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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…
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Galderma has reported OLYMPIA LTE study data assessing Nemluvio in 508 pts with prurigo nodularis up to 4yrs., from the P-II trial & the P-III (OLYMPIA 1 & 2) trials
At Wk. 148, >70% of pts had clear or almost clear lesions per IGA score, >85% achieved ≥75% of healed lesions by prurigo activity…
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Bayer has reported the P-III (PEACE-3) trial assessing Xofigo (radium-223 dichloride; 55kBq/kg, IV, QM for 6 cycles) + enzalutamide (160mg, PO, QD) vs enzalutamide in asymptomatic or mildly symptomatic pts (Brief Pain Inventory score <4) with mCRPC & ≥2 bone metastases
Trial showed improved OS (2EP), with a 24% reduction in death risk &…
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ViiV Healthcare has reported 12mos. interim data from P-IIb (EMBRACE) trial assessing lotivibart (IV or SC, Q4M) + cabotegravir (CAB LA; IM, QM) vs SoC for the treatment of HIV
lotivibart + cabotegravir maintained viral suppression in 94% of lotivibart IV & 82% of SC recipients vs 88%, with confirmed virologic failure in 4%…

