repurchase-and-investor-lock-up
MeiraGTx Holdings plc recently announced a share repurchase agreement where it bought back 2.3 million ordinary shares from Perceptive Life Sciences Master Fund for approximately $18.2 million. As part of this deal, Perceptive and its affiliates, significant shareholders in MeiraGTx, agreed to a 12-month lock-up on further share sales, aiming to stabilize the shareholder base and strengthen governance ties. Meanwhile, TipRanks’ AI Analyst, Spark, rates MGTX as Neutral due to financial challenges, despite the positive outlook from its collaboration with Eli Lilly.

MeiraGTx Holdings enters agreement to repurchase 2.3 million shares from Perceptive

https://m.investing.com/news/sec-filings/meiragtx-holdings-enters-agreement-to-repurchase-23-million-shares-from-perceptive-93CH-4427690?ampMode=1
MeiraGTx Holdings plc has agreed to repurchase 2.3 million ordinary shares from Perceptive Life Sciences Master Fund for $18,193,000, executed on December 31, 2025. This transaction, representing 2.8% of the company's market capitalization, was driven by Perceptive Master Fund's year-end portfolio tax optimization. Additionally, Perceptive and its affiliates have agreed to a 12-month lock-up period for remaining shares, underscoring their ongoing investment and the company's strategic financial management.

MeiraGTx Holdings PLC (NASDAQ:MGTX) Given Average Rating of "Moderate Buy" by Analysts

https://www.marketbeat.com/instant-alerts/meiragtx-holdings-plc-nasdaqmgtx-given-average-rating-of-moderate-buy-by-analysts-2025-12-31/
MeiraGTx Holdings PLC has received a "Moderate Buy" average rating from six research firms, with an average 12-month price target of $26.00. Despite analyst optimism, the company reported weaker-than-expected quarterly earnings, missing EPS estimates and showing low revenue. Insider selling by the CEO and CFO has also occurred, contrasting with institutional investors who hold a significant portion of the company's stock.

How Meiragtx Holdings Plc (MGTX) Affects Rotational Strategy Timing

https://news.stocktradersdaily.com/news_release/98/How_Meiragtx_Holdings_Plc_MGTX_Affects_Rotational_Strategy_Timing_122625074802_1766753282.html
This article analyzes Meiragtx Holdings Plc (MGTX) for rotational strategy timing, highlighting weak near-term sentiment but strong long-term potential. It presents three AI-generated trading strategies—Position Trading, Momentum Breakout, and Risk Hedging—with specific entry, target, and stop-loss zones, alongside multi-timeframe signal analysis. The analysis details key findings, including an exceptional risk-reward short setup and divergent sentiment across different time horizons.
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MeiraGTx Holdings plc (NASDAQ:MGTX) has caught the attention of institutional investors who hold a sizeable 31% stake

https://finance.yahoo.com/news/meiragtx-holdings-plc-nasdaq-mgtx-102942030.html
Institutional investors hold a significant 31% stake in MeiraGTx Holdings plc (NASDAQ:MGTX), indicating their confidence in the company's future prospects. A total of six investors collectively own 54% of the company, with Perceptive Advisors LLC being the largest shareholder at 16%. Insiders, including CEO Alexandria Forbes, own US$28 million worth of the company's shares.

Discipline and Rules-Based Execution in MGTX Response

https://news.stocktradersdaily.com/news_release/24/Discipline_and_Rules-Based_Execution_in_MGTX_Response_121525055402_1765796042.html
This article details an AI-generated analysis for Meiragtx Holdings Plc (NASDAQ: MGTX), highlighting strong sentiment across all horizons and an exceptional 68.0:1 risk-reward setup. It outlines three distinct trading strategies—Position, Momentum Breakout, and Risk Hedging—with specific entry zones, targets, and stop losses. The analysis also provides multi-timeframe signal analysis and access to real-time signals for MGTX.

683 Capital Management LLC Boosts Stock Holdings in MeiraGTx Holdings PLC $MGTX

https://www.marketbeat.com/instant-alerts/filing-683-capital-management-llc-boosts-stock-holdings-in-meiragtx-holdings-plc-mgtx-2025-12-13/
683 Capital Management LLC increased its stake in MeiraGTx Holdings PLC (NASDAQ:MGTX) by 4.5% in Q2, raising its total holdings to 2,690,000 shares. Despite this institutional accumulation, company insiders, including CFO Richard Giroux and CEO Alexandria Forbes, sold shares. MeiraGTx missed quarterly earnings expectations, but analysts maintain a "Moderate Buy" consensus with an average target price of $26.00.

