Report

IRLAB Therapeutics - Positive FDA mesdopetam outlook following EoP2

IRLAB Therapeutics reported positive feedback from its FDA end-of-Phase II (EoP2) meeting earlier in the week for mesdopetam. According to management, the meeting was held in a constructive and engaging spirit, and discussions during the meeting suggested alignment between the company and the regulatory authority on the design of a Phase III programme for mesdopetam as a potential treatment for levodopa-induced dyskinesias (PD-LIDs). In our view, this update is a positive sign for further clinical development of IRLAB’s lead asset, and we expect management to share more details on the formal feedback, which is expected in approximately 30 days.
Underlying
IRLAB Therapeutics

IRLAB Therapeutics AB is a Sweden-based research and development company. It focuses on illnesses in the central nervous system and primarily on development of drugs to assist patients with Parkinson's disease. The Company possesses a research platform Integrative Screening Process (ISP), which aims to discover and develop drug candidates for the treatment of brain diseases. The Company operates projects on both clinical phase and preclinical phases. The primary projects are IRL790 and IRL752, both on clinical phase. The IRL790 project is a psychomotor stabilizer for the treatment of levodopa (L-dopa) amino acid that dyskinesia induces in Parkinson's Disease (PD-LIDs) and Parkinson Disease psychosis (PD-Psychosis). The IRL752 project aims at cortical enhancement for the treatment of Parkinson Disease Dementia (PD-D) and Behavioral and Psychological Symptoms of Dementia (BPSD).

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Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Sean Conroy

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