Shots:
Diagonal has dosed the first patient with DIAG723, a clustering agonist antibody, in P-I/II (DIAMOND) trial (n=~93) for people living with hereditary hemorrhagic telangiectasia (HHT)
Trial will evaluate DIAG723 (SC) vs PBO in 3 parts: Part A (P-I) will assess single ascending doses; Part B (P-II) will evaluate multiple doses over 14wks. for safety…
Shots:
Merck has reported the P-III (KEYNOTE‑C93) trial assessing Keytruda (400mg, IV, Q6W for ~18 cycles) vs carboplatin + paclitaxel in pts (n=299) with dMMR advanced or recurrent endometrial cancer who have not previously been treated with systemic CT
Trial met its 1EP of improved PFS, & showed improvements across ORR, CRR, & DoR; OS (1EP)…
Shots:
Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%)
IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…
Shots:
GSK has reported global P-II (AZUR-1) trial data assessing Jemperli (dostarlimab) (500mg, IV, Q3W for 9 cycles) in 154 pts with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer
Trial met its 1EP, with a meaningful & sustained clinical complete response rate at 12mos. Interim AZUR-1 data will be shared with global…
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Novo Nordisk has reported P-III (FRONTIER4) extension study data assessing Mim8 (denecimig, SC) prophylaxis in paediatric & adult pts with hemophilia A, with or without inhibitors, across a range of dosing frequencies incl. QM, Q2W, & QW
Interim data (n=426) showed Mim8’s safety was consistent with prior studies, while efficacy EPs demonstrated low mean ABRs…
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Hansoh has reported the P-III (ARTEMIS-008) trial results assessing risvutatug rezetecan (Ris-Rez/HS-20093) vs topotecan in pts with advanced or relapsed SCLC after prior Pt-based therapy
Trial met its 1EP of improved OS in the interim analysis, with consistent benefit also observed across 2EPs, incl. PFS; data will be presented at an upcoming conference
Based on…
Shots:
CervoMed has completed enrollment in the P-IIa study of neflamapimod for the treatment of nonfluent variant primary progressive aphasia (nfvPPA), a type of frontotemporal dementia, with interim results to be presented at CTAD 2026
The study will evaluate the safety, PK, & clinical effects of neflamapimod (40mg, PO, TID; n=19 and 80mg, BID; n=6)…
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Ipsen has reported topline P-III (E-BEOND & C-BEOND) trial results assessing Dysport (abobotulinumtoxinA) vs PBO in a total of 1,510 adults with episodic & chronic migraine, respectively
Both trials met their 1EP, with a reduction in monthly migraine days vs PBO & demonstrated a favorable safety profile; detailed results will be presented at a future…
Shots:
Insilico has initiated a P-III trial assessing Rentosertib vs PBO in ~320 pts with idiopathic pulmonary fibrosis (IPF) over 52wks.
Earlier P-IIa (GENESIS-IPF) trial data showed Rentosertib (30mg, QD or BID, & 60mg, QD) met its 1EP, plus 60mg arm demonstrated a mean FVC change of +98.4mL vs -20.3mL at 12wks.
Rentosertib, an oral…
Shots:
Ionis has completed enrollment in Cohort 1 (n=136; 2 to <18yrs.) of the global P-III (REVEAL) study assessing obudanersen (ION582) in pts with AS with genetic confirmation of either a UBE3A deletion or UBE3A mutation
The Cohort 2 comprises adult pts (18 to ≤50yrs.) living with AS, with enrollment expected to be completed in…

