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Makers of organoids and cell models cheered the decision and said it will bolster the development of precision medicines, ...
The agency approved the treatment based on data from 57 patients with previously treated KRAS-mutant recurrent low-grade serous ovarian cancer.
The firm will test LP-184 as a monotherapy and in combination with a PARP inhibitor in patients who have DNA damage repair gene mutations.
The study will include two cohorts of breast cancer patients: triple-negative breast cancer and HR-positive, HER2-negative breast cancer.
The firm develops RNA-guided therapeutics that target the regulatory genome, composed of genes that regulate expression of other genes.
A "productive" meeting with the FDA has given the firm confidence in its regulatory filing and commercialization plans for ST-920.
Phase II trial results indicated that treatment with the firm's antisense oligonucleotide led to stable or improved best-corrected visual acuity.
Patients on Enhertu followed by a chemotherapy and dual anti-HER2 regimen fared better than those on standard therapy.
The team is exploring whether biomarker testing could also identify patients who benefit more from immune checkpoint inhibitors after radiation.
The firm said it is in discussions with the FDA to resubmit its biologics license application seeking approval for Ebvallo.
After establishing dosing and safety in Phase I, researchers will evaluate the drug's anti-tumor activity in patients with PSMA-expressing cancers.
DCx sees potential to build multifunctional ADCs using the same technology Repare used to create its small molecule synthetic lethal therapies.
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