multiQure stock: Granzer supports FDA filing for multiQure stock on MQ-201

Published on 10/22/2026 at 07:15 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

The first-half loss reached PLN 150.24 million. multiQure stock faces a November 16, 2026 report date after FDA filing work for MQ-201.

Regulatory path and financial figures

multiQure agreed on October 12, 2026, to regulatory support for the MQ-201 filing.
Revenue was PLN 968,000 in the first half of 2026, while the net loss reached PLN 150.24 million.
The next quarterly report is scheduled for November 16, 2026.

Pure Biologics, PLPRBLG00010, Illustration mit AI erstellt.

multiQure (ISIN PLPRBLG00010) agreed on October 12, 2026, with Granzer Regulatory Consulting & Services to support regulatory discussions with the US Food and Drug Administration and prepare an investigational new drug filing for MQ-201, according to Investing.com. The agreement moves the Huntington disease gene therapy program toward a formal US regulatory submission.

Half-year figures show funding pressure

The company reported PLN 968,000 of operating revenue for the first half of 2026, compared with PLN 968,000 in the first half of 2025. The operating loss narrowed to PLN 2.503 million from PLN 3.501 million, while the net loss widened to PLN 150.240 million from PLN 6.057 million, according to the half-year filing published by Parkiet. The reported loss increase was therefore PLN 144.183 million year over year.

Operating cash flow was negative PLN 4.047 million in the first half of 2026, compared with negative PLN 969,000 a year earlier. The figures leave the regulatory timetable and access to financing as the central operating questions for the development program.

Three steps toward first patients

On September 28, 2026, multiQure signed a letter of intent concerning experimental RNAi treatment for the first patients with Huntington disease, according to GPW Alert. On October 5, 2026, Chief Executive Filip Jelen disclosed a PLN 100,000 share purchase in a regulatory report carried by Puls Biznesu. On October 12, 2026, the Granzer agreement added a regulatory workstream to the same program.

What does the filing work mean?

The immediate deliverable is a complete IND package covering regulatory strategy, FDA meeting preparation, manufacturing and quality documentation, preclinical work and the planned clinical study. The source report said Granzer had handled more than 20 gene therapy projects before the agreement, a concrete measure of the partner's stated experience.

Which date comes next?

multiQure's investor calendar lists November 16, 2026, for its third-quarter 2026 periodic report. The calendar also places the start of a closed period on October 17, 2026, before that report, according to the company's multiQure investor page.

Stock quote and investor context

multiQure is a biotechnology company listed on the Warsaw Stock Exchange under ticker MQR. Its portfolio centers on RNAi gene therapy for Huntington disease and includes immuno-oncology projects. The Warsaw Stock Exchange quote for multiQure was PLN 1.51 on October 22, 2026.