Superluminal Medicines Inc. and Eli Lilly and Co. are collaborating in a deal to develop cardiometabolic disease and obesity therapies by aiming at undisclosed G protein-coupled receptor targets. The deal could bring Superluminal as much as $1.3 billion, including up-front and near-term investments, an equity investment, development and commercial milestones, plus tiered royalties on net sales.
Taking weight off with a glucagon-like peptide-1 (GLP-1) receptor agonist and keeping it off once the drug has been discontinued has been a tall order but Response Pharmaceuticals Inc. is seeing progress. Top-line results from its randomized, double-blind, placebo-controlled, parallel-group phase II study of RDX-002, in those who had already wrapped up a GLP-1 receptor agonist course for reducing obesity, were positive.
Insmed Inc. CEO William Lewis said that offering two doses of Brinsupri (brensocatib) will complicate payer coverage “not at all, just the opposite. It’s going to give the flexibility to physicians to choose how they want to engage with their patients, wrestle with whatever issues may be in their minds related to safety [and] what have you.” The U.S. FDA approved Insmed’s first-in-class dipeptidyl peptidase 1 inhibitor, Brinsupri, given in 10-mg and 25-mg tablets as a once-daily treatment for noncystic fibrosis bronchiectasis in adults and children 12 and older.
Fosun Pharmaceutical Co. Ltd. subsidiary Fosun Pharma Industrial is out-licensing its phase II dipeptidyl peptidase 1 inhibitor, XH-S004, to newco Expedition Therapeutics Inc. in a deal worth up to $645 million. Under terms of the deal, Expedition gains global rights to rights to develop, manufacture and commercialize XH-S004, except in mainland China, Hong Kong and Macau.
With a packed pipeline of drug candidates targeting multiple markers of cancer, Bayer AG signed on for a new project, this time going after the KRAS pathway with a global deal that could bring Kumquat Biosciences Inc. up to $1.3 billion in payments.
Experimental drugs that directly inhibit the NSD2 enzyme have shown potential as an effective strategy against hard-to-treat cancers, such as lung and pancreatic tumors driven by KRAS mutations. The therapeutic mechanism involves reversing a histone H3 methylation that promotes open chromatin and the expression of oncogenes.
Boehringer Ingelheim GmbH’s zongertinib enters the market as the first oral HER2-targeted therapy for patients with non-small-cell lung cancer, following an accelerated approval by the U.S. FDA. Branded Hernexeos, the drug is cleared for use in adults with unresectable disease or whose tumors have HER2 tyrosine kinase domain activating mutations and who have received prior systemic therapy.
Quantumpharm Inc., known as Xtalpi Inc., announced receiving $51 million up front from a potential $5.99 billion deal with Dovetree LLC on Aug. 6. The collaboration, first inked through a letter of intent between the two parties on June 23, will combine Shenzhen, China-based Xtalpi’s AI-based and robotics-driven discovery platform with Dovetree’s “biological insights.” The goal will be to select and validate potential first-in-class candidates for Dovetree across five areas of oncology, immunology and inflammatory diseases, neurological disorders and metabolic dysregulation.
Jazz Pharmaceuticals plc is prepped and ready for launch following U.S. FDA accelerated approval of dordaviprone as the first systemic therapy for H3 K27M-mutant diffuse glioma. Branded Modeyso, the orally administered first-in-class imipridone was acquired via Jazz’s acquisition earlier this year of Chimerix Inc. in a deal valued at about $935 million.
Agios Pharmaceuticals Inc. said the patients’ deaths tied to anemia therapy Pyrukynd (mitapivat) that were announced in a securities analyst’s Aug. 4 note to investors hasn’t changed the drug’s already established benefit-risk profile on the drug’s U.S. prescribing information.