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TOP STORIES from the week

AK158D1 Granted NMPA Ph 1 Clearance for Advanced Solid Tumors

$92.5M Series E Financing to Advance First-in-class Cyclin D1 Program CID-615 into Clinical Development Announced

FDA Fast-Tracks KST-6051 for Advanced Solid Tumors

GSK to acquire T cell-engager for multiple myeloma from Chimagen Biosciences

Target enrollment achieved in registrational TEBE-AM trial with KIMMTRAK® (tebentafusp) in previously treated advanced melanoma

FDA Grants Accelerated Approval to ZENBEXUS in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma

FDA Fast-Tracks KST-6051 for Advanced Solid Tumors

Lunsumio-based regimen significantly improves PFS in follicular lymphoma in Ph 3 CELESTIMO study

Ph 2 ALISCA®-Lung2 Trial of Alisertib + Paclitaxel Initiated for Patients with Advanced SCLC

GSK to acquire T cell-engager for multiple myeloma from Chimagen Biosciences

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Drug approvals

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

KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Approved in Japan for SubQ Administration for All KEYTRUDA Indications Approved in Japan

FDA approves BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs

US FDA grants accelerated approval to sevabertinib in 1L HER2-mutant NSCLC

Regulatory news

AK158D1 Granted NMPA Ph 1 Clearance for Advanced Solid Tumors

FDA Fast-Tracks KST-6051 for Advanced Solid Tumors

FDA aligns with MHRA and EMA on adaptive design for Ph 3 trial for OST-HER2

MAA submitted to EMA for Lirafugratinib for Advanced/Metastatic Cholangiocarcinoma (CCA) Harboring FGFR2 Fusions or Rearrangements

Trial results

New Analyses Reinforcing Consistent Efficacy of IBTROZI® (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC Announced

Lunsumio-based regimen significantly improves PFS in follicular lymphoma in Ph 3 CELESTIMO study

Complete Full Cohort Ph 1 Results for JNJ-1900 (NBTXR3) in Inoperable, Recurrent NSCLC Announced

GX-BP1 Suppresses Tumor Regrowth despite Osimertinib and Dato-DXd Combination and Achieves 6/6 Complete Responses in Triple Combination

trial status

Target enrollment achieved in registrational TEBE-AM trial with KIMMTRAK® (tebentafusp) in previously treated advanced melanoma

Ph 2 ALISCA®-Lung2 Trial of Alisertib + Paclitaxel Initiated for Patients with Advanced SCLC

Clinical proof of mechanism for AVA6103 achieved in Ph 1 FOCUS-01 trial

First US Patient Dosed in Ongoing Ph 2 THIO-101 NSCLC Clinical Trial

Business news

$92.5M Series E Financing to Advance First-in-class Cyclin D1 Program CID-615 into Clinical Development Announced

GSK to acquire T cell-engager for multiple myeloma from Chimagen Biosciences

Circle Pharma Announces $92.5 Million Series E Financing to Advance First-in-class Cyclin D1 Program into Clinical Development

ANGELIS Oncology launches, acquires PLX038, and initiates clinical trial in GBM

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