We also know that births are down and we also surmise based on discussions with investigators and KOLs that new moms are much more reluctant to come into care during the pandemic. Stock Advisor will renew at the then current list price. Your line is open. This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. Can you talk about how an early response correlates with positive longer-term outcomes in MDD, and also a comment on how the onset of response for Zuranolone compares to other novel anti-depressant such as esketamine. Discounted offers are only available to new members. I'm pleased to share the first patient has been dosed in the Phase I program for SAGE-689 and we're on track to complete the Phase I SAM study in late 2021. I just had a quick question. We’re motley! Making the world smarter, happier, and richer. That was compared to a net loss of $136.3 million for the comparable period of 2020. 1y. So what we know about MDD, and there has been many studies from us and others, is that the earlier you diagnose and the more rapidly you get people better, the better the longer-term outcomes for depression and other comorbidities such as cardiovascular disease and diabetes. So we think of this is coming as a treat as needed therapy and as Steve mentioned this earlier on the call very important. Founded in 1960, Primoris, through various subsidiaries, has grown to become one of the largest construction service enterprises in the United States. We believe with pharmacologic characteristics of SAGE-324 are well suited to address unmet needs for these patients. Name Ticker High Low; Bellicum Pharmaceuticals, Inc. BLCM: 7.02: 2.67: James River Group Holdings, Ltd. JRVR: 54.7: 32.29: Workiva Inc. WK: 149: 82.51: New Relic, Inc . The advancement of the SAGE-689 and SAGE-319 programs represents meaningful expansion and acceleration of our SAGE developed wholly owned pipeline. Thanks, Jeff, and thank you everyone for joining us this morning. [Operator Instructions]. Investor Relations Corporate Profile We are a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined diseases in areas of high unmet medical need, with an initial focus on rare diseases. As we continue to review the substantial amount of data from the WATERFALL study in the rest of the Landscape Program, we are also committed to sharing data a premier scientific forums as quickly as possible. What We Do. Vice President, Investor, Media Relations and Corporate Development (626) 303-7902, Ext. Kimi will then provide an update on our financial progress during the quarter. We seek to make a positive impact on the unmet treatment needs of patients by advancing product candidates from a robust development pipeline of potential brain health disorder treatments. We look for disorders, where there is known or suspected NMDA hypofunction and were 718 we're looking at neurodegenerative disorders. So we're moving forward rapid. And with 4 positive data readouts in the first half of the year and multiple potential catalysts pending in the coming months, we are demonstrating the Sage methodology is working while executing across all three of our franchise, depression, neuropsych and neurology. Thank you. So when we lean into getting patients better with a two-week course of therapy that very much builds on a well described phenomenon, which is get people better quickly and we know that we're going to be able to get them back into their life, their role functioning and be able to begin that journey of of true recovery. It's sterling to see what's been achieved to date and we're just getting started. What happens when we co-administer an antidepressant with patients with zuranolone and the data we have today have patients [Technical Issues] these are not patients that you assume experience from the horrific side effects that you might on antidepressant. When we think about the last 35 to 50 years antidepressants, when we think about what's in development today, including some later stage programs nobody has seen an oral medicine that works after one or two doses, and as you know, we've seen statistical significance at day 3 with continued efficacy, and I'll ask Steve talked about the totality of data seen SHORELINE help to emphasize that point. Yeah, I mean the most important thing. Latest Financial Results Q2 2021. It's an exciting time for Sage and we're expanding and moving our pipeline forward for position of strength, underpinned by our strong financial position. We firmly believe zuranolone has the potential to offer a unique and compelling profile, if approved, with clinical data to date showing clinically meaningful reductions in depressive symptoms with consistent improvements in mood, anxiety and sleep. We'll have the actual metrics and numbers when the study completes. We're seeing 80% responses and somewhere between 40% and 50% remissions, you are not seeing that with any drug, let alone after a limited course of therapy. ET to discuss the KINETIC Study topline results. Real innovation has been absent treatments for depression for decades. We recorded $1.6 million in net revenue in the second quarter from the sales of ZULRESSO. The main part of the book outlines the collaborative process that clients and therapist work through to bring about change and highlights the role of the therapist in: ] creating the conditions for clients to express their thoughts, ... Thank you. And third, we're working to build a best-in-class commercialization program designed to help us address patients, HCPs and payers if our products are approved. I'll start the call by reviewing the progress made this quarter and our approach to supporting the millions of patients worldwide with brain health disorders, who are need of innovative medicines. I'm going to ask Steve to talk about the rest of experience to multiple steps to help anaswer that question for an improved drug. We also saw a statistically significant correlation between TETRA scores and activities of daily living at every time point. Quarter Ended Jun 30, 2021. But let me say this, a CORAL, as you highlighted as that an important question. So the kinds of things we've talked about, RSA, agitation where we know there remains an unmet need, whether it be an emergency settings or for people with severe dementia. We look forward to sharing more on our approach to engaging and educating key stakeholders as we ramp up our disease education and launch planning efforts for zuranolone. Q3 2020 Results (2) 23 July 2020. So, we're seeing really good response, that's been continuing both for first with 30 mg and now throughout the 50 mg dosing. Yeah, let me start and then ask Steve to comment. This call is being webcast live on the Investors and Media section of Sage's website at sagerx.com. I can say that this is the last data cut it was more than 500 patients enrolled in the trial and this will be the equivalent of a long-term safety study where we expect attrition throughout the year. Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced that the Company will present at the following upcoming investor conferences: Is it fair for us to assume the comparator arm, which is the typical SSRI could essentially be viewed as a traditional placebo arm since SSRIs takes 6 to 8 weeks to work or does co-initiated with an SSRI or still somehow change the calculus and then a corollary to that is, as we think about Day 42 could both arms improve on HAM-D as SSRI start to kick in. Investors. Salveen Richter -- Goldman Sachs -- Analyst. Found insideChapters in this book are contributed by: Jonathan Adeniji, Max Coates, Richard Davies, Rob Loe, Pauline Lovelock, Riccarda Matteucci, Elizabeth Negus, Kim Orton, Luke Sage, Rosemary Sage, and Sera Shortland. Note that this service is only available for 7 days and will end on Thursday 5th . Investors. Also in our depression franchise today we announced top line data from the Chickadee study evaluating the safety and tolerability and pharmacokinetics of ZULRESSO in adoloscent females aged 15 to 17 with postpartum depression. Perhaps just as importantly we saw clear maintenance of effect through day 42, four weeks after treatment was stopped. Corporate Profile. In May, we announced positive data from Part A of the PARADIGM study and SAGE-718 in Parkinson's disease cognitive dysfunction. These observations are important as they may help provide future regulatory flexibility. August 11, 2020 August 11, 2020. . They're going about their business. And also later this year we intend to initiate a randomized, placebo-controlled Phase 2 study in Huntington's disease, which is positive we expect will bring us one step closer and pursuing the initial regulatory indication for SAGE-718 as you can see so far in 2021 we've executed on the promised expansion and acceleration across our growing portfolio. With the SHORELINE data we patient off drug and Steve highlighted this earlier and they say that they are not seeking to get back on drug even though they're off drug. Found insideIn response to the needs of lecturers, the acclaimed Handbook of Organization Studies has been made available as two major paperback textbooks. Found inside – Page 5Number Employees : 9,000 SAGE Year Founded : 1981 SAHARA SAPHLITE GENUINE PARTS COMPANY Business Description : SEPRA ... Inti ) E - Mail For Key Personnel : VP - Fin ) Thomas J. DesRosier ( Gen Counsel , Public Relations : markus.sauter ... At Sage, our goal is to originate meaningfully differentiated drug candidates. So we will be aggressive in ensuring that that mom with depression has access to zuranolone. Moving beyond the narrow clinical perspective this book offers a view that takes into account the complex ways in which a batterer′s abusive and controlling behaviors are woven into the fabric of daily life. It's interesting because you're seeing elevated depression rates elsewhere, but not in postpartum depression. Jeff? Every mom as you know has a plan for when her water breaks, you knows where the bag is who is taking there in, who her position is going to be, where you're giving birth, but almost no momns have a plan for being depressed a week, two months, three months after the baby is born. 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