HC Wainwright & Co. Initiates Coverage of MeiraGTx Holdings (MGTX) with Buy Recommendation

https://www.nasdaq.com/articles/hc-wainwright-co-initiates-coverage-meiragtx-holdings-mgtx-buy-recommendation
HC Wainwright & Co. has initiated coverage of MeiraGTx Holdings (MGTX) with a Buy recommendation, with an average one-year price target of $28.56/share, suggesting a significant upside of 282.84% from its last reported closing price. The company's projected annual revenue is 65MM, a 135.43% increase, and institutional ownership remains substantial despite minor fluctuations. This report highlights analyst confidence and key institutional holdings in MeiraGTx.

Analysts Have Lowered Expectations For MeiraGTx Holdings plc (NASDAQ:MGTX) After Its Latest Results

https://www.sahmcapital.com/news/content/analysts-have-lowered-expectations-for-meiragtx-holdings-plc-nasdaqmgtx-after-its-latest-results-2025-11-17
Analysts have significantly lowered their revenue outlook and increased loss per share expectations for MeiraGTx Holdings plc (NASDAQ:MGTX) after disappointing Q3 results. Despite the downgrades, the average price target remained unchanged at US$28.57, suggesting that the market may not view the weaker earnings outlook as having a long-term impact on valuation. The company is, however, still expected to grow much faster than its industry, with forecasted annualized revenue growth of 263% to the end of 2026.
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Analysts Have Lowered Expectations For MeiraGTx Holdings plc (NASDAQ:MGTX) After Its Latest Results

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-mgtx/meiragtx-holdings/news/analysts-have-lowered-expectations-for-meiragtx-holdings-plc-1
Analysts have significantly lowered revenue and earnings expectations for MeiraGTx Holdings plc (NASDAQ:MGTX) following disappointing Q3 results. Although revenue growth is still projected to be substantial, the consensus now points to higher losses per share and a decrease in revenue outlook for 2026. Despite these lowered forecasts, the average price target remained largely unchanged, suggesting analysts don't expect a long-term impact on valuation.

MeiraGTx Reports Q3 2025 Results and Strategic Advances

https://www.tipranks.com/news/company-announcements/meiragtx-reports-q3-2025-results-and-strategic-advances
MeiraGTx Holdings has released its Q3 2025 earnings, reporting a net loss of $50.5 million and cash and cash equivalents of $14.8 million. The company highlighted strategic advancements including a collaboration with Eli Lilly for genetic medicines in ophthalmology and progress in its clinical programs for Parkinson’s disease and other rare diseases. MeiraGTx anticipates additional funding, extending its operations into the second half of 2027.

MeiraGTx Holdings plc Enters Strategic Collaboration with Eli Lilly to Advance Gene Therapy in Ophthalmology and Reports Q3 2025 Financial Results

https://www.quiverquant.com/news/MeiraGTx+Holdings+plc+Enters+Strategic+Collaboration+with+Eli+Lilly+to+Advance+Gene+Therapy+in+Ophthalmology+and+Reports+Q3+2025+Financial+Results
MeiraGTx Holdings plc announced a strategic collaboration with Eli Lilly for gene therapy in ophthalmology, granting Lilly global rights to its AAV-AIPL1 program for LCA4. Despite a significant Q3 2025 net loss of $50.5 million and decreased service revenue, the company highlighted advancements in clinical programs like AAV-hAQP1 and AAV-GAD, securing substantial funding from collaborations to continue operations into 2027.

MeiraGTx Holdings plc SEC 10-Q Report

https://www.tradingview.com/news/tradingview:5b7de956e9611:0-meiragtx-holdings-plc-sec-10-q-report/
MeiraGTx Holdings plc (MGTX) has released its Q3 2025 Form 10-Q report, detailing a significant decrease in total revenue and an increased net loss compared to the previous year, primarily due to reduced service revenue and higher operating expenses. Despite these financial challenges, the clinical-stage gene therapy company is actively expanding its operational capacity with new lease agreements and anticipates a strategic collaboration with Hologen to advance its clinical programs and manufacturing capabilities, though it expects to incur substantial losses in upcoming periods.

MeiraGTx: Latest Eli Lilly Partnership Ignites Riboswitch Technology Potential (MGTX)

https://seekingalpha.com/article/4842666-meiragtx-latest-eli-lilly-partnership-ignites-riboswitch-technology-potential
MeiraGTx Holdings plc has secured a significant partnership with Eli Lilly, granting worldwide rights to its AAV-AIPL1 gene therapy and providing $75 million upfront, plus potential milestones up to $400 million and tiered royalties. This deal strengthens MeiraGTx's financial position and reduces dilution risk, while its riboswitch technology and multiple collaborations highlight its innovative potential. Given these developments, MGTX is rated a 'Strong Buy' for long-term investors.
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MeiraGTx stock rating initiated at Strong Buy by Raymond James with $29 target

https://www.investing.com/news/analyst-ratings/meiragtx-stock-rating-initiated-at-strong-buy-by-raymond-james-with-29-target-93CH-4297903
Raymond James has initiated coverage on MeiraGTx Holdings plc (NASDAQ:MGTX) with a "Strong Buy" rating and a $29 price target. The firm's bullish outlook is based on MeiraGTx's integrated manufacturing platform, unique vector constructs, and full ownership of two major commercial opportunities in gene therapy, despite facing challenges like cash burn. The price target specifically models the potential of their AAV-AQP1 program for xerostomia and AAV-GAD for Parkinson's disease.

