Why Are Soligenix Shares Plummeting Today?

• The FDA has provided a Refusal to File (RTF) letter for Soligenix Inc's (NASDAQ: SNGX) HyBryte (synthetic hypericin) new drug application (NDA) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL).

• Upon preliminary review, the FDA determined that the NDA submitted was not sufficiently complete to permit substantive review.

• Soligenix first learned of the RTF decision via this letter and is reviewing its contents to determine the appropriate next steps.

• The company plans to request a Type A meeting with the FDA to clarify and respond to the issues identified in the letter and to seek additional guidance.

• Related: Soligenix Shares Gain On HyBrytes Data From Blood Cancer Study.

• When the company submitted the application to the FDA, it anticipated potential approval in the second half of 2023, and the U.S. launch targeted for the first quarter of 2024.

• Price Action: SNGX shares are down 33.60% at $3.85 on the last check Tuesday.

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

This article Why Are Soligenix Shares Plummeting Today? originally appeared on Benzinga.com

.

© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.