MGTX - MeiraGTx Holdings plc
Graviton BioScience Corporation Announces Publication of Positive Ph1b Trial Results for GV101 (TDI01) in Chronic Graft versus Host Disease in S
GV101, a novel, highly selective ROCK2 inhibitor, yielded an 86.2% best overall response rate (bORR) at 400 mg and a 67.9% bORR at 200 mg at 24 weeks in chronic Graft versus Host Disease (cGvHD) patients who had failed at least two prior lines of therapy. GV101's 24-week bORR exceeds published 6-month bORRs for all existing, approved steroid-refractory cGvHD therapies.
MeiraGTx Holdings PLC (MGTX) came out with quarterly earnings of $1.71 per share, beating the Zacks Consensus Estimate of a loss of $0.39 per share. This compares to a loss of $0.48 per share a year ago.
Received FDA Breakthrough Therapy Designation for AAV2-hAQP1 and reported positive three-year data from Phase 1 AQUAx clinical trial evaluating AAV2-hAQP1 for the treatment of moderate to severe grade 2/3 radiation-induced xerostomia Completed the acquisition of all interests and rights to botaretigene sparoparvovec (bota-vec) for the treatment of X-linked retinitis pigmentosa (XLRP) from Johnson & Johnson* (J&J) for $25 million Strengthened balance sheet with $100 million equity financing concurrent with the bota-vec acquisition Secured up to $400 million strategic investment from Oberland Capital, with up to $375 million in non-dilutive capital to support development and commercialization of AAV2-hAQP1 and bota-vec Anticipate submission of global regulatory filings for approval of bota-vec in 2026 and potential BLA filing for AAV2-hAQP1 in mid-2027 LONDON and NEW YORK, Aug. 13, 2026 (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, 2026, and provided a corporate update. “During the second quarter of 2026, we made tremendous progress towards transforming MeiraGTx into a commercial company,” said Alexandria Forbes, Ph.D.
Graviton received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a novel capsule formulation of GV101 on August 7, 2026. FDA clearance marks a critical regulatory milestone in advancing this formulation of GV101, a capsule with improved PK and oral availability, into human trials for Friedreich's ataxia (FA).
LONDON and NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced that the Compensation Committee of the Company's Board of Directors approved equity awards under the Company's 2026 Employment Inducement Award Plan to a new employee. The equity awards were granted as an inducement material to the new employee entering employment with MeiraGTx in accordance with Nasdaq Listing Rule 5635(c)(4).
MeiraGTx Holdings plc is positioned potentially for significant upside with late-stage gene therapy assets targeting large, high-unmet-need indications. AAV2-hAQP1 for radiation-induced xerostomia could address a $3.7B peak sales market with no direct competition; pivotal Phase 2 data expected 2Q27. Robust optionality from GAD for Parkinson's, bota-vec for XLRP, milestone payments, and the innovative Riboswitch platform enhances MGTX's valuation case.
The mean of analysts' price targets for MeiraGTx (MGTX) points to a 128.1% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
Stuart Naylor liquidated 27,659 shares for $409,000 on July 7, 2026, at a weighted average price of $14.80 per share. The transaction resulted in a 4% reduction of the insider's total direct equity holdings in the company.
MeiraGTx (MGTX) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.
LONDON and NEW YORK, July 07, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced that it has entered into an agreement with Oberland Capital Management LLC (Oberland Capital) for an investment of up to $400 million in the Company, including up to $375 million in non-dilutive capital for capped royalty payments on certain products and up to $25 million in equity.
MeiraGTx is evolving into a late-stage, manufacturing-enabled genetic medicine company with multiple near-term regulatory catalysts. MGTX's robust manufacturing infrastructure and targeted therapies, such as Bota-vec and AAV2-hAQP1, position it for commercial inflection without mass-market commercialization burdens. Recent equity raise and anticipated milestone payments extend MGTX's cash runway through 2H 2028, supporting execution of late-stage programs.
MeiraGTx Holdings plc (MGTX) Presents at Jefferies Global Healthcare Conference 2026 Transcript
MeiraGTx Holdings plc (MGTX) Presents at Bank of America Global Healthcare Conference 2026 Transcript
LONDON and NEW YORK, May 14, 2026 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced that the Compensation Committee of the Company's Board of Directors approved equity awards to Penny Fleck in connection with her employment with the Company as Chief Development Officer. The equity awards were granted as an inducement material to the new employee entering employment with MeiraGTx in accordance with Nasdaq Listing Rule 5635(c)(4).
MeiraGTx Holdings PLC (MGTX) came out with a quarterly loss of $0.57 per share versus the Zacks Consensus Estimate of a loss of $0.43. This compares to a loss of $0.51 per share a year ago.
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.
MeiraGTx (MGTX) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
MeiraGTx (MGTX) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
MeiraGTx Holdings PLC (NASDAQ: MGTX - Get Free Report) shares saw unusually-strong trading volume on Friday after Royal Bank Of Canada raised their price target on the stock from $16.00 to $24.00. Royal Bank Of Canada currently has an outperform rating on the stock. Approximately 623,122 shares traded hands during trading, an increase of 13% from