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[6-K] – Sanofi (SNY, SNYNF) (CIK 0001121404)

Filing Impact
(Low)
Filing Sentiment
(Neutral)
Form Type
6-K

Sanofi furnished a Form 6-K announcing a press release dated October 8, 2025. The release states that AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in a phase 2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This update highlights mid-stage clinical results disclosed via an attached exhibit.

Sanofi ha fornito un Form 6-K annunciando un comunicato stampa datato 8 ottobre 2025. Il comunicato afferma che AlphaMedixTM (212Pb-DOTAMTATE) ha raggiunto tutti gli endpoint primari di efficacia in uno studio di fase 2, dimostrando benefici clinicamente significativi nei pazienti con tumori neuroendocrini gastro-entero-pancreatici (GEP-NET). Questo aggiornamento evidenzia i risultati clinici di metà studio divulgati tramite un allegato.

Sanofi proporcionó un Form 6-K anunciando un comunicado de prensa con fecha 8 de octubre de 2025. El comunicado indica que AlphaMedixTM (212Pb-DOTAMTATE) alcanzó todos los endpoints primarios de eficacia en un estudio de fase 2, demostrando beneficios clínicamente significativos en pacientes con tumores neuroendocrinos gastroenteropancreáticos (GEP-NET). Esta actualización resalta resultados clínicos de fase intermedia divulgados a través de un anexo adjunto.

사노피는 2025년 10월 8일자 보도자료를 담은 Form 6-K를 제출했다. 보도자료에 따르면 AlphaMedixTM (212Pb-DOTAMTATE)2상 연구에서 모든 주요 효능 평가 지표를 달성했고, 위장관췌장 신경내분비종양(GEP-NET) 환자에서 임상적으로 의미 있는 이점을 보여주었다. 이 업데이트는 첨부된 부록을 통해 공개된 중간 규모의 임상 결과를 강조한다.

Sanofi a fourni un Form 6-K annonçant un communiqué de presse daté du 8 octobre 2025. Le communiqué indique que AlphaMedixTM (212Pb-DOTAMTATE) a atteint tous les critères d'efficacité primaires dans une étude de phase 2, démontrant des bénéfices cliniquement significatifs chez les patients atteints de tumeurs neuroendocrines gastro-entéro-pancreatiques (GEP-NET). Cette mise à jour met en évidence les résultats cliniques de stade intermédiaire divulgués via une pièce jointe.

Sanofi hat ein Form 6-K vorgelegt, das eine Pressemitteilung vom 8. Oktober 2025 ankündigt. Die Mitteilung besagt, dass AlphaMedixTM (212Pb-DOTAMTATE) in einer Phase-2-Studie alle primären Wirksamkeitsendpunkte erreicht hat und klinisch signifikante Vorteile bei Patienten mit gastro-entero-pancreatischen Neuroendokrinen Tumoren (GEP-NET) gezeigt hat. Dieses Update hebt mid-stage klinische Ergebnisse hervor, die über eine beigefügte Ausstellung veröffentlicht wurden.

Sanofi قدمت نموذج Form 6-K يعلن عن بيان صحفي بتاريخ 8 أكتوبر 2025. تنص الرسالة على أن AlphaMedixTM (212Pb-DOTAMTATE) حقق جميع نقاط الكفاءة الأساسية في دراسة من المرحلة الثانية، مُظهراً فوائد سريرية ذات مغزى لدى مرضى الأورام العصبية الغدية المعوية-البنكرياسية (GEP-NET). يبرز هذا التحديث نتائج سريرية في مرحلة متوسطة مُعلنة عبر مرفق مرفق.

Sanofi 提供了一份 Form 6-K,宣布日期为 2025 年 10 月 8 日的新闻稿。新闻稿称 AlphaMedixTM (212Pb-DOTAMTATE) 在一项 二阶段 研究中达到了所有主要疗效终点,显示对患有 胃肠胰神经内分泌肿瘤(GEP-NET) 的患者具有临床意义的益处。这一更新通过附带的展品披露了中阶段的临床结果。

Positive
  • None.
Negative
  • None.

