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Odonate Therapeutics Announces Discontinuation of Development of Tesetaxel

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Following feedback from the U.S. Food and Drug Administration (FDA) in a pre-New Drug Application meeting, Odonate Therapeutics, Inc. (NASDAQ: ODT) has concluded that the clinical data package for tesetaxel is unlikely to support FDA approval. Therefore, Odonate is discontinuing the development of tesetaxel and will wind down the operations of the Company. The Company will work with clinical sites to transition patients in ongoing tesetaxel clinical studies to appropriate alternative therapies.

“We thank the investigators, study team personnel, and especially the patients and their caregivers for their endeavors to improve treatments for patients with breast cancer,” said Kevin Tang, Chief Executive Officer of Odonate.

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Medicinal and Botanical Manufacturing
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Odonate Therapeutics, Inc. is a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. Odonate’s initial focus is on the development of tesetaxel, an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Odonate’s goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives.