MBX Biosciences Inc. has submitted an IND application to the FDA for MBX-4291, a long-acting glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP) receptor co-agonist prodrug for the treatment of obesity.
Centessa Pharmaceuticals plc has obtained IND clearance from the FDA to initiate a phase I study of ORX-142 in healthy volunteers. ORX-142 is an investigational, novel, highly potent and selective OX2R agonist being developed for the treatment of select neurological and neurodegenerative disorders.
Myrio Therapeutics Pty Ltd. is set to advance lead product PHOX2B PC-CAR T (PHOX2B peptide-centric chimeric antigen receptor autologous T cells) into clinical trials for relapsed neuroblastoma following IND clearance by the FDA. The first patient will be enrolled around mid-year.
Capsida Biotherapeutics Inc. has obtained IND clearance from the FDA for CAP-003, an intravenously administered gene therapy, for Parkinson’s disease associated with GBA mutations (PD-GBA). A phase I/II trial will begin dosing in the third quarter of this year.
Monte Rosa Therapeutics Inc. has gained IND clearance from the FDA for MRT-8102, a NEK7-directed molecular glue degrader being developed to treat inflammatory conditions linked to NLRP3, IL-1β and IL-6 dysregulation.
Alys Pharmaceuticals Inc. has submitted a clinical trial application (CTA) to Germany’s Paul-Ehrlich-Institut (PEI) to initiate a phase I/Ib study of ALY-301 in healthy volunteers and patients with cold urticaria, a subtype of chronic inducible urticaria.
Myosin Therapeutics Inc. has obtained IND clearance by the FDA for MT-125. A phase I study will evaluate MT-125 in combination with standard-of-care radiation in patients with newly diagnosed IDH wild type, MGMT unmethylated glioblastoma.
The EMA’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending European orphan drug designation for Hemispherian AS’s GLIX-1 for the treatment of glioma.
Biocytogen Pharmaceuticals (Beijing) Co. Ltd. and Nanjing Chia Tai Tianqing Pharmaceutical Co. Ltd. have announced IND clearance by China’s National Medical Products Administration (NMPA) for NTB-003 (formerly BCG-009) for thyroid eye disease.
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