Shots:
Cerevance has reported the P-III (ARISE) trial data assessing solengepras (75 or 150mg, QD, PO) vs PBO as an adjunct to levodopa & other PD medications in 341 PD pts (≥30yrs.) with motor fluctuations & ≥3hrs. of daily OFF time (91% pts completed the trial)
Solengepras (150mg) met the 1EP, reducing average daily OFF time…
Shots:
Kairos Pharma announced positive interim efficacy data from its ongoing P-II study evaluating ENV-105 (carotuximab) in combination with apalutamide in pts. with metastatic castration-resistant prostate cancer (mCRPC)
The combination demonstrated a statistically significant improvement in progression-free survival, with median PFS of 17.7 mons. vs 2 mons. with apalutamide alone (P=0.0008)
Following the interim results,…
Shots:
AbbVie and Genmab announced positive topline results from the P-III (EPCORE DLBCL-2) study, demonstrating a statistically significant and clinically meaningful improvement in PFS vs R-CHOP alone (SoC) in newly diagnosed diffuse large B-cell lymphoma (DLBCL) pts. with an IPI score of 2-5
The study evaluated fixed treatment duration epcoritamab(SC) plus rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and…
Shots:
J&J has reported the 2yr. P-III (ICONIC-TOTAL) trial data assessing Icotyde vs PBO for the treatment of PsO in pts with at least moderate severity affecting special areas (e.g., scalp, genital, &/or hands and feet)
Icotyde maintained durable skin clearance, with IGA 0/1 rates increasing from 57% at Wk. 16 to 67% at Wk.…
Shots:
P-III trial of survodutide (3.6 or 6mg, QW) in 755 pts, met both co-1EP using treatment-regimen & efficacy estimands. At Wk. 76, weight loss reached up to an average of 13.1% vs 3.1% with PBO, while up to 79.3% vs 32.7% pts achieved ≥5% weight loss (efficacy estimand)
In 2EPs, trial showed reduced HbA1c…
Shots:
Merck has presented the P-IIb (MK-7240-012) study data assessing tulisokibart vs PBO in pts with moderate to severe hidradenitis suppurativa at EADV’26
Trial met its 1EP, with HiSCR50 at Wk. 16 achieved by 72% pts on high-dose tulisokibart (480mg, Q2W) & 64% on medium-dose (480mg, Q4W), representing a 37% & 29% improvement over PBO…
Shots:
Vanda Pharmaceuticals has reported the P-III (VP-VEC-162-3502) trial data assessing Hetlioz (tasimelteon; 20mg, PO, QD; n=20) vs PBO (n=20) in 43 adults with Delayed Sleep-Wake Phase Disorder (DSWPD)
Trial met its 1EP, showing Hetlioz (20mg) shifted the time of sleep onset 42.5 min. earlier vs 5.4 min. shift on PBO, plus in an exploratory…
Shots:
Takeda has presented the P-III (LATITUDE) studies data assessing zasocitinib (TAK-279) in adults with mod. to sev. plaque psoriasis (PsO) at EADV’26
In P-III (LATITUDE Atlas) study, zasocitinib was superior to deucravacitinib across 1 & all key 2EPs, with complete skin clearance emerging as early as Wk. 8 & 36.5% vs 13.9% pts achieving…
Shots:
TRIUMPH-2 assessed retatrutide (4, 9, or 12mg, QW) vs PBO in 1152 pts with T2D & obesity/overweight, with trial using a stepwise dose-escalation approach at Q4W. Lilly plans to file BLA in Q1’27
At 80wks., avg. body weight reductions were 12.7% (4mg), 19.1% (9mg), & 20.8% (12mg) vs 4%, plus A1C reduced by 1.4%,…
Shots:
Kodiak has reported the P-III (DAYBREAK) trial data assessing Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) in parallel vs aflibercept in pts with wet age-related macular degeneration (wAMD)
Zenkuda met its 1EP, showing meaningful vision gains & rapid, sustained retinal drying, with 54% of pts achieving 6mos. durability at Yr. 1. tabirafusp-ted also met its vision…

