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PEP-Therapy, a clinical-stage biotechnology company developing first-in-class peptides as targeted therapies in oncology, and Institut Curie, France’s leading cancer center, announced the dosing of the first patients in a Phase Ib clinical trial evaluating PEP-Therapy’s lead candidate, PEP-010, based on highly encouraging Phase Ia results.

RION’s Phase 2A clinical trial focuses on evaluating the safety and efficacy of Platelet Exosome Product™ (PEP™) combined with TISSEEL fibrin sealant for treating Diabetic Foot Ulcers (DFU).

The FDA has put a stop to U.S. initiation of PepGen’s Phase II trial for its Duchene muscular dystrophy treatment. The company faced the same hurdle for an earlier neuromuscular candidiate in 2023.

RION, a clinical-stage regenerative medicine company at the forefront of exosome therapeutics, announced today the first subject was dosed in the Phase 2 clinical trial with its novel product, known as Purified Exosome Product™ (PEP™).

After failing to receive the RMAT designation from the FDA for its early-stage Batten disease gene therapy, Neurogene tells investors that it’s evaluating options for the program.

In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified Huntington’s Disease Rating Scale, and neurofilament light chain levels to support the accelerated approval of its gene therapy AMT-130.