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TOP STORIES from the week

Interim Safety Data in Ph 1 Trial of ENV-105 in EGFR-Mutated Lung Cancer Patients Reported

Ph 3 Study of Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as 1L PD-L1-Neg Non-Squamous NSCLC Met Primary EndpointĀ 

Fast Track Designation for Pelareorep in 2L+ Anal Cancer

KEYTRUDA Monotherapy Significantly Improved PFS vs chemo in Certain Patients With Advanced or Recurrent MMR-deficient Endometrial CancerĀ 

FDA Clears IND Application for UB-VV400 for R/R B Cell Malignancies

FDA Approves KEYTRUDA and KEYTRUDA QLEX each with Trodelvy as 1L Treatment of PD-L1+ (CPS ā‰„10) Advanced TNBC

FDA Clears IND Application for UB-VV400 for R/R B Cell Malignancies

Ph 3 Study of Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as 1L PD-L1-Neg Non-Squamous NSCLC Met Primary EndpointĀ 

First patient dosed in RASolute 305 Ph 3 Trial of Zoldonrasib-Chemo combo in 1L RAS G12D Metastatic Pancreatic CancerĀ 

FORE Biotherapeutics Announces Closing of Upsized $67.4 Million Series D-2 Extension Financing and Highlights Recent Plixorafenib Achievements

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Drug approvals

FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

FDA approves SC Sarclisa (isatuximab-irfc) Escena + SOC for multiple myeloma patients across all existing indications of Sarclisa IV formulation

FDA Approves REVTORPYK (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA WT Locally Advanced or Metastatic Breast Cancer

FDA Approves KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Treatment Before and After Surgery for Adults With MIBC

Regulatory news

Fast Track Designation for Pelareorep in 2L+ Anal Cancer

FDA Clears IND Application for UB-VV400 for R/R B Cell Malignancies

Jaypirca (pirtobrutinib) recommended by CHMP for approval in the EU for adults with CLL across all lines of therapy

FDA Provides Written Feedback on NEO212 CMC Development and Capsule-to-Tablet Transition

Trial results

Interim Safety Data in Ph 1 Trial of ENV-105 in EGFR-Mutated Lung Cancer Patients Reported

Ph 3 Study of Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab as 1L PD-L1-Neg Non-Squamous NSCLC Met Primary EndpointĀ 

KEYTRUDA Monotherapy Significantly Improved PFS vs chemo in Certain Patients With Advanced or Recurrent MMR-deficient Endometrial CancerĀ 

Ph 1 Results of ALLO-316 Highlighting First Durable Remissions Following Allogeneic CAR T for Treatment of Metastatic Solid Tumors published in the JCO

trial status

First Patient Dosed in Ph 1 Trial of IM-3050 in Patients with FAP-Expressing Advanced Solid Tumors

Patient Treatment Restarted in Ph 2 INVINCIBLE-4 Study of Neoadjuvant INT230-6 in TNBC Patients

First solid tumour patient dosed with ZI-MA4-1 in the ZIMA-101 Ph 1 trial

FDA Registration-Enabling Ph 3 Confirmatory Study of MultikineĀ® launched in Newly Diagnosed Head and Neck Cancer

Business news

AdvanCell Closes US $315 Million Oversubscribed Series D Financing to Advance Targeted Alpha Therapies

Biocytogen and Whitehawk Therapeutics Enter Global Collaboration for Bispecific Antibody ADC Development

FORE Biotherapeutics Announces Closing of Upsized $67.4 Million Series D-2 Extension Financing and Highlights Recent Plixorafenib Achievements

Allotera Therapeutics (Formerly Wugen) Closes $35 Million Financing to Advance Off-the-Shelf CAR-T Therapies for T-Cell Cancers

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