Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

Shots: Ipsen has reported P-II (ELMWOOD) trial data assessing elafibranor (80 or 120mg) vs PBO in 68 PSC pts for 12wks.; 96wks. OLE study evaluating elafibranor (120mg) is ongoing Trial demonstrated favorable safety & tolerability (1EP) at Wk. 12, with elafibranor 80 or 120mg vs PBO showing TRAEs 68.2%, 78.3% vs 69.6% pts, respectively Elafibranor…

ByRidhi RastogiApril 24, 2025

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BMS Reports Topline P-III (ARISE) Trial Data of Cobenfy as an Adjunctive Therapy for Schizophrenia

Shots: The P-III (ARISE) trial assessed Cobenfy (xanomeline & trospium chloride) vs PBO as an adj. therapy to atypical antipsychotics in adults with inadequately controlled schizophrenia symptoms; eligible pts could enter a 52wk. OLE study At Wk. 6, trial showed a PANSS score change (1EP) of -14.3 vs -12.2, which was not statistically significant, &…

ByRidhi RastogiApril 23, 2025

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Gilead Reports Topline P-III (ASCENT-04/KEYNOTE-D19) Trial Data of Trodelvy Regimen for Previously Untreated Triple-Negative Breast Cancer (TNBC)

Shots: The P-III (ASCENT-04/KEYNOTE-D19) trial assessed Trodelvy (10mg/kg, IV, Day 1 & 8 of 21-day cycle) + Keytruda (200mg, IV, Day 1 of 21-day cycle) vs Keytruda + CT in pts (n=443) with inoperable, locally advanced or metastatic TNBC expressing PD-L1 (CPS ≥ 10) Trial showed improved PFS (1EP); OS (2EP) was immature but showed…

ByRidhi RastogiApril 22, 2025

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Daiichi Sankyo & AstraZeneca Report Topline P-III (DESTINY-Breast09) Trial Data of Enhertu for HER2+ Metastatic Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca have reported topline P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± pertuzumab vs taxane, trastuzumab & pertuzumab (THP) as a 1L treatment of HER2+ metastatic breast cancer pts (n=1157) Enhertu + pertuzumab showed improved PFS (1EP), with PFS benefit observed across all pre-specified subgroups during interim analysis; OS (2EP) remain immature…

ByRidhi RastogiApril 21, 2025

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Endevica Bio Reports the First Patient Dosing in P-II Study Evaluating TCMCB07 (B07)

Shots: Endevica Bio conducting P-II study in collaboration with WuXi Clinical reported the dose administration of B07 in first patient to prevent weight loss in cancer patients diagnosed with stage 4 metastatic colorectal cancer undergoing CT In 2024, Endevica Bio completed its P-I study, with early results showing strong safety and efficacy. In current P-II…

ByPrince GiriApril 18, 2025

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Eli Lilly Reported the Data from P-III (ACHIEVE-1) Trial Evaluating an Oral GLP-1, Orforglipron

Shots: The P-III (ACHIEVE-1) trial assessed orforglipron vs PBO in T2D adults (n=559) having inadequate glycemic control with diet & exercise alone; subjects started at 1mg QD, with dose escalation at every Q4W till assigned doses of 3, 12mg (via 1, 3 & 6mg), or 36mg (via 1, 3, 6, 12, & 24mg) Trial met…

ByPrince GiriApril 18, 2025

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BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Shots: BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer 37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data Trial showed 25/37…

ByRidhi RastogiApril 17, 2025

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Telix Pharmaceuticals Reports Preliminary P-II (IPAX-Linz) Trial Data of TLX101 to Treat Glioma

Shots: The IIT P-II (IPAX-Linz) trial assessed TLX101 (IV) in 8 glioblastoma pts with recurrent tumors & PET-confirmed amino acid uptake, who received adaptive dosing with ~4GBq before & ~2GBq after, 2L EBRT; 5/8 had MGMT-unmethylated tumors Trial showed mOS of 12.4mos. or 32.2mos. from initial diagnosis, complementing P-I (IPAX-1) trial results of 13mos. & 23mos.,…

ByRidhi RastogiApril 17, 2025

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Pfizer to Discontinue Danuglipron’s Development Program for Chronic Weight Management

Shots: Pfizer has discontinued the development of danuglipron (PF-06882961) as a potential therapy for chronic weight management Danuglipron was evaluated in 2 P-I trials (NCT06567327 & NCT06568731), meeting key PK objectives & confirming formulation & dose with potential for strong efficacy & tolerability in P-III. However, a case of drug-induced liver injury & recent regulatory input led…

ByRidhi RastogiApril 14, 2025

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Johnson & Johnson Reveals P-III (ICONIC-LEAD) Trial Data of Icotrokinra for Plaque Psoriasis

Shots: J&J has reported subgroup analysis from P-III (ICONIC-LEAD) trial assessing icotrokinra (QD, PO; n=456) vs PBO (n=228) in 684 adolescents & adults with mod. to sev. plaque PsO At Wk. 16, 84.1% adolescent achieved IGA 0/1 vs 27.3%, & 70.5% vs 13.6% reached PASI 90. By Wk. 24, 86.4% achieved IGA 0/1, 88.6% reached PASI…

ByRidhi RastogiApril 11, 2025

Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

BMS Reports Topline P-III (ARISE) Trial Data of Cobenfy as an Adjunctive Therapy for Schizophrenia

Gilead Reports Topline P-III (ASCENT-04/KEYNOTE-D19) Trial Data of Trodelvy Regimen for Previously Untreated Triple-Negative Breast Cancer (TNBC)

Daiichi Sankyo & AstraZeneca Report Topline P-III (DESTINY-Breast09) Trial Data of Enhertu for HER2+ Metastatic Breast Cancer

Endevica Bio Reports the First Patient Dosing in P-II Study Evaluating TCMCB07 (B07)

Eli Lilly Reported the Data from P-III (ACHIEVE-1) Trial Evaluating an Oral GLP-1, Orforglipron

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Telix Pharmaceuticals Reports Preliminary P-II (IPAX-Linz) Trial Data of TLX101 to Treat Glioma

Pfizer to Discontinue Danuglipron’s Development Program for Chronic Weight Management

Johnson & Johnson Reveals P-III (ICONIC-LEAD) Trial Data of Icotrokinra for Plaque Psoriasis

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