Why Are Soligenix Shares Plummeting

 

• The FDA has provided a Refusal to File (RTF) letter for Soligenix Inc's 
  SNGX-18.1%+ Free Alerts
   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.
• 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.

https://www.benzinga.com/general/biotech/23/02/30899787/why-are-soligenix-shares-plummeting-today