Editas Medicine gets Australian EDIT-401 trial approval
In an ongoing non-human-primate study, EDIT-401 maintained an approximately 90 percent LDL-C reduction over 10 months.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
Editas Medicine, Inc. received approval to initiate the Phase 1/2 Strive trial of EDIT-401 in patients with heterozygous familial hypercholesterolemia in Australia. The trial has Human Research Ethics Committee approval and completed Australia’s Clinical Trial Notification process with the Therapeutic Goods Administration. New Zealand review is pending; if approved, patients in both countries may enroll. Editas selected five trial sites across Australia and New Zealand.
The trial evaluates the safety, tolerability, and efficacy of a single dose. Part 1 is a single-ascending-dose, dose-finding, open-label study; Part 2 is a randomized, placebo-controlled expansion study. In non-human primates, EDIT-401 showed approximately 90 percent or greater mean reductions in multiple atherogenic lipoproteins, and an ongoing study maintained approximately 90 percent LDL-C reduction over 10 months. Editas expects initial safety and tolerability data in the first quarter of 2027 and plans to complete Part 1 enrollment with topline safety and efficacy data later in 2027.
8-K Event Classification
3 items: 7.01, 8.01, 9.01
3 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Mean reduction in atherogenic lipoproteins: Approximately 90 percent or greater
Maintained LDL-C reduction: Approximately 90 percent over 10 months
Selected clinical trial sites: Five sites
+3 more
6 metrics
Mean reduction in atherogenic lipoproteins
Approximately 90 percent or greater
Preclinical studies in non-human primates
Maintained LDL-C reduction
Approximately 90 percent over 10 months
Ongoing study in non-human primates
Selected clinical trial sites
Five sites
Across Australia and New Zealand
Initial safety and tolerability data
First quarter of 2027
Expected from the EDIT-401 clinical trial
Topline safety and efficacy data
Later in 2027
Planned following Part 1 enrollment
AHA presentation
November 8, 2026
Oral presentation of new EDIT-401 preclinical data
Key Terms
Clinical Trial Notification, single ascending dose, open-label, placebo-controlled expansion study, +1 more
5 terms
Clinical Trial Notification regulatory
"completed the Clinical Trial Notification process with Australia's Therapeutic Goods Administration"
A clinical trial notification is an official message sent to health regulators or ethics boards to inform them that a company plans to start, change, or stop a medical study involving human volunteers. Investors care because such notifications signal where a drug or medical device stands in the development process, similar to a builder telling city inspectors that construction will begin—helping assess timing, regulatory risk, and potential future value.
single ascending dose medical
"Part 1 is a single ascending dose, dose-finding, open-label trial"
A single ascending dose is a method used in testing new medicines where small amounts are given to participants, gradually increasing each time to find the safest and most effective dose. For investors, it provides important information about a drug’s safety and potential, helping gauge the progress and prospects of a pharmaceutical development.
open-label medical
"single ascending dose, dose-finding, open-label trial"
Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.
placebo-controlled expansion study medical
"single-dose randomized, placebo-controlled expansion study"
atherogenic lipoproteins medical
"mean reduction in multiple atherogenic lipoproteins"
Particles in the blood that carry cholesterol and other fats and that promote buildup of fatty plaque in artery walls; the term highlights their role in causing atherosclerosis, the process that can lead to heart attacks and strokes. Investors watch levels and therapies targeting these particles because changes can affect demand for drugs, medical devices, insurance costs and regulatory approvals, and can influence the financial outlook of healthcare and life-science companies.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What preclinical results did EDIT report for EDIT-401?
In non-human primates, EDIT-401 showed approximately 90 percent or greater mean reductions in multiple atherogenic lipoproteins, including LDL-C, Lp(a), and ApoB. An ongoing study maintained approximately 90 percent LDL-C reduction over 10 months.
When does EDIT expect EDIT-401 clinical trial data?
