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MeiraGTx Holdings plc

MGTX
Richly ValuedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$10.5
▼ -0.32 · -2.96%

Financials

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52W LOW $6.6252W HIGH $15.35
Volume
830.38 K
Value Traded
4.06 M
Short % Float
5.45%
-2.69%Week
-20.81%1 Month
-21.58%3 Month
+17.06%6 Month
-30.68%5 Year
-38.81%All Time

Cash Data

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Key Stats

Market Cap
1.01 B
EPS (TTM)
0.82
P/E Ratio
12.77
Ent. Value
865.29 M
Total Shares
96.04 M
Float Shares
73.60 M
Insiders
23.37%
Institutions
62.99%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 2 data readout
AAV-hAQP1
grade 2 or 3 radiation-induced xerostomia (RIX)
Phase 2Gene TherapiesOtolaryngologic System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

MGTX Catalyst Timeline

Dated clinical, regulatory and corporate events for MeiraGTx Holdings plc

Catalyst Timeline

Dated clinical, regulatory & corporate events for MeiraGTx Holdings plc

279Total events
7Upcoming
68Tier-1 (high impact)
2018 to 2027Coverage

Upcoming catalysts 2

T1Topline Readout
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AAV-AQP1
T2Product Launch
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botaretigene sparoparvovec

Event history 50

●Management ChangeCorporate
Alan M. Sebulsky appointed to MeiraGTx Board of Directors
▲Breakthrough Therapy DesignationAAV2-hAQP1Designation
FDA granted Breakthrough Therapy Designation for AAV2-hAQP1
moderate to severe grade 2/3 radiation-induced xerostomiasource ↗
▲Full ResultsAAV2-hAQP1Clinical Data
Positive three-year data from Phase 1 AQUAx trial reported
moderate to severe grade 2/3 radiation-induced xerostomiasource ↗
◆AcquisitionCorporate
Completed acquisition of all interests and rights to [asset]
▲Breakthrough Therapy DesignationAAV2-hAQP1Designation
FDA Breakthrough Therapy Designation for AAV2-hAQP1
grade 2/3 late radiation-induced xerostomiasource ↗
▲Full ResultsAAV2-hAQP1Clinical Data
Positive three-year data from Phase 1 AQUAx study of AAV2-hAQP1
grade 2/3 late radiation-induced xerostomiasource ↗
▲Partnership / Licensebotaretigene sparoparvovecCorporate
Asset purchase agreement with Johnson & Johnson to acquire all interests in bota-vec
X-linked retinitis pigmentosasource ↗
▼Equity OfferingCorporate
$100 million public equity offering
●Quarterly UpdateCorporate
First quarter 2026 financial results
●Management ChangeCorporate
Stuart Naylor appointed Chief Scientific Officer, Ophthalmology
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How MGTX actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
-Example Drug Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D33 / 100
Pipeline Score
$39M
Pipeline Value
Richly Valued
Valuation Signal
4
Drugs Scored
0.0x
rNPV / MCap
Top 60%
Micro Cap
(rank 395 of 658)
Percentile Rank
MeiraGTx Holdings plc faces pipeline headwinds (33/100), with $160M risk-adjusted pipeline value, led by AAV- CNGB3 in Achromatopsia (Phase 1).
Showing 1 of 4 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
AAV- CNGB3 Gene therapyCompletedNCT03001310AchromatopsiaPhase 1 COMPLETED 23Oct 25, 2019
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Clinical Trial Results

Readouts, endpoints and source filings for every MGTX program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
AAV-hAQP1 Grade 2/3 Late Radiation-Induced XerostomiaPhase 12026-04-16Clinically meaningful improvements in xerostomia symptoms measured by PRO Xerostomia Questionnaire (XQ) maintained out to 3 years post treatment; Increases in Unstimulated Whole Saliva Flow Rate (UWSFR) maintained out to 3 yearsRead MoreMeiraGTx Announces Positive Three-year Data from the Phase 1 AQUAx Clinical Study of AAV-hAQP1 for the Treatment of Grade 2/3 Late Radiation-Induced Xerostomia - Clinically meaningful improvements in xerostomia symptoms Read More
Scroll for more · summaries link to the source press release
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Inside Trades

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InsiderSideSharesPriceValueDate
Naylor StuartOfficer (CHIEF SCI OFCR, OPHTHALMOLOGY)Sell -27,659 613,187 held$10.64 10/06/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
PERCEPTIVE ADVISORS LLC 2.2 % (29.4 %) 145.73 M 10.79 M 4.46% ( 460.56 K)
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Shares held by hedge funds each quarter, and who bought or sold.

