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TOP STORIES from the week

Cytovation to Evaluate Getacatetide (CY-101) in Combination with Tislelizumab in CRC

Ph 2 ARASEC Data Supports the Efficacy and Safety of NUBEQA® (darolutamide) Plus ADT in Patients with Metastatic CSPC

Supplemental NDA submitted in Japan for PADCEV + Keytruda in Cisplatin-Eligible Patients with MIBC

CREATE Medicines Announces $122 Million Series B Financing to Advance In Vivo CAR Pipeline

New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic HSPC

Enhertu approved for use before surgery based on DESTINY-Breast11 Ph 3 trial and following surgery based on DESTINY-Breast05 Ph 3 trial in HER2-positive early breast cancer

FDA fast track designation for SUPLEXA in CRC

New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic HSPC

First patient dosed in clinical trial of EDV™ (EnGeneIC Dream Vector) therapy in patients with recurrent GBM

CREATE Medicines Announces $122 Million Series B Financing to Advance In Vivo CAR Pipeline

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Drug approvals

US FDA Approves INQOVI® in Combination with Venetoclax in AML Patients Ineligible for Intensive Induction Chemo

Enhertu approved for use before surgery based on DESTINY-Breast11 Ph 3 trial and following surgery based on DESTINY-Breast05 Ph 3 trial in HER2-positive early breast cancer

BEQALZI™ (sonrotoclax) Approved by US FDA for R/R Mantle Cell Lymphoma

FDA Approves BIZENGRI® (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner’s National Priority Voucher

Regulatory news

Supplemental NDA submitted in Japan for PADCEV + Keytruda in Cisplatin-Eligible Patients with MIBC

FDA fast track designation for SUPLEXA in CRC

FDA Grants Priority Review to Supplemental NDA for HYRNUO® (sevabertinib) Under Investigation in 1L HER2-Mutated NSCLC

NDA approval from NMPA CDE for Opamtistomig (LBL-024) to initiate Ph 3 trial for 1L EP-NEC

Trial results

Ph 2 ARASEC Data Supports the Efficacy and Safety of NUBEQA® (darolutamide) Plus ADT in Patients with Metastatic CSPC

New PSMAddition data show 58% lower risk of PSA progression with Pluvicto® in metastatic HSPC

Extended Clinical Benefit Over Multiple Clinical Endpoints Reported from Ph 3 Trial of Aglatimagene Besadenovec in Localized Prostate Cancer at longer Follow-up

Positive Interim Data Reported from Ph 1/1b PARADIGM-1 trial of ZH9 in NMIBC patients

trial status

First Patient Dosed with MST-0312 in Ph 1 STARLYS Trial

First interim unblinding expected in June 2026 following 45 subject enrollment milestone achieved in MIRACLE trial

First Patient Dosed in ASPENOVA Ph 3 Trial of Azenosertib in Patients with Cyclin E1-Positive Platinum-Resistant Ovarian Cancer

First patient dosed in clinical trial of EDV™ (EnGeneIC Dream Vector) therapy in patients with recurrent GBM

Business news

Cytovation to Evaluate Getacatetide (CY-101) in Combination with Tislelizumab in CRC

CREATE Medicines Announces $122 Million Series B Financing to Advance In Vivo CAR Pipeline

Regeneron Announces Strategic Collaboration with Parabilis Medicines to Advance Novel Antibody-Helicon™ Conjugates Across Multiple Therapeutic Areas

Context Therapeutics Enters into License Agreement Amendment with BioAtla for CT-202

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