Editas expects initial safety and tolerability data in the first quarter of 2027. The company plans to complete Part 1 enrollment, with topline safety and efficacy data available later in 2027.
How is EDIT-401’s Strive trial designed?
The trial evaluates the safety, tolerability, and efficacy of a single dose. Part 1 is a single-ascending-dose, dose-finding, open-label trial; Part 2 is a single-dose randomized, placebo-controlled expansion study.
What is the status of EDIT-401 trial review in New Zealand?
The trial has been submitted for review in New Zealand. If approved there, patients in both Australia and New Zealand will be eligible to enroll in the Strive trial.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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): October 8, 2026
_________________________________________________________________________________________
(Exact Name of Registrant as Specified in its Charter)
_________________________________________________________________________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: (617 ) 401-9000
(Former Name or Former Address, if Changed Since Last Report)
__________________________________________________________________________________________________
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 (see General Instruction A.2. below):
| 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)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
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).
Emerging growth company o
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. o
Item 7.01 Regulation FD Disclosure.
On October 8, 2026, Editas Medicine, Inc. (the “Company”) issued a press release titled “Editas Medicine Receives Approval to Initiate First-in-Human Clinical Trial of EDIT-401 in Patients with Hyperlipidemia,” a copy of which is furnished as Exhibit 99.1 hereto.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On October 8, 2026, the Company announced that it has received approval to initiate the Phase 1/2 Strive™ clinical trial of EDIT-401 in patients with heterozygous familial hypercholesterolemia in Australia. The trial has received Human Research Ethics Committee approval and completed the Clinical Trial Notification process with Australia’s Therapeutic Goods Administration and has also been submitted for review in New Zealand. If approved in New Zealand, patients in both countries will be eligible to enroll in the Strive trial.
EDIT-401 is an experimental, potentially best-in-class in vivo gene editing medicine for the treatment of hyperlipidemia. Utilizing Editas’ differentiated upregulation approach, EDIT-401 is designed to directly edit the LDL receptor (“LDLR”) gene to increase LDLR protein expression and reduce LDL-cholesterol (“LDL-C”) levels. In preclinical studies, EDIT-401 demonstrated approximately 90 percent or greater mean reduction in multiple atherogenic lipoproteins, including LDL-C, lipoprotein(a) (Lp(a)), an independent risk factor for atherosclerotic cardiovascular disease (“ASCVD”), and apolipoprotein B (ApoB), a key measure of total plaque-causing cholesterol particles and predictive measure for ASCVD, in non-human primates. New preclinical data also demonstrated an LDL-C reduction of approximately 90 percent was maintained over 10 months in an ongoing study in non-human primates.
The Strive trial is designed to evaluate the safety, tolerability, and efficacy of a single dose of EDIT-401. The trial is designed in two parts: Part 1 is a single ascending dose, dose-finding, open-label trial. Part 2 will be a single-dose randomized, placebo-controlled expansion study. The Company has selected five clinical trial sites across Australia and New Zealand.
