SNGX - Soligenix falls after updating the regulatory path for SGX301

Soligenix (SNGX) is trading sharply lower after the company announced its decision not to pursue a rolling submission for its marketing application of HyBryte (SGX301) in the treatment of cutaneous T-cell lymphoma ((CTCL)).After discussions with the FDA, “the company decided not to pursue a rolling NDA submission at this time in a regulatory filing,” due in part to COVID-19 related delays in manufacturing, the company said in a regulatory filing,Soligenix added that the decision was taken “to provide additional supportive data for inclusion in the NDA filing” which is expected in H1 2022 leading to potential approval in H1 2023.In January, the company announced an exclusive Supply, Distribution, and Services Agreement with Daavlin for SGX301.

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Soligenix falls after updating the regulatory path for SGX301