Wall Street wasn’t jumping up and down about Repare Therapeutics Inc.’s early data in gynecological cancers, though the findings look positive and the company has big plans for the combo therapy.

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.

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.

Ideaya Biosciences Inc. has announced FDA clearance of an IND application for IDE-275 (GSK-959), a small-molecule inhibitor of Werner helicase (WRN) discovered by Ideaya in collaboration with GSK plc.

Endometrial cancer (EC) accounts for 20% to 30% of most malignant tumors of the female reproductive system, making it one of the most common. Furthermore, the 5-year survival rate of patients with early-stage EC is 90%, but this number decreases to 20% in late-stage disease.

For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.

CDR-Life Inc. has expanded its pipeline of novel T-cell engagers (TCE) with the addition of CDR-813 and CDR-505. CDR-813 is a highly potent and selective TCE candidate targeting tumors expressing PRAME (preferentially expressed antigen in melanoma) in HLA-A*02:01 patients.

Day One Biopharmaceuticals Inc. has entered into an exclusive licensing agreement with Mabcare Therapeutics for MTX-13, a novel antibody-drug conjugate (ADC) targeting protein-tyrosine kinase 7 (PTK7). Under the agreement, Day One has exclusive rights to develop, manufacture and commercialize MTX-13 (now DAY-301), worldwide, excluding Greater China.