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Hutchmed

HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib + Sintilimab for Renal Cell Carcinoma (RCC)

Shots: HUTCHMED has reported the P-II/III (FRUSICA-2) trial data assessing fruquintinib + sintilimab vs axitinib/everolimus as 2L treatment in 234 pts with locally advanced or metastatic RCC  As of Feb 17, 2025 (mFU of 16.6mos.), regimen showed a mPFS of 22.2 vs 6.9mos., ORR of 60.5% vs 24.3%, & mDoR 23.7 vs 11.3mos., with benefits observed…

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Arcus Biosciences Reports the P-II (EDGE-Gastric) Trial Data on Domvanalimab + Yutuo (Zimberelimab) for Gastroesophageal Adenocarcinomas

Shots: Arcus has reported data from Arm A1 (n=41) of the P-II (EDGE-Gastric) trial assessing domvanalimab (1600mg, IV, Q4W) + Yutuo (480mg, IV, Q4W) & CT in pts with locally advanced unresectable or metastatic G/GEJ or esophageal adenocarcinoma As of Mar 3, 2025 (mFU of 26.4mos.), pts showed 24mos. OS rate of 50.2% (mOS: 26.7mos.)…

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PharmaShots Weekly Snapshots (Oct 06, 2025 – Oct 10, 2025)   

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below:      AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer  Read More: AstraZeneca and Daiichi Sankyo  AstraZeneca Reports P-III (Bax24) Trial Data on…

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ONO Pharma

Ono Pharmaceutical Reports the P-II (ONO-4578-08) Trial Findings of ONO-4578 in Gastric or Gastroesophageal Junction (G/GEJ) Cancer

Shots: Ono Pharmaceutical has reported the P-II (ONO-4578-08) trial findings of ONO-4578 (EP4 antagonist) regimen for previously untreated, HER2-negative unresectable advanced or recurrent G/GEJ cancer ONO-4578-08 assessed ONO-4578 (40mg, QD, PO) + Opdivo (360mg, Q3W) & CT (S-1 + Oxa or CapOx) vs PBO + Opdivo & CT in G/GEJ cancer pts across Japan, South Korea…

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Bavarian Nordic

Bavarian Nordic Announces Topline P-II Trial Data of MVA-BN Mpox/Smallpox Vaccine in Younger Population

Shots: Bavarian Nordic has reported topline P-II trial results evaluating two standard doses of the MVA-BN mpox/smallpox vaccine in 460 participants, incl. children (2–11 yrs) & adults (18–50 yrs) across 2 cohorts in the DRC & Uganda In the trial, 227 children among 451 evaluable subjects showed a non-inferior immune response to adults (n=224) 2wks.…

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Sanofi

Sanofi Reports P-II (ALPHAMEDIX-02) Trial Data of AlphaMedix for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

Shots: Sanofi has reported data from the ongoing P-II (ALPHAMEDIX-02) trial assessing AlphaMedix (67.6μCi/kg, Q8W, ~4 cycles) in pts, incl. PRRT-naïve (n=35) & exposed (n=26) pts with histologically confirmed unresectable or metastatic SSTR+ GEP-NETs & ≥1 site of measurable disease Trial met all 1EPs with improved ORR & prolonged benefit, plus showed improvement across 2EPs…

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Abbvie

AbbVie Reports Topline P-II (ELATE) Trial Data on Botox (OnabotulinumtoxinA) for Upper Limb Essential Tremor

Shots: AbbVie has reported topline P-II (ELATE) trial data assessing Botox (onabotulinumtoxinA) vs PBO in pts with upper limb essential tremor Trial met its 1EP with improved Tremor Disability Scale-Revised scores at 18wks. & showed a greater TREDS-R total unilateral score reduction (-2.61 vs -1.61), plus it also achieved all six 2EPs; data to be…

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Astrazeneca

AstraZeneca Reports P-III (Bax24) Trial Data on Baxdrostat for Treatment-Resistant Hypertension

Shots: AstraZeneca has reported P-III (Bax24) trial data assessing baxdrostat (2mg; QD) + SoC vs PBO + SoC in 218 pts with treatment-resistant hypertension for 12wks. Trial achieved its 1EP, showing reduced 24hr. ambulatory systolic blood pressure at 12wks., with consistent efficacy across the day, incl. early morning; data to be presented at AHA’25 &…

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