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Google Scholar. Emily W. Evans, Pharm.
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Unresolved Staff Comments. Legal Proceedings. Mine Safety Disclosures. Selected Financial Data. Financial Statements and Supplementary Data. Controls and Procedures. Other Information. Directors, Executive Officers and Corporate Governance. Executive Compensation. Principal Accountant Fees and Services. Exhibits and Financial Statement Schedules. Form K Summary. We own or have rights to various copyrights, trademarks, and trade names used in our business in the U.
This report also includes trademarks, service marks and trade names of other companies. Trademarks, service marks and trade names appearing in this Annual Report on Form K are the property of their respective owners. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, time frames or achievements to be materially different from any future results, performance, time frames or achievements expressed or implied by the forward-looking statements.
We discuss many of these risks, uncertainties and other factors in this Annual Report on. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this filing. We hereby qualify our forward-looking statements by our cautionary statements. Except as required by law, we assume no obligation to update our forward-looking statements publicly, or to update the reasons that actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Item 1. Our lead marketed products are:.
Our strategy is to create shareholder value by:. Growing sales of the existing products in our portfolio, including by identifying and investing in growth opportunities such as new treatment indications and new geographic markets;. Acquiring or licensing rights to clinically meaningful and differentiated products on the market or product candidates at various stages of development; and. Pursuing targeted development of post-discovery differentiated product candidates. We apply a disciplined approach to allocating our resources between investments in our current commercial and development portfolio and acquisitions or in-licensing of new assets.
A summary of our ongoing development activities is provided below:. Disease Area. Solriamfetol JZP ES in narcolepsy. First patient enrolled in Phase 2 trial in first quarter of ; targeting completion of enrollment by late EDS and cataplexy in pediatric narcolepsy patients with cataplexy. EDS and cataplexy in narcolepsy. First patient enrolled in Phase 3 trial in first quarter of ; expect to complete enrollment in fourth quarter of ; subject to results of trial, expect to submit an NDA to the FDA in Idiopathic hypersomnia, or IH.
Expect to initiate Phase 3 trial in second half of Oxybate once-nightly dosing. Program progressing; evaluation of deuterated oxybate and other formulation options continues as part of once-nightly development process.
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High-risk AML. Myelodysplastic syndrome, or MDS.
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Preparing for Phase 2 trial with cooperative group with planned initiation in second half of First patient enrolled in Phase 3 trial in first quarter of First patient enrolled in Phase 2 proof of concept trial in first quarter of Expect to activate sites in pivotal Phase 2 trial in fourth quarter of ALL and other hematological malignancies. Evaluation of early-stage product candidates. CombiPlex combinations. Pre-clinical evaluation of oncology therapeutic combinations.