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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).

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.

The FDA has followed in the footsteps of its European counterparts and granted accelerated approval to PTC Therapeutics’ gene therapy Kebilidi for AADC deficiency. It is the first approved gene therapy to be delivered directly to the brain.

Neurogene’s shares fell by 36% as the market opened Monday morning following news that a patient experienced systemic hyperinflammatory syndrome in a Phase I/II clinical trial of Rett syndrome gene therapy NGN-401.