Shots:
Trial enrolled 695 MIBC pts undergoing radical cystectomy who were ineligible for or declined cisplatin & randomized them to Arm 1 [neoadj. 3 Imfinzi + EV cycles with Imjudo (2 cycles), then adj. Imfinzi (9 cycles) + 1 Imjudo cycle], Arm 2 [neoadj. Imfinzi + EV (3 cycles), then adj. Imfinzi (9 cycles)], or…
Shots:
The GATHER1 & GATHER2 studies assessed Izervay (QM) vs sham in pts with GA secondary to AMD for 18 & 12mos., respectively, where in GATHER2, pts were later re-randomized to Izervay QM or Q2M for 24mos.
In the driving-eligible pts (BCVA of ≥70 ETDRS letters; n=403), Izervay reduced the risk of losing driving eligibility…
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Trial assessed eneboparatide (ENB; QD, SC) vs PBO for 24wks. in 202 adults with HypoPT on active vitamin D & oral Ca supplements; Pts then continued ENB (ENB/ENB) or switched from PBO to ENB (PBO/ENB) in a 28wk. OLE
Trial met its composite 1EP, with 31.1% pts achieving normalized albumin-adjusted sCa levels & independence…
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Novo Nordisk has reported sub-analysis from the STEP UP trial assessing Wegovy (7.2mg, QW) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention for 72wks. in >1,400 obese adults without diabetes (BMI ≥30kg/m²)
Wegovy 7.2mg achieved 20.7% average weight loss vs 17.5% (2.4mg) & 2.4% (PBO); among early responders (≥15% loss by wk. 24), 26.9%…
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PulseSight has presented the P-I (PST-611-CT1) trial data assessing two dose levels (low and high) of PST-611 in two successive dose groups involving 6 pts with late-stage dry AMD/Geographic Atrophy, with a 16wk. follow-up, at ARVO 2026
Trial met its 1 & 2EPs, showing favorable safety & tolerability, along with stable BCVA, no SAEs/SUSARs…
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ALX Oncology presented data from exploratory analyses of P-Ib/II trial assessing evorpacept + Ziihera in pts with heavily pre-treated HER2+ mBC, all of whom had received prior Enhertu therapy, at ESMO Breast Cancer 2026
Exploratory analyses in 24 pts treated with evorpacept + Ziihera at dosages of 20mg/kg (n=3) or 30mg/kg (n=21), showed a…
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Beacon has reported the 12mos. data from P-II (DAWN) trial assessing laruparetigene zovaparvovec (laru-zova) in pts with XLRP who have previously been treated with an AAV vector-based gene therapy delivering the full-length RPGR protein
Data showed sustained improvements in low luminance visual acuity (LLVA) & microperimetry mean sensitivity through Mos. 12, with 50% of…
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The P-III (TRuE-AD4) study assessed Incyte's Opzelura cream (BID) vs vehicle in 241 adults with mod. AD who had an inadequate response, intolerance, or contraindication to topical corticosteroids (TCSs) & calcineurin inhibitors (TCIs); data presented at EADV’26
As previously reported, the study met its co-1EPs, with 83.5% pts achieving EASI75 & 74.4% reaching IGA-TS, while 74.3% pts…
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Bayer has reported topline P-III (REVEAL) trial data assessing PET/CT radiotracerI 124 evuzamitide (IV) vs clinical SoC diagnosis in 170 adults with suspected cardiac amyloidosis
Trial met its 1EPs of sensitivity & specificity for the diagnosis of cardiac amyloidosis based on visual scan; data will be discussed with regulators, presented in future & submitted…
Shots:
Alebund has completed patient enrollment in the global P-III (RESPOND-2) trial assessing AP301 for the treatment of hyperphosphatemia across the US (n=138) & China (n=144)
The RESPOND-2 trial enrolled 282 pts (planned n=264) aged ≥12yrs with chronic kidney disease on maintenance dialysis with hyperphosphatemia & incl. an 8wk. double-blind phase, a 24wk. open-label phase,…

