LTZ Therapeutics Inc.’s LTZ-232 has gained IND clearance from the FDA, enabling initiation of a phase I study in patients with advanced metastatic colorectal cancer and other solid tumors.
Ascletis Pharma Inc. has submitted two IND applications to the FDA for ASC-36 once-monthly injection and ASC-36_35 once-monthly injection co-formulation for the treatment of obesity.
Ascletis Pharma Inc. has received IND clearance from the FDA for ASC-35, a once-monthly subcutaneously administered GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual peptide agonist, for the treatment of obesity.
Unixell Biotechnology Co. Ltd. has obtained IND clearance from the FDA for UX-DA003, its allogeneic induced pluripotent stem cell (iPSC)-derived therapy for Parkinson’s disease. IND approval was also gained in China earlier this month, enabling concurrent clinical development in both China and the U.S.
Anhorn Medicines Co. Ltd. has obtained IND clearance from the FDA for its lead neuroprotective candidate, AH-008, for the prevention of chemotherapy-induced peripheral neuropathy.
Prime Medicine Inc. has obtained clearance from the New Zealand authority, Medsafe, for the company’s clinical trial application for PM-577a, an investigational Prime Editor for Wilson’s disease.
Cenna Biosciences Inc. has obtained IND clearance from the FDA for 8M2D, a first-in-class peptide for the treatment of Alzheimer’s disease. A phase Ia/Ib trial of 8M2D in healthy volunteers and patients with early Alzheimer’s disease is expected to begin dosing late this year.
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