Newron Pharmaceuticals Advances Pivotal Phase III Program for Treatment-Resistant Schizophrenia
• Newron Pharmaceuticals has received regulatory approval for its ENIGMA-TRS Phase III program evaluating Evenamide as an add-on therapy for treatment-resistant schizophrenia, with patient recruitment beginning immediately.
• The pivotal program consists of two studies designed to meet requirements for marketing authorization in major markets including the USA and Europe, with results expected by late 2026.
• Evenamide, a first-in-class glutamate modulator, has shown promising results in earlier trials with 70% of TRS patients experiencing clinically significant benefits and 25% achieving remission during one-year treatment.
Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development
• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development.
• FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer.
• Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.
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