[6-K] NeuroSense Therapeutics Ltd. Current Report (Foreign Issuer)

Rhea-AI Filing Summary

NeuroSense Therapeutics Ltd. (NRSN) submitted a report stating that it has received FDA clearance to initiate a pivotal phase 3 clinical trial of its lead candidate PrimeC in amyotrophic lateral sclerosis (ALS). The update is provided through a press release furnished as an exhibit and is also incorporated by reference into several of the company’s existing registration statements. The filing itself does not include trial design details, timelines, or financial data, but signals that the program has advanced to a late-stage study under FDA oversight.

Insights

Biotech and Regulatory Analyst

FDA cleared NeuroSense to start a pivotal phase 3 ALS trial for PrimeC.

NeuroSense Therapeutics reports that the FDA has cleared it to initiate a pivotal phase 3 trial of PrimeC in ALS. This indicates the company has aligned key clinical and regulatory elements with the agency to move its lead asset into a late-stage study, a necessary step before any potential marketing application.

The update does not describe the trial design, number of patients, endpoints, or expected duration, so the operational and cost implications cannot be assessed from this document alone. It also does not disclose any new financing or partnerships linked to the trial, focusing strictly on the regulatory milestone.

The advance to a pivotal phase 3 stage in ALS places greater importance on future clinical readouts and subsequent disclosures, which would typically appear in later company communications and periodic reports once enrollment progress and interim data become available.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of November 2025

Commission File Number: 001-41084

NeuroSense Therapeutics Ltd.
(Translation of registrant’s name into English)

NeuroSense Therapeutics Ltd.

11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9- 7996183
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒     Form 40-F ☐

Explanatory Note

Attached is the Company’s press release regarding receipt of FDA clearance to initiate pivotal phase 3 trial for PrimeC in ALS, furnished herewith as Exhibit 99.1.

This Report on Form 6-K (other than the fourth paragraph in Exhibit 99.1) is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-262480 and 333-289658) and Form F-3 (File No. 333-269306, 333-260338, 333-283656, 333-284051 and 333-291122) to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

Exhibit Index

Exhibit No.		Description
99.1		Press Release dated November 24, 2025

1

SIGNATURES

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, thereunto duly authorized.

	NeuroSense Therapeutics Ltd.
Date: November 24, 2025	By:	/s/ Alon Ben-Noon
		Alon Ben-Noon
		Chief Executive Officer

2

FAQ

What did NeuroSense Therapeutics (NRSN) announce in this Form 6-K?

NeuroSense Therapeutics announced that it has received FDA clearance to initiate a pivotal phase 3 trial of its lead drug candidate PrimeC in ALS, as described in an attached press release.

Which NeuroSense drug is moving into a pivotal phase 3 ALS trial?

The filing states that PrimeC is cleared by the FDA to move into a pivotal phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS).

Does this NeuroSense 6-K include financial or earnings information?

No. The report primarily notes the FDA clearance for a pivotal phase 3 ALS trial of PrimeC and incorporates this information into existing registration statements; it does not present financial or earnings data.

How is this 6-K used in NeuroSense Therapeutics’ registration statements?

The report states that it (other than the fourth paragraph in the exhibit) is incorporated by reference into NeuroSense’s Form S-8 and Form F-3 registration statements, meaning the information becomes part of those filings.

Does the NeuroSense filing describe the design of the PrimeC phase 3 ALS trial?

The document only notes FDA clearance to initiate a pivotal phase 3 trial for PrimeC in ALS and does not provide design details such as endpoints, size, or timeline.

Is this NeuroSense 6-K about a financing or major transaction?

No. The content focuses on regulatory clearance for a pivotal phase 3 ALS trial of PrimeC and the incorporation of this information into existing registration statements, without describing a new financing or acquisition.