U.S. FDA declines to review Soligenix's cancer drug; shares sink

[February 15, 2023]  (Reuters) -The U.S. Food and Drug Administration (FDA) has declined to review Soligenix Inc's application seeking approval of its cancer treatment, the drug developer said on Tuesday, sending its shares down more than 30% in early trading.

The application was rejected on grounds that it was insufficient to permit a review, and the company will work with the agency to clarify a path forward for the treatment.

The drug, HyBryte, is a light-activated ointment to be applied to skin lesions caused by cutaneous T-cell lymphoma - a rare type of cancer that begins in the white blood cells and attacks the skin.

HyBryte is the New Jersey-based company's lead experimental therapy and Soligenix had previously expected the drug to be approved in the second half of 2023. It had filed the marketing application to the FDA in December.

In November, the company said it was assessing several strategic options including merger and acquisition opportunities. It had $16.9 million in cash as of Sept. 30.

The application was based on a late-stage study in which 16% patients receiving the drug achieved at least a 50% reduction in their lesions, compared with only 4% of patients in the placebo group at 8 weeks during the first treatment cycle.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The company's shares were down 31% at $4.01.

There is no cure for cutaneous T-cell lymphoma, which affects over 25,000 individuals in the United States, according to the company.

(Reporting by Sriparna Roy in Bengaluru; Editing by Maju Samuel and Devika Syamnath)

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