Positive top-line phase III data for Immunome Inc.’s oral, once daily treatment for progressing desmoid tumors have prompted the company to say it plans to submit an NDA to the U.S. FDA in the second quarter of next year. Varegacestat, an oral gamma secretase inhibitor, hit its primary endpoint by significantly improving progression-free survival compared to placebo. The small molecule produced a statistically significant and clinically meaningful improvement vs. placebo with its 84% reduction in the risk of disease progression or death.
Cycle Group Holdings Ltd. is buying Applied Therapeutics Inc. for a small fraction of the company’s value when it went public in 2019. Cycle is paying $0.088, nearly 9 cents, in cash per share plus a contingent value right (CVR).
The quest for metabolic disease assets continues with another player promising top dollar for novel therapeutics that deliver. Copenhagen, Denmark-based Zealand Pharma A/S entered a collaboration and license agreement with newly formed OTR Therapeutics to pursue next-generation small-molecule therapeutics, beyond the Danish firm’s current peptide pipeline candidates focused on the GLP-1, GLP-2, GIP, amylin and glucagon mechanisms.
Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system (CNS) candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio.
Zealand Pharma A/S and OTR Therapeutics (Shanghai) Co. Ltd. have signed a multi-program strategic collaboration and license agreement to discover and develop novel therapeutics for metabolic diseases.
D3 Bio Inc. secured $108 million in a series B financing round Dec. 9 to support its planned phase III program of lead oral KRAS G12C inhibitor, elisrasib (D3S-001).
Kazia Therapeutics Ltd. raised AU$50 million (US$33.15 million) in a private placement of equity securities to advance lead candidate paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor in clinical trials for brain cancer and advanced breast cancer.
A month after besting rival Novo Nordisk A/S in a bidding war for obesity drug developer Metsera Inc., Pfizer Inc. is again adding to its GLP-1 arsenal, this time via a $2 billion licensing and collaboration agreement with Yaopharma, a subsidiary of China’s Fosun Pharmaceutical Co. Ltd.
Exicure Inc.’s buyout early this year of GPCR Therapeutics Inc. is paying off in a big way with data from the finished phase II trial testing burixafor (GPC-100). The agent is used with propranolol and granulocyte colony-stimulating factor to mobilize hematopoietic progenitor cells in patients with multiple myeloma (MM) undergoing autologous hematopoietic cell transplant.
Australian researchers have found a drug combination that can bypass the cellular defenses in neuroblastoma that lead to relapse, and the discovery could lead to better treatment strategies for children whose cancers have stopped responding to standard chemotherapy.
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