Make a note! Several possible catalysts coming!
$FibroGen(FGEN.US$ Upcoming Milestones:
Pamrevlumab
•Topline data from the PanCAN Precision PromiseSM Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in mid-2024, reflecting PanCAN’s updated timing to complete database lock and subsequent analysis of the topline results by the independent Statistical Monitoring Committee.•Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 3Q 2024, due to the current trend in reported blinded overall survival events needed to complete the study.
Roxadustat
•Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca.
Oncology Pipeline
•Initial data from Phase 1 investigator-initiated combination study of FG-3246 with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) to be presented at ASCO 2024. •Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 2H 2024. •Anticipate filing of an IND for FG-3175 (anti-CCR8 mAb) in 2025.
Pamrevlumab
•Topline data from the PanCAN Precision PromiseSM Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in mid-2024, reflecting PanCAN’s updated timing to complete database lock and subsequent analysis of the topline results by the independent Statistical Monitoring Committee.•Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 3Q 2024, due to the current trend in reported blinded overall survival events needed to complete the study.
Roxadustat
•Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca.
Oncology Pipeline
•Initial data from Phase 1 investigator-initiated combination study of FG-3246 with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) to be presented at ASCO 2024. •Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 2H 2024. •Anticipate filing of an IND for FG-3175 (anti-CCR8 mAb) in 2025.
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