4 - MeiraGTx Holdings plc (0001735438) (Issuer)

Chardan Capital Markets resumed coverage of MeiraGTx with a rating of Buy and set a new price target of $36.00

Received 3 Rare Pediatric Disease Designations (RPDD) from FDA for each of 3 potential therapies for 3 different rare inherited retinopathies including AAV-AIPL1 Agreed on pathway with MHRA for Marketing Authorization Application (MAA) under exceptional circumstances for AAV-AIPL1 for the treatment of Leber congenital amaurosis (LCA4) retinal dystrophy without further clinical studies Announced positive data from randomized, sham-controlled clinical bridging study of AAV-GAD for the treatment of Parkinson's disease LONDON and NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage genetic medicines company, today announced

LONDON and NEW YORK, Oct. 22, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced the Company will exhibit five posters at the European Society of Gene and Cell Therapy (ESGCT) 2024 Annual Congress, which is being held from October 22-25, 2024, in Rome, Italy. The posters are available on the Posters and Publications page of the Company's website. The details of the poster presentations are as follows: Poster Number: P0015Abstract Title: Evolution of a high-producing, modular upstream platform for AAV manufacturingPoster Session III: Tuesday 22 October from 19:30 to 21:00 CESTAbstract:The

The primary study objective of safety and tolerability was met Significant and clinically meaningful improvements from baseline demonstrated for key efficacy endpoints at 26 weeks Significant improvement of 18 points in Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 in the high dose group at 26 weeks Significant improvement in the Parkinson's Disease Questionnaire (PDQ-39) score, a key quality of life measure, for both the high and low dose groups at 26 weeks LONDON and NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced top-line data from its clinical bridging stu

LONDON and NEW YORK, Oct. 09, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage genetic medicine company, today announced a poster presentation at the 2024 Society for Neuroscience Conference (SfN), which is being held from October 5-9, 2024, in Chicago, IL. "We are pleased to share data at this year's Society for Neuroscience Conference on the remarkable efficacy of our AAV-BDNF treatment in diet-induced obesity animal models," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. "We leveraged our proprietary vector design platform to create a highly potent construct with the potential to treat children with

- Positive data from the Phase 1 AQUAx study in radiation-induced xerostomia (RIX) presented at the American Academy of Oral Medicine 2024 annual meeting (AAOM) showed meaningful improvements in patient-reported outcomes and saliva production with AAV2-hAQP1 treatment - Company awarded Innovation Passport Designation by the U.K. Innovative Licensing and Access Pathway Steering Group for AAV8-RK-AIPL1 for the treatment of AIPL1-Leber congenital amaurosis 4 (LCA4) LONDON and NEW YORK, Aug. 12, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical-stage genetic medicine company, today announced financial and operational results f

LONDON and NEW YORK, Aug. 12, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage genetic medicine company, today announced the pricing of an underwritten offering of 12,500,000 of its ordinary shares at an offering price of $4.00 per share. Gross proceeds to MeiraGTx from the offering are expected to be $50 million, before deducting underwriting discounts and commissions and offering expenses. All of the ordinary shares in the offering are being sold by MeiraGTx. The financing was led by Sanofi, which made a $30 million equity investment in MeiraGTx through the offering. Other participants included Perceptive Advisors and leading inst

- Positive data from the Phase 1 AQUAx study in radiation-induced xerostomia (RIX) presented in an oral session at the American Academy of Oral Medicine 2024 annual meeting (AAOM) April 17-20, 2024 - Received $50 million milestone following initiation of the extension study for the Phase 3 LUMEOS clinical trial for botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) for the treatment of X-linked retinitis pigmentosa (XLRP) - Clinical development milestones met and remain on track for the rest of the year for AAV-hAQP1 for RIX, bota-vec for XLRP, and AAV-GAD for Parkinson's disease LONDON and NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a verticall

