Report

IRLAB Therapeutics - End-of-Phase II FDA meeting set

IRLAB Therapeutics has scheduled an end-of-Phase II (EoP2) meeting (on 20 February 2024) with the US FDA for the mesdopetam programme. This marks an important milestone for IRLAB as it will evaluate the clinical data generated to date and aim to reach a conclusion for the design of the planned Phase III programme. The meeting should also outline a clear path to a possible new drug application (NDA), including if any other information is required to support an NDA submission. Management will announce the outcome of the EoP2 meeting within Q124 as feedback from the regulatory authority is provided up to 30 days afterwards.
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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