Ligand Pharma Inc Roche Contingent Value Rights (LGNDZ)

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4:08PM Ligand Pharma initiates pivotal trial of captisol-enabled, Propylene Glycol-Free Melphalan in patients with Multiple Myeloma (LGND) 18.95 +0.57 : Co announced that it has initiated a pivotal trial of Captisol-enabled, propylene glycol-free (PG-free) high-dose melphalan as a conditioning treatment prior to autologous transplant for patients with multiple myeloma. This multi-center trial will evaluate safety and efficacy in 60 patients, and is intended to confirm the results from an earlier Phase 2 study demonstrating that the PG-free melphalan intravenous formulation was safe and well-tolerated, and met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan (Sold by GSK as Alkeran for injection). Given the robust dataset compiled to date along with the pivotal study design, Ligand believes that should this pivotal trial produce positive results, the Company will be in a position to submit a 505(b)(2) New Drug Application to the U.S. Food and Drug Administration.