MGTX
MeiraGTxDDocument history
Earnings documents stored for MGTX.
Investor releaseQuarter not tagged2026-05-17Here's What Analysts Are Forecasting For MeiraGTx Holdings plc (NASDAQ:MGTX) After Its First-Quarter Results
Simply Wall St.
Here's What Analysts Are Forecasting For MeiraGTx Holdings plc (NASDAQ:MGTX) After Its First-Quarter Results
MeiraGTx Holdings plc (NASDAQ:MGTX) missed earnings with its latest first-quarter results, disappointing overly-optimistic forecasters. Statutory earnings fell substantially short of expectations, with revenues of US$293k missing forecasts by 98%. Losses exploded, with a per-share loss of US$0.57 some 46% below prior forecasts. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on MeiraGTx Holdings after the latest results. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Taking into account the latest results, the seven analysts covering MeiraGTx Holdings provided consensus estimates of US$49.5m revenue in 2026, which would reflect a substantial 38% decline over the past 12 months. Per-share losses are expected to explode, reaching US$1.65 per share. Before this latest report, the consensus had been expecting revenues of US$50.4m and US$1.94 per share in losses. Although the revenue estimates have not really changed MeiraGTx Holdings'future looks a little different to the past, with a cut to the loss per share forecasts in particular. Check out our latest analysis for MeiraGTx Holdings The average price target held steady at US$28.25, seeming to indicate that business is performing in line with expectations. There's another way to think about price targets though, and that's to look at the range of price targets put forward by analysts, because a wide range of estimates could suggest a diverse view on possible outcomes for the business. The most optimistic MeiraGTx Holdings analyst has a price target of US$50.00 per share, while the most pessimistic values it at US$19.00. We would probably assign less value to the analyst forecasts in this situation, because such a wide range of estimates could imply that the future of this business is difficult to value accurately. As a result it might not be a great idea to make decisions based on the consensus price target, which is after all just an average of this wide range of estimates. One way to get more context on these forecasts is to look at how they compare to both p...
Investor releaseQuarter not tagged2026-05-14MeiraGTx Reports First Quarter 2026 Financial and Operational Results
GlobeNewswire
MeiraGTx Reports First Quarter 2026 Financial and Operational Results
Received FDA Breakthrough Therapy Designation for AAV2-hAQP1 Reported positive three-year data from the Phase 1 AQUAx study of AAV2-hAQP1 for the treatment of grade 2/3 late radiation-induced xerostomia Entered into an asset purchase agreement with Johnson & Johnson* (J&J) to acquire all interests in botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP) Strengthened balance sheet with $100 million financing LONDON and NEW YORK, May 14, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced financial and operational results for the first quarter ended March 31, 2026, and provided a corporate update. “Our achievements in the first few months of 2026 have materially strengthened MeiraGTx – we are now in a position to file for potential approval and launch two wholly-owned therapies in the next 2 years,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “The compelling three-year durability data from our AAV2-hAQP1 Phase 1 study continue to demonstrate disease-modifying benefit following a simple one-time treatment of patients with moderate to severe persistent radiation-induced xerostomia, an otherwise debilitating life-long condition. The recent receipt of Breakthrough Therapy Designation for this program reinforces the strength of the data and the potential for an expedited development and regulatory pathway.” Dr. Forbes continued, “We are very excited to have re-acquired bota-vec for the treatment of X-linked retinitis pigmentosa (XLRP). This is a highly strategic addition to our pipeline, given our long-term experience developing this drug while partnered with J&J, our deep expertise in ophthalmology, and our long-standing relationships with the inherited retinal disease patient community and KOL networks globally. Data from the Phase 3 LUMEOS study of bota-vec highlight the potential of this therapy to improve vision and significantly change the lives of those suffering with this otherwise inexorably degenerative disease. We are now working expeditiously to complete regulatory submissions in the U.S., EU, UK and Japan.” “To that end, I am extremely pleased to announce that Penny Fleck has joined MeiraGTx as Chief Development Officer,” said Dr. Forbes. “Penny brings tremendous experience from he...
Investor releaseQuarter not tagged2026-05-07Will Alector (ALEC) Report Negative Q1 Earnings? What You Should Know
Zacks
Will Alector (ALEC) Report Negative Q1 Earnings? What You Should Know
The market expects Alector (ALEC) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biotechnology company is expected to post quarterly loss of $0.35 per share in its upcoming report, which represents a year-over-year change of +14.6%. Revenues are expected to be $3 million, down 18.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 7.96% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP...
Investor releaseQuarter not tagged2026-05-05Will MeiraGTx Holdings PLC (MGTX) Report Negative Q1 Earnings? What You Should Know
Zacks
Will MeiraGTx Holdings PLC (MGTX) Report Negative Q1 Earnings? What You Should Know
The market expects MeiraGTx Holdings PLC (MGTX) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.43 per share in its upcoming report, which represents a year-over-year change of +15.7%. Revenues are expected to be $1.55 million, down 19.7% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 6.45% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A po...