MGTX Institutional Ownership Trends

Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2027-01-15
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How MGTX ranks across every disease it competes in

Competitive Position is a premium feature
See how MGTX ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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MGTX News

MGTX
Sep 23, 2026
MGTXGeneral

MeiraGTx Appoints Accomplished Healthcare Portfolio Manager Alan M. Sebulsky to Board of Directors

MeiraGTx Holdings plc has appointed Alan M. Sebulsky to its Board of Directors. With over 40 years of experience in healthcare investment, Sebulsky has a strong background in biopharmaceutical portfolio management. His expertise is expected to support MeiraGTx's transformation into a commercial entity, enhancing its strategic growth.

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MGTX
Aug 13, 2026
MGTXFDA Updates

MeiraGTx Reports Second Quarter 2026 Financial and Operational Results

MeiraGTx announced its second quarter 2026 financial and operational results, highlighting the receipt of FDA Breakthrough Therapy Designation for AAV2-hAQP1. The company also reported encouraging three-year data from its Phase 1 AQUAx clinical trial, which evaluates AAV2-hAQP1 for treating moderate to severe radiation-induced xerostomia. Additionally, MeiraGTx completed the acquisition of all interests and rights related to this treatment.

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MGTX
Aug 6, 2026
MGTXGeneral

MeiraGTx Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

MeiraGTx Holdings plc has announced the approval of equity awards by its Compensation Committee under Nasdaq Listing Rule 5635(c)(4). This decision reflects the company's strategy to incentivize its employees as it continues to develop its genetic medicines. The equity awards are part of the company's broader efforts to align employee interests with shareholder value.

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MGTX
Jul 7, 2026
MGTXGeneral
▲ +5.5%on this news

MeiraGTx Announces $400 million Strategic Investment by Oberland Capital to Support Development and Commercialization of AAV2-hAQP1 and Botaretigene Sparoparvovec (bota-vec)

MeiraGTx has announced a strategic investment of $400 million from Oberland Capital, which includes $375 million in non-dilutive cash and $25 million in equity. This funding aims to support the development and commercialization of AAV2-hAQP1, a treatment for late radiation-induced xerostomia. Following regulatory approval, Oberland Capital will receive capped royalties on net sales of the product.

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MGTX
May 14, 2026
MGTXFDA Updates

MeiraGTx Reports First Quarter 2026 Financial and Operational Results

MeiraGTx Holdings plc reported strong financial and operational results for the first quarter of 2026, highlighted by the FDA granting Breakthrough Therapy Designation for AAV2-hAQP1, which has shown positive three-year data in treating late radiation-induced xerostomia. The company also announced a strategic asset acquisition of bota-vec for X-linked retinitis pigmentosa, further enriching its therapeutic portfolio. Financially, MeiraGTx strengthened its position with a $100 million funding increase, enabling continued development and potential regulatory submissions across multiple regions for both therapies.

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MGTX
Apr 16, 2026
MGTXGeneral
▼ -15.7%on this news

MeiraGTx Announces Pricing of $100 Million Offering of Ordinary Shares

MeiraGTx Holdings plc has announced a $100 million underwritten offering of 11,111,111 ordinary shares priced at $9.00 each. The proceeds will support operational expenses and potential launches of two treatments if approved. The offering is set to close on April 17, 2026, pending customary conditions.

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MGTX
Apr 16, 2026
MGTXGeneral
▼ -15.7%on this news

MeiraGTx Announces the Acquisition of Botaretigene Sparoparvovec (bota-vec) for the Treatment of X-linked Retinitis Pigmentosa (XLRP) - Company entered into an asset purchase agreement with Johnson & Johnson (J&J) to acq

MeiraGTx Holdings plc has announced the acquisition of botaretigene sparoparvovec (bota-vec) from Johnson & Johnson for treating X-linked retinitis pigmentosa (XLRP). MeiraGTx plans to expedite regulatory filings for bota-vec in the U.S., EU, and Japan, aiming for a potential market launch in 2027. The Phase 3 LUMEOS study indicated significant improvements in vision metrics among participants. The acquisition involves a $25 million upfront payment with further financial commitments tied to regulatory and sales milestones.

