Latest From Alaric DeArment
Gilead’s big push into oncology bore more fruit with the FDA approval of Trodelvy based on the TROPiCS-02 trial. More development catalysts lie ahead for 2023, company said in its earnings.
Yescarta surged ahead of competitors Kymriah and Breyanzi, helping Gilead’s oncology sales exceed $2bn, while the company reported the strongest sales in its HIV-dominated core business since 2015.
The company said the first three cohorts of its Phase II atopic dermatitis study failed, while another trial with a faster-release formulation of EDP1815 continues, along with a Phase III study in psoriasis.
The Loxo@Lilly drug got FDA accelerated approval in mantle cell lymphoma as the first non-covalent BTK inhibitor, enabling its use in post-BTKi disease.
The companies unblinded data from CARTITUDE-4, which met its primary endpoint, but analysts citing KOLs said they continue to face issues with limited manufacturing slots and out-of-spec product.
The diabetic retinopathy candidate failed on its Phase II primary endpoint, but showed efficacy on a key secondary endpoint that the company hopes to use as the Phase III primary outcome measure.