Lilly’s pair of deals includes rights to MeiraGTx’s vision-restoring gene therapy: Deals Report

https://www.biocentury.com/article/657538/lilly-s-pair-of-deals-includes-rights-to-meiragtx-s-vision-restoring-gene-therapy-deals-report
Eli Lilly and Co. has entered into two new agreements, one of which includes the in-licensing of a gene therapy from MeiraGTx Holdings plc for AIPL1-associated Leber congenital amaurosis 4 (LCA4). Lilly will pay MeiraGTx $75 million upfront for exclusive worldwide rights to this vision-restoring gene therapy, which has shown promise in clinical trials. The second deal involves using artificial intelligence in drug design, expanding Lilly's approach to drug development.

MeiraGTx (MGTX) Surges 18% After Strategic Deal with Eli Lilly

https://www.gurufocus.com/news/3198215/meiragtx-mgtx-surges-18-after-strategic-deal-with-eli-lilly
MeiraGTx (MGTX) saw an 18% surge in premarket trading after announcing a strategic collaboration with Eli Lilly (LLY) for gene therapies for eye diseases. MeiraGTx will receive $75 million upfront and could earn over $400 million in milestone payments, plus royalties, for its AAV-AIPL1 program targeting Leber congenital amaurosis 4 (LCA4). Despite this positive development, the company faces financial vulnerabilities, including negative operating and net margins, potential liquidity issues, and a low Piotroski F-Score.

MeiraGTx, Lilly Enter $475M Collaboration for Genetic Meds in Ophthalmology

https://www.contractpharma.com/breaking-news/meiragtx-lilly-enter-475m-collaboration-for-genetic-meds-in-ophthalmology/
MeiraGTx and Eli Lilly and Co. have formed a strategic collaboration worth up to $475 million to develop genetic medicines for ophthalmology. Lilly gains exclusive worldwide rights to MeiraGTx's AAV-AIPL1 program for Leber congenital amaurosis 4, which has shown promise in restoring vision in legally blind children. Additionally, Lilly will have access to MeiraGTx’s gene therapy technologies for other ocular targets and its proprietary riboswitch technology for gene editing in the eye.

MeiraGTx Holdings PLC expected to post a loss of 49 cents a share - Earnings Preview

https://www.tradingview.com/news/reuters.com,2025:newsml_L8N3WJ257:0-meiragtx-holdings-plc-expected-to-post-a-loss-of-49-cents-a-share-earnings-preview/
MeiraGTx Holdings PLC (MGTX) is projected to report a loss of 49 cents per share for the quarter ending September 30, 2025, according to analysts polled by LSEG. The company is also expected to see a 36.2% decrease in quarterly revenue year-over-year. Analysts currently rate MGTX as a "buy" with a median 12-month price target of $28.00.
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MeiraGTx Holdings PLC (MGTX) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release

https://www.nasdaq.com/articles/meiragtx-holdings-plc-mgtx-expected-beat-earnings-estimates-what-know-ahead-q3-release
MeiraGTx Holdings PLC (MGTX) is projected to report a year-over-year increase in earnings and lower revenues for the quarter ended September 2025. The company's Zacks Earnings ESP of +2.00% combined with a Zacks Rank #3 suggests a high probability of beating the consensus EPS estimate. Investors should consider these factors and other indicators like past earnings surprises when evaluating the stock.

MeiraGTx Holdings (NASDAQ:MGTX) Is Making Moderate Use Of Debt

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-mgtx/meiragtx-holdings/news/meiragtx-holdings-nasdaqmgtx-is-making-moderate-use-of-debt
MeiraGTx Holdings (NASDAQ:MGTX) has a net debt of US$41.6m as of June 2025, with total liabilities exceeding cash and short-term receivables by US$156.8m. While the company's market capitalization of US$662.9m suggests it could raise capital if needed, its significant EBIT loss of US$158m and negative free cash flow of US$134m in the last year indicate a strained balance sheet, despite a 367% revenue growth. The article concludes that the stock appears very risky due to these financial challenges.

MeiraGTx Reports Second Quarter 2025 Financial and Operational Results

https://investingnews.com/meiragtx-reports-second-quarter-2025-financial-and-operational-results/
MeiraGTx Holdings plc announced its second-quarter 2025 financial and operational results, highlighting significant progress in its clinical programs and regulatory interactions. Key developments include FDA alignment on the AAV-hAQP1 Phase 2 study for radiation-induced xerostomia, RMAT designation for AAV-GAD in Parkinson's disease, and advancements toward MAA and BLA filings for AAV-AIPL1 for LCA4. The company also detailed a strategic collaboration with Hologen AI and provided financial figures, reporting a net loss of $38.8 million for the quarter.

FDA Expedites Review of Gene Therapy Co.'s Drug

https://www.streetwisereports.com/article/2024/12/23/fda-expedites-review-of-gene-therapy-co-s-drug.html
The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to MeiraGTx Holdings Plc's AAV2-hAQP1 treatment for radiation-induced xerostomia. This designation expedites the development and review of the gene therapy, which targets a debilitating condition affecting head and neck cancer patients with no alternative treatments. Analysts from RBC Capital Markets and Chardan Research view the stock as undervalued, with significant upside potential due to the large addressable market and promising clinical data.

Loss-Making MeiraGTx Holdings plc (NASDAQ:MGTX) Expected To Breakeven In The Medium-Term

https://www.sahmcapital.com/news/content/loss-making-meiragtx-holdings-plc-nasdaqmgtx-expected-to-breakeven-in-the-medium-term-2024-01-26
MeiraGTx Holdings plc, a clinical stage gene therapy company, is expected to reach breakeven in the medium-term, specifically by 2025, according to industry analysts. The company's recent loss has widened to US$132m, but analysts anticipate positive profits of US$43m in 2025, with an average annual growth rate of 59%. Investors should also note the company's relatively high debt level, which currently stands at 78% of equity.
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Janssen Announces Late-Breaking Data from Two Gene Therapy Programs

https://www.multivu.com/players/English/9071351-janssen-announces-late-breaking-data-from-two-gene-therapy-programs/
Janssen announced late-breaking data from two gene therapy programs at the American Academy of Ophthalmology 2022 Annual Meeting. Results from the Phase 1/2 MGT009 study of botaretigene sparoparvovec for X-linked retinitis pigmentosa demonstrated an acceptable safety profile and suggested sustained vision improvement. Additionally, Phase 1 data for JNJ-1887 in geographic atrophy met its primary safety endpoint, showing a continual decline in lesion growth over six-month increments.

Taoiseach opens MeiraGTx Shannon facility

https://clareherald.com/business/taoiseach-to-open-meiragtx-shannon-facility/
MeiraGTx Holdings plc has officially opened its 150,000 square feet GMP manufacturing facility in Shannon, Ireland, marking it as the first commercial-scale gene therapy manufacturing site in the country. The facility is designed to accelerate the development and delivery of gene therapy treatments for various diseases and will also offer manufacturing services to collaborators. This strategic investment is expected to create up to 300 jobs and reinforce Ireland's position in the biopharmaceutical sector.

Watkins Advises MeiraGTx in Secured Growth Financing Agreement with Perceptive Advisors

https://www.lw.com/en/news/2022/08/latham-watkins-advises-meiragtx-in-secured-growth-financing-agreement-with-perceptive-advisors
Latham & Watkins LLP advised MeiraGTx Holdings plc in a secured growth financing agreement with affiliates of Perceptive Advisors for up to US$100 million. This financing, which includes US$75 million upfront, will support the continued development of MeiraGTx's clinical-stage product candidates, preclinical programs, and technology platforms. The transaction involved a multidisciplinary team across the United States, United Kingdom, Ireland, and the Cayman Islands.

Major expansion at MeiraGTx’s Shannon facility

https://clareherald.com/business/major-expansion-at-meiragtxs-shannon-facility-80088/
MeiraGTx Holdings plc is investing multi-million euros to expand its Shannon facility in Ireland, establishing a second cGMP viral vector manufacturing facility and a cGMP plasmid production facility. This expansion, supported by IDA Ireland, aims to provide significant capacity for gene therapy product manufacturing and create new highly skilled biopharma jobs in the region. The plasmid facility is expected to be operational by late 2020 and the viral vector facility by late 2021.

MeiraGTx, Janssen Enter Research Collaboration

https://www.contractpharma.com/breaking-news/meiragtx-janssen-enter-research-collaboration/
MeiraGTx has announced a research collaboration and evaluation agreement with Janssen Pharmaceuticals, facilitated by Johnson & Johnson Innovation. Under the agreement, MeiraGTx will utilize its proprietary riboswitch technology to engineer regulatable gene therapy constructs using Janssen's gene sequences. This collaboration aims to evaluate the utility of MeiraGTx's gene regulation platform for future product development, offering a mechanism to activate and deactivate gene therapies using a small molecule based on patient needs.
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