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TOP STORIES from the week

Jazz Pharmaceuticals and AbCellera Announce Collaboration to Discover Next-Gen T-cell Engaging Multispecific Antibodies

Final Patient Dosed in Ph 2 DURIPANC Study in Metastatic Pancreatic Cancer

FAILED TRIAL: Ph 3 TRIDENT trial of TTFields did not meet primary endpoint of significant OS increase in GBM patients when used early

FDA Fast Track Designation for Givastomig in 1L HER2-Neg Metastatic Gastric Cancer

Nuvectis Announces Strategic Portfolio Expansion via License Agreement for Ex-China Rights with Haisco Pharmaceutical Group for NPX200 and NPX900

FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each With WELIREG, for Adjuvant Treatment of Certain Patients With Clear Cell RCC

FDA accepts supplemental BLA for Lunsumio – Polivy combo for people with R/R LBCL

Positive Updated Results from RAMP 205 of Avutometinib, Defactinib and SOC chemo in 1L Metastatic Pancreatic Cancer Announced

Ph 3 DAREON®-Lung-1 in SCLC, DAREON®-NEC-1 in extrapulmonary NEC, and Beamion LUNG-3 trials in HER2-mutant NSCLC initiated

Nuvectis Announces Strategic Portfolio Expansion via License Agreement for Ex-China Rights with Haisco Pharmaceutical Group for NPX200 and NPX900

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Drug approvals

Japan Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of R/R DLBCL Announced

Sarclisa subQ formulation approved in Japan for patients with multiple myeloma

Sarclisa SQ approved in the EU as the first anticancer treatment administered via an on-body injector

FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each With WELIREG, for Adjuvant Treatment of Certain Patients With Clear Cell RCC

Regulatory news

FDA Fast Track Designation for Givastomig in 1L HER2-Neg Metastatic Gastric Cancer

FDA accepts supplemental BLA for Lunsumio – Polivy combo for people with R/R LBCL

UAE IND Approval obtained for NEO212 Following Successful Ph 1 Completion, Advancing Toward Global Ph 2 Development

IND application for HLX3902 approved in China for treatment of metastatic CRPC and solid tumors

Trial results

FAILED TRIAL: Ph 3 TRIDENT trial of TTFields did not meet primary endpoint of significant OS increase in GBM patients when used early

Positive Updated Results from RAMP 205 of Avutometinib, Defactinib and SOC chemo in 1L Metastatic Pancreatic Cancer Announced

Multiple Complete Responses Reported After ELI-002 7P Treatment and Subsequent Therapy with Checkpoint Inhibition in Metastatic mKRAS Pancreatic Cancer

Ph 3 STELLAR-303 Trial of Zanzalintinib + Tecentriq in Metastatic CRC Patients didn’t meet the dual primary endpoint of OS improvement in the liver mets patients

trial status

Final Patient Dosed in Ph 2 DURIPANC Study in Metastatic Pancreatic Cancer

Ph 3 DAREON®-Lung-1 in SCLC, DAREON®-NEC-1 in extrapulmonary NEC, and Beamion LUNG-3 trials in HER2-mutant NSCLC initiated

The third U.S. clinical site in Ph 2 THIO-101 expansion trial of ateganosine enrolling patients in 3L NSCLC

First patients dosed in Ph 1 trials of NEOK001 and NEOK002 in solid tumor cancers

Business news

Jazz Pharmaceuticals and AbCellera Announce Collaboration to Discover Next-Gen T-cell Engaging Multispecific Antibodies

Nuvectis Announces Strategic Portfolio Expansion via License Agreement for Ex-China Rights with Haisco Pharmaceutical Group for NPX200 and NPX900

Voro Therapeutics and Alloy Therapeutics Enter Strategic Research Collaboration to Advance Next-Gen Masked TCE Therapeutics

Antengene Announces Exclusive License Agreement with K2 Therapeutics for ATG-106 and Option for Undisclosed Bispecific TCE

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