The Company expects to report initial safety and tolerability data in the first quarter of 2027. The Company plans to complete enrollment in Part 1, the dose-finding portion of the Phase 1/2 trial of EDIT-401, with topline safety and efficacy data results available later in 2027.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this Current Report on Form 8-K include statements regarding the initiation, timing, progress and results of the Company’s planned clinical trials, including the Company’s expectation to begin patient dosing in 2026 and complete enrollment in Part 1, the dose-finding portion of the Phase 1/2 trial of EDIT-401, with topline safety and efficacy data results available later in 2027; the timing for the Company’s receipt and presentation of data from its preclinical and planned clinical studies, including reporting initial safety and tolerability data in the clinical trial of EDIT-401 in the first quarter of 2027; and the potential of, and expectations for, EDIT-401. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation, timing, progress, and results of preclinical studies and clinical trials; uncertainty regarding availability and timing of results from preclinical studies and clinical trials; uncertainties relating to planned regulatory submissions to initiate clinical trials, including that results of preclinical studies will warrant such submissions or that regulatory agencies may require additional preclinical studies, that regulatory submissions shall occur on the expected timelines and that regulatory authorities will provide clearance for trials to be initiated on the expected timelines or at all; and uncertainties as to whether the Company’s cash resources are sufficient to fund its
foreseeable and unforeseeable operating expenses and capital expenditure requirements for the period anticipated. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Company’s subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this Current Report on Form 8-K represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company explicitly disclaims any obligation to update any forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
(d)Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | Press release issued by the Company on October 8, 2026* | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
*This exhibit shall be deemed to be furnished and not filed.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EDITAS MEDICINE, INC. | ||||||||
| Date: October 8, 2026 | By: | /s/ Amy Parison | ||||||
| Amy Parison | ||||||||
| Chief Financial Officer | ||||||||
Exhibit 99.1
Editas Medicine Receives Approval to Initiate First-In-Human Clinical Trial of EDIT-401 in Patients with Hyperlipidemia
Phase 1/2 clinical trial of EDIT-401 cleared to initiate dosing in patients who require additional LDL-C lowering
Company remains on track to begin patient dosing this year and report initial safety and tolerability data in the first quarter of 2027
New EDIT-401 preclinical data demonstrating durability of LDL-C reduction to be presented in oral presentation at AHA Scientific Sessions 2026
CAMBRIDGE, Mass., October 8, 2026 – Editas Medicine, Inc. (Nasdaq: EDIT), a pioneering gene editing company focused on developing transformative medicines for serious diseases, today announced it has received approval to initiate the Phase 1/2 Strive™ clinical trial of EDIT-401 in patients with Heterozygous Familial Hypercholesterolemia (HeFH) in Australia. The trial has received Human Research Ethics Committee (HREC) approval and completed the Clinical Trial Notification (CTN) process with Australia’s Therapeutic Goods Administration (TGA) and has also been submitted for review in New Zealand. If approved in New Zealand, patients in both countries will be eligible to enroll in the Strive trial. The Company also announced that new preclinical data, demonstrating durability of LDL-C reduction with EDIT-401, will be released via an oral presentation at the American Heart Association (AHA) Scientific Sessions 2026, taking place November 6-9, 2026, in Chicago, Illinois.
EDIT-401 is an experimental, potentially best-in-class in vivo gene editing medicine for the treatment of hyperlipidemia. Utilizing Editas’ differentiated upregulation approach, EDIT-401 is designed to directly edit the LDLR gene to increase LDLR protein expression and reduce LDL-cholesterol (LDL-C) levels. In preclinical studies, EDIT-401 demonstrated ~90 percent or greater mean reduction in multiple atherogenic lipoproteins, including LDL-C, Lp(a), and ApoB in non-human primates. New preclinical data to be presented at AHA also demonstrated an LDL-C reduction of ~90 percent was maintained over 10 months in an ongoing study in non-human primates.
“The receipt of regulatory and ethics approval for clinical trial initiation in Australia is a significant step in advancing the clinical development of EDIT-401, a potentially transformative in vivo gene editing medicine designed to upregulate LDLR expression and reduce LDL-C levels in patients living with hyperlipidemia. We look forward to initiating the Strive study and generating our first-in-human data as we advance EDIT-401 through key clinical milestones in 2027,” said Dan Ory, M.D., Chief Medical Officer, Editas Medicine. “We are also encouraged by the new EDIT-401 preclinical data to be presented at AHA, which further support its potential to provide durable, lifelong benefits to patients.”
The Strive trial is designed to evaluate the safety, tolerability, and efficacy of a single dose of EDIT-401. The trial is designed in two parts: Part 1 is a single ascending dose, dose-finding,
open-label trial. Part 2 will be a single-dose randomized, placebo-controlled expansion study. Editas has selected five clinical trial sites across Australia and New Zealand.
