Inhibitor – Talk Bio

Ascletis’ Sagimet-Sourced Oral FASN Inhibitor Achieves All Endpoints in Pivotal Acne Study

3 days ago talkbio0Tagged Acne Vulgaris, Ascletis, Biosciences, Chinese study, clinical endpoints, Clinical Trials, Denifanstat, Inhibitor, Lesion, oral FASN, Phase 3, Sagimet

Ascletis; Sagimet Biosciences; denifanstat; oral FASN inhibitor; phase 3 clinical trial; acne vulgaris; clinical endpoints; lesion reduction; Chinese study

J&J’s Akeega Advances PARP Inhibition in Prostate Cancer, but FDA Pathway in Broader Patient Subsets Remains Unclear

4 days ago talkbio0Tagged Akeega, Amplitude, Approved, BRCA, HRR gene, Inhibitor, J&J, Malignant neoplasm of prostate, mCSPC, Metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, Mutation, PARP1 gene, United States Food and Drug Administration

Akeega; J&J; prostate cancer; PARP inhibitor; FDA approval; BRCA mutations; HRR gene alterations; AMPLITUDE study; metastatic castration-sensitive prostate cancer (mCSPC); metastatic castration-resistant prostate cancer (mCRPC)

Boundless Bio Lays Off 33% of Staff Following Stumble of Lead Program

2 weeks ago talkbio0Tagged BBI-355, BBI-825, Bio, Boundless, CHEK1 protein, human, Clinical Trials, Combined Modality Therapy, Inhibitor, layoffs, pipeline restructuring, ribonucleoside-diphosphate reductase activity, Solid Neoplasm

Boundless Bio; layoffs; biotech; clinical trial; BBI-355; BBI-825; RNR inhibitor; CHK1 inhibitor; combination therapy; solid tumors; pipeline restructuring

FDA Advisory Committee Unanimously Votes Against Expanding Pfizer’s Prostate Cancer Drug Combo

2 weeks ago talkbio0Tagged Advisory Committees, enzalutamide, expansion, Inhibitor, Labels (device), Malignant neoplasm of prostate, mCRPC, PARP1 gene, Pfizer, talazoparib, Talzenna, unanimous vote, United States Food and Drug Administration

FDA; advisory committee; Pfizer; Talzenna; talazoparib; enzalutamide; prostate cancer; mCRPC; PARP inhibitor; label expansion; unanimous vote

Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection

3 weeks ago talkbio0Tagged Approved, Clinical Trials, Combination Drug Therapy, first-line therapy, Immunotherapy, Incyte, Inhibitor, Malignant neoplasm of anus, PDCD1 gene, POD1UM-303, Retifanlimab, United States Food and Drug Administration, Zynyz

Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy

AstraZenecas Truqap Posts Another Pivotal Disappointment as Phase III Prostate Cancer Study Fails

1 month ago talkbio0Tagged ADT, androgen-deprivation therapy, AstraZeneca, CAPItello-280, capivasertib, Clinical Trials, Discontinuation (procedure), docetaxel, Failure (biologic function), Inhibitor, Metastatic castration-resistant prostate cancer, oncology setback, Phase 3 Clinical Trials, Progression-Free Survival, Proto-Oncogene Proteins c-akt, Radiographic, Survival, Truqap

Truqap, capivasertib, AstraZeneca, Phase III trial failure, CAPItello-280, metastatic castration-resistant prostate cancer (mCRPC), AKT inhibitor, docetaxel, androgen-deprivation therapy (ADT), oncology setback, clinical trial discontinuation, radiographic progression-free survival, overall survival

AbbVie’s Rinvoq cleared for giant cell arteritis in US

1 month ago talkbio0Tagged Approved, Giant Cell Arteritis, Inhibitor, Janus kinase, Rinvoq, Steroids, United States Food and Drug Administration, upadacitinib

Giant Cell Arteritis, Rinvoq, upadacitinib, Approved, Janus kinase, Inhibitor, United States Food and Drug Administration, Steroids

Pfizer’s Sasanlimab Shows 32% Reduction in Bladder Cancer Risk But Misses Secondary Endpoints in Phase 3 CREST Trial

1 month ago talkbio0Tagged BCG Vaccine, Event-Free Survival, Inhibitor, Invasive, Malignant neoplasm of urinary bladder, Non-Muscle, Non-Muscle Invasive Bladder Neoplasms, Overall Survival, PDCD1 gene, Phase 3 CREST trial, Sasanlimab, subcutaneous administration

Sasanlimab (PD-1 inhibitor), Bladder cancer risk reduction, Phase 3 CREST trial, BCG combination therapy, Non-muscle invasive bladder cancer (NMIBC), Event-free survival (EFS), Overall survival (OS) endpoint missed, Subcutaneous administration