LONDON and NEW YORK, April 24, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced that Alexandria Forbes, Ph.D., President and Chief Executive Officer, will participate in the following investor conferences: Chardan 8th Annual Genetic Medicines and Cell Therapy Manufacturing Summit, Virtual Corporate presentation: Monday, April 29, 2024, at 11:00 a.m. ET  BofA Securities Healthcare Conference 2024, Las Vegas Corporate presentation: Wednesday, May 15, 2024, at 10:40 a.m. PT  Goldman Sachs 45th Annual Global Healthcare Conference, Miami Corporate presentation: Wednesday, June 12, 2024,

LONDON and NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company gave an oral presentation at the American Academy of Oral Medicine Annual Conference, being held from April 16-20, 2024, at the Hyatt Regency Grand Cypress in Orlando, FL. The details of the oral presentation are below: Session: Oral Abstract Session IPresentation ID #196Title: Results of a Phase 1, Open-label, Dose-escalation Study of Gene Therapy with AAV2-hAQP1 as Treatment for Grade 2 and 3 Radiation-induced Late Xerostomia and Parotid Gland Hypofunction – The AQUAx StudyPresenting Author: Dr. Michael Br

- Company aligned with FDA on requirements for ongoing Phase 2 AQUAx2 clinical trial for Grade 2/3 radiation-induced xerostomia to be considered pivotal supporting potential BLA filing - Company to present data from the Phase 1 AQUAx study in an oral presentation at the American Academy of Oral Medicine 2024 annual meeting (AAOM) April 17-20, 2024 - Completed dosing the three-arm randomized, sham-controlled Phase 1 clinical bridging study for AAV-GAD for the treatment of Parkinson's disease - Company to present positive data on AAV-AIPL1 treatment of 8 LCA4 patients each with meaningful responses in second quarter 2024 - Entered int

Company cofounder and CTO to lead button battery safety tech company toward commercialization The Directors of Landsdowne Labs, LLC, are pleased to announce the appointment of Bryan Laulicht to Chief Executive Officer. Laulicht, a company cofounder, has served as Lansdowne's Chief Technology Officer since the company's formation in 2017. He has also co-founded and served in leadership positions at two other companies focused on applying biophysics and bioengineering approaches to fulfilling unmet medical and safety needs. Both of those companies have been acquired for a combined total greater than $500M. Lansdowne's technology, applied to small, coin-like "button" batteries, is design

LONDON and NEW YORK, April 27, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced the appointment of Dr. Debra Yu to its Board of Directors. Dr. Yu currently serves as President and Chief Strategy Officer of LianBio, and previously served as LianBio's President and Chief Business Officer. Dr. Yu has more than 30 years of healthcare industry experience in business development, alliance management, investment banking and capital markets. She has held senior positions at Pfizer in its Worldwide Business Development organization and Labrador Advisors, LLC, where she advised numerous partnerships and licen

On CNBC's “Mad Money Lightning Round,” Jim Cramer recommended buying Dutch Bros Inc. (NYSE:BROS). On May 7, Dutch Bros posted better-than-expected first-quarter financial results and raised its full-year revenue guidance. “The outlook is fabulous. There is a lawsuit in July that, involving formula,” Cramer said when asked about Abbott Laboratories (NYSE:ABT). “We're waiting until at least it gets to par or 100 to be able to buy more. But we believe in the company.” On April 17, Abbott Laboratories reported better-than-expected earnings for its first quarter. The company posted first-quarter sales of $9.96 billion, up 10.8% on an organic basis for the underlying base business, beatin

MeiraGTx Hldgs (NASDAQ:MGTX) reported quarterly losses of $(0.32) per share which beat the analyst consensus estimate of $(0.50) by 36 percent. This is a 48.39 percent increase over losses of $(0.62) per share from the same period last year. The company reported $697.00 thousand in sales this quarter. This is a 79.09 percent decrease over sales of $3.33 million the same period last year.

RBC Capital analyst Luca Issi reiterates MeiraGTx Hldgs (NASDAQ:MGTX) with a Outperform and maintains $11 price target.

