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Levo Therapeutics, Inc.

https://www.levotx.com/

Latest From Levo Therapeutics, Inc.

Deal Watch: Sanofi To Tap Owkin’s AI, Machine Learning In Oncology

French pharma makes $180m equity investment in Owkin under collaboration targeting four cancer types. Pyramid gets global license to MPS1 precision cancer candidate from Voronoi.

Deal Watch Business Strategies

Unmet Need Is Not Enough: US FDA AdComm Rejects Levo’s Carbetocin For Prader Willi Syndrome

Patient representative was lone ‘yes’ vote, and even she acknowledged using a broad interpretation of ‘substantial evidence.’ The only route forward for Levo may be a new trial, though expanded access could be an option in the near term.

Advisory Committees Rare Diseases

Levo’s Carbetocin Faces Advisory Committee Hurdle Given FDA ‘Uncertainty’ About Its Effectiveness

US FDA points to inconsistency in Phase II and Phase III study results, lack of additional substantiating studies and lack of robust statistical findings. Advisory committee is to vote on whether there is ‘substantial evidence’ that the nasal spray is effective in treatment of hyperphagia associated with Prader-Willi syndrome.

Advisory Committees Rare Diseases

A Break-Even Year For US FDA Advisory Committees?

Meetings have continued to be sparse through 2021, but there will end up being nearly as many panels on withdrawing approved uses as on approving new ones.

Advisory Committees Approvals
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