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Wednesday, 05/04/2022 10:19:55 AM

Wednesday, May 04, 2022 10:19:55 AM

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The second half of the year will be very interesting .

Recent Highlights and Upcoming Milestones

Citius anticipates filing a biologics license application (BLA) for I/ONTAK® with the U.S. Food and Drug Administration (FDA) in the second half of 2022;
Topline data from the Phase 3 study of cancer immunotherapy I/ONTAK are consistent with the previously-approved formulation of denileukin diftitox (ONTAK), and there are no new safety signals;
Halo-Lido Phase 2b trial initiated in April 2022 with last patient enrollment anticipated by the end of 2022;
Phase 3 Mino-Lok® trial proceeding without modification as recommended by the independent data monitoring committee (DMC) following all three DMC reviews;
Mino-Lok Phase 3 trial completion anticipated by end of 2022; and,
Pre-clinical development ongoing for Citius' Mino-Wrap and induced mesenchymal stem cell programs.
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