MeiraGTx Hldgs (NASDAQ:MGTX) reported its Q4 earnings results on Thursday, March 14, 2024 at 08:30 AM. Here's what investors need to know about the announcement. Earnings MeiraGTx Hldgs beat estimated earnings by 482.0%, reporting an EPS of $0.42 versus an estimate of $-0.11. Revenue was up $7.33 million from the same period last year. Past Earnings Performance Last quarter the company missed on EPS by $0.19 which was followed by a 2.0% increase in the share price the next day. Here's a look at MeiraGTx Hldgs's past performance: Quarter Q3 2023 Q2 2023 Q1 2023 Q4 2022 EPS Estimate -0.55 -0.56 -0.66 -0.49 EPS Actual -0.74 -0.53 -0.62 -0.58 Revenue Estimate 3.27M 4.17M 4.86M 8.92M

MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced the achievement of the first milestone under the asset purchase agreement the Company entered into with Janssen Pharmaceuticals, Inc. (J&J), a Johnson & Johnson company, in December 2023 relating to bota-vec for the treatment of XLRP. "We are very happy to announce that the LUMEOS extension study has been initiated, which triggered the $50 million milestone payment to MeiraGTx under the asset purchase agreement with J&J," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx.Agreements related to bota-vec:MeiraGTx anticipates receiving an additional $1

Shares of CarMax, Inc. (NYSE:KMX) moved higher during Thursday’s session following better-than-expected quarterly earnings. KMX reported a third-quarter sales decline of 5.5% year-on-year to $6.15 billion, missing the analyst consensus estimate of $6.33 billion. EPS of $0.52 beat the consensus estimate of $0.44. CarMax shares climbed 7.7% to $80.42 on Thursday. Here are some other stocks moving in today's mid-day session. Gainers Infrared Cameras Holdings Inc (NASDAQ:MSAI) shares jumped 222% to $8.43 after falling over 61% on Wednesday. HOOKIPA Pharma Inc. (NASDAQ:HOOK) surged 75% to $0.9874 after the company announced a $21.25 million equity investment from Gilead Sciences. DMK Ph

Gainers HOOKIPA Pharma (NASDAQ:HOOK) stock moved upwards by 73.2% to $0.98 during Thursday's regular session. The market value of their outstanding shares is at $82.1 million. HeartBeam (NASDAQ:BEAT) stock increased by 54.23% to $1.82. The market value of their outstanding shares is at $47.9 million. PetVivo Hldgs (NASDAQ:PETV) shares moved upwards by 39.02% to $1.14. The market value of their outstanding shares is at $16.4 million. OneMedNet (NASDAQ:ONMD) shares moved upwards by 37.5% to $1.1. The company's market cap stands at $35.4 million. Anebulo Pharmaceuticals (NASDAQ:ANEB) stock moved upwards by 28.57% to $2.7. The company's market cap stands at $69.2 million. MeiraGTx Hldgs (N

MeiraGTx Holdings plc (NASDAQ:MGTX) on Thursday announced an asset purchase agreement with Janssen Pharmaceuticals Inc, a Johnson & Johnson (NYSE:JNJ) company, for the remaining interests in botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) for X-linked retinitis pigmentosa (XLRP). MeiraGTx will monetize potential future royalties and milestones related to bota-vec, with J&J acquiring the remaining rights for developing, manufacturing, and commercializing bota-vec. MeiraGTx is to receive $130 million in upfront and near-term milestone payments, including $65 million at signing, an additional $50 million anticipated in the first quarter of 2024, with the remaining $15 million in mile

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10-Q - MeiraGTx Holdings plc (0001735438) (Filer)

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Clinically meaningful improvements in xerostomia symptoms measured by two different xerostomia PROs demonstrated across both unilaterally and bilaterally treated cohorts at 12 monthsIncreases in whole saliva flow rates observed post-treatment, providing objective evidence of biological activity, reaching the normal range in bilaterally treated participants by 2 months and persisting through the Month 12 assessmentAcross assessments, greater improvements observed in bilaterally treated participants compared to those treated unilaterally Early long-term follow-up data suggest durability of improvement to at least 3 years post-treatmentAAV2-hAQP1 appears safe and well tolerated at each dose te

