Inex Marqibo Phase III Preparation Includes Company Restructuring
This article was originally published in The Pink Sheet Daily
Executive Summary
The company will reduce its workforce from 165 to 62 employees, including executive-level resignations. Inex plans a Phase III comparative trial of the liposomal vincristine product in first- or second-line non-Hodgkin’s lymphoma or acute lymphoblastic leukemia following a negative advisory committee review for third-line NHL.
You may also be interested in...
Inex Restructures: COO Is Timothy Ruane, Senior Execs Depart
Inex is shedding 60% of its workforce in a cost-cutting move aimed at reducing cash burn to under $1 mil. a month. CEO David Main and senior execs depart under reorganization, the second since an advisory committee’s unfavorable recommendation for Inex’ oncologic Marqibo.
Inex Restructures: COO Is Timothy Ruane, Senior Execs Depart
Inex is shedding 60% of its workforce in a cost-cutting move aimed at reducing cash burn to under $1 mil. a month. CEO David Main and senior execs depart under reorganization, the second since an advisory committee’s unfavorable recommendation for Inex’ oncologic Marqibo.
Inex/Enzon's Marqibo Accelerated Approval Application "Not Approvable"
FDA recommends additional randomized studies comparing Marqibo to other chemotherapy agents; the agency also cites CMC deficiencies. The "not approvable" letter follows a negative committee review for the non-Hodgkin's lymphoma therapy.