Among the drug developers with clinical results featured at the annual meeting of the Society for Urologic Oncology (SUO) in Dallas were Protara Therapeutics Inc. with phase II numbers and CG Oncology Inc. with a phase III update. Protara’s shares (NASDAQ:TARA) closed Dec. 5 at $6.02, up $2.48, or 70%, having traded as high as $10.48 during the day. Less reactive was stock in CG (NASDAQ:CGON), which ended at $33.56, down $2.35.
China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
Elevar Therapeutics Inc. will license Relay Therapeutics Inc.’s “NDA-ready” bile duct cancer therapy, lirafugratinib (RLY-4008), through a potential $500 million deal as Elevar, an HLB Co. Ltd. subsidiary, seeks to diversify its oncology portfolio following the U.S. FDA rejection of its liver cancer drug candidate in May.
Duality Biologics is out-licensing preclinical antibody-drug conjugate (ADC) candidate DB-1324 under an option agreement with GSK plc potentially worth more than $1 billion.
Takeda Pharmaceutical Co. Ltd. is licensing Keros Therapeutics Inc.’s activin inhibitor elritercept in a global development and commercialization deal worth up to $1.3 billion that excludes mainland China, Hong Kong and Macau.
Tubulis GmbH has sealed a potential $415 million option and licensing deal under which it will apply proprietary technologies to discover an antibody-drug conjugate (ADC) against a solid tumor target for Gilead Sciences Inc.
South Korean billionaire and chairman of Celltrion Group Jungjin Seo is returning Celltrion Inc. to its contract manufacturing organization (CMO) roots, as it relies on biosimilar sales to anchor the company in a fiercely competitive novel drug R&D arena.
Kiromic Biopharma Inc. and two former senior officials have settled with the U.S. SEC to resolve charges involving nondisclosure of U.S. FDA clinical holds on two cancer candidates before and after a July 2021 follow-on public offering that raised $40 million the company desperately needed.
Janux Therapeutics Inc. CEO David Campbell said the firm will be talking with the U.S. FDA about “what we may or may not be able to do [in order to get JANX-007] to patients more rapidly,” though he noted that the agency has “primarily been focused on overall survival” in considering prostate cancer drugs, so more work on that endpoint may be required. “We’ll keep that in mind,” he said.
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. won local approval of the first China-made trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC), sacituzumab tirumotecan, as a third-line therapy for advanced breast cancer.
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