LONDON and NEW YORK, June 22, 2023 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced it will host a conference call and webcast to present an update on the Company's AAV-hAQP1 clinical program for the treatment of grade 2/3 radiation-induced xerostomia (RIX) on Tuesday, June 27, 2023, at 8:00 a.m. ET. The presentation will include: 1) Data from the completed Phase 1 AQUAx clinical study for the 24 patients treated with AAV-hAQP1 in the unilateral and bilateral cohorts: Safety and tolerability12-month data for PRO assessments of xerostomia symptoms in the unilateral cohorts (n=12)12-month data for

Clinically meaningful improvements in xerostomia symptoms and disease burden reported in patient reported outcome (PRO) measures in both unilateral and bilateral cohortsIncreases in whole saliva flow rates were seen in both unilateral and bilateral cohorts Overall degree of improvement was greater in bilateral compared to unilateral cohorts AAV2-hAQP1 appears safe and well tolerated at each dose tested Webcast and conference call to be held today, December 13, 2022, at 8:00 a.m. ET LONDON and NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced positive clinical data from the ongoin

LONDON and NEW YORK, Dec. 08, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced it will host a conference call and webcast to present clinical data from the Company's AAV-hAQP1 Phase 1 AQUAx clinical trial for the treatment of radiation-induced xerostomia (RIX) on Tuesday, December 13, 2022, at 8:00 a.m. ET. The Phase 1 AQUAx conference call will also include a clinical program update for product candidate AAV-hAQP1, a potential treatment for RIX, from MeiraGTx's senior management and lead investigator Michael Brennan, DDS, Chairman of the Department of Oral Medicine and Director of the Sjögren's Syn

• The primary outcome of the MGT009 study is safety, and botaretigene sparoparvovec treatment was found to be generally safe and well-tolerated • Significant improvements were demonstrated in multiple different endpoints in botaretigene sparoparvovec-treated patients across each of the three domains of vision: retinal function, visual function and functional vision • MeiraGTx to host a conference call on Tuesday, June 28, 2022, at 8am ET LONDON and NEW YORK, June 28, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced top-line data from the Phase 1/2 clinical study MGT009 (NCT03252847) of

LONDON and NEW YORK, Dec. 14, 2021 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, will host a virtual R&D Day via webcast and conference call on Wednesday, December 15, 2021, from 10:00 a.m. to 12:00 p.m. ET highlighting the Company's gene regulation platforms. MeiraGTx's R&D Day webcast will feature a presentation by Alexandria Forbes, Ph.D., President and Chief Executive Officer. The event will provide a detailed overview of the Company's gene regulation platforms including promoter engineering and MeiraGTx's proprietary platform driven by novel synthetic riboswitches controlled by oral small molecules. The presenta

Clinically meaningful improvements in xerostomia symptoms and disease burden reported in two validated Patient Reported Outcome (PRO) measures6 of the 7 participants through 90-day assessments following treatment achieved clinically meaningful improvement in symptoms using both the McMaster Global Rate of Change PRO and the Xerostomia QuestionnaireOne participant with the maximum response evaluable at 12 months has now reached 24 months and the same level of response/xerostomia symptom improvement was maintainedAAV-hAQP1 appears safe and well-tolerated at each dose testedWebcast and conference call to be held today, December 7, 2021 at 8:00 a.m. ET LONDON and NEW YORK, Dec. 07, 2021 (GLOB

LONDON and NEW YORK, Nov. 29, 2021 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage gene therapy company, today announced it will host a conference call and webcast to provide an update on the Company's AAV-hAQP1 Phase 1 AQUAx clinical trial for the treatment of radiation-induced xerostomia (RIX) on Tuesday, December 7, 2021, at 8:00 a.m. ET. MeiraGTx will also host a virtual R&D Day via webcast and conference call that will be held on Wednesday, December 15, 2021, from 10:00 a.m. to 12:00 p.m. ET to focus on the Company's gene regulation platforms. The Phase 1 AQUAx conference call will include a clinical program update for product candida