Levo Therapeutics

6 articles about Levo Therapeutics

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  Levo's Prader-Willi Drug Strikes Out on Efficacy with FDA

  1/18/2022

  ​The agency recommended another clinical trial be conducted to confirm the data from the study on the 3.2-mg dose of the intranasal carbetocin for Prader-Willi syndrome.
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  Clinical Catch-Up: August 3-7

  8/10/2020

  It was a moderately busy week for clinical trial news, with some particularly interesting announcements related COVID-19 vaccine trials. Here’s a look.

• Levo Therapeutics Announces Top-line Results from Phase 3 CARE-PWS Study of LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome

  8/6/2020

  Levo Therapeutics, Inc., a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome (PWS) and related disorders, announced today top-line results from the Phase 3 CARE-PWS clinical study evaluating LV-101 (intranasal carbetocin) for the treatment of PWS. This syndrome is a complex, neurodevelopmental disorder that occurs in approximately 1 in 16,000 births i and is characterized b

• Levo Therapeutics Receives Fast Track Designation From FDA for Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome

  11/18/2019

  Levo Therapeutics, Inc. announced that the U.S. Food and Drug Administration has granted Fast Track designation for LV-101 for the treatment of Prader-Willi syndrome Levo is currently enrolling participants in its Phase 3 clinical study of intranasal carbetocin for the treatment of PWS.

• Levo Therapeutics Announces Initiation of the CARE-PWS Phase 3 Study of Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome

  12/12/2018

  The study is a multi-center, randomized, double-blind, placebo-controlled study called CARE-PWS. 

• Levo Therapeutics Announces Publication of Phase 2 Study Results and Planned Phase 3 Study of Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome

  6/21/2018

  Levo Therapeutics Inc. announced today that JCI Insight has published the results of a Phase 2 study of intranasal carbetocin (LV-101).