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MGTX
Apr 16, 2026
MGTXPhases
▼ -15.7%on this news

MeiraGTx Announces Positive Three-year Data from the Phase 1 AQUAx Clinical Study of AAV-hAQP1 for the Treatment of Grade 2/3 Late Radiation-Induced Xerostomia

MeiraGTx announced positive three-year data from the Phase 1 AQUAx clinical trial for AAV-hAQP1, targeting late radiation-induced xerostomia. The study demonstrated sustained improvements in symptoms and saliva flow for both bilateral and unilateral treatment groups up to three years post-administration. AAV-hAQP1 has been shown to be safe and well-tolerated, contributing to its potential as a transformative treatment for a condition with significant unmet medical needs.

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MGTX
Apr 14, 2026
MGTXPhases
▲ +17.2%on this newsshared move

MeiraGTx to Present 3-Year Data from the Phase 1 AQUAx Clinical Study of AAV-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia on Thursday, April 16, 2026

MeiraGTx Holdings plc will present 3-year data from the Phase 1 AQUAx clinical study on April 16, 2026. The presentation will cover patient-reported outcomes and objective measures related to radiation-induced xerostomia. The study aims to evaluate the safety and efficacy of the AAV-hAQP1 gene therapy. A question-and-answer session will follow the presentation.

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MGTX
Mar 26, 2026
MGTXFDA Updates

MeiraGTx Announces FDA Breakthrough Therapy Designation for AAV2-hAQP1 for the Treatment of Grade 2 and Grade 3 Radiation-Induced Xerostomia (RIX) and Reports

MeiraGTx has received FDA Breakthrough Therapy Designation for its AAV2-hAQP1 treatment targeting Grade 2 and Grade 3 radiation-induced xerostomia. Supported by three years of clinical data, this designation is expected to accelerate development efforts. The company also reported its financial results for 2025, highlighting a strategic collaboration with Eli Lilly and a partnership with Hologen AI to optimize clinical data analysis. Despite receiving a boost in potential revenue from collaborations, MeiraGTx faces challenges with increased operating expenses and a decline in service revenue.

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MGTX
Nov 13, 2025
MGTXGeneral

MeiraGTx Reports Third Quarter 2025 Financial and Operational Results

MeiraGTx Holdings plc reported its third-quarter results for 2025, highlighting a strategic collaboration with Eli Lilly to develop genetic medicines in ophthalmology. The partnership includes exclusive rights to AAV-AIPL1 for treating Leber congenital amaurosis 4, backed by promising data showing vision restoration in children. Financially, cash reserves decreased significantly year-over-year, alongside a notable decline in service revenue, raising concerns about operational performance. However, advancements in clinical trials for various programs indicate that the company remains focused on expanding its impactful gene therapy pipeline.

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MGTX
Nov 10, 2025
MGTXGeneral

MeiraGTx Enters into Strategic Collaboration with Eli Lilly and Company to Develop and Commercialize Genetic Medicines in Ophthalmology

MeiraGTx Holdings plc has announced a strategic collaboration with Eli Lilly and Company to develop and commercialize genetic medicines specifically targeting ophthalmology. Under this partnership, Lilly will gain exclusive rights to MeiraGTx's AAV-AIPL1 program, which has demonstrated remarkable success in restoring vision in children affected by Leber congenital amaurosis 4. Additionally, the collaboration includes access to MeiraGTx's other innovative gene therapy technologies, allowing both companies to expedite the delivery of transformational treatments for severe eye diseases. MeiraGTx will receive an initial payment of $75 million along with potential milestone payments exceeding $400 million.

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MGTX
Aug 14, 2025
MGTXPhases

MeiraGTx Reports Second Quarter 2025 Financial and Operational Results

MeiraGTx Holdings plc has reported positive financial and operational outcomes for Q2 2025, demonstrating progress in several pivotal clinical programs. The company has secured alignment with the FDA for the Phase 2 study of AAV-hAQP1 aimed at treating radiation-induced xerostomia, potentially leading to a Biologics License Application in the future. Additionally, the FDA has granted RMAT designation for AAV-GAD, signaling a promising trajectory for its Parkinson's disease treatment. The announcement included updates on the company's collaborations and clinical advancements, positioning MeiraGTx for future regulatory approvals and potentially significant market opportunities.

