“We are thrilled to collaborate with the FDA on this important initiative,” said
“We applaud the FDA for undertaking this initiative to partner with pioneers in emerging modalities. We are making significant investments to ensure commercial readiness for RYZ101, including building our own manufacturing facility in
About gastroenteropancreatic neuroendocrine tumors
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are rare tumors with an incidence of approximately 18,000 patients annually in
About RYZ101
RYZ101 is an investigational targeted radiopharmaceutical therapy, designed to deliver a highly potent radioisotope, Actinium-225 (Ac225), to tumors expressing SSTR2. RYZ101 is being evaluated in clinical studies for patients with SSTR+ GEP-NETs who have previously been treated with Lu177-based somatostatin therapies and also in patients with newly diagnosed extensive stage small cell lung cancer. Details of the studies can be found at https://clinicaltrials.gov/ct2/show/NCT05477576 and https://clinicaltrials.gov/ct2/show/NCT05595460.
Ac225 for the study was provided by multiple sources including the
About RayzeBio
RayzeBio is building a vertically integrated radiopharmaceutical therapeutics (RPT) company to treat various cancers, with its lead program in a Phase 3 clinical trial. RayzeBio has created a pipeline of multiple drug candidates in therapeutic areas with significant market opportunities. Much like antibody drug conjugates emerged as a new and transformative treatment modality in certain cancers, the company sees an opportunity for innovative radiopharmaceutical therapeutics to follow a similar path. RayzeBio believes its strategic investments in building a robust product pipeline, development capabilities, and manufacturing infrastructure position the company to be an industry-leading pioneer in the broad application of RPT for cancer.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the potential benefits of RYZ101 based on preliminary response data, the anticipated development timeline of RYZ101, the expected benefits of the CDRP program, and the ability of RayzeBio to expedite commercial manufacturing readiness for RYZ101. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the beliefs of the management of the company as well as assumptions made by and information currently available to the company. Such statements reflect the current views of the company with respect to future events and are subject to known and unknown risks and uncertainties, including business, regulatory, economic and competitive risks and uncertainties about the company, including, without limitation, risks inherent in developing drug candidates, future results from the company’s ongoing and planned clinical trials, the company’s ability to obtain adequate financing to fund its planned clinical trials and other expenses, risks that future clinical trial results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials, trends in the industry, the legal and regulatory framework for the industry and future expenditures. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause the company’s actual results to differ from current expectations are discussed in the company’s filings with the
Contact: Arvind Kush
Email: info@rayzebio.com
![](https://ml.globenewswire.com/media/OWJmYjc5YzQtMGI5NS00Y2Y0LWFkZWUtOWU2ZWYxNzU5ZDBhLTEyNTcwMDE=/tiny/Rayzebio-Inc-.png)
2023 GlobeNewswire, Inc., source