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Merck Presents P-III (HYPERION) Trial Data of Winrevair (sotatercept-csrk) for Pulmonary Arterial Hypertension at ERS 2025

Shots: The P-III (HYPERION) trial assessed Winrevair vs PBO, both with background therapy in recently diagnosed adults (n=320) with PAH (WHO Group 1) FC II or III at intermediate or high risk of disease progression Trial showed 76% reduction in clinical worsening, where 10.6% vs 36.9% pts experienced ≥1 event, with treatment benefit seen in…

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Astrazeneca and Daiichi-Sankyo New

Daiichi Sankyo and AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer

Shots: The global P-III (DESTINY-Breast05) trial data assessed Enhertu (trastuzumab DXd; 5.4mg/kg) vs trastuzumab emtansine in 1,635 HER2+ primary breast cancer pts with residual invasive disease in breast or axillary lymph nodes after neoadj. therapy & a high risk of recurrence Trial showed improved invasive disease-free survival (1EP), while OS (2EP) was immature during interim…

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PharmaShots Weekly Snapshots (Sep 22, 2025 – Sep 26, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A and Biosimilars. Check out our full report below:   Roche Reports P-III (evERA Breast Cancer) Trial Data on Giredestrant + Everolimus for ER-Positive Breast Cancer Read More: Roche BMS Reports the P-III (EXCALIBER-RRMM) Trial Data of Iberdomide Regimen to Treat…

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Acadia Pharmaceuticals Reports Topline P-III (COMPASS PWS) Trial Data of Carbetocin for Hyperphagia in Prader-Willi Syndrome

Shots: Acadia Pharmaceuticals has reported topline P-III (COMPASS PWS) trial data of carbetocin (ACP-101; intranasal) in pts with hyperphagia in Prader-Willi syndrome The global trial evaluated carbetocin (3.2mg, TID) vs PBO for 12wks. in 175 pts (5 to 30yrs) with Prader-Willi syndrome & failed to meet its 1EP of change in HQ-CT alongside any 2EP Additionally,…

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ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests

Shots: ClearNote Health has received the UKCA certification for its Avantect Multi-Cancer & Ovarian Cancer tests to detect multiple cancers & support early diagnosis of ovarian cancer, respectively The Multi-Cancer Detection Test screens multiple cancers from a simple blood sample using 5-hydroxymethylcytosine & genomic biomarkers in cell-free DNA, & was selected for the NCI-funded Vanguard…

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BMS

BMS Reports the P-III (EXCALIBER-RRMM) Trial Data of Iberdomide Regimen to Treat R/R Multiple Myeloma

Shots: BMS has reported the P-III (EXCALIBER-RRMM) trial data assessing iberdomide + daratumumab + dexamethasone (IberDd) vs daratumumab + bortezomib + dexamethasone (DVd) in pts with r/r multiple myeloma The trial has 2 stages: Stage 1 randomized ~200 pts to iberdomide (1, 1.3, or 1.6mg) plus daratumumab & dexamethasone, identifying 1mg as the selected dose; Stage…

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PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)   

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)    This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:    MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC  Read More: MAIA Biotechnology  Akeso Reports First…

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Intellia Therapeutics

Intellia Therapeutics Completes Enrollment in the P-III (HAELO) Study of Lonvoguran Ziclumeran (lonvo-z) in Hereditary Angioedema (HAE) Patients

Shots: Intellia Therapeutics completed enrollment in the global P-III (HAELO) study evaluating lonvo-z for treating HAE, finishing within 9mos. since the first patient was dosed in Jan 2025, with nearly half of the participants enrolled from the US The study P-III (HAELO) study will evaluate the efficacy and safety of lonvo-z in ≥60 adults and…

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