Business
Praxis Precision Medicines Provides Corporate Update and Reports First Quarter 2022 Financial Results
PRAX-944 demonstrated clinically meaningful functional improvement in essential tremor patients in Part B of Phase 2a study PRAX-114 Phase 2/3 monotherapy MDD
About this update from Praxis Precision Medicines, Inc.
[{"type":"text","content":"PRAX-944 demonstrated clinically meaningful functional improvement in essential tremor patients in Part B of Phase 2a study PRAX-114 Phase 2/3 monotherapy MDD Aria Study completed; topline results expected in June 2022 Epilepsy Day showcases largest targeted epilepsy portfolio in industry Cash and investments of $222.5 million as of March 31, 2022 supports runway into 3Q23 BOSTON, May 09, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today provided a corporate update, including a video highlighting recent business and pipeline progress, and reported financial results for the first quarter 2022. “This is an incredibly exciting time at Praxis, with recent events bringing us closer to our long-term vision,” said Marcio Souza, president and chief executive officer of Praxis. “With positive topline results from our PRAX-944 Phase 2a study in essential tremor, and plans to accelerate development in the ongoing Essential1 study, we will soon have a second late-stage clinical asset along with a deep and innovative early-stage pipeline. We also recently completed our PRAX-114 Aria study, with last patient last visit achieved, and look forward to sharing those topline results in June.” Recent Business Highlights and Upcoming Milestones: Psychiatry Following the completion of the PRAX-114 Phase 2/3, placebo-controlled Aria Study for monotherapy treatment of Major Depressive Disorder (MDD), Praxis expects to report topline results in June 2022. The Aria Study is intended to serve as one of two trials required by the U.S. Food and Drug Administration (FDA) to demonstrate clinical efficacy to support registration of PRAX-114 for monotherapy treatment of MDD. Following topline results from the Aria Study, the Company intends to engage with the FDA for an end-of-Phase 2 meeting and subsequently initiate a Phase 3, placebo-controlled study in the fourth quarter of 2022.The Company anticipates topline results from the PRAX-114 Phase 2, placebo-controlled, dose-ranging Acapella Study for treatment of MDD in the third quarter of 2022. The Acapella Study is intended to provide additional understanding of the dose rang...