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TOP STORIES from the week

Natera and TransCode Therapeutics to Collaborate on Ph 2a Trial of TTX-MC138 in CRC

Positive Topline Results from Interim Analysis of Ph 3 ACTION-1 for RYZ101 Announced in Patients with GEP-NETs

Opamtistomig Granted FDA Fast Track Designation for 1L Advanced or Metastatic Biliary Tract Cancer

KymaThera Announces $80 Million Series B Financing to Advance K-1728, a Next-Gen Pan-Mutant Selective PI3Kα Inhibitor

First Patient dosed in Ph 3 RASolute 309 Trial of RASONQUE™ (daraxonrasib) + Zoldonrasib in 1L Metastatic RAS G12D Pancreatic Cancer

FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

EMA validates the MAA for Wevdury® (fuzuloparib) in combination with abiraterone acetate and prednisone/prednisolone for metastatic CRPC patients

ZENBEXUS (iberdomide) + ZDd Demonstrates Superior PFS vs. SOC in RRMM patients in Ph 3 EXCALIBER-RRMM Study

Development of vispa-cel in R/R B cell NHL and CB-011 in R/R multiple myeloma to be discontinued

KymaThera Announces $80 Million Series B Financing to Advance K-1728, a Next-Gen Pan-Mutant Selective PI3Kα Inhibitor

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Drug approvals

TUKYSA Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer

FDA approved adjuvant Tecentriq and Tecentriq Hybreza in combination with a fluoropyrimidine and oxaliplatin for the treatment of stage III dMMR colon cancer

Jaypirca (pirtobrutinib) receives expanded indication from US FDA for 1L CLL/SLL patients

FDA Approves Lyrfigtu (Lirafugratinib) for 2L Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement Treatment Option

Regulatory news

Opamtistomig Granted FDA Fast Track Designation for 1L Advanced or Metastatic Biliary Tract Cancer

EMA validates the MAA for Wevdury® (fuzuloparib) in combination with abiraterone acetate and prednisone/prednisolone for metastatic CRPC patients

Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the US FDA for CRC and NSCLC

FDA Alignment obtained on ENABLE-2 Ph 3 Trial Design for Relcobatinib (ELVN-001) in Previously Treated CLL

Trial results

Positive Topline Results from Interim Analysis of Ph 3 ACTION-1 for RYZ101 Announced in Patients with GEP-NETs

ZENBEXUS (iberdomide) + ZDd Demonstrates Superior PFS vs. SOC in RRMM patients in Ph 3 EXCALIBER-RRMM Study

Epcoritamab + R-CHOP Demonstrates Statistically Significant PFS Improvement in Patients with 1L DLBCL

Carotuximab + Apalutamide Improves PFS in Interim Ph 2 Prostate Cancer trial of ENV-105

trial status

First Patient dosed in Ph 3 RASolute 309 Trial of RASONQUE™ (daraxonrasib) + Zoldonrasib in 1L Metastatic RAS G12D Pancreatic Cancer

Development of vispa-cel in R/R B cell NHL and CB-011 in R/R multiple myeloma to be discontinued

First Patient Enrolled in Ph 1b/2 Combination Study of Bexobrutideg in CLL

First Patient Enrolled in Global Ph 3 Trial of Cadonilimab vs Nivolumab in 1L Gastric Cancer

Business news

Natera and TransCode Therapeutics to Collaborate on Ph 2a Trial of TTX-MC138 in CRC

KymaThera Announces $80 Million Series B Financing to Advance K-1728, a Next-Gen Pan-Mutant Selective PI3Kα Inhibitor

Prelude and Lilly to Evaluate PRT13722 in Combination with Verzenio® and Inluriyo® in Patients with HR+/HER2- Breast Cancer

Genezen and InterAct Therapeutics Partner to Advance AAV8-based Gene Therapy for Liver-Dominant Metastatic Breast Cancer

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