BRIEF—Odonate falls as it discontinues tesetaxel development

Following feedback from the US Food and Drug Administration in a pre-New Drug Application meeting, Odonate Therapeutics has concluded that the clinical data package for tesetaxel is unlikely to support FDA approval.

The news sent the US firm’s shares down nearly 818% to $3.24 by late morning.

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 of Odonate.