Magrolimab Falls Off The Fast Track As Gilead Reveals New Clinical Holds
Biktarvy Settlement Totals $1.25bn Up Front, 3% US Bictegravir Royalty
The company said in its fourth quarter earnings report that it would not seek accelerated approval for the drug, while it also settled an HIV drug-related intellectual property lawsuit with GSK/ViiV.
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The clinical holds, initially announced in January, raised concerns about the company losing its edge in CD47-targeting drugs. Partial holds on the DLBCL and myeloma programs remain in place.
Kite beats BMS’s Breyanzi to the first CAR-T approval in second-line large B-cell lymphoma. The added indication could nearly double the number of potential US patients for Yescarta.
Gilead is staying mum about the TROPiCS-02 data, which is fueling speculation that the drug’s benefit may have been modest.