Investor releaseQuarter not tagged2026-03-26MeiraGTx Holdings PLC (MGTX) Q4 Earnings and Revenues Surpass Estimates
Zacks
MeiraGTx Holdings PLC (MGTX) Q4 Earnings and Revenues Surpass Estimates
MeiraGTx Holdings PLC (MGTX) came out with quarterly earnings of $0.19 per share, beating the Zacks Consensus Estimate of a loss of $0.6 per share. This compares to a loss of $0.5 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +131.67%. A quarter ago, it was expected that this company would post a loss of $0.5 per share when it actually produced a loss of $0.62, delivering a surprise of -24%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. MeiraGTx, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $75.36 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 3,027.14%. This compares to year-ago revenues of $21.39 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. MeiraGTx shares have lost about 4.2% since the beginning of the year versus the S&P 500's decline of 3.7%. While MeiraGTx has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for MeiraGTx was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 R...
Investor releaseQuarter not tagged2026-03-26MeiraGTx Announces FDA Breakthrough Therapy Designation for AAV2-hAQP1 for the Treatment of Grade 2 and Grade 3 Radiation-Induced Xerostomia (RIX) and Reports Fourth Quarter and Full Year 2025 Financial and Operational Results
GlobeNewswire
MeiraGTx Announces FDA Breakthrough Therapy Designation for AAV2-hAQP1 for the Treatment of Grade 2 and Grade 3 Radiation-Induced Xerostomia (RIX) and Reports Fourth Quarter and Full Year 2025 Financial and Operational Results
FDA granted Breakthrough Therapy Designation for AAV2-hAQP1 for the treatment of Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract MeiraGTx to hold a program update and present long-term data for AAV2-hAQP1 program for the treatment of Grade 2/3 Radiation-Induced Xerostomia on Thursday, April 16th, 2026 LONDON and NEW YORK, March 26, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced financial and operational results for the fourth quarter and full-year ended December 31, 2025, and provided a corporate update. “We are delighted to have been awarded Breakthrough Designation for our AAV2-hAQP1 treatment for Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “This Breakthrough application was supported by 3-year data from the Phase 1 dose escalation study. On April 16th, we will be providing an AAV2-hAQP1 program update with information about the commercial opportunity for this therapy, as well as presenting the 3-year data. We have also had huge enthusiasm about our Phase 2 AQUAx2 study in the RIX community, amongst physicians and patients.” “In 2025 we executed two important strategic collaborations bringing immediate non-dilutive financing into the company, as well as potential significant near-term financial milestones. We signed a collaboration with Eli Lilly and Company (Lilly) focused on our AAV-AIPL1 program for the treatment of LCA4, one of the most severe forms of inherited retinopathies. In addition to AAV-AIPL1, Lilly gained exclusive rights to two preclinical ocular programs as well as our intravitreal capsids, bespoke promoters and certain rights to our riboswitch platform in the eye. Lilly is working with global regulatory agencies to expeditiously gain approval of AAV-AIPL1 and to provide access to this life changing therapy for LCA4 to children globally.” Dr. Forbes continued, “Earlier in the year, we entered into a strategic collaboration with Hologen Limited, a world-leader in the development of multi-modal generative AI foundation models which were built specifically to remove noise from clinical data and to allow the real clinical effects of treatment to be cl...
Investor releaseQuarter not tagged2026-03-04AnaptysBio, Inc. (ANAB) Q4 Earnings and Revenues Top Estimates
Zacks
AnaptysBio, Inc. (ANAB) Q4 Earnings and Revenues Top Estimates
AnaptysBio, Inc. (ANAB) came out with quarterly earnings of $1.58 per share, beating the Zacks Consensus Estimate of $0.89 per share. This compares to a loss of $0.72 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +78.53%. A quarter ago, it was expected that this company would post a loss of $1.06 per share when it actually produced earnings of $0.52, delivering a surprise of +149.06%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. AnaptysBio, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $108.25 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 28.47%. This compares to year-ago revenues of $43.11 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. AnaptysBio shares have added about 13.3% since the beginning of the year versus the S&P 500's gain of 0.5%. While AnaptysBio has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for AnaptysBio was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank...
Investor releaseQuarter not tagged2026-02-26TG Therapeutics (TGTX) Misses Q4 Earnings Estimates
Zacks
TG Therapeutics (TGTX) Misses Q4 Earnings Estimates
TG Therapeutics (TGTX) came out with quarterly earnings of $0.14 per share, missing the Zacks Consensus Estimate of $0.35 per share. This compares to earnings of $0.15 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -60.45%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.24 per share when it actually produced earnings of $2.43, delivering a surprise of +912.5%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. TG Therapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $192.57 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 0.22%. This compares to year-ago revenues of $108.18 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. TG Therapeutics shares have lost about 0.5% since the beginning of the year versus the S&P 500's gain of 1.5%. While TG Therapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for TG Therapeutics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see th...
