Biophytis (BPTS) secures EMA and Belgian approval for Phase 3 sarcopenia study

Rhea-AI Filing Summary

Biophytis S.A. reported that it has received approval from the European Medicines Agency (EMA) and Belgian regulators to start a Phase 3 clinical trial in sarcopenia, a muscle loss condition often linked to aging. This clearance allows the company to begin late-stage testing of its sarcopenia treatment candidate in Europe, an important step in evaluating whether the therapy can demonstrate meaningful clinical benefit in a larger patient population.

The update was communicated through a press release dated August 28, 2025, which is attached to the report as an exhibit.

Positive

• Regulatory milestone: EMA and Belgian approval to initiate a Phase 3 sarcopenia trial marks a major advancement of Biophytis’ lead program into late-stage clinical testing.

Negative

• None.

Insights

Biotech regulatory and clinical development analyst

Regulatory clearance enables Biophytis to start a Phase 3 sarcopenia trial in Europe.

Biophytis S.A. has obtained approval from both the European Medicines Agency and Belgian regulators to initiate a Phase 3 clinical trial in sarcopenia. Moving into Phase 3 is a key transition from earlier-stage testing to larger, confirmatory studies that are typically required before any potential marketing application in major markets.

This regulatory green light suggests that prior data and the trial design were sufficient for authorities to allow late-stage evaluation, but it does not imply any efficacy or safety conclusions. The actual impact for the company will depend on how quickly the trial is activated, the pace of patient enrollment, and eventual Phase 3 results, which are not discussed in this report.

Future disclosures in company filings or press releases may provide details on the trial’s design, size, primary endpoints, and timelines, which will help investors better understand the scope and potential significance of this Phase 3 program in sarcopenia.

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: August 28, 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 August 28, 2025, Biophytis S.A. issued a press release announcing that it has received EMA and Belgian regulatory approval to initiate Phase 3 Sarcopenia clinical trial. 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 August 28, 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: August 28, 2025	By:	/s/ Stanislas Veillet
		Name: Stanislas Veillet
		Title: Chairman and Chief Executive Officer

FAQ

What did Biophytis S.A. (BPTS) announce in this report?

Biophytis S.A. announced that it has received approval from the European Medicines Agency (EMA) and Belgian regulators to initiate a Phase 3 clinical trial in sarcopenia.

Which regulators approved Biophytis S.A.’s Phase 3 sarcopenia trial?

The Phase 3 sarcopenia trial was approved by the European Medicines Agency (EMA) and the relevant Belgian regulatory authorities.

What stage of development is Biophytis S.A.’s sarcopenia program in now?

With these approvals, Biophytis S.A.’s sarcopenia program is cleared to enter Phase 3, a late-stage clinical development phase involving larger patient populations.

How was this Biophytis S.A. Phase 3 update communicated?

The update was communicated through a press release dated August 28, 2025, which is attached as Exhibit 99.1 to the report.

Does this approval mean Biophytis S.A.’s sarcopenia drug is already approved for sale?

No. The approvals allow Biophytis S.A. to start a Phase 3 clinical trial in sarcopenia; they are not marketing approvals and do not authorize commercial sale of the product.

What condition is targeted by Biophytis S.A.’s Phase 3 trial?

The Phase 3 trial targets sarcopenia, a condition characterized by loss of muscle mass and strength, often associated with aging.