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Karuna Therapeutics, Inc. (NASDAQ: KRTX) reported positive topline results from its Phase 3 EMERGENT-3 trial of KarXT, aimed at treating schizophrenia. The trial met its primary endpoint with an 8.4-point reduction in PANSS total score compared to placebo at Week 5 (p<0.0001). KarXT was well tolerated, with side effects consistent with previous studies. The company plans to submit a New Drug Application (NDA) to the FDA in mid-2023, targeting a launch in the second half of 2024 if approved. A pre-NDA meeting is set for early Q2 2023.
Karuna Therapeutics (NASDAQ: KRTX) announced a net loss of $76.2 million for Q4 2022 and $276.3 million for the year, driven by increased operating expenses totaling $300.3 million. The company plans to submit a New Drug Application for KarXT in schizophrenia by mid-2023, with topline data from the Phase 3 EMERGENT-3 trial expected soon. A global exclusive license for TRPC4/5 inhibitors, including KAR-2618, was secured for $15 million. Cash reserves reached $1.1 billion, projected to fund operations through 2025. Overall, 2022 marked significant achievements with ongoing trials and anticipated milestones for 2023 and beyond.
Karuna Therapeutics, Inc. (NASDAQ: KRTX) will present at the SVB Securities Global Biopharma Conference on February 14, 2023, at 2:20 p.m. EST. The conference will showcase Karuna's commitment to developing transformative medicines for psychiatric and neurological conditions. A live webcast of the presentation will be available on the Investor Relations page of Karuna's website, and a replay will be archived for up to 30 days post-conference. Karuna focuses on creating differentiated treatments that address critical patient needs by utilizing advanced neuroscience insights.
Karuna Therapeutics has secured an exclusive global license to develop and commercialize TRPC4/5 candidates, including lead candidate GFB-887, from Goldfinch Bio. Karuna will make a $15 million upfront payment and could pay up to $520 million in milestone payments plus royalties. GFB-887 is aimed at treating mood and anxiety disorders, with detailed development plans to be shared in late 2023. The deal aligns with Karuna's goal to become a fully integrated neuroscience company and addresses a significant unmet need for innovative psychiatric treatments.
Karuna Therapeutics, Inc. (NASDAQ: KRTX) has appointed Will Kane as chief commercial officer (CCO), effective February 6, 2023. This strategic move aims to facilitate the transition of Karuna into a fully integrated research and development and commercial organization, with a significant focus on the potential approval and launch of KarXT for treating schizophrenia. Kane brings over 30 years of experience in the pharmaceutical industry, having held senior roles in leading companies like Allergan and Pfizer, and successfully launched brands like VRAYLAR and UBRELVY. This leadership change could enhance the company's strategic direction in commercializing its products.
Karuna Therapeutics (NASDAQ: KRTX) announced that its CEO, Bill Meury, will present at the 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023, at 9:00 a.m. PST (12:00 p.m. EST). A live webcast of the presentation will be available on the company's Investor Relations page and can be rewatched for up to 30 days post-conference. The company focuses on developing transformative medicines for psychiatric and neurological conditions, aiming to enhance treatment effectiveness for patients.
Karuna Therapeutics (NASDAQ: KRTX) announced the appointment of Bill Meury as the new president and CEO, effective January 3, 2023. He succeeds Steve Paul, M.D., who transitions to president of research and development and chief scientific officer. Christopher Coughlin will become chairman of the board. Meury brings over 25 years of experience in the pharmaceutical industry, including significant roles at Allergan, where he managed over $16 billion in revenue. Meury's leadership aligns with Karuna's strategy for advancing its innovative treatments for psychiatric and neurological conditions.
Karuna Therapeutics (KRTX) announced its financial results for Q3 2022, reporting a net loss of $77 million, up from $50.9 million in Q3 2021. This loss was driven by enhanced research and development expenses totaling $62 million, primarily due to ongoing Phase 3 trials for schizophrenia and Alzheimer’s psychosis. The company bolstered its cash reserves to $1.2 billion, expected to support operations through 2025. Key milestones include the NDA submission for KarXT in schizophrenia anticipated in mid-2023 and topline data from ongoing trials, with positive outcomes from the EMERGENT-2 trial.
Karuna Therapeutics, Inc. (NASDAQ: KRTX) announced that CFO Troy Ignelzi will participate in a fireside chat at the Jefferies 2022 London Healthcare Conference on Wednesday, November 16, 2022, at 3:50 p.m. GMT (10:50 a.m. EST). A live webcast will be available on Karuna's Investor Relations page, with a replay accessible for 30 days post-event. Karuna is focused on developing transformative medicines for psychiatric and neurological conditions, leveraging neuroscience to create effective treatments for severe disorders.
PsychoGenics Inc. announced an extension of its collaboration with Karuna Therapeutics, Inc. (NASDAQ: KRTX) for drug discovery targeting severe neuropsychiatric disorders. Initially established in July 2020, the partnership allows Karuna to utilize PsychoGenics' advanced AI-driven screening platforms, enhancing its pipeline for neuropsychiatric treatments. Both companies expressed optimism about the collaboration's potential to deliver innovative therapies for serious mental health conditions. PsychoGenics' expertise in drug discovery and collaboration with major pharmaceutical firms continues to yield promising results.