CAMBRIDGE, Mass. / Nov 26, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: SAGE), today announced that the Company will participate in a fireside chat at the Piper Sandler 36 th Annual Healthcare Conference on Wednesday, December 4, 2024, at 9:00 a.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... Read More

The Phase 2 DIMENSION Study did not meet its primary endpoint Dalzanemdor was generally well-tolerated; no new safety signals were observed Based on these data, the Company does not plan further development of dalzanemdor CAMBRIDGE, Mass. / Nov 20, 2024 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with... Read More

Achieved $11 million in ZURZUVAE ® (zuranolone) collaboration revenue during the third quarter of 2024 (50% of the net revenue recorded by Biogen), representing 49% growth from the second quarter Sage and Biogen will not pursue further development of zuranolone in major depressive disorder (MDD) in the U.S. Topline data from the DIMENSION Study in Huntington’s Disease (HD) expected late 2024 Cash, cash equivalents and... Read More

Planned workforce reduction of approximately 33% of employees expected to extend the company’s cash runway CAMBRIDGE, Mass. / Oct 17, 2024 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE), today announced a strategic reorganization of its business operations to support the ongoing launch of ZURZUVAE in postpartum depression and focus pipeline development efforts ahead of a clinical study readout for dalzanemdor in... Read More

CAMBRIDGE, Mass. / Oct 15, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: SAGE), today announced that it will host a live webcast on Tuesday, October 29, 2024 at 4:30 p.m. ET to review third quarter 2024 financial results and discuss recent business updates. 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 following the completion... Read More

In the Phase 2 LIGHTWAVE Study, dalzanemdor (SAGE-718) did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the primary endpoint Dalzanemdor was generally well-tolerated and no new safety signals were observed Topline data from the Phase 2 DIMENSION Study of dalzanemdor in Huntington’s Disease expected later this year CAMBRIDGE, Mass. / Oct 08,... Read More

Sage and Biogen will continue to partner on ZURZUVAE®, the first and only FDA-approved oral treatment for women with postpartum depression CAMBRIDGE, Mass. / Sep 26, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: Sage) today announced that Biogen has terminated its rights under the collaboration and license agreement with Sage specific to the SAGE-324 program. The companies recently announced negative results from... Read More

Achieved $7.4 million in ZURZUVAE™ (zuranolone) collaboration revenue during the second quarter of 2024 (50% of the net revenues recorded by Biogen), representing 19% growth from the first quarter More than 1,400 prescriptions shipped and delivered during the second quarter of 2024, nearly doubling from the first quarter Dalzanemdor (SAGE-718) topline data from the LIGHTWAVE (Alzheimer’s Disease) and DIMENSION (Huntington’s... Read More

SAGE-324 (BIIB124) did not demonstrate a statistically significant dose-response relationship on the primary endpoint in participants with essential tremor No statistically significant differences were demonstrated between any dose of SAGE-324 and placebo in the change from baseline for the primary endpoint CAMBRIDGE, Mass. / Jul 24, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: Sage) and Biogen Inc. (NASDAQ: BIIB)... Read More

CAMBRIDGE, Mass. / Jul 17, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that it will host a live webcast on Wednesday, July 31, 2024 at 4:30 p.m. ET to review second quarter 2024 financial results and discuss recent business updates. The webcast can be accessed on the Investor page of Sage’s website at... Read More

The SURVEYOR Study met its primary endpoint demonstrating a statistically significant difference as measured by the HD-Cognitive Assessment Battery (HD-CAB) composite score at baseline between healthy participants and participants with Huntington’s Disease (HD) prior to any treatment with dalzanemdor (SAGE-718) or placebo; further underscoring the cognitive impact of HD For participants with HD that received dalzanemdor or... Read More

CAMBRIDGE, Mass. / Jun 05, 2024 / 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 45th Annual Global Healthcare Conference on Wednesday, June 12, 2024, at 2:00 p.m. ET in Miami, FL. A live webcast of the presentation can be accessed on the... Read More

CAMBRIDGE, Mass. / May 07, 2024 / 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 the following upcoming investor conferences in May: 2024 RBCCM Global Healthcare Conference (New York, NY) : fireside chat on Tuesday, May 14, 2024 at 11:30 a.m. ET. BofA Securities 2024 Health... Read More

Achieved $6.2 million in ZURZUVAE™ (zuranolone) collaboration revenue during the first quarter of 2024, representing 50% of the net revenues reported by Biogen Encouraging initial demand for ZURZUVAE; More than 700 prescriptions shipped and delivered in the first quarter of 2024 Payor coverage now in place for a majority of commercially covered lives for ZURZUVAE in the treatment of women with postpartum depression (PPD)... Read More

In the Phase 2 PRECEDENT Study, dalzanemdor (SAGE-718) did not show statistically significant differences versus placebo on the primary endpoint in patients with mild cognitive impairment in Parkinson’s disease Dalzanemdor (SAGE-718) was generally well-tolerated and there were no new safety signals observed Topline data readouts from the Phase 2 studies in Huntington’s disease and Alzheimer’s disease are expected later this... Read More

CAMBRIDGE, Mass. / Apr 11, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that it will host a live webcast on Thursday, April 25, 2024 at 8:00 a.m. ET to review first quarter 2024 financial results and discuss recent business updates. The webcast can be accessed on the Investor page of Sage’s website at... Read More

CAMBRIDGE, Mass. / Feb 28, 2024 / 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 March: TD Cowen 44 th Annual Health Care Conference (Boston, MA): fireside chat on Tuesday, March 5, 2024 at 2:50 p.m. ET. Stifel 2024 Virtual CNS Days... Read More

ZURZUVAE™ (zuranolone), the first-and-only oral treatment indicated for adults with postpartum depression (PPD), became commercially available mid-December; Sage achieved $0.8 million in collaboration revenue as of December 31, 2023, 50% of the net revenues Biogen reports for ZURZUVAE Encouraging early launch results for ZURZUVAE with approximately 120 prescriptions in December Catalyst rich 2024 with multiple topline data... Read More

CAMBRIDGE, Mass. / Jan 31, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that it will host a live webcast on Wednesday, February 14, 2024 at 8:00 a.m. ET to review fourth quarter and full year 2023 financial results and discuss recent business updates. The webcast can be accessed on the Investor page of... Read More

Excitement over December 2023 launch of ZURZUVAE™ (zuranolone), the first and only oral treatment indicated for adults with postpartum depression (PPD) Continued progress on clinical pipeline, with topline data expected from multiple ongoing Phase 2 trials across 2024 Catalyst rich year supported by strong financial foundation and focused execution CAMBRIDGE, Mass. / Jan 08, 2024 / Business Wire / Sage Therapeutics, Inc.... Read More

CAMBRIDGE, Mass. / Jan 08, 2024 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the retirement of Kevin Starr from the company’s board of directors. Geno Germano has assumed the role of Chair of the Board of Directors. Mr. Starr led the early efforts to launch Sage Therapeutics, served as CEO prior to the... Read More

CAMBRIDGE, Mass. / Jan 02, 2024 / 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 42 nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 4:30 p.m. PT in San Francisco, CA. A live webcast of the presentation can be accessed on the Investor page of Sage’s... Read More

CAMBRIDGE, Mass. / Nov 08, 2023 / 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 November: Stifel 2023 Healthcare Conference (New York, NY): fireside chat on Wednesday, November 15, 2023 at 9:10 a.m. ET. Piper Sandler 35th Annual... Read More

ZURZUVAE™ (zuranolone), first and only oral treatment approved for adults with postpartum depression (PPD), designated Schedule IV by the DEA; progressing towards planned commercial availability in December Announces expected wholesale acquisition cost of ZURZUVAE of $15,900 SAGE-718 granted FDA Orphan Drug Designation for the treatment of Huntington’s Disease Sage product pipeline provides potential for significant value... Read More

CAMBRIDGE, Mass. / Oct 24, 2023 / 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 Tuesday, November 7, 2023 at 8:00 a.m. ET to review third quarter 2023 financial results and discuss recent business updates. The webcast can be accessed on the Investor page of Sage’s website at... Read More

CAMBRIDGE, Mass. / Oct 18, 2023 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) 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... Read More

CAMBRIDGE, Mass. / Sep 06, 2023 / 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 September: Morgan Stanley 21 st Annual Global Healthcare Conference (New York, NY): fireside chat on Wednesday, September 13, 2023 at 12:15 p.m. ET. TD... Read More

Potential growth catalysts include planned 4Q 2023 launch of ZURZUVAE (zuranolone) and expected data read-outs for SAGE-718 and SAGE-324 in 2024 Approximately 40% workforce reduction supports focus on agile execution of business priorities Strengthened financial position with expected annualized net savings of approximately $240 million anticipated to extend cash runway into 2026 CAMBRIDGE, Mass. / Aug 31, 2023 / Business... Read More

ZURZUVAE™ (zuranolone) approved as first-and-only oral treatment specifically indicated for adults with postpartum depression (PPD) and on-track for planned launch in the fourth quarter of 2023 shortly after DEA scheduling Sage brain health pipeline provides potential for significant long-term value creation Remain well capitalized with $1.0 billion of cash, cash equivalents and marketable securities as of June 30, 2023... Read More

CAMBRIDGE, Mass. / Aug 04, 2023 / 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... Read More

Postpartum depression (PPD) approval based on results from two Phase 3 clinical trials; in the SKYLARK Study treatment with ZURZUVAE rapidly improved symptoms of PPD at Day 15 and as early as Day 3 with sustained effect to Day 45 Mental health conditions are the leading cause of maternal mortality 1 with PPD among the most common complications during and after pregnancy 2 CAMBRIDGE, Mass., Aug. 04, 2023 (GLOBE NEWSWIRE) --... Read More

CAMBRIDGE, Mass. / Jun 05, 2023 / 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 44 th 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... Read More

CAMBRIDGE, Mass. / May 03, 2023 / 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... Read More

New Drug Application (NDA) for zuranolone in the treatment of Major Depressive Disorder (MDD) and Postpartum Depression (PPD) under priority review by U.S. Food and Drug Administration (FDA) with a PDUFA date of August 5, 2023 Sage and Biogen progressing key commercial preparations to support a potential launch of zuranolone in late 2023, following DEA scheduling period, if approved and expected timelines are met Continued... Read More

CAMBRIDGE, Mass. / Apr 18, 2023 / 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 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... Read More

CAMBRIDGE, Mass. / Mar 22, 2023 / 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 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 . A replay of... Read More

CAMBRIDGE, Mass. / Mar 16, 2023 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the appointment of Jessica Federer to the company’s Board of Directors. “We are thrilled to have Jessica join our Board of Directors. Jessica is a champion for patients and has a track record of innovation in data and digital... Read More

CAMBRIDGE, Mass. / Mar 08, 2023 / 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).... Read More

CAMBRIDGE, Mass. / Feb 22, 