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Incyte

Incyte Reports 24-week P-III (TRuE-AD4) Trial Data on Opzelura (Ruxolitinib) Cream in Moderate Atopic Dermatitis (AD)

Shots: 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

Bayer Reports P-III (REVEAL) Trial Data on Iodine 124 evuzamitide to Diagnose Cardiac Amyloidosis

Shots: 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…

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Alebund Pharmaceuticals Completes Patient Enrollment in P-III (RESPOND-2) Trial of AP301 for Hyperphosphatemia

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,…

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Sensei Biotherapeutics Reports First Patient Dosing in P-Ib/II Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer

Shots: Sensei Biotherapeutics has dosed the first patient in P-Ib/II (FTH-PIK-101) trial assessing PIKTOR (serabelisib & sapanisertib) + fulvestrant &/or other anticancer therapies in pts with HR+/HER2- advanced or metastatic breast cancer  PIKTOR was evaluated in the P-Ib study in heavily pretreated advanced breast, endometrial, & ovarian cancers, where PIKTOR + paclitaxel achieved a 47%…

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Mirum Pharmaceuticals

Mirum Pharmaceuticals Reports P-IIb (VISTAS) Trial Data on Volixibat in Primary Sclerosing Cholangitis (PSC) Patients with Cholestatic Pruritus

Shots: Mirum has reported global P-IIb (VISTAS) trial data evaluating volixibat (20mg, BID) vs PBO in 158 patients with cholestatic pruritus caused by PSC, incl. 111 pts in the primary analysis cohort with mod. to sev. itch & 47 pts in the secondary cohort with mild itch In the primary cohort, volixibat met the 1EP,…

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Celcuity

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor The trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while…

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Theradaptive Receives US FDA Approval to Initiate P-III Trial of OsteoAdapt SP for Spinal Fusion Procedures

Shots: The US FDA has approved initiation of the P-III (OASIS) trial evaluating OsteoAdapt SP as an alternative to autologous & allograft bone graft in TLIF, ALIF, and LLIF procedures for symptomatic degenerative lumbosacral spine disease This approval builds on prior clinical experience in ~100 participants & expanded enrollment in Australia & Israel, while the…

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Pfizer New

Pfizer Reports the P-III (MagnetisMM-5) Trial Data on Elrexfio (Elranatamab) for R/R Multiple Myeloma (MM)

Shots: Pfizer has reported the P-III (MagnetisMM-5) trial data assessing Elrexfio monotx. (SC) vs daratumumab + pomalidomide & dexamethasone for the treatment of adults (n= 497) with r/r MM who received prior ≥1L of treatment Trial met its 1EP of improved PFS, as assessed by BICR, while OS data (2EP) remain immature & is under assessment; data…

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