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FDA

Xcovery SHP2 Inhibitor IND Approved by US FDA

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.

May 23, 2022

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2 min read

U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

Xcovery Holdings, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

March 13, 2024

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2 min read

Business

Xcovery Acquires Majority Controlling Stake in Meryx Pharmaceuticals

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.

December 7, 2021

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2 min read

Business

Xcovery Announces the Appointment of Giovanni Selvaggi as Chief Executive Officer

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

March 18, 2021

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2 min read

Press Releases

FDA Approval of Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

December 18, 2024

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2 min read

Ensartinib Secured Its First Approval for 1st Line Treatment in ALK+ NSCLC

Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, today announced that Xcovery’s affiliate Betta Pharmaceuticals has received the National Medical Products Administration (NMPA)’s approval of ensartinib in China for the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC).

March 22, 2022

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1 min read

Business

Xcovery Announces the Appointment of Li Mao as Chief Executive Officer and Giovanni Selvaggi as Chief Medical Officer

Xcovery Holdings, Inc. announced the appointment of Li Mao, M.D., as Chief Executive Officer and Giovanni Selvaggi, M.D., as Chief Medical Officer.

March 28, 2019

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4 min read

Press Releases

FDA Roundup: December 20, 2024

December 23, 2024

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7 min read

Drug Development

Xcovery Announces Initiation of Phase II Clinical Trial for Ensartinib in Melanoma Patients with ALK Alternations

The trial is being conducted by the renowned Memorial Sloan Kettering Cancer Center (MSK) and led by MSK’s Dr. Alexander Shoushtari.

February 7, 2018

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3 min read

Drug Development

Xcovery Announces Updated Clinical Data On X-396 In Patients With ALK+ Non-Small Cell Lung Cancer At The 4th Xcovery-IASLC International Joint Conference

January 11, 2016

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3 min read