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[6-K] ProQR Therapeutics N.V. Current Report (Foreign Issuer)

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(Low)
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Form Type
6-K
Rhea-AI Filing Summary

ProQR Therapeutics has submitted a Clinical Trial Application (CTA) for a Phase 1 study of AX-0810, a novel drug candidate targeting NTCP (sodium taurocholate co-transporting polypeptide). This regulatory filing marks a significant milestone in the company's drug development pipeline.

Key points from the Form 6-K filing:

  • The announcement was made via press release on June 26, 2025
  • The filing includes a press release as Exhibit 99.1
  • The information is being furnished under Form 6-K and is not considered "filed" under Section 18 of the Securities Exchange Act
  • The document was signed by Dennis Hom, Chief Financial Officer

This development represents a strategic advancement in ProQR's clinical program, potentially expanding their therapeutic portfolio. The CTA submission indicates the company is progressing toward clinical trials for AX-0810, which could have implications for investors following ProQR's drug development pipeline.

ProQR Therapeutics ha presentato una Domanda di Sperimentazione Clinica (CTA) per uno studio di Fase 1 su AX-0810, un nuovo candidato farmaco che agisce sul NTCP (polipeptide co-trasportatore del taurocolato di sodio). Questa richiesta regolatoria rappresenta una tappa importante nel percorso di sviluppo farmaceutico dell'azienda.

Punti salienti dal deposito del Modulo 6-K:

  • L'annuncio è stato diffuso tramite comunicato stampa il 26 giugno 2025
  • Il deposito include il comunicato stampa come Allegato 99.1
  • Le informazioni sono fornite tramite il Modulo 6-K e non sono considerate "depositate" ai sensi della Sezione 18 del Securities Exchange Act
  • Il documento è stato firmato da Dennis Hom, Chief Financial Officer

Questo sviluppo rappresenta un progresso strategico nel programma clinico di ProQR, con potenziali ampliamenti del loro portafoglio terapeutico. La presentazione della CTA indica che l'azienda sta avanzando verso le sperimentazioni cliniche per AX-0810, un fatto rilevante per gli investitori che seguono il percorso di sviluppo farmaceutico di ProQR.

ProQR Therapeutics ha presentado una Solicitud de Ensayo Clínico (CTA) para un estudio de Fase 1 de AX-0810, un nuevo candidato a fármaco que actúa sobre NTCP (polipéptido co-transportador de taurocolato de sodio). Esta presentación regulatoria representa un hito importante en la línea de desarrollo de medicamentos de la compañía.

Puntos clave del formulario 6-K:

  • El anuncio se realizó mediante comunicado de prensa el 26 de junio de 2025
  • La presentación incluye el comunicado de prensa como Anexo 99.1
  • La información se proporciona bajo el Formulario 6-K y no se considera "presentada" según la Sección 18 de la Ley de Intercambio de Valores
  • El documento fue firmado por Dennis Hom, Director Financiero

Este avance representa un progreso estratégico en el programa clínico de ProQR, con potencial para ampliar su portafolio terapéutico. La presentación de la CTA indica que la compañía avanza hacia los ensayos clínicos de AX-0810, lo que puede tener implicaciones para los inversores que siguen la línea de desarrollo de medicamentos de ProQR.

ProQR Therapeutics는 NTCP(나트륨 타우로콜산 공동수송 폴리펩타이드)를 표적으로 하는 신약 후보물질 AX-0810의 1상 임상시험 신청서(CTA)를 제출했습니다. 이번 규제 제출은 회사의 신약 개발 과정에서 중요한 이정표입니다.

Form 6-K 제출서의 주요 내용:

  • 발표는 2025년 6월 26일 보도자료를 통해 이루어졌습니다.
  • 제출서에는 보도자료가 Exhibit 99.1로 포함되어 있습니다.
  • 이 정보는 Form 6-K를 통해 제공되었으며, 증권거래법 섹션 18에 따라 "제출됨"으로 간주되지 않습니다.
  • 문서는 최고재무책임자(CFO)인 Dennis Hom이 서명했습니다.

이번 개발은 ProQR의 임상 프로그램에서 전략적 진전을 의미하며, 치료제 포트폴리오 확장 가능성을 내포합니다. CTA 제출은 회사가 AX-0810의 임상시험 단계로 나아가고 있음을 보여주며, ProQR의 신약 개발 과정을 주시하는 투자자들에게 중요한 의미를 가질 수 있습니다.

ProQR Therapeutics a soumis une demande d’essai clinique (CTA) pour une étude de phase 1 portant sur AX-0810, un nouveau candidat médicament ciblant NTCP (polypeptide co-transporteur du taurocholate de sodium). Ce dépôt réglementaire constitue une étape importante dans le pipeline de développement de médicaments de l’entreprise.

