Inhibitor
Regeneron Leads $66M Series B for Actio Biosciences’ Rare Disease Therapeutics
Regeneron; Actio Biosciences; rare diseases; Series B financing; KCNT1 inhibitor; TRPV4 inhibitor; ABS-1230; ABS-0871; Charcot-Marie-Tooth disease; epilepsy; orphan drug; clinical trials
Scholar Rock’s SMA drug helps Zepbound patients retain muscle in phase 2 trial
Scholar Rock; apitegromab; SMA drug; Zepbound; tirzepatide; muscle preservation; obesity; weight loss; phase 2 trial; lean mass; myostatin inhibitor
FDA Approves CSL’s Andembry, Directly Competing With Takeda’s Takhzyro in HAE
Andembry; garadacimab-gxii; FDA approval; hereditary angioedema; HAE; CSL; Takhzyro; Takeda; factor XIIa inhibitor; once-monthly dosing; subcutaneous injection
Ascletis’ Sagimet-Sourced Oral FASN Inhibitor Achieves All Endpoints in Pivotal Acne Study
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
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
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
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
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
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
Giant Cell Arteritis, Rinvoq, upadacitinib, Approved, Janus kinase, Inhibitor, United States Food and Drug Administration, Steroids