EMA clears Biophytis (BPTS) to start Phase 2 obesity clinical trial

Rhea-AI Filing Summary

Biophytis S.A. reports that it has obtained authorization from the European Medicines Agency (EMA) to launch a Phase 2 clinical trial in obesity. The company communicated this development through a press release, which is included as an exhibit to the report for additional detail.

Insights

Biotech regulatory and clinical development analyst

Biophytis receives EMA clearance to begin a Phase 2 obesity trial, marking a formal step forward in its clinical program.

Biophytis S.A. states it has obtained EMA authorization to launch a Phase 2 clinical trial in obesity. EMA authorization is a required regulatory step in Europe before initiating this level of human study, so the notice confirms the program is cleared to proceed to this stage.

The report itself is brief and mainly points to a press release for details, without describing the trial design, size, or objectives. The development is directionally important for the obesity program, but the absence of efficacy or safety data means the information is still early-stage and does not, by itself, indicate clinical success.

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

Date of report: September 3, 2025

Commission File Number: 001-38974

BIOPHYTIS S.A.

(Translation of registrant’s name into English)

Stanislas Veillet
Biophytis S.A.

Sorbonne University—BC 9, Bâtiment A 4ème étage

4 place Jussieu

75005 Paris, France

+33 1 44 27 23 00

(Address of principal executive office)

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

x Form 20-F ¨  Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨

On September 2, 2025, Biophytis S.A. issued a press release announcing that the company has obtained EMA authorization to launch its Phase 2 clinical trial in obesity. A copy of the press release is attached as Exhibit 99.1 to this Form 6-K.

EXHIBIT LIST

Exhibit		Description
99.1		Press Release dated September 3, 2025.

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.

	BIOPHYTIS S.A.
Date: September 3, 2025	By:	/s/ Stanislas Veillet
		Name: Stanislas Veillet
		Title: Chairman and Chief Executive Officer

FAQ

What did Biophytis (BPTS) announce in its latest 6-K filing?

Biophytis announced it has obtained EMA authorization to launch a Phase 2 clinical trial in obesity. The company issued a press release describing this regulatory development, which is attached as an exhibit to the report for investors and other stakeholders.

What stage of development is Biophytis (BPTS) pursuing for its obesity program?

Biophytis is preparing to begin a Phase 2 clinical trial in obesity, after receiving EMA authorization. Phase 2 studies typically evaluate a treatment’s effectiveness and further assess safety in patients, representing a more advanced stage than initial human testing.

Which regulator authorized Biophytis (BPTS) to start its obesity trial?

The European Medicines Agency (EMA) authorized Biophytis to launch its Phase 2 clinical trial in obesity. This authorization allows the company to proceed with the planned study under European regulatory oversight, as described briefly in the company’s 6-K report and accompanying press release.

Does the Biophytis (BPTS) 6-K include details of the Phase 2 obesity trial?

The 6-K itself does not provide detailed trial parameters, but it states that a press release with more information is attached as an exhibit. Readers must reference that press release to learn specifics about the Phase 2 obesity study Biophytis plans to conduct.

How did Biophytis (BPTS) disclose the EMA authorization for its obesity trial?

Biophytis disclosed the EMA authorization through a Form 6-K report, noting that it issued a press release announcing the decision. The press release, dated early September 2025, is attached to the report as Exhibit 99.1 for additional context and detail.