Points clés du dépôt du formulaire 6-K :

  • L’annonce a été faite via un communiqué de presse le 26 juin 2025
  • Le dépôt inclut le communiqué de presse en tant qu’Exhibit 99.1
  • Les informations sont fournies sous le formulaire 6-K et ne sont pas considérées comme « déposées » selon la Section 18 du Securities Exchange Act
  • Le document a été signé par Dennis Hom, Directeur financier

Ce développement représente une avancée stratégique dans le programme clinique de ProQR, pouvant potentiellement élargir leur portefeuille thérapeutique. La soumission de la CTA indique que la société progresse vers les essais cliniques pour AX-0810, ce qui pourrait avoir des implications pour les investisseurs suivant le pipeline de développement de ProQR.

ProQR Therapeutics hat einen Antrag auf Durchführung einer klinischen Studie (CTA) für eine Phase-1-Studie mit AX-0810, einem neuartigen Wirkstoffkandidaten, der auf NTCP (Natrium-Taurocholat-Co-Transport-Polypeptid) abzielt, eingereicht. Diese regulatorische Einreichung stellt einen bedeutenden Meilenstein in der Arzneimittelentwicklung des Unternehmens dar.

Wesentliche Punkte aus der Form 6-K Einreichung:

  • Die Bekanntgabe erfolgte per Pressemitteilung am 26. Juni 2025
  • Die Einreichung enthält die Pressemitteilung als Anlage 99.1
  • Die Informationen werden im Rahmen des Formulars 6-K bereitgestellt und gelten nicht als "eingereicht" gemäß Abschnitt 18 des Securities Exchange Act
  • Das Dokument wurde von Dennis Hom, Chief Financial Officer, unterzeichnet

Diese Entwicklung stellt einen strategischen Fortschritt im klinischen Programm von ProQR dar und könnte das therapeutische Portfolio erweitern. Die CTA-Einreichung zeigt, dass das Unternehmen auf klinische Studien für AX-0810 zusteuert, was für Investoren, die die Arzneimittelentwicklung von ProQR verfolgen, von Bedeutung sein könnte.

Positive
  • None.
Negative
  • None.

ProQR Therapeutics ha presentato una Domanda di Sperimentazione Clinica (CTA) per uno studio di Fase 1 su AX-0810, un nuovo candidato farmaco che agisce sul NTCP (polipeptide co-trasportatore del taurocolato di sodio). Questa richiesta regolatoria rappresenta una tappa importante nel percorso di sviluppo farmaceutico dell'azienda.

Punti salienti dal deposito del Modulo 6-K:

  • L'annuncio è stato diffuso tramite comunicato stampa il 26 giugno 2025
  • Il deposito include il comunicato stampa come Allegato 99.1
  • Le informazioni sono fornite tramite il Modulo 6-K e non sono considerate "depositate" ai sensi della Sezione 18 del Securities Exchange Act
  • Il documento è stato firmato da Dennis Hom, Chief Financial Officer

Questo sviluppo rappresenta un progresso strategico nel programma clinico di ProQR, con potenziali ampliamenti del loro portafoglio terapeutico. La presentazione della CTA indica che l'azienda sta avanzando verso le sperimentazioni cliniche per AX-0810, un fatto rilevante per gli investitori che seguono il percorso di sviluppo farmaceutico di ProQR.

ProQR Therapeutics ha presentado una Solicitud de Ensayo Clínico (CTA) para un estudio de Fase 1 de AX-0810, un nuevo candidato a fármaco que actúa sobre NTCP (polipéptido co-transportador de taurocolato de sodio). Esta presentación regulatoria representa un hito importante en la línea de desarrollo de medicamentos de la compañía.

Puntos clave del formulario 6-K:

  • El anuncio se realizó mediante comunicado de prensa el 26 de junio de 2025
  • La presentación incluye el comunicado de prensa como Anexo 99.1
  • La información se proporciona bajo el Formulario 6-K y no se considera "presentada" según la Sección 18 de la Ley de Intercambio de Valores
  • El documento fue firmado por Dennis Hom, Director Financiero

Este avance representa un progreso estratégico en el programa clínico de ProQR, con potencial para ampliar su portafolio terapéutico. La presentación de la CTA indica que la compañía avanza hacia los ensayos clínicos de AX-0810, lo que puede tener implicaciones para los inversores que siguen la línea de desarrollo de medicamentos de ProQR.

ProQR Therapeutics는 NTCP(나트륨 타우로콜산 공동수송 폴리펩타이드)를 표적으로 하는 신약 후보물질 AX-0810의 1상 임상시험 신청서(CTA)를 제출했습니다. 이번 규제 제출은 회사의 신약 개발 과정에서 중요한 이정표입니다.

Form 6-K 제출서의 주요 내용:

  • 발표는 2025년 6월 26일 보도자료를 통해 이루어졌습니다.
  • 제출서에는 보도자료가 Exhibit 99.1로 포함되어 있습니다.
  • 이 정보는 Form 6-K를 통해 제공되었으며, 증권거래법 섹션 18에 따라 "제출됨"으로 간주되지 않습니다.
  • 문서는 최고재무책임자(CFO)인 Dennis Hom이 서명했습니다.