Editas expects to report initial safety and tolerability data in the first quarter of 2027. The Company plans to complete enrollment in Part 1, the dose-finding portion of the Phase 1/2 trial of EDIT-401, with topline safety and efficacy data results available later in 2027.
American Heart Association (AHA) Scientific Sessions 2026 Oral Presentation
Editas will present new preclinical data demonstrating the durability of EDIT-401, supporting its potential as a transformative therapy for people living with hyperlipidemia, at the AHA Scientific Sessions on Sunday, November 8.
Presentation Details:
Title: EDIT-401: In Vivo Gene Editing to Enhance LDLR Function for Durable LDL-C Reduction
Session Date and Time: Sunday, November 8, 2026, 3:30 - 4:45 p.m. CT
Session Title: Translational Gene and Epigenome Therapies For Lipid Management: A New Frontier
Presenter: Dan Ory, M.D., Chief Medical Officer, Editas Medicine
The final presentation can be accessed on the AHA website. A copy of the presentation will also be posted to the “Posters & Presentations” section of the Company’s website during the conference.
About EDIT-401
EDIT-401 is an experimental, potentially best-in-class in vivo gene editing medicine, based on Editas’ differentiated upregulation approach. EDIT-401 is designed to treat hyperlipidemia by directly editing the LDLR gene to increase LDLR protein expression and reduce LDL-C levels. This targeted approach has demonstrated a favorable preclinical profile in both efficacy data and tolerability and supports the potential of EDIT-401 to deliver meaningful clinical outcomes for patients underserved by current lipid-lowering therapies.
About Heterozygous Familial Hypercholesterolemia (HeFH)
Heterozygous Familial Hypercholesterolemia (HeFH) is an inherited genetic disorder that leads to significantly elevated LDL‑C levels from an early age. Individuals with HeFH are at high risk of heart disease, heart attack, or stroke if the condition is not identified and treated early. An estimated 1.2 million people in the United States are living with HeFH, though many remain undiagnosed. Elevated LDL-C, also known as hyperlipidemia, is a highly prevalent disease affecting over 70 million patients in the United States alone. Substantial unmet need exists across multiple at-risk segments of patients with hyperlipidemia, including the HeFH population.
About Editas Medicine
As a pioneering gene editing company, Editas Medicine is focused on translating the power and potential of CRISPR genome editing systems into a robust pipeline of transformative in vivo medicines for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize durable, precision in vivo gene editing
medicines for a broad class of diseases. Editas Medicine is the exclusive licensee of Broad Institute’s Cas12a patent estate and Broad Institute and Harvard University’s Cas9 patent estates for human medicines. For the latest information and scientific presentations, please visit www.editasmedicine.com.
Forward-Looking Statements
This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the initiation, timing, progress and results of the Company’s planned clinical trials, including the Company’s expectation to begin patient dosing in 2026 and complete enrollment in Part 1, the dose-finding portion of the Phase 1/2 trial of EDIT-401, with topline safety and efficacy data results available later in 2027; the timing for the Company’s receipt and presentation of data from its preclinical and planned clinical studies, including reporting initial safety and tolerability data in the clinical trial of EDIT-401 in the first quarter of 2027; and the potential of, and expectations for, EDIT-401. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation, timing, progress, and results of preclinical studies and clinical trials; uncertainty regarding availability and timing of results from preclinical studies and clinical trials; uncertainties relating to planned regulatory submissions to initiate clinical trials, including that results of preclinical studies will warrant such submissions or that regulatory agencies may require additional preclinical studies, that regulatory submissions shall occur on the expected timelines and that regulatory authorities will provide clearance for trials to be initiated on the expected timelines or at all; and uncertainties as to whether the Company’s cash resources are sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements for the period anticipated. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent Annual Report on Form 10-K, which is on file with the Securities and Exchange Commission, as updated by the Company’s subsequent filings with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company explicitly disclaims any obligation to update any forward-looking statements.
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