Investor releaseQuarter not tagged2025-11-13MeiraGTx Reports Third Quarter 2025 Financial and Operational Results
GlobeNewswire
MeiraGTx Reports Third Quarter 2025 Financial and Operational Results
Entered into broad strategic collaboration with Eli Lilly and Company (“Lilly”) in the area of ophthalmology, granting Lilly worldwide exclusive rights to the Company’s AAV-AIPL1 program for treatment of one of the most severe inherited retinopathies, Leber congenital amaurosis 4 (LCA4) Released material under the Company’s Specials license for a second rare pediatric ophthalmology condition caused by mutations in BBS10, with the prescribing physician treating the first patient during the quarter. The BBS10 program has been awarded Rare Pediatric Disease Designation (RPDD) LONDON and NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced financial and operational results for the third quarter ended September 30, 2025, and provided a corporate update. “Following the close of the third quarter, we are very pleased to have signed a strategic collaboration in ophthalmology with Eli Lilly, led by our AAV-AIPL1 program for the treatment of LCA4, one of the most severe forms of inherited retinopathies,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “The unprecedented data from the 11 LCA4 children born blind who all gained vision after treatment with AAV-AIPL1 illustrates the power of gene therapy in the eye to cure even the most severe genetic defects, particularly when treatment takes place at a very young age. In addition to AAV-AIPL1, Lilly has gained rights to two preclinical ocular programs as well as our intravitreal capsids, bespoke promoters generated from our AI driven promoter platform, and certain rights to our riboswitch platform in the eye. We are excited to be entering into this collaboration with Lilly and view this as a testament to the power of our broad toolkit of proprietary gene therapy technologies for both rare and prevalent ocular disease. We are particularly pleased that Lilly, a global leader in development and commercialization of innovative medicines, has chosen to partner with us in this area of high unmet need, and shares our dedication to bringing truly life changing therapies to patients with otherwise intractable conditions.” Dr. Forbes continued, “During the quarter we continued to make progress in our late-stage clinical programs. Our pivotal Phase 2 study of AAV-hAQP1 for the treatment...
Investor releaseQuarter not tagged2025-11-05MeiraGTx Holdings PLC (MGTX) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release
Zacks
MeiraGTx Holdings PLC (MGTX) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release
Wall Street expects a year-over-year increase in earnings on lower revenues when MeiraGTx Holdings PLC (MGTX) reports results for the quarter ended September 2025. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.50 per share in its upcoming report, which represents a year-over-year change of +7.4%. Revenues are expected to be $4.08 million, down 62.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 6.14% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings...
Investor releaseQuarter not tagged2025-08-15MeiraGTx Holdings Second Quarter 2025 Earnings: Misses Expectations
Simply Wall St.
MeiraGTx Holdings Second Quarter 2025 Earnings: Misses Expectations
Revenue: US$3.69m (up by US$3.41m from 2Q 2024). Net loss: US$38.8m (loss narrowed by 20% from 2Q 2024). US$0.48 loss per share (improved from US$0.76 loss in 2Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 43%. Earnings per share (EPS) also missed analyst estimates by 2.7%. Looking ahead, revenue is forecast to grow 43% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are up 9.3% from a week ago. It is worth noting though that we have found 2 warning signs for MeiraGTx Holdings (1 is a bit concerning!) that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Investor releaseQuarter not tagged2025-08-14MeiraGTx Reports Second Quarter 2025 Financial and Operational Results
GlobeNewswire
MeiraGTx Reports Second Quarter 2025 Financial and Operational Results
- Gained alignment with U.S. Food and Drug Administration (FDA) on the ongoing Phase 2 AQUAx2 randomized double-blind, placebo-controlled pivotal study in Grade 2/3 radiation-induced xerostomia (RIX) to support a potential Biologics License Application (BLA) filing; on track for potential data readout late 2026 - FDA Granted Regenerative Medicine Advanced Therapy (RMAT) designation for AAV-GAD for the treatment of Parkinson’s disease - In collaboration with Hologen, FDG-PET data from positive Phase 2 double-blind, sham-surgery controlled clinical trials of AAV-GAD shows significant disease-modifying effects in pathological basal ganglia circuitry, including the substantia nigra – the site of dopamine-producing neurons affected in Parkinson’s disease - On track to file for Marketing Authorization Approval (MAA) under exceptional circumstances with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of LCA4, and BLA in the US with the FDA via a similar pathway to approval in the fourth quarter of 2025 LONDON and NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced financial and operational results for the second quarter ended June 30, 2025, and provided a corporate update. “During the second quarter, we continued to have very productive regulatory interactions with the MHRA and FDA around multiple later stage clinical programs as well as manufacturing,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “We aligned with the FDA on our ongoing Phase 2 study of AAV-hAQP1 in radiation induced xerostomia (RIX) to potentially support a BLA. We received RMAT designation for AAV-GAD in Parkinson’s disease and achieved a very successful outcome in our FDA audit of the Phase 1/2 bridging study of AAV-GAD. We continue to have productive dialogue with the MHRA and FDA around expedited approval of AAV-AIPL1 for LCA4, including alignment on an expedited CMC PPQ package for MAA and BLA filing.” Dr. Forbes continued, “Our late-stage clinical programs are all advancing as planned, with our pivotal Phase 2 study of AAV-AQP1 in RIX targeting enrollment by the end of the year with the potential for BLA enabling data read out at the end of 2026.” “We are most excited about the potential of AAV-GAD to show...