이번 개발은 ProQR의 임상 프로그램에서 전략적 진전을 의미하며, 치료제 포트폴리오 확장 가능성을 내포합니다. CTA 제출은 회사가 AX-0810의 임상시험 단계로 나아가고 있음을 보여주며, ProQR의 신약 개발 과정을 주시하는 투자자들에게 중요한 의미를 가질 수 있습니다.

ProQR Therapeutics a soumis une demande d’essai clinique (CTA) pour une étude de phase 1 portant sur AX-0810, un nouveau candidat médicament ciblant NTCP (polypeptide co-transporteur du taurocholate de sodium). Ce dépôt réglementaire constitue une étape importante dans le pipeline de développement de médicaments de l’entreprise.

Points clés du dépôt du formulaire 6-K :

  • L’annonce a été faite via un communiqué de presse le 26 juin 2025
  • Le dépôt inclut le communiqué de presse en tant qu’Exhibit 99.1
  • Les informations sont fournies sous le formulaire 6-K et ne sont pas considérées comme « déposées » selon la Section 18 du Securities Exchange Act
  • Le document a été signé par Dennis Hom, Directeur financier

Ce développement représente une avancée stratégique dans le programme clinique de ProQR, pouvant potentiellement élargir leur portefeuille thérapeutique. La soumission de la CTA indique que la société progresse vers les essais cliniques pour AX-0810, ce qui pourrait avoir des implications pour les investisseurs suivant le pipeline de développement de ProQR.

ProQR Therapeutics hat einen Antrag auf Durchführung einer klinischen Studie (CTA) für eine Phase-1-Studie mit AX-0810, einem neuartigen Wirkstoffkandidaten, der auf NTCP (Natrium-Taurocholat-Co-Transport-Polypeptid) abzielt, eingereicht. Diese regulatorische Einreichung stellt einen bedeutenden Meilenstein in der Arzneimittelentwicklung des Unternehmens dar.

Wesentliche Punkte aus der Form 6-K Einreichung:

  • Die Bekanntgabe erfolgte per Pressemitteilung am 26. Juni 2025
  • Die Einreichung enthält die Pressemitteilung als Anlage 99.1
  • Die Informationen werden im Rahmen des Formulars 6-K bereitgestellt und gelten nicht als "eingereicht" gemäß Abschnitt 18 des Securities Exchange Act
  • Das Dokument wurde von Dennis Hom, Chief Financial Officer, unterzeichnet

Diese Entwicklung stellt einen strategischen Fortschritt im klinischen Programm von ProQR dar und könnte das therapeutische Portfolio erweitern. Die CTA-Einreichung zeigt, dass das Unternehmen auf klinische Studien für AX-0810 zusteuert, was für Investoren, die die Arzneimittelentwicklung von ProQR verfolgen, von Bedeutung sein könnte.

 

 

 

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 of

the Securities Exchange Act of 1934

 

For the month of June 2025

 

Commission File Number: 001-36622

 

PROQR THERAPEUTICS N.V.

 

Zernikedreef 9

2333 CK Leiden

The Netherlands

Tel: +31 88 166 7000

(Address, Including Zip Code, and Telephone Number,
Including Area Code, of Registrant’s Principal Executive Offices)

 

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

 

Form 20-F x Form 40-F o

 

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): o

 

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): o

 

 

 

 

 

 

On June 26, 2025, ProQR Therapeutics N.V. (“ProQR”) issued a press release titled “ProQR Announces CTA Submission for Phase 1 Study of AX-0810 Targeting NTCP.” A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

The information in this Report on Form 6-K, including Exhibit 99.1 attached hereto, of ProQR is being 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 a filing.

 

 

 

 

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.

 

  PROQR THERAPEUTICS N.V.
   
Date: June 26, 2025 By: /s/ Dennis Hom
    Dennis Hom
    Chief Financial Officer

 

 

 

 

INDEX TO EXHIBITS

 

Number   Description
     
99.1   Press Release of ProQR Therapeutics N.V. dated June 26, 2025.

 

 

 

FAQ

What regulatory submission did PRQR announce in June 2025?

PRQR announced the submission of a Clinical Trial Application (CTA) for a Phase 1 study of their drug candidate AX-0810, which targets NTCP. This announcement was made via press release on June 26, 2025.

Who is the current CFO of PRQR as of June 2025?

According to the Form 6-K filing, Dennis Hom is serving as the Chief Financial Officer of ProQR Therapeutics N.V., as evidenced by his signature on the document dated June 26, 2025.

What type of annual reports does PRQR file with the SEC?

According to the filing, PRQR files annual reports under Form 20-F, as indicated by the checkbox marked 'x' next to Form 20-F in the document.

Where is PRQR's principal executive office located?

ProQR Therapeutics N.V.'s principal executive office is located at Zernikedreef 9, 2333 CK Leiden, The Netherlands, with telephone number +31 88 166 7000.
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