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J&J
NEWS

J&J Presents P-III (AMPLITUDE) Trial Data of Akeega for Metastatic Castration-Sensitive Prostate Cancer (mCSPC) at ASCO 2025

Shots: The P-III (AMPLITUDE) trial assessed Akeega (niraparib & abiraterone acetate tablet) + prednisone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mCSPC, meeting its 1EP of improved rPFS In BRCA-altered pts (n=191), trial showed a 48% & 56% reduction in rPFS & symptomatic progression risk, respectively,…
June 4, 2025

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Bayer
NEWS

Bayer Presents P-III (OASIS 4) Study Data of Elinzanetant for Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies at ASCO 2025

Shots: The P-III (OASIS-4) study evaluated elinzanetant (120mg, PO, QD) vs PBO for 52wks. to treat mod. to sev. VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer, with an optional 2yr. extension; regulatory filings are ongoing in the US, EU & other regions Trial showed reduced VMS frequency (1EP), with…
June 3, 2025

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Novartis
NEWS

Novartis Reveals Interim P-III (PSMAddition) Trial Data of Pluvicto for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Novartis has reported interim P-III (PSMAddition) trial data assessing Pluvicto + SoC (ARPI + ADT) vs SoC in PSMA+ mHSPC adults, with pts switching to Pluvicto upon confirmation of radiographic progression & per physician's discretion Trial met its 1EP of improved rPFS, with favorable OS trend (2EP) observed; data to be shared in future…
June 2, 2025

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Regeneron & Sanofi
NEWS

Regeneron and Sanofi Report P-III (AERIFY-1 & AERIFY-2) Trials Data of Itepekimab for Chronic Obstructive Pulmonary Disease (COPD)

Shots: P-III (AERIFY-1 & AERIFY-2) trials assessed itepekimab (SC, Q2W or Q4W) vs PBO as an add-on therapy in pts (40-85yrs.) with mod. to sev. COPD, who haven’t smoked for ≥6mos.; data to be discussed with regulatory bodies  AERIFY-1 (n=1127) met its 1EP of reduced exacerbations, with Q2W (n=375) showing a 27% reduction at Wk.…
May 30, 2025

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GSK & Spero Therapeutics
NEWS

GSK & Spero Therapeutics Reports Early Conclusion of P-III (PIVOT-PO) Trial of Tebipenem HBr for Complicated Urinary Tract Infections (cUTIs) 

Shots: GSK & Spero Therapeutics have reported early conclusion of P-III (PIVOT-PO) trial for efficacy of tebipenem HBr to treat cUTIs, incl. pyelonephritis following IDMC recommendation based on positive interim analysis; US FDA’s filing is expected in H2’25 The P-III (PIVOT-PO) trial assessed tebipenem pivoxil HBr (600mg, PO, every 6hrs.) vs imipenem-cilastin (500mg, IV, every…
May 29, 2025

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Rezolute
NEWS

Rezolute Reports Enrollment Completion in P-III (sunRIZE) Trial of Ersodetug for Congenital Hyperinsulinism

Shots: Rezolute has completed pts enrollment in P-III (sunRIZE/RZ358-301) trial of ersodetug as an add-on treatment of hypoglycemia in congenital hyperinsulinism pts, with 62 pts enrolled, exceeding the target of 56; the US FDA’s BLA filing is expected in 2026 Trial assessed ersodetug (5 or 10mg/kg, Q2W during initial loading then Q4W for 6mos.) + SoC vs…
May 29, 2025

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