Ipsen Biopharmaceuticals, Inc.

NEWS
The deal focuses on ICT01, a monoclonal antibody being tested in acute myeloid leukemia. ImCheck is also developing assets in infectious disease and other oncology indications.
In its second antibody-drug conjugate licensing agreement this year, Ipsen has secured exclusive rights to Foreseen Biotechnology’s FS001, which targets a novel antigen expressed across a range of solid tumors.
In 2023, the ADC market exceeded $10 billion, and this momentum is persisting into 2024, as evidenced by several strategic deals and a robust pipeline of candidate drugs.
FDA
In the next two weeks, the FDA is scheduled to decide on four drug applications and hold two highly anticipated advisory committee meetings.
Ipsen is looking to deepen its expertise in movement disorders in a research collaboration with Skyhawk Therapeutics to develop small molecule drugs for RNA targets in neurological diseases.
Under the agreement, Ipsen nabs exclusive global rights for development and commercialization of Sutro Biopharma’s STRO-003, an antibody-drug conjugate which is completing the final stages of preclinical development.
FDA
Approved in combination with three chemotherapies, Onivyde is the first new frontline treatment option in more than 10 years for adults living with metastatic pancreatic adenocarcinoma.
In a late-stage trial, treatment with Ipsen and Genfit’s elafibranor led to high rates of biochemical response and the normalization of alkaline phosphatase levels compared with placebo.
FDA
Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
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