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.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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, 2023. “We are currently at a tipping point with the burden and prevalence of brain health conditions accelerating at an alarming rate. The need has never been greater than it is today and our team is singularly focused on changing the trajec.

Sage Therapeutics Announces Second Quarter 2023 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 it will host a live webcast on Monday, August 7, 2023 at 8:00 a.m. ET to provide a business update. Second quarter 2023 financial results will also be announced on Monday, August 7. The webcast can be accessed on the Investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available.

Sage Therapeutics to Host Business Update Webcast and Announce Second Quarter Financial Results on Monday, August 7, 2023

Biogen

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced the U.S. Food and Drug Administration (FDA) approved ZURZUVAETM (zuranolone) 50 mg for adults with postpartum depression (PPD). ZURZUVAE is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD. ZURZUVAE is expected to launch and be commercially available in the fourth quarter of 2023 shortly following sc.

FDA Approves ZURZUVAE™ (zuranolone), the First and Only Oral Treatment Approved for Women with Postpartum Depression, and Issues a Complete Response Letter for Major Depressive Disorder

The Food and Drug Administration late Friday approved the first-ever pill that can be taken at home for postpartum depression.

FDA approves first-ever pill for postpartum depression in new mothers

The U.S. Food and Drug Administration on Friday approved Biogen and Sage Therapeutics' oral pill for two common forms of depression, paving the way for patients to get a faster-acting therapy to treat their mood disorders.

US FDA approves Biogen-Sage Therapeutics pill for clinical depression

LOS ANGELES, CA / ACCESSWIRE / August 3, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Sage Therapeutics, Inc. ("Sage" or "the Company") (NASDAQ:SAGE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

ONGOING INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Sage Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / July 27, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Sage Therapeutics, Inc. ("Sage" or "the Company") (NASDAQ:SAGE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against Sage Therapeutics, Inc. and Encourages Investors with Losses In Excess of $100,000 to Contact the Firm

Biogen's CEO downplayed the ongoing regulatory review for a Sage-partnered depression drug. The FDA is scheduled to hand down its decision by Aug. 5.

Why Sage Therapeutics Stock Is Tumbling Today

Sage Therapeutics, Inc. should find out in August whether its drug targeting major depressive disorder and postpartum depression, zuranolone, will be approved. Zuranolone is being co-developed with Biogen, who made an upfront payment to Sage of $1.5bn, in 2020, and could pay another $1.5bn in milestone payments. Sage stock traded >$150 back in 2019 before zuranolone's failure to meet endpoints in a key study dropped the share price by >50%.

Sage Therapeutics: Zuranolone August Approval Likely, Opportunity Uncertain

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 participate in a fireside chat at the Goldman Sachs 44th Annual Global Healthcare Conference on Monday, June 12, 2023, at 11:20 a.m. PT in Dana Point, CA. 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.

Sage Therapeutics to Present at the Goldman Sachs 44th Annual Global Healthcare Conference

PDUFA date of August 5, 2023, was established to review zuranolone for the treatment of patients with major depressive disorder and postpartum depression. Biogen is a partner who is helping Sage advance zuranolone for the treatment of patients with MDD and PD.

Sage Therapeutics: Mid-2023 Data Readout And Possible FDA Approval Make This A Must Watch

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 May: BofA Securities 2023 Health Care Conference (Las Vegas, NV): presentation on Wednesday, May 10, 2023 at 2:20 p.m. PT. 2023 RBC Capital Markets Global Healthcare Conference (New York, NY): fireside chat on Wednesday, May 17, 2023 at 11:.

Sage Therapeutics to Present at Upcoming May Investor Conferences

Sage Therapeutics, Inc. (NASDAQ:SAGE ) Q1 2023 Earnings Conference Call May 2, 2023 8:00 AM ET Company Participants Helen Rubinstein - Director of Investor Relations Barry Greene - Chief Executive Officer Jim Doherty - Chief Development Officer Chris Benecchi - Chief Business Officer Kimi Iguchi - Chief Financial Officer Laura Gault - Chief Medical Officer Conference Call Participants Anupam Rama - JPMorgan Ritu Baral - PD Cowen Yasmeen Rahimi - Piper Sandler Jay Olson - Oppenheimer Paul Matteis - Stifel Sumant Kulkarni - Canaccord Neena Bitritto-Garg - Citi Tim Lugo - William Blair Marc Goodman - SVB Securities Operator Good morning. Welcome to the Sage Therapeutics' First Quarter 2023 Financial Results Conference Call.

Sage Therapeutics, Inc. (SAGE) Q1 2023 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 first quarter ended March 31, 2023. “The first quarter was marked by important advancements across our brain health pipeline and product engine, which lay the groundwork for continued execution and the potential for long-term value creation, particularly as we approach t.

Sage Therapeutics Announces First Quarter 2023 Financial Results and Highlights Pipeline and Business Progress

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, announced today that it will host a live webcast on Tuesday, May 2, 2023 at 8:00 a.m. ET to review first quarter 2023 financial results and discuss recent business updates. The webcast can be accessed on the Investor page of Sage's website at investor.sagerx.com.

Sage Therapeutics to Report First Quarter 2023 Financial Results on Tuesday, May 2, 2023

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, announced today that the Company will present at the Stifel 2023 CNS Days on Wednesday, March 29, 2023, at 11:00 a.m. ET. A live webcast of the presentation can be accessed on the Investor page of Sage's website at investor.sagerx.com.

Sage Therapeutics to Present at the Stifel 2023 CNS Days

Sage Therapeutics, Inc. (SAGE) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

Sage Therapeutics, Inc. (SAGE) Soars 9.6%: Is Further Upside Left in the Stock?

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) notified the companies that the agency does not currently plan to convene an advisory committee meeting to discuss the New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).

Sage Therapeutics and Biogen Share Update on FDA Advisory Committee for 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 Cowen 43rd Annual Health Care Conference on Monday, March 6, 2023, at 10:30 a.m. ET in Boston, MA. A live webcast of the presentation can be accessed on the Investor page of Sage's website at investor.sagerx.com.

Sage Therapeutics to Present at the Cowen 43rd Annual Health Care Conference

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 the European Medicines Agency (EMA) granted Orphan Drug Designation to SAGE-718 for the treatment of Huntington's disease (HD). SAGE-718 is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction.

Sage Therapeutics Announces European Medicines Agency Granted SAGE-718 Orphan Drug Designation for the Treatment of Huntington's Disease

Sage's first approved drug, Zulresso, did not sell well. Zuranolone offers significant improvements for depression over current therapies.

Sage Therapeutics Looking To FDA Approval Of Zuranolone

Sage Therapeutics, Inc. (NASDAQ:SAGE ) Q4 2022 Earnings Conference Call February 16, 2023 8:00 AM ET Company Participants Helen Rubinstein - Director of Investor Relations Barry Greene - Chief Executive Officer Jim Doherty - Chief Development Officer Chris Benecchi - Chief Business Officer Kimi Iguchi - Chief Financial Officer Laura Gault - Chief Medical Officer Conference Call Participants Tazeen Ahmad - Bank of America Salveen Richter - Goldman Sachs Anupam Rama - JPMorgan Ritu Baral - Cowen Eason Lee - Needham Jay Olson - Oppenheimer Laura Chico - Wedbush Securities Sumant Kulkarni - Canaccord Genuity Yatin Suneja - Guggenheim Tim Lugo - William Blair Neena Bitritto-Garg - Citi Douglas Tsao - H.C. Wainwright Rudy Li - SVB Securities Gary Nachman - BMO Capital Markets Brian Abrahams - RBC Capital Markets Alex Nackenoff - Raymond James Joon Lee - Truist Securities Operator Good morning.

Sage Therapeutics, Inc. (SAGE) Q4 2022 Earnings Call Transcript

Sage Therapeutics, Inc. (SAGE) delivered earnings and revenue surprises of -4.22% and 38.54%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

Sage Therapeutics, Inc. (SAGE) Reports Q4 Loss, Tops Revenue Estimates

CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 fourth quarter and full year ended December 31, 2022. “We set out in 2022 to deliver on a bold agenda; starting with the goal of transforming the treatment of depression.

Sage Therapeutics Announces Fourth Quarter and Full Year 2022 Financial Results and Highlights Pipeline and Business Progress

Sage Therapeutics, Inc. (SAGE) and partner, Biogen Inc.'s (BIIB) NDA for zuranolone to treat adults with MDD and PPD accepted by the FDA and granted priority review.

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