Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II diabetic kidney disease cohort. Conducted at 40 sites across China, the 2-Succeed phase II trial is designed to evaluate the efficacy and safety of SC-0062 in patients with chronic kidney disease with proteinuria.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Cosette Pharmaceuticals Inc. announced plans to acquire Adelaide, Australia-based Mayne Pharma Pty Ltd. for AU$672 million (US$430 million) to grow its women’s health and dermatology franchise in the U.S. Under terms, Cosette, of Bridgewater, N.J., will acquire 100% of Mayne’s shares at AU$7.40 per share in cash. The price represents a 37% premium to Mayne’s closing share price on Feb. 20. The deal is expected to close in the second quarter of 2025.
Qyuns Therapeutics Co. Ltd.’s monoclonal antibody targeting IL-17A, QX-002N, met both primary and secondary endpoints in a phase III trial in ankylosing spondylitis.
Cosette Pharmaceuticals Inc. announced plans to acquire Adelaide, Australia-based Mayne Pharma Pty Ltd. for AU$672 million (US$430 million) to grow its women’s health and dermatology franchise in the U.S. Under terms, Cosette, of Bridgewater, N.J., will acquire 100% of Mayne’s shares at AU$7.40 per share in cash. The price represents a 37% premium to Mayne’s closing share price on Feb. 20. The deal is expected to close in the second quarter of 2025.
Biomissile Pharmaceuticals Co. Ltd. is developing multispecific antibodies that overcome resistance associated with antibody-drug conjugates via its next-generation natural killer (NK) cell engagers. “ADCs are very efficacious, but they do have a drawback with side effects and resistance, because ultimately ADCs are similar to chemotherapy because you bring toxins to the tumor site,” Biomissile co-founder and CEO Chao Tu told BioWorld.
Harrison.ai raised AU$179 million (US$112 million) in a series C round to expand its radiology and pathology solutions across the U.S., Europe, the Middle East, Africa and Asia Pacific.
Radiopharm Theranostics Ltd.’s radiotracer RAD-101 (F18-Pivalate) successfully detected brain metastases in a variety of primary solid tumors in a phase II study.
