Laekna Inc. outlicensed select rights to LAE-002 (afuresertib), an oral pan-AKT kinase inhibitor licensed from Novartis AG in 2018, to Qilu Pharmaceutical Co. Ltd. under a potential ¥2.045 billion (US$287.23 million) deal.
Engene Holdings Inc.’s protocol amendment to its phase II trial with detalimogene voraplasmid in bladder cancer worked out in a big way, and shares of the firm closed Nov. 11 at $8.82, up $2.81, or 47%. Engene rolled out additional preliminary data from the pivotal cohort of the ongoing Legend study testing the nonviral gene therapy in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without concomitant papillary disease.
CEO Lynn Seely said Lyell Immunopharma Inc. is going “full steam ahead” with development of rondecabtagene autoleucel (ronde-cel, also known as LYL-314) amid the excitement of the firm’s latest news: the buy of global rights to LYL-273, an autologous guanylyl cyclase-C-targeted CAR T-cell candidate for metastatic colorectal cancer (mCRC), from Innovative Cellular Therapeutics Inc. (ICT) for an up-front payment of $40 million and 1.9 million shares of Lyell common stock.
Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
Blocking progesterone receptor (PR) activity has long been viewed as a possible approach to breast cancer prevention. Historically, most supporting evidence came from animal models, epidemiological studies or mechanistic pathway analyses. Now, a team at the University of Manchester has uncovered direct mechanistic and clinical evidence that PR antagonists can reprogram the breast tissue microenvironment, suggesting a novel avenue for reducing breast cancer risk in women.
Enara Bio Ltd. is staking a claim to having validated the first in a new class of tumor antigens derived from unannotated regions of the dark genome, describing its findings in talks and posters being presented at the Society of Immunotherapy in Cancer (SITC) meeting in National Harbor, Md., Nov. 5-9, 2025.
Industry watchers were surprised when Eli Lilly and Co.’s oral GLP-1 candidate, orforglipron, did not appear among the first nine recipients of the U.S. FDA’s commissioner’s national priority voucher (CNPV) program aimed at shortening regulatory review times, boosting domestic manufacturing and improving affordability. But orforglipron, which recently nailed endpoints in a second phase III trial and has been hailed a potentially best-in-class compound, was among the second batch of six drugs added to the CNPV list.
San Francisco Bay Area researchers from UC Berkeley, UC San Francisco and Stanford University have combined their technologies to create Azalea Therapeutics Inc., a company focused on editing cells in vivo.
Aussie radiopharma company Advancell Co. Ltd. unveiled promising early clinical data that could redefine how advanced prostate cancer is treated by targeted alpha therapies in the radiopharmaceutical space.
Celltrion Inc. scored a hat-trick of deals to license new antibody candidates, including a $744 million deal with Kaigene Inc. Nov. 3, and a near $500 million deal with Mustbio Co. Ltd. Oct. 31.
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