SAGE Therapeutics

SAGE Therapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of novel medicines. It targets diseases and disorders of the brain with three key focus areas: depression, neurology, and neuropsychiatry. The company was founded by Steven Marc Paul and Douglas Covey on April 16, 2010, and is headquartered in Cambridge, MA.

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SAGE Therapeutics poised for Zuranolone launch in 2023, overcoming challenges

SAGE Therapeutics showcased strong financial performance and promising developments with Zuranolone, positioning the drug favorably for potential launch in 2023.
While facing challenges such as enrollment issues and DEA scheduling impacts, the company is leveraging opportunities in commercialization strategies and post-marketing studies to enhance Zuranolone's market presence.
Overall, Zuranolone's rapid and durable effects, alignment with current treatment practices, and targeted commercialization approach present a compelling opportunity for SAGE Therapeutics in the mental health treatment landscape.
By addressing challenges effectively and capitalizing on opportunities, SAGE Therapeutics is poised to make a significant impact in advancing treatments for mood disorders and improving patient outcomes.

Sage Therapeutics reports strong Q1 performance and eyes market expansion

Sage Therapeutics had a strong Q1 2023, focusing on brain health medicines and preparing for zuranolone's launch.
The company's financial position is solid, with growth opportunities in pipeline programs and proactive payer engagements.
Challenges include regulatory uncertainties and competition, but Sage is well-positioned to capitalize on market demand.
Opportunities lie in expanding product indications, proactive agreements with payers, and learning from competitors for strategic advantage.

SAGE Therapeutics to Launch Zurzuvae for Postpartum Depression, Overcomes FDA Setback

SAGE Therapeutics is poised to launch Zurzuvae for postpartum depression, leveraging its financial strength and clinical success. While facing challenges in MDD, the company is strategically adapting to focus on PPD and enhance operational efficiency. Opportunities lie in collaborations, pricing strategies, and addressing the significant market need for PPD treatments.

SAGE Therapeutics advances women's health with ZURZUVAE approval

SAGE Therapeutics navigates financial challenges while advancing innovative treatments for women's health.
ZURZUVAE's approval and commercialization plans present opportunities in a significant market segment.
Strategic focus on engagement, access, and market positioning key to ZURZUVAE's success.
Pipeline advancements and collaboration efforts position SAGE for future growth and impact.

SAGE Therapeutics excels with ZURZUVAE launch, poised for continued growth

SAGE Therapeutics had a strong performance in 2023, driven by the successful launch of ZURZUVAE and positive early market reception.
While facing challenges in data tracking and market competition, the company's focus on innovation and patient access presents growth opportunities.
With a robust pipeline and strategic initiatives in place, SAGE is well-positioned to maintain momentum and drive further success in the brain health space.

SAGE Therapeutics reports strong Zurzuvae launch amidst Parkinson's study setback

SAGE Therapeutics is navigating challenges from the PRECEDENT study while capitalizing on Zurzuvae's successful launch for PPD.
The company's pipeline progress and commitment to addressing cognitive disorders in neurodegenerative diseases showcase a strong focus on brain health.
Collaborative efforts with Biogen, strong payer coverage, and positive market feedback position Zurzuvae as a frontline treatment for PPD.
Strategic initiatives to educate prescribers, expand market reach, and refine study designs present promising growth opportunities for SAGE.

SAGE Therapeutics faces setbacks but sees success with ZURZUVAE in Q2

SAGE Therapeutics navigates setbacks with SAGE-324 study closure but sees success with ZURZUVAE in PPD treatment. Strong financial foundation and commitment to brain health initiatives position the company for future growth.

SAGE Therapeutics focuses on Zurzuvae for PPD treatment success

SAGE Therapeutics prioritizes Zurzuvae for PPD, showing strong revenue growth and prescription uptake
Challenges include discontinuation of certain programs and mixed results in clinical studies
Opportunities lie in focusing resources, upcoming study results, and strategic program ownership
Overall, SAGE's reorganization reflects a strategic shift towards maximizing Zurzuvae's potential

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SAGE Therapeutics, Inc. is a biopharmaceutical company, which engages in providing solutions to brain health medicines. It focuses on diseases and disorders of the brain. Its products include ZURZUVAE and ZULRESSO. The company was founded by Steven Marc Paul and Douglas Covey on April 16, 2010 and is headquartered in Cambridge, MA.

The stock price of SAGE Therapeutics Inc (NASDAQ: SAGE) increased by 3.53% in the most recent trading session. This is why.

SAGE Stock: 3.53% Increase Explanation

Shares of Sage Therapeutics Inc. SAGE, -0.96% gained about 5% in premarket trading on Monday after the company said the experimental treatment for major depressive disorder and postpartum depression that it's developing with Biogen Inc. BIIB, -1.35% received Priority Review.

FDA grants Priority Review to depression drug; Sage's stock rallies

Biogen

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational drug being evaluated as a 14-day, rapid-acting, once-daily, oral treatment in adults with MDD and PPD. The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5, 2023.

Sage Therapeutics and Biogen Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that it will host a live webcast on Thursday, February 16, 2023 at 8:00 a.m. ET to review fourth quarter and full year 2022 financial results and discuss recent business updates.

Sage Therapeutics to Report Fourth Quarter and Full Year 2022 Financial Results on Thursday, February 16, 2023

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Biotech's Blockbuster Week: 3 Stocks to Watch

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that Chief Executive Officer, Barry Greene, will discuss the Company's progress in developing a leading brain health pipeline at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Sage Therapeutics to Provide Update on 2023 Key Initiatives at 41st Annual J.P. Morgan Healthcare Conference

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 10:30 a.m. PT in San Francisco, CA.

Sage Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023

Sage Therapeutics, Inc. completed its rolling submission to the FDA for zuranolone in two indications. Zuranolone is a better formulation of Sage Therapeutics' marketed postpartum drug.

Sage Therapeutics Could Be In For A Depressing FDA Review

Atai Life Sciences BV

Atai, Biogen, and Sage are working to develop new treatments for mental illness.

3 Biotech Stocks Aiming to Reinvent Mental Health Treatment

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an investigational drug being evaluated as a rapid-acting, once-daily, 14-day oral short course treatment in adults with MDD and PPD. The submission completes the NDA filing that was initiated earlier this year.

Sage Therapeutics and Biogen Complete Rolling Submission of New Drug Application for Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the Piper Sandler 34th Annual Healthcare Conference on Thursday, December 1, 2022, at 8:00 a.m. ET in New York, NY.

Sage Therapeutics to Present at the Piper Sandler 34th Annual Healthcare Conference

CAMBRIDGE, Mass.--( BUSINESS WIRE )--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced that the companies will host a joint investor webcast to discuss the planned commercialization approach and opportunity for their investigational product, zuranolone, on Tuesday, December 6 at 8:00 a.m. ET.

Sage Therapeutics and Biogen to Host Investor Webcast on December 6, 2022 to Discuss Potential Commercialization Plans for Zuranolone

Sage Therapeutics to Present at the Stifel 2022 Healthcare Conference

Sage Therapeutics, Inc. (NASDAQ:SAGE ) Q3 2022 Earnings Conference Call November 8, 2022 8:00 AM ET Company Participants Helen Rubinstein - Director, IR Barry Greene - Chief Executive Officer Kimi Iguchi - Chief Financial Officer Jim Doherty - Chief Development Officer Chris Benecchi - Chief Business Officer Jeff Jonas - Chief Innovation Officer Conference Call Participants Yasmeen Rahimi - Piper Sandler Ritu Baral - Cowen Salveen Richter - Goldman Sachs Paul Matteis - Stifel Laura Chico - Wedbush Jay Olson - Oppenheimer Ami Fadia - Needham & Company Sumant Kulkarni - Canaccord Genuity Joon Lee - Truist Operator Good morning. Welcome to the Sage Therapeutics' Third Quarter 2022 Financial Results Conference Call.

Sage Therapeutics, Inc. (SAGE) Q3 2022 Earnings Call Transcript

Sage Therapeutics Announces Third Quarter 2022 Financial Results and Highlights Pipeline and Business Progress

Sage Therapeutics Appoints Laura M. Gault, M.D.

Sage Therapeutics, Inc. (SAGE) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Sage Therapeutics, Inc. (SAGE) May Report Negative Earnings: Know the Trend Ahead of Q3 Release

Sage Therapeutics to Report Third Quarter 2022 Financial Results on Tuesday, November 8, 2022

Sage Therapeutics and Biogen Present Further Analyses from Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression at the European College of Neuropsychopharmacology (ECNP) Congress

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced new analyses from across the development program for zuranolone, an investigational, oral, once-daily, 14-day treatment in clinical development for adult patients with major depressive disorder (MDD) and postpartum depression. The 11 new analyses are being presented at the 2022 Psych Congress in New Orleans, September 17 to 20. An analysis from the ongoing open-label, longitu

Sage Therapeutics and Biogen Present New Analyses at Psych Congress Further Evaluating the Efficacy and Safety of Zuranolone

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022, at 3:40 p.m. ET in New York, NY. A live webcast of the presentation can be accessed on the Investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available approxi

Sage Therapeutics to Present at Morgan Stanley 20th Annual Global Healthcare Conference

The "brain health pandemic" since Covid struck exposed a glaring void: Current depression treatments don't fit many patients' needs. A group of biotech stocks hope to change that.

Covid Exposed A 'Brain Health Pandemic' — Here's How Biotech Stocks Like Biogen, Sage Therapeutics Could Help

Sage Therapeutics, Inc. (NASDAQ:SAGE ) Q2 2022 Earnings Conference Call August 2, 2022 8:00 AM ET Company Participants Helen Rubinstein - IR Barry Greene - CEO Albert Robichaud - Chief Scientific Officer Chris Benecchi - Chief Business Officer Kimi Iguchi - CFO Conference Call Participants Ritu Baral - Cowen Paul Matteis - Stifel Ami Fadia - Needham Jay Olson - Oppenheimer Swapnil Malekar - Piper Sandler Yatin Suneja - Guggenheim Marc Goodman - SVB Leerink Gospel Enyindah-Asonye - Morgan Stanley Gary Nachman - BMO Neena Bitritto-Garg - Citi Stephen Mallon - RBC Capital Markets Alex Nackenoff - Raymond James Operator Good morning. Welcome to Sage Therapeutics' Second Quarter 2022 Financial Results Conference Call.

Sage Therapeutics, Inc. (SAGE) CEO Barry Greene on Q2 2022 Results - Earnings Call Transcript

CAMBRIDGE, Mass.--(BUSINESS WIRE)---- $SAGE #Sage--Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the second quarter ended June 30, 2022. “The first half of 2022 has been marked by important clinical and regulatory achievements across our entire pipeline, paving the way for continued focused execution throughout the remainder of the year,” said Barry Greene, Chief Execut

Sage Therapeutics Announces Second Quarter 2022 Financial Results and Highlights Pipeline and Business Progress

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, announced today that the Company will present at the following upcoming investor conferences in August: 2022 Wedbush PacGrow Healthcare Conference (Virtual): fireside chat on Tuesday, August 9, 2022 at 9:00 a.m. ET. Canaccord Genuity 42nd Annual Growth Conference (Boston, MA): fireside chat on Wednesday, August 10, 2022 at 10:00 a.m.

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