Sanofi ha fornito un Form 6-K annunciando un comunicato stampa datato 8 ottobre 2025. Il comunicato afferma che AlphaMedixTM (212Pb-DOTAMTATE) ha raggiunto tutti gli endpoint primari di efficacia in uno studio di fase 2, dimostrando benefici clinicamente significativi nei pazienti con tumori neuroendocrini gastro-entero-pancreatici (GEP-NET). Questo aggiornamento evidenzia i risultati clinici di metà studio divulgati tramite un allegato.

Sanofi proporcionó un Form 6-K anunciando un comunicado de prensa con fecha 8 de octubre de 2025. El comunicado indica que AlphaMedixTM (212Pb-DOTAMTATE) alcanzó todos los endpoints primarios de eficacia en un estudio de fase 2, demostrando beneficios clínicamente significativos en pacientes con tumores neuroendocrinos gastroenteropancreáticos (GEP-NET). Esta actualización resalta resultados clínicos de fase intermedia divulgados a través de un anexo adjunto.

사노피는 2025년 10월 8일자 보도자료를 담은 Form 6-K를 제출했다. 보도자료에 따르면 AlphaMedixTM (212Pb-DOTAMTATE)2상 연구에서 모든 주요 효능 평가 지표를 달성했고, 위장관췌장 신경내분비종양(GEP-NET) 환자에서 임상적으로 의미 있는 이점을 보여주었다. 이 업데이트는 첨부된 부록을 통해 공개된 중간 규모의 임상 결과를 강조한다.

Sanofi a fourni un Form 6-K annonçant un communiqué de presse daté du 8 octobre 2025. Le communiqué indique que AlphaMedixTM (212Pb-DOTAMTATE) a atteint tous les critères d'efficacité primaires dans une étude de phase 2, démontrant des bénéfices cliniquement significatifs chez les patients atteints de tumeurs neuroendocrines gastro-entéro-pancreatiques (GEP-NET). Cette mise à jour met en évidence les résultats cliniques de stade intermédiaire divulgués via une pièce jointe.

Sanofi hat ein Form 6-K vorgelegt, das eine Pressemitteilung vom 8. Oktober 2025 ankündigt. Die Mitteilung besagt, dass AlphaMedixTM (212Pb-DOTAMTATE) in einer Phase-2-Studie alle primären Wirksamkeitsendpunkte erreicht hat und klinisch signifikante Vorteile bei Patienten mit gastro-entero-pancreatischen Neuroendokrinen Tumoren (GEP-NET) gezeigt hat. Dieses Update hebt mid-stage klinische Ergebnisse hervor, die über eine beigefügte Ausstellung veröffentlicht wurden.

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 October 2025

Commission File Number: 001-31368

SANOFI

(Translation of registrant’s name into English)

46, avenue de la Grande Armée, 75017 Paris, FRANCE

(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

 

1


In October 2025, Sanofi published the press release attached hereto as Exhibit 99.1 which is incorporated herein by reference.

Exhibit Index

 

Exhibit No.    Description        
Exhibit 99.1    Press Release dated October 8, 2025: AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in phase  2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors

 

2


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.

 

Dated: October 15, 2025     SANOFI
    By     

/s/ Alexandra Roger

      Name: Alexandra Roger
      Title: Head of Legal Corporate & Finance

 

3

FAQ

What did Sanofi (SNY) report in this 6-K?

Sanofi furnished a press release stating AlphaMedixTM (212Pb-DOTAMTATE) met all primary efficacy endpoints in a phase 2 study for GEP-NETs.

What is AlphaMedixTM (212Pb-DOTAMTATE)?

It is Sanofi’s radioligand therapy candidate referenced in the press release attached to the 6-K.

What clinical stage is AlphaMedixTM in according to the filing?

Phase 2, with all primary efficacy endpoints achieved per the exhibit description.

Which patients were studied?

Patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

When was the press release issued?

October 8, 2025, and it was furnished as Exhibit 99.1 to the 6-K.

Does the filing include detailed efficacy data or safety results?

The excerpt references the outcome but does not provide detailed data within the text provided.
Sanofi FR

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