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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Sage Therapeutics Inc | NASDAQ:SAGE | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.69 | -4.95% | 13.25 | 13.25 | 14.27 | 14.3089 | 13.23 | 14.00 | 524,747 | 22:14:01 |
ZULRESSO™ (brexanolone) injection approved by U.S. FDA and on track for launch in late June
Commercial team is launch ready; field teams focusing on payer engagement and identifying pathways to care
Strong financial position with ~$1.4B in cash
Milestones anticipated throughout 2019 in clinical studies across all three franchises: depression, neurology and neuropsychiatry
Conference call today at 8:00 A.M. ET
Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today reported business highlights and financial results for the first quarter ended March 31, 2019.
“We started 2019 with positive data from a Phase 3 clinical trial of our lead oral compound SAGE-217 in postpartum depression and this was quickly followed by the FDA approval of ZULRESSO in PPD,” said Jeff Jonas, M.D., chief executive officer at Sage. “It was gratifying that our first drug approval generated extensive media coverage of a disorder that for too long has been shrouded by stigma and shame. We anticipate additional momentum in our development efforts during the remainder of the year across our three franchises in depression, neurology and neuropsychiatry and believe the depth and breadth of our novel portfolio of compounds in these areas is unrivaled in the industry. We are confident in our potential to create a paradigm shift in the way brain health is thought about and treated.”
Depression Franchise:Led by ZULRESSO™ (brexanolone) injection, approved by the U.S. Food and Drug Administration (FDA) in March 2019 as the first treatment specifically indicated for postpartum depression (PPD), and SAGE-217, which is being evaluated in clinical studies as a treatment for major depressive disorder (MDD), PPD, bipolar depression as well as comorbid MDD and insomnia. SAGE-217 has received breakthrough therapy designation from the FDA for the treatment of MDD.
Neurology Franchise:Led by SAGE-324, a next-generation positive allosteric modulator (PAM) of GABAA receptors, in development as a potential therapy for neurological conditions, such as essential tremor (ET) and epileptiform disorders.
Neuropsychiatry Franchise:Led by SAGE-718, a first-in-class NMDA receptor PAM, in development as a potential therapy for certain cognition-related disorders impacted by NMDA receptor dysfunction.
Anticipated Upcoming Milestones
Financial Results for the First Quarter of 2019
Financial Guidance
Conference Call InformationSage will host a conference call and webcast today at 8:00 A.M. ET to discuss its first quarter 2019 financial results and recent corporate updates. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. The conference call can be accessed by dialing 1-866-450-8683 (toll-free domestic) or 1-281-542-4847 (international) and using the conference ID 5968036. 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.
About Sage TherapeuticsSage Therapeutics is a biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders. Sage’s portfolio of novel compounds targets critical receptor systems in the brain and includes the first treatment specifically approved by the U.S. Food and Drug Administration for postpartum depression as well as compounds being developed as potential treatments for diseases such as major depressive disorder, insomnia, bipolar disorder and essential tremor. For more information, please visit www.sagerx.com.
Forward-Looking StatementsVarious statements in this release concern Sage's future expectations, plans and prospects, including without limitation: our expectations regarding the timing of scheduling and launch of ZULRESSO in the treatment of PPD; our plans regarding anticipated future commercial and patient support activities; our expectations regarding availability of REMS-certified sites of care for the administration of ZULRESSO and access to treatment for women with PPD; our statements regarding the potential for reimbursement of ZULRESSO; our view as to the potential for us to change the way brain health is treated; our statements regarding the target product profiles, plans and timelines for development of our product candidates, including planned clinical activities and reporting of results; our views as to the depth and breadth of our portfolio and the opportunity represented by our programs and business; and our expectations regarding our cash position at year-end and increases in operating expense. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. 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: scheduling and launch of ZULRESSO may not occur on the timelines we expect; we may encounter issues or other challenges in launching and commercializing ZULRESSO, including issues related to market acceptance by healthcare providers, healthcare settings and women with PPD, challenges with reimbursement, issues related to limitations on the site of administration of ZULRESSO to REMS-certified supervised healthcare settings and the other requirements of the REMS, and challenges associated with execution of our sales and patient support activities, which in each case could limit the potential of ZULRESSO; results achieved with use of ZULRESSO in the treatment of PPD once we have launched the product may be different than observed in clinical trials, and may vary among patients; the number of women with PPD or the unmet need for additional treatment options may be significantly smaller than we expect; we may encounter unexpected safety or tolerability issues with ZULRESSO or any of our product candidates; we may not be successful in our development of any of our current or future 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; the FDA may decide that the development program for any of our product candidates, even if positive, is not sufficient for a new drug application filing or approval; 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; we may experience slower than expected enrollment in ongoing or future clinical trials; the internal and external costs required for our anticipated launch and commercialization activities and ongoing and planned research and development efforts, and to build our organization in connection with such activities, and the resulting expense increases and use of cash, may be higher than expected, or we may conduct additional clinical trials or pre-clinical studies, or engage in new activities, requiring additional expenditures and using cash more quickly than anticipated and we may encounter technical and other unexpected hurdles in the commercialization of ZULRESSO or in the development of our product candidates; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent report filed with the Securities and Exchange Commission (SEC), and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. 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.
Sage Therapeutics, Inc. and SubsidiariesCondensed Consolidated Statements of Operations(in thousands, except share and per share data)(Unaudited)
Three Months Ended March 31,2019
2018
Collaboration revenue $ 465 $ - Operating expenses: Research and development 86,398 49,270 General and administrative 83,919 28,849 Total operating expenses 170,317 78,119 Loss from operations (169,852 ) (78,119 ) Interest income, net 6,442 3,529 Other income (expense), net 4 (8 ) Net loss $ (163,406 ) $ (74,598 ) Net loss per share - basic and diluted $ (3.37 ) $ (1.68 ) Weighted average shares outstanding - basic and diluted 48,491,834 44,325,371Sage Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands)
(Unaudited)
March 31,2019
December 31,2018
Cash, cash equivalents, restricted cash and investments $ 1,353,618 $ 925,143 Total assets $ 1,422,914 $ 952,705 Total liabilities $ 103,380 $ 89,734 Total stockholders' equity $ 1,319,534 $ 862,971Important Safety Information:
What is ZULRESSO™?
ZULRESSO is a prescription medicine used in adults to treat a certain type of depression called Postpartum Depression.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ZULRESSO?
ZULRESSO can cause serious side effects, including:
Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
ZULRESSO and some medicines may interact with each other and cause serious side effects.
Especially tell your healthcare provider if you take other antidepressants, opioids, or Central Nervous System (CNS) depressants (such as benzodiazepines).
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.
How will I receive ZULRESSO?
ZULRESSO is given to you by continuous intravenous (IV) infusion into your vein. The infusion will last for a total of 60 hours (2.5 days).
What should I avoid while receiving ZULRESSO?
What are the possible side effects of ZULRESSO?
ZULRESSO can cause serious side effects, including:
How can I watch for and try to prevent suicidal thoughts and actions?
Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
The most common side effects of ZULRESSO include:
These are not all the side effects of ZULRESSO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for ZULRESSO™ and discuss any questions you may have with your healthcare provider.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190502005211/en/
Investor Contact:Maren Killackey, 617-949-4113maren.killackey@sagerx.com
Media Contact:Jeff Boyle, 617-949-4256jeff.boyle@sagerx.com
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