5/18/2023 0 Comments Russian sage![]() ![]() ![]() Now as I mentioned during our last earnings call, during this review period, we'll not be making detailed comments on the potential label, FDA interactions or other related topics for zuranolone.Īs we prepare for the potential answer of zuranolone, we and Biogen are continuing permitted prelaunch commercialization activities. First, the NDA filing for zuranolone in MDD and PPD is under review by the FDA with a PDUFA action date of August 5th. Looking forward, we have many key milestones on the horizon. Importantly, our work is backed by a strong financial foundation that we believe puts us in a position to further our pipeline ambitions with the goal of being able to launch new drugs or new indications for years to come. We believe our pipeline holds the potential to help millions of people suffering from brain health disorders and deliver significant long-term value creation. We're also advancing our robust brain health pipeline comprised of several new chemical entity development candidates that is a result of our product engine. We are laser focused on preparing for the potential launch of zuranolone and believe we're on our way to achieving our vision of transforming the treatment of depression if zuranolone brew Time is now proceeds to lead the way in making a difference for patients.Ģ023 will be a pivotal year for Sage and is already off to a strong start. This reflects Mental Health Awareness Month reminds us all that we must do more to challenge these trends. Alarming research published recently by the World Health Organization shows that rates of suicide have increased in the U.S. This month marks Mental Health Awareness Month, which is an important reminder that the need for innovative brain health medicines has never been greater.ĭepression is the leading cause of disability for young people and those in their prime working years and the problem, as we all know, continues to grow. We do this by acting with urgency and challenging scientific convention to think differently as we work to develop new and effective treatments. At Sage, we are driven by our mission to develop brain health medicines that deliver what matters most to patients, so every person can thrive. Thanks, Helen, and thank you everyone for joining us this morning. With that, I'll now turn the call over to Barry. We will also be joined by Jim Doherty, our Chief Development Officer, who will review recent progress and development activities across our program, our Chief Business Officer, Chris Benecchi, who will provide an update on our preparations for the potential launch of zuranolone in MDD and PPD, and we will then be joined Kimi Iguchi, our Chief Financial Officer, who will review the financial results from the first quarter 2023, Laura Gault, our Chief Medical Officer will be available during the Q&A portion of the call. We will begin the call with prepared remarks by Barry Greene, our Chief Executive Officer, who will provide an overview of our progress during the first quarter of 2023. Please review the risk factors discussed in today's press release and in our SEC filings for additional details. These statements are subject to certain risks and uncertainties and our actual results may differ materially. ![]() I'd like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. Before we begin, I encourage everyone to go to the Investors and Media section of our website at, where you can find the press release related to today's call, as well as the slides that we would be reviewing today. Good morning and thank you for joining Sage Therapeutics' first quarter 2023 financial results conference call. I would now like to introduce Helen Rubinstein, Director of Investor Relations at Sage. Please note that this call is being recorded. This call is the property of Sage Therapeutics and recording, reproduction, or transmission of this call without the expressed written consent of Sage Therapeutics is strictly prohibited. This call is being webcast live on the Investors and Media section of Sage's website at. ![]() Currently, all participants are in a listen-only mode. Welcome to the Sage Therapeutics' First Quarter 2023 Financial Results Conference Call. Helen Rubinstein - Director of Investor Relations ( NASDAQ: SAGE) Q1 2023 Earnings Conference Call 8:00 AM ET ![]()
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