PTX-100 receives US FDA Fast Track Designation for the treatment of adults with R/R mycosis fungoides, the most common subtype of CTCL
Prescient Therapeutics CEO, James McDonnell commented: “Getting Fast-Track designation is a critical milestone towards our goal of advancing PTX-100 into a registration-enabling trial designed to support potential accelerated approval and, from there, commercialisation. As we progress our Phase 2 trials, we will be engaging closely with the FDA to ensure alignment on endpoints and study scope.”
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Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.
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Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that the first patient has been dosed in a Phase III clinical trial evaluating its novel Nectin-4-targeting ADC (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).