Pentixapharm Receives FDA “Study May Proceed” Letters for Dual Theranostic INDs in CXCR4-Based Hemato-Oncology Program

Pentixapharm Receives FDA “Study May Proceed” Letters for Dual Theranostic INDs in CXCR4-Based Hemato-Oncology Program

• U.S. Investigational New Drug (IND) applications for radiotheranostic pair PentixaFor and PentixaTher became active following completion of the FDA 30-day review period.
• Proposed phase I/II trial designed to confirm the suitability of CXCR4-directed radiotherapy for bone marrow conditioning in patients undergoing stem cell transplant.
• Overall aim is to complement or reduce conventional chemotherapy for acute myeloid leukemia (AML) and multiple myeloma (MM) patients.

Berlin, Germany – February 25, 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day safety review of two Investigational New Drug (IND) applications for the Company’s CXCR4-targeted theranostic program in hemato-oncology and confirmed that the proposed clinical study may proceed.

The two IND submissions support the single PENTHERA Phase I/II protocol, which evaluates the combined use of PentixaFor imaging and [⁹⁰Y]Y-PentixaTher as targeted bone marrow conditioning prior to stem cell transplantation in patients with acute myeloid leukemia (AML) and multiple myeloma (MM).

Hematopoietic Stem cell transplantation remains the only potentially curative treatment option for many patients with these hematologic malignancies, yet conventional conditioning regimens rely on highly toxic chemotherapy and/or total body irradiation. Pentixapharm’s CXCR4-directed radiopharmaceutical approach is designed to enable more biologically targeted conditioning while delivering antitumor activity with precision.

In Europe and the US alone, AML and MM together account for more than 25,000 stem cell transplantations annually, each requiring a conditioning regimen prior to transplant.

“The U.S. INDs provide important regulatory validation of our CXCR4-targeted approach and support its advancement in the stem cell transplant setting, combining PentixaFor imaging with [⁹⁰Y]Y-PentixaTher,” said Dirk Pleimes, CEO of Pentixapharm. “AML and MM are significant hematologic malignancies where transplantation remains central to treatment. We believe that targeted bone marrow conditioning has the potential to offer a differentiated strategy within this established chemotherapy-based paradigm. This regulatory milestone also builds on our ongoing investigator-initiated clinical studies in AML in Europe.”

The Company will determine the timing of future clinical studies under the IND in accordance with its broader portfolio prioritisation and resource planning.

About Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM)
AML and MM are serious hematologic malignancies associated with high relapse rates and ongoing unmet medical need. In eligible patients, stem cell transplantation represents a potentially curative treatment option. Conditioning therapy prior to transplantation, designed to reduce residual disease and prepare the bone marrow for engraftment, is an established component of the procedure. Conventional conditioning regimens typically rely on intensive chemotherapy and/or external beam radiation, which act systemically and may be associated with significant off-target toxicity.

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.

Pentixapharm Investor and Media Contact
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