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TOP STORIES from the week

Outcome from the End-of-Phase 1 Meeting with the FDA and Pivotal Ph 2 Trial Design for OMNI-EGFR™ Inhibitor, BH-30643, in EGFR C797S-Positive NSCLC Announced

Astellas and Audax Biosciences Enter Exclusive Option and License Agreement for DAX-044 for Immuno-Oncology

Updated Clinical Data of Zocilurtatug Pelitecan (Zoci) in Previously Treated Extrapulmonary Neuroendocrine Carcinomas Presented

IND Clearance for KT-300 in for RAS-Driven Cancers Announced

Helix 51 Company Saros Therapeutics Receives Second $2 Million Award to Advance Cancer Immunotherapy

European Commission approves TECVAYLI (teclistamab) monotherapy for relapsed/refractory multiple myeloma

IND Clearance for KT-300 in for RAS-Driven Cancers Announced

Preliminary Findings from the Investigator-Sponsored Ph 2a PICASSO Trial in Metastatic Melanoma Announced

First Patient dosed in Ph 3 RASolve 308 Trial of Zoldonrasib + Pembrolizumab and Chemo in 1L Metastatic RAS G12D Non-Squamous NSCLC

Helix 51 Company Saros Therapeutics Receives Second $2 Million Award to Advance Cancer Immunotherapy

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Drug approvals

Enhertu approved in the EU as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer

FDA approves TALZENNA plus XTANDI for HRR gene-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer

European Commission approves TECVAYLI (teclistamab) monotherapy for relapsed/refractory multiple myeloma

FDA grants traditional approval for Keytruda or Keytruda Qlex for unresectable or metastatic TMB-H solid tumors with updated indication

Regulatory news

Outcome from the End-of-Phase 1 Meeting with the FDA and Pivotal Ph 2 Trial Design for OMNI-EGFR™ Inhibitor, BH-30643, in EGFR C797S-Positive NSCLC Announced

IND Clearance for KT-300 in for RAS-Driven Cancers Announced

FDA grants Orphan Drug Designation for Cantrixil in AML

Regulatory Filings Accepted for Review for ORPATHYS® plus TAGRISSO® in MET-Driven EGFR-Mutated Lung Cancer in Europe and Japan

Trial results

Updated Clinical Data of Zocilurtatug Pelitecan (Zoci) in Previously Treated Extrapulmonary Neuroendocrine Carcinomas Presented

Preliminary Findings from the Investigator-Sponsored Ph 2a PICASSO Trial in Metastatic Melanoma Announced

Incremental Data and Analyses from Ph 1/2a Trial of [212Pb]Bamzireotide Navoxetan (VMT-α-NET) in Advanced SSTR2 Expressing NETs Presented

Ph 2a PICASSO Trial of MaaT013 (Xervyteg®) + immune checkpoint inhibitors in selected melanoma patients met primary endpoint

trial status

First Patient Dosed in OVACT Ph 1/1b Trial of CryptiVax™-1001 in Advanced High-Grade Serous Ovarian Cancer

Ph 1/2 Study of Vopimetostat in Combination with ERAS-0015 Initiated in patients with MTAP-deleted pancreatic cancer and MTAP-deleted/RAS mutant NSCLC

First Patient Dosed in Ph 1 Trial of UGN-501 for NMIBC

Ph 3 IMpactMF trial of imetelstat in JAK inhibitor R/R myelofibrosis to be discontinued based on DMC recommendation

Business news

Astellas and Audax Biosciences Enter Exclusive Option and License Agreement for DAX-044 for Immuno-Oncology

Helix 51 Company Saros Therapeutics Receives Second $2 Million Award to Advance Cancer Immunotherapy

Boehringer Ingelheim and SBP Group enter partnership to advance next-generation cancer therapies

Zenith Epigenetics and Lilly to collaborate on Registration Enabling Study of ZEN-3694 and Verzenio® (Abemaciclib) in NUT Carcinoma

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