Odonate Therapeutics Announces Discontinuation of Development of Tesetaxel

Rhea-AI Summary

Odonate Therapeutics, Inc. (NASDAQ: ODT) has announced the discontinuation of its tesetaxel development following FDA feedback, indicating that the current clinical data will not support approval. The company will wind down operations and assist in transitioning patients in ongoing tesetaxel studies to alternative therapies. CEO Kevin Tang expressed gratitude to all involved in the research efforts for breast cancer treatments.

Positive

• Odonate will assist in transitioning patients from ongoing clinical studies to alternative therapies.

Negative

• Development of tesetaxel discontinued due to FDA feedback on insufficient clinical data.
• Company will wind down operations, indicating potential layoffs and loss of business.
• Uncertainty surrounding future prospects for Odonate post-tesetaxel development cancellation.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210322005211/en/

FAQ

What led to the discontinuation of tesetaxel by Odonate Therapeutics (ODT)?

Odonate Therapeutics discontinued tesetaxel development after receiving feedback from the FDA indicating the clinical data package was unlikely to support approval.

What will happen to patients involved in tesetaxel studies?

Odonate Therapeutics will work with clinical sites to transition patients in ongoing tesetaxel studies to appropriate alternative therapies.

What is the future of Odonate Therapeutics (ODT) after ceasing tesetaxel development?

The company is winding down operations, which raises concerns about its long-term viability and future projects.