Why Citius Pharmaceuticals Stock Is Plunging Today?

The FDA issued a Complete Response Letter regarding Citius Pharmaceuticals Inc's CTXR Biologics License Application (BLA) seeking approval for denileukin diftitox (Lymphir), an engineered IL-2-diphtheria toxin fusion protein for relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

The FDA has required Citius to incorporate enhanced product testing and additional controls agreed to with the FDA during the market application review. 

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There were no concerns relating to the safety and efficacy clinical data package submitted with the application or the proposed prescribing information.

In 2021, denileukin diftitox received regulatory approval in Japan for CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize Lymphir in all markets except for Japan and certain parts of Asia.

Price Action: CTXR shares are down 16% at $0.94 on the last check Monday.