FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in 1L AML for Patients Unfit for Induction Chemotherapy Treatment September 24, 2024
First patient dosed in Investigator-initiated Ph Ib study of iadademstat in 1L AML September 18, 2024
GBM program of INB-200 and INB-400 to be suspended; AML program of INB-100 to be prioritized September 10, 2024
New clinical data from ongoing Ph 1/2 VBP101 study of patients with R/R AML receiving trem-cel followed by Mylotarg announced September 10, 2024
FDA Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in R/R AML September 10, 2024
Positive Results Announced From Real-World Study of ORG-101 CAR-T Therapy in Patients with CD19+ ALL September 3, 2024
Nadunolimab clinical trials in AML/MDA and TNBC to be initiated in Q4 2024 and H2 2025, respectively September 3, 2024
Enrollment discontinued in SELECT-AML-1 Ph 2 trial of tamibarotene + venetoclax & azacitidine in newly diagnosed, unfit AML patients with RARA gene overexpression August 22, 2024
Ph 3 SIERRA trial deemed inadequate to support BLA filing for Iomab-B; additional head-to-head RCT demonstrating OS benefit required August 22, 2024
FDA provides IND requirements for the development of ALA-101 in first-inhuman clinical trials for lymphoma and leukaemia August 13, 2024
Fixed-duration Calquence + venetoclax, with or without obinutuzumab, significantly improved PFS in 1L CLL in AMPLIFY Ph 3 trial August 7, 2024
PDUFA Action Date Extension Announced for Revumenib NDA for R/R KMT2Ar Acute Leukemia; new PDUFA action date: Dec 26, 2024 August 7, 2024
Pivotal, adaptive MIRACLE Ph 3 trial designed for possible accelerated approval of Annamycin + cytarabine for the treatment of R/R AML August 7, 2024
Scemblix® Granted FDA Priority Review For The Treatment Of Adults With Newly Diagnosed CML based on ASC4FIRST Ph 3 study data August 6, 2024
Fixed-duration Calquence plus venetoclax, with or without obinutuzumab, significantly improved PFS in 1L CLL in AMPLIFY Ph 3 trial July 30, 2024
FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to UCART22 product candidate for ALL Treatment July 30, 2024
Regulatory path forward for uproleselan in R/R AML would require an additional clinical trial July 30, 2024
