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TOP STORIES from the week

FDA grants Fast Track Designation to iSCIB1+ in advanced melanoma 

JANX008 Clinical Development to be discontinued

Tovecimig Demonstrates Statistically Significant PFS Benefit but misses the OS benefit in COMPANION-002 Ph 2/3 Study in Patients with Biliary Tract Cancer

US FDA Grants Priority Review to TEVIMBRA in 1L HER2+ GEA

Telomir Pharmaceuticals Completes Acquisition of TELI Pharmaceuticals, Securing Global Rights to Telomir-1 (Telomir-Zn)

FDA Approves Lifyorli™ (relacorilant) Plus Nab-Paclitaxel for Treatment of Patients with Platinum-Resistant Ovarian Cancer

US FDA Grants Priority Review to TEVIMBRA in 1L HER2+ GEA

Ph 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful PFS Improvement in PIK3CA Mutant Cohort

First Patient Dosed in Ph 1 Trial of KST-6051 in Patients with KRAS-driven Malignancies

Terremoto Biosciences Closes $108 Million Series C Financing to Advance Selective AKT1-Inhibitors in Oncology

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Drug approvals

FDA Approves VEPPANU (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

FDA Approves Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis

Ojemda® approved in the EU in R/R pediatric low-grade glioma regardless of BRAF alteration

ZEPZELCA + Tecentriq approved for use in Australia and Singapore as 1L maintenance treatment for adult patients with ES-SCLC

Regulatory news

FDA grants Fast Track Designation to iSCIB1+ in advanced melanoma 

US FDA Grants Priority Review to TEVIMBRA in 1L HER2+ GEA

FDA Expanded Access Authorization for Daraxonrasib in Patients with Previously Treated Metastatic Pancreatic Cancer

Ph 2/3 Clinical Trial Application submitted to Germany’s BfArM for SIL204 in KRAS-Driven Locally Advanced Pancreatic Cancer

Trial results

Tovecimig Demonstrates Statistically Significant PFS Benefit but misses the OS benefit in COMPANION-002 Ph 2/3 Study in Patients with Biliary Tract Cancer

Ph 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful PFS Improvement in PIK3CA Mutant Cohort

Journal of Clinical Oncology Publishes Final Results of Duvelisib PRIMO Ph 2 Trial in R/R Peripheral T-cell Lymphoma

ELREXFIO Significantly Improves PFS for Double-Class Exposed RRMM Patients

trial status

JANX008 Clinical Development to be discontinued

First Patient Dosed in Ph 1 Trial of KST-6051 in Patients with KRAS-driven Malignancies

Molecular Partners publishes Ph 1 MP0317 data in Nature Cancer

CD20 mono CAR-T cell therapy and CD19-CD20 bi-CAR-T programs to be discontinued

Business news

Telomir Pharmaceuticals Completes Acquisition of TELI Pharmaceuticals, Securing Global Rights to Telomir-1 (Telomir-Zn)

Huahui Health and BeOne Medicines Enter into a Global Exclusive Option, License and Collaboration Agreement for Innovative Oncology Drug HH160

Gilead Sciences Completes Acquisition of Arcellx Ahead of Potential Commercial Launch of Anito-cel

Lilly to acquire Ajax Therapeutics to advance outcomes for patients with myelofibrosis and polycythemia vera

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