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:
The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026
Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs…
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…
Shots:
The NMPA has granted conditional approval to Orpathys for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments
Approval was supported by the P-II trial of Orpathys in GC/GEJ adenocarcinoma pts with MET amplification in China, which showed 32.3% ORR (1EP), & improved 2EPs, incl. 63.1% DCR, 1.4mos.…
Shots:
Ipsen has entered into a definitive share purchase agreement to acquire all issued & outstanding shares of Memo Therapeutics, with closing expected in Q3’26
As per the deal, Memo shareholders will receive €200M upfront at closing, with total consideration exceeding €700M upon achieving development, regulatory, & sales milestones. Assets & employees unrelated to potravitug…
Shots:
Edgewise has reported the 12wk. P-II Part D (CIRRUS-HCM) trial data assessing EDG-7500 (PO) in obstructive (oHCM; n=20) and nonobstructive (nHCM; n=33) Hypertrophic Cardiomyopathy, where pts in both groups received doses ranging from 25 to 150mg
In oHCM pts, EDG-7500 showed 90% pts had improved LVOT-G, 74% achieved NT-proBNP normalization, or ≥50% reduction, KCCQ-OSS…
Shots:
Akeso has enrolled the first patient in the P-Ib/II (AK138D1-202) study assessing its AK138D1 monotx. or in combination with ivonescimab for the treatment of advanced breast cancer
The trial is evaluating AK138D1 in 2 breast cancer subtypes: HR+/HER2- & triple-negative breast cancer. The study incl. pts ranging from treatment-naïve to heavily pretreated & enrolls…
Shots:
The P-II/III (ENERGY) trial assessed 2 different dose schedules of J&J's Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts received Imaavy for 144wks. with a follow-up of 6wks. after the last assessment
In the 30mg/kg group, Imaavy showed mean increase of 1g/dL in Hgb…
Shots:
Part B of P-II (APEX) trial assessed high, medium, or low-dose zumilokibart vs PBO in 346 pts, where mid & high-doses met the 1EP at 16wks., with 61.6% pts on high dose, 65.9% on mid-dose & 50.5% on low dose achieved EASI-75 vs 23.4% on PBO
At Wk. 16, mid-dose also met key 2EP…
Shots:
D&D Pharmatech has reported the topline P-II (DD01-DN-02) trial data assessing zabopegdutide (DD01) vs PBO in 67 overweight/obese pts with MASH & significant liver fat across the US, which met its all 3 key histological EPs
Pts received a 2wk. 20mg titration followed by maintenance dosing of DD01 (40mg, QW) or PBO; the Wk.…