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MGTX
May 13, 2025
MGTXGeneral
▼ -8.4%on this news

MeiraGTx Reports First Quarter 2025 Financial and Operational Results

MeiraGTx Holdings plc announced its first-quarter 2025 financial results, highlighting a strategic collaboration with Hologen AI that includes a $200 million upfront payment and a joint venture aimed at accelerating the development of AAV-GAD for Parkinson's disease. The FDA granted RMAT designation for this therapy, potentially expediting its approval process. Additionally, encouraging efficacy data for rAAV8.hRKp.AIPL1 was published, supporting an application for marketing authorization based on positive treatment responses in children with LCA4. The company reported sufficient capital to support operations into 2027, bolstering its financial position.

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MGTX
May 9, 2025
MGTXFDA Updates

MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV-GAD for the Treatment of Parkinson's Disease

MeiraGTx Holdings plc announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational gene therapy AAV-GAD for treating Parkinson's disease. This designation was based on data from three clinical studies demonstrating clinically meaningful benefits in patients inadequately managed by current medications. AAV-GAD aims to restore normal brain activity through a one-time infusion procedure. The company expressed optimism about working closely with the FDA to further develop this potential treatment.

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MGTX
Mar 13, 2025
MGTXPhases
▲ +28.7%on this news

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

MeiraGTx has entered a strategic collaboration with Hologen AI to accelerate the Phase 3 development of its AAV-GAD treatment for Parkinson's disease. As part of this partnership, MeiraGTx will receive $200 million in upfront cash and Hologen AI will contribute an additional $230 million for the project's completion. The joint venture, Hologen Neuro AI Ltd, will utilize advanced AI technologies to enhance drug development for neurological disorders. This collaboration significantly strengthens MeiraGTx's financial position and expands its clinical development capabilities.

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MGTX
Dec 9, 2024
MGTXFDA Updates
▲ +5.5%on this news

MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV2-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia - RMAT designation recognizes the preliminary clinical evidence of

MeiraGTx Holdings plc has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational gene therapy AAV2-hAQP1, aimed at treating Grade 2/3 radiation-induced xerostomia. This designation highlights the therapy's potential benefits and allows for expedited regulatory privileges, including increased interaction with the FDA. The treatment addresses a significant unmet need, as patients suffering from xerostomia due to radiation treatment currently have no alternative options. The RMAT designation is expected to fast-track the development and review of AAV2-hAQP1, promoting accessibility to this promising therapy for patients.

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MGTX
Nov 13, 2024
MGTXFDA Updates
▲ +5.7%on this news

MeiraGTx Announces Third Quarter 2024 Financial and Operational Results and Recent Business Updates - Received 3 Rare Pediatric Disease Designations (RPDD) from FDA for each of 3 potential therapies for 3 different rare

MeiraGTx Holdings plc reported its financial and operational results for Q3 2024, announcing significant advancements, including the receipt of three Rare Pediatric Disease Designations from the FDA for its therapies targeting inherited retinal diseases. The company plans to submit a Marketing Authorization Application in the UK for its AAV-AIPL1 program without further clinical studies. Positive data from a Parkinson's disease treatment study supports the initiation of a Phase 3 study. These developments underscore the company's potential to deliver transformative treatments for rare pediatric disorders more rapidly.

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MGTX
Oct 15, 2024
MGTXPhases
▲ +14.9%on this news· ran to +32% by day 3

MeiraGTx Announces Positive Data from Randomized, Sham-controlled Clinical Bridging Study of AAV-GAD for the Treatment of Parkinson's Disease The primary study objective of safety and tolerability was met Significant and

MeiraGTx Holdings plc reported positive results from their clinical bridging study of AAV-GAD for Parkinson's disease, achieving key safety and tolerability objectives. The study showed significant improvements in key efficacy endpoints, including an 18-point increase in the Unified Parkinson's Disease Rating Scale among high-dose participants. Additionally, both high and low-dose groups demonstrated notable enhancements in quality of life metrics. These outcomes suggest that AAV-GAD has the potential to improve treatment for Parkinson's patients, supporting future regulatory discussions for Phase 3 trials.

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About MeiraGTx Holdings plc

New York, NY 393 employees meiragtx.com
Headquarters655 THIRD AVENUE, NEW YORK, NY, 10017
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