“Our regulatory application is planned for later in the year.”

In context

“EX and Iverdemine [ph]. We'll begin seeing data from these combinations next year, which could enable Phase 3 lines of therapy. Now moving to neuroscience. Interim data from the long term TEMPO-4 Phase 3 study continued to support Tavapadon’s favorable benefit risk profile. Efficacy in both early and advanced Parkinson's patients was maintained beyond a year and the safety profile was consistent with that observed in the previous Phase III studies with no new safety concerns identified. Rates of adverse events of special interest remained low with impulse control disorder and peripheral edema less than 1%, dyskinesia approximately 2% and sedation less than 5%. These results underscored Tavapadon's potential to become an important new treatment option for patients with Parkinson's disease. Our regulatory application is planned for later in the year. Moving to other areas of our pipeline. In aesthetics, the regulatory application for our rapid onset short acting toxin BoNT/E was recently submitted. We also began the clinical program to evaluate co administration of BoNT/E and BOTOX, which has the potential to be co-formulated as a novel product, offering the combined benefits of rapid onset and Botox like duration. In obesity, our partner, Gubra recently announced positive interim results from the first part of a multiple ascending dose study for our long acting amylin analog ABBV-295. This initial phase of the study tested one and two milligrams dosed once weekly for six weeks in healthy, lean and overweight patients. The study showed 295 performed well, demonstrating a dose dependent mean weight loss compared to placebo and a tolera”