Oncopeptides (Buy, TP: SEK290.00) - FDA issue safety alert for Pepaxto
The FDA issued a safety alert relating to the clinical trial OCEAN and the partial clinical hold announced by the company earlier in July. Overall, the market already knew about the partial clinical hold and thus we regard this as old news. Our impression is that the company is working with the FDA to settle the question marks regarding the shorter mOS for Pepaxto compared to pomalidomide in certain subgroups. Our take is that the clinical hold issue should be resolved during the coming months and will most likely result in some changes to inclusion criteria in the ongoing trials.Oncopeptides AB is a Sweden-based clinical development pharmaceutical company, which is primarily engaged in the healthcare industry. The Company focuses on research and development of cancer treatment solutions. The Company's product Ygalo is a peptidase potentiated alkylator, a type of cytotoxic drug that is targeted for use in the treatment of multiple myeloma. Ygalo is an alkylating agent that leverages the overrepresentation of peptidase enzymes in cancer cells to rise the concentration of active cancer fighting molecules in myeloma cells. Ygalo is intended for the treatment of patients with late-stage relapsed and refractory multiple myeloma. Ygalo is administered intravenously and is transported into cells where it is cleaved by peptidase enzymes, which impair transport of its active cancer-fighting agents out of the cell at the same time as driving more Ygalo into the cell.
DNB Markets is the investment banking arm of DNB Bank ASA and is focused primarily on the Nordic region, as well as internationally on niches such as global shipping, energy and related services, and seafood. DNB Markets offers services in FICC, Equities and Investment Banking advisory from offices in Oslo, Stockholm, London, Singapore and New York. Equity research coverage is offered on c250 Nordic companies. DNB was ranked no.2 in Extel Nordic Research 2017. The DNB Markets’ Credit and FICC Macro & FX Research teams are repeatedly highly rated by Prospera Nordic Institutional Investor Surveys.
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