Larimar Therapeutics Announces FDA Breakthrough Therapy Designation for Nomlabofusp in FA and Reiterates Planned BLA Submission in June 2026

Nomlabofusp program granted Breakthrough Therapy Designation for the treatment of adults and children with FA based on FDA’s review of available ...
Morningstar

Kelun-Biotech Announces Breakthrough Therapy Designation Granted in China for Sacituzumab Tirumotecan (sac-TMT) in Combination with Immunotherapy Pembrolizumab for First-Line ...

CHENGDU, China, Jan. 5, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company," 6990.HK) today announced that its TROP2-directed antibody-drug ...
Morningstar

Akeso's Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer

HONG KONG, Nov. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) announced that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for ...