Shots:
Amgen has reported the global P-III (VESALIUS-CV) trial findings assessing Repatha vs PBO, both in addition to optimized lipid-lowering therapy in adults (n >12,000) at high CV risk without prior heart attack or stroke
At an mFU of 4.5yrs., the trial met its co-1EPs of time to first occurrence of composite of coronary heart…
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…
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…
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…
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,…
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…
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…
Shots:
The P-III (evERA Breast Cancer) trial evaluated giredestrant + everolimus vs SoC ET + everolimus in ER+, HER2-, LA/M breast cancer pts previously treated with CDK4/6 inhibitors & endocrine therapy (ET) in adj. or LA/M settings
Trial met its co-1EPs of improved PFS in both the ITT & ESR1-mutated populations, while OS showed a…
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…
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…

