Partner Therapeutics, Inc.

• Belfast-based Diaceutics has signed a multi-year contract worth up to £11.5 million with Partner Therapeutics to commercialize the oncology precision medicine BIZENGRI (zenocutuzumab). • The agreement leverages Diaceutics' DXRX platform and PMx commercialization solutions to identify patients based on genomic profiles and accelerate optimal treatment delivery. • The contract includes £4.5 million in recurring service revenues through September 2026, with potential extension to 2028 that would add another £7 million in revenue.

• Merus N.V. has received FDA approval for Bizengri, its first commercial product, targeting NRG1 gene fusions in various cancers. • Bizengri offers a new treatment option for patients with aggressive cancers who have progressed despite prior systemic therapies. • Merus has partnered with Partner Therapeutics, Inc. for the commercialization of zenocutuzumab (Zeno) in the U.S. for NRG1 fusion-positive cancers.

• Novocure's electrical field-emitting device, combined with chemotherapy, significantly extended survival in locally advanced pancreatic cancer patients by two months in a Phase 3 trial. • The FDA is set to decide on Cytokinetics' aficamten for obstructive hypertrophic cardiomyopathy by September 26, 2025, following positive Phase 3 trial results. • Merus has granted Partner Therapeutics U.S. rights to zenocutuzumab, an experimental cancer drug currently under FDA review for NRG1 fusion-positive tumors, with a decision expected by February 4, 2025. • The FDA is investigating blood cancer cases linked to Bluebird bio's gene therapy Skysona, advising caution and consideration of alternative treatments like stem cell transplants.

The FDA has granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced pancreatic adenocarcinoma and non-small cell lung cancer with NRG1 gene fusions.

• The FDA has granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced unresectable or metastatic NRG1+ pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC). • Bizengri is the first and only FDA-approved therapy specifically targeting NRG1 gene fusions in these cancers, offering a new treatment option for patients with disease progression after prior systemic therapy. • Approval was based on overall response rate (ORR) and duration of response (DOR) data from the eNRGy trial, with continued approval contingent on confirmatory trial results. • Bizengri carries a Boxed Warning for Embryo-Fetal Toxicity and warnings for infusion-related reactions, interstitial lung disease/pneumonitis, hypersensitivity/anaphylactic reactions and left ventricular dysfunction.