FDA Has Accepted the New Drug Application (NDA) for Ensartinib
PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)-- Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational New Drug application (IND) of BPI-442096 , a small molecule Src homology region 2 domain-containing phosphatase 2 (SHP2) inhibitor, in solid tumors. Xcovery will initiate a phase I clinical trial in the United States to assess the tolerability, safety, and efficacy of BPI-442096 .
PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, is proud to announce the acquisition of a majority and controlling stake in Meryx Inc., a clinical stage immuno-oncology company based in Chapel Hill, North Carolina developing TKIs in a range of hematologic and solid malignancies, including lung cancer. The partnership and synergies between Xcovery and Meryx will accelerate and enhance both Xcovery’s and Meryx's missions to develop small molecule oncology drugs for patients all over the world. A new leadership and board of directors reflecting the new ownership will be established in the coming weeks.
PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, today announced that Giovanni Selvaggi, M.D., has been appointed as the Chief Executive Officer (CEO), replacing Li Mao, M.D., who is leaving for personal reasons. Dr. Selvaggi will also continue as Xcovery’s Chief Medical Officer (CMO).