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Innovent Biologics Collaborates with Roche to Develop IBI3009 for SCLC
Shots: Innovent & Roche have entered into a collaboration & exclusive license agreement for developing IBI3009 to treat advanced SCLC As per the terms, Roche secures exclusive worldwide rights to develop, manufacture & commercialize IBI3009 plus will lead full development after early-stage studies, conducted jointly. Innovent will get $80M upfront, up to $1B development…
January 2, 2025
Hutchmed
HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification
Shots: The NMPA has accepted and granted priority review to NDA of Orpathys (savolitinib) + Tagrisso (osimertinib) for treating locally advanced or metastatic EGFR-mutated NSCLC with MET amplification in patients progressed on 1L EGFR inhibitor therapy. HUTCHMED will receive milestone from AstraZeneca Submission was based on P-III (SACHI) study assessing the safety & efficacy…
January 2, 2025
Galera Therapeutics Completes Nova Pharmaceuticals’ Acquisition
Shots: Galera has completed Nova’s acquisition to form Galera Therapeutics, trading on OTC under GRTX ticker. Acquisition was backed by a $3M investment from a group of investors led by Ikarian Capital Galera issued 21.1M common shares, pre-funded warrants for 23M shares & 119,318 Series B convertible preferred shares. At closing, Galera stockholders will…
January 1, 2025
ADC Therapeutics Reports Enrollment Completion in P-III (LOTIS-5) Study of Zynlonta Plus Rituximab for 2L+ Diffuse Large B-Cell Lymphoma
Shots: The patient enrollment in confirmatory P-III (LOTIS-5) study assessing Zynlonta + rituximab for treating 2L+ r/r DLBCL has been completed. Zynlonta was previously approved in 2021 under accelerated pathway for the same The study aims to convert accelerated approval & support label expansion to 2L+ with rituximab. Part 1 enrolled 20 patients for…
January 1, 2025
Corcept Therapeutics Reports NDA Submission of Relacorilant to the US FDA for Treating Hypercortisolism
Shots: Corcept has submitted NDA of relacorilant to the US FDA for the treatment of endogenous hypercortisolism (Cushing’s syndrome) Submission was based on pivotal GRACE study, confirmatory P-III (GRADIENT) & long-term extension trials plus P-II hypercortisolism trial. Relacorilant showed improved symptoms without adrenal insufficiency, hypokalemia, QT prolongation, or progesterone receptor-related AEs (endometrial thickening or…
January 1, 2025
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