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| • | | Initiated a Phase 1 double-blind, placebo-controlled MAD study to determine the safety, tolerability and pharmacokinetics ofSAGE-718 in approximately 10 patients with early manifest Huntington’s disease. Topline results are anticipated in 2H 2019. |
Webcast Information for J.P. Morgan Healthcare Conference Presentation
Sage is scheduled to present at the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 at 3:30 p.m. PST (6:30 p.m. EST), followed by a Q&A session. A live webcast of the presentation and Q&A session can be accessed on the investor page of Sage’s website at investor.sagerx.com. A replay of the webcast will be available on Sage’s website approximately two hours after the completion of the event and will be archived for up to 30 days.
Forward-Looking Statements
Various statements in this release concern Sage’s future expectations, plans and prospects, including without limitation statements regarding: our expectations regarding the possible approval of our NDA filing for ZULRESSO™ (brexanolone) injection, including the target timing of a decision by the FDA; our plans regarding the timing of launch of ZULRESSO in PPD and future commercial activities, if approved; our statements regarding plans and timelines for clinical development ofSAGE-217,SAGE-324 andSAGE-718, including potential indications and the potential timing of data availability; and our views as to the opportunity represented by Sage’s portfolio and business. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: the FDA may decide not to approve ZULRESSO as a treatment for PPD and may determine that additional trials or data are necessary in order to obtain approval; the FDA may not complete its review of our filing within the target timelines; even if ZULRESSO is successfully approved for PPD in the U.S., we may encounter issues, delays or other challenges in launching or commercializing the product, including issues related to timing of DEA scheduling, issues related to market acceptance and reimbursement, challenges associated with restrictions or conditions that may be imposed by regulatory authorities, including challenges related to limiting the site of administration to a certified healthcare facility monitored by a qualified healthcare provider, and the necessity for a REMS, and challenges associated with the execution of our sales and patient support activities, which in each case could limit the potential of our product; we may encounter unexpected safety or tolerability issues with ZULRESSO,SAGE-217,SAGE-324,SAGE-718 or any of our other product candidates in ongoing or future development; we may not be successful in our development ofSAGE-217,SAGE-718,SAGE-324 or any of our other product candidates in any indication we are currently pursuing or may in the future pursue; success in early stage clinical trials may not be repeated or observed in ongoing or future studies of any of our product candidates; ongoing and future clinical results may not support further development or be sufficient to gain regulatory approval of our product candidates; we may decide that a development pathway for one of our product candidates in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, progress and cost of clinical trials and our ability to proceed with further development or may impact the regulatory pathway; we may experience slower than expected enrollment in ongoing or planned clinical trials; the internal and external costs required for our activities, and to build our organization in connection with such activities, and the resulting use of cash, may be higher than expected, or we may conduct additional clinical trials orpre-clinical studies, or engage in new activities, requiring additional expenditures and using cash more quickly than anticipated which could delay, slow or limit our efforts; and we may encounter technical and other unexpected hurdles in the development, manufacture and potential future commercialization of our product candidates; as well as those risks more fully discussed in the section entitled “Risk Factors” in our most recent Quarterly Report on Form10-Q, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.