Shots:
Aplagon has dosed the first patient with APAC (IV) in its P-IIa (HEALING) trial in Finland for peripheral arterial occlusive disease (PAOD), leading to chronic limb-threatening ischemia (CLTI)
Trial will evaluate APAC in ~42 CTLI pts across 4 cohorts to assess safety, efficacy, & effects on thrombo-inflammatory biomarkers. Additionally, an associated PET imaging study with…
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The P-II trial consists of 4 overlapping stages: Stage 1 (vs PBO) for tilrekimig & ompekimig; Stage 2 (dose-ranging) & Stage 3 (ongoing) evaluated tilrekimig, with Stage 3 involving biologic-experienced adults; Stage 4 is an ongoing ompekimig dose-ranging study
Trial met its 1EP with more pts achieving EASI-75 at Wk. 16; PBO-adjusted rates were…
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BMS has reported the P-II/III (SUCCESSOR-2) trial data assessing mezigdomide (PO) + carfilzomib & dexamethasone vs carfilzomib & dexamethasone alone in pts with r/r multiple myeloma
The P-III portion showed improved PFS (1EP), with safety consistent with the known profile of the regimen & mezigdomide. The trial will continue to follow pts for survival…
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Insilico Medicine & TaiGen have reported complete enrolment of the trial & dosing of the first patient with ISM4808 in the P-I trial to treat CKD-related anemia
The P-I study consists of both single-ascending-dose & multiple-ascending-dose cohorts, designed to evaluate ISM4808 in healthy adults against PBO
In Dec 2025, TaiGen gained exclusive rights to…
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The P-II trial assessed 5 doses of petrelintide (SC, QW) vs PBO for 42wks. in 493 overweight or obese pts (mean BMI of 37 kg/m²) with weight-related comorbidities
Trial met its 1EP, with Q4W dose-escalated injections delivering significant weight loss across 5 arms after 28wks. & sustaining ~10.7% vs 1.7% mean reduction through Wk.…
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The P-II (COMPASSION-03/AK104-201) trial assessed cadonilimab in pts with recurrent or metastatic CC who have failed prior Pt-based CT, showing mOS of 17.5mos. in pts regardless of PD-L1 expression, with18 & 24mos. OS rates of 47.8% & 40.9%, respectively
Updated data with 26.5mos. mFU showed that among 99 efficacy-evaluable pts achieving CR, mOS & PFS…
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Lynk has reported topline P-III trial data assessing zemprocitinib (12 or 24mg) vs PBO in 356 pts with mod. to sev. atopic dermatitis
At Wk. 16, zemprocitinib (12 & 24mg) met both co-1EPs, showing superiority vs PBO in EASI-75 (+38.1% & +46.4%) & vIGA-AD 0/1 (+30.3% & +31%), & significantly improved WI-NRS4 itch response…
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Merck & Eisai has reported the P-III (LITESPARK-011) trial data assessing Welireg (belzutifan; 120mg, PO, QD) + Lenvima (lenvatinib; 20mg, PO, QD) vs cabozantinib in 747 pts with advanced RCC whose disease progressed on or after anti-PD-1/ PD-L1 therapy
At mFU of 29mos., trial met its 1EP of improved PFS by 30% (mPFS: 14.8 vs…
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Roche has reported P-III (FENhance 1) trial results in RMS pts, randomized to either fenebrutinib (PO, BID) with PBO-matched to teriflunomide or teriflunomide (PO, QD) with PBO matched to fenebrutinib
Trial met its 1EP, reducing ARR by 51% over ≥96wks., consistent with the P-III (FENhance 2) study showing 59% reduction, while 2EPs showed significant…
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The P-III (KEYNOTE-B15/EV-304) trial assessed Keytruda + Padcev (IV), followed by surgery & then Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC pts
Trial showed 47% reduction in the risk of tumor recurrence, progression, or death, with an estimated 79.4% pts event-free at 2yrs. vs 66.2% with SoC, plus the combination…

