[8-K] MeiraGTx Holdings plc Reports Material Event

Rhea-AI Filing Summary

MeiraGTx (NASDAQ:MGTX) filed an 8-K Regulation FD disclosure announcing it has obtained all required UK foreign-direct-investment clearances for its previously announced transactions with Hologen Ltd., signed March 9 2025.

The clearance removes the final regulatory hurdle, allowing the deal—which management expects to close in July 2025—to proceed to funding and execution.

Insights

M&A Specialist

TL;DR: UK FDI clearance green-lights Hologen deal; closing now imminent.

The only material update is confirmation that UK regulators approved the Hologen transaction. Clearance eliminates a gating risk, accelerating cash inflow and strategic collaboration benefits scheduled for July 2025. While financial terms were disclosed earlier, today’s milestone materially de-risks completion, supporting valuation uplift and reducing timeline uncertainty. No new liabilities or conditions surfaced. Rating: positive.

Event Analyst

TL;DR: Regulatory hurdle cleared; execution risk meaningfully lower.

Item 7.01 signals progress rather than completion, yet regulatory approval typically carries high binary risk in cross-border biotech deals. With authorization in hand, investors can shift focus to integration and milestone payments. Forward-looking caution remains, but absence of additional conditions suggests limited residual risk. Overall impact tilts positive, albeit dependent on July closing.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

Current Report Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 26, 2025

MeiraGTx Holdings plc

(Exact name of registrant as specified in its charter)

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Cayman Islands		001-38520		98-1448305
(State or other jurisdiction of incorporation or organization)		(Commission File Number)		(I.R.S. Employer Identification No.)

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450 East 29th Street, 14^th Floor

New York, NY 10016

(Address of principal executive offices) (Zip code)

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(646) 860-7985

(Registrant’s telephone number, including area code)

Not applicable

(Former name or former address, if changed since last report)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 

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Securities registered pursuant to Section 12(b) of the Act:

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Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary Shares, $0.00003881 par value per share		MGTX		The Nasdaq Global Select Market

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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Emerging growth company  ☐

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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

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Item 7.01 Regulation FD Disclosure.

MeiraGTx Holdings plc (the “Company”) has received the clearances and approvals under the foreign direct investment laws of the United Kingdom that are applicable to the proposed transactions the Company entered into with Hologen Limited (“Hologen”) on March 9, 2025. The transactions are expected to close in July 2025.

Forward Looking Statements

This Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the anticipated timing of the closing and funding of the proposed transactions with Hologen, as well as statements that include the words “expect,” “will,” “intend,” “plan,” “believe,” “project,” “forecast,” “estimate,” “may,” “could,” “should,” “would,” “continue,” “anticipate” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, raise additional capital, repay our debt obligations, identify additional and develop existing product candidates, successfully execute strategic transactions or priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug or rare pediatric disease designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of pandemics, epidemics or outbreaks of infectious diseases on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this Form 8-K. Any such forward-looking statements represent management’s estimates as of the date of this Form 8-K. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this Form 8-K.

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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Date: June 26, 2025	​
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​	MEIRAGTX HOLDINGS PLC
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​	By:	/s/ Richard Giroux
​	Name:	Richard Giroux
​	Title:	Chief Financial Officer and Chief Operating Officer

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