Soligenix Receives Refusal To File Letter From FDA For HyBryte NDA

Soligenix, Inc. (SNGX) announced that the FDA has provided the company with a Refusal to File letter for its HyBryte new drug application in the treatment of early stage cutaneous T-cell lymphoma. The FDA determined that the submitted NDA was not sufficiently complete to permit substantive review. Soligenix plans to seek guidance from the FDA on how to further advance HyBryte towards potential approval.

"We are fully determined to work with the FDA staff as quickly as possible to better understand the open issues and clarify the potential path to successfully resubmitting our application," said Christopher Schaber, CEO of Soligenix.

For More Such Health News, visit rttnews.com.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT