Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
The U.S. FDA has cleared Zymeworks Inc.’s IND application for ZW-251, a novel glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) incorporating the company’s proprietary topoisomerase 1 (TOPO1) inhibitor payload, ZD-06519, for the treatment of hepatocellular carcinoma (HCC).
The U.S. FDA has granted Precision Biosciences Inc.’s PBGENE-DMD orphan drug designation for the treatment of Duchenne muscular dystrophy (DMD). PBGENE-DMD uses two complementary Arcus nucleases delivered via a one-time administration in a single AAV to excise exons 45-55 of the dystrophin gene in order to restore near full-length dystrophin protein within the body to improve functional outcomes.
SK Bioscience Ltd. announced that the company has submitted an investigational new drug (IND) application to the South Korean Ministry of Food and Drug Safety.
Amphix Bio LLC has been granted U.S. FDA orphan drug designation for its lead candidate AMFX-200 for the treatment of acute spinal cord injury (SCI). AMFX-200 is an FGFR (fibroblast growth factor receptor) and ITGB1 (integrin β1) agonist peptide amphiphile scaffold. In preclinical models of acute SCI, a single injection of AMFX-200 into the spinal cord enabled motor neurons from the brain to regrow past the injury site.
The U.S. FDA has cleared Genetic Leap’s IND application for GL-IL2-138, a small-molecule RNA drug that modulates natural IL-2, allowing for downregulating or upregulating of the immune system to fight diseases.
The U.S. FDA has cleared Aavantgarde Bio Srl’s IND application for AAVB-039, the company’s gene therapy program for Stargardt disease, the most common inherited form of macular degeneration.
Palatin Technologies Inc. has announced preclinical results for PL-7737, an oral selective melanocortin MC4 receptor (MC4R) agonist, showing effectiveness in rodent models of obesity.
The U.S. FDA has granted orphan drug designation to Klotho Neurosciences Inc.’s secreted-Klotho (s-KL) promoter, gene and delivery system (KLTO-202 or s-KL-AAV.myo) for the treatment of amyotrophic lateral sclerosis (ALS).
Eluciderm Inc. has received clearance from the U.S. FDA for its IND to conduct a phase I/IIa open-label study evaluating the safety and efficacy of ELU-42, a topical spray-on solution for open wound healing, in patients with diabetic foot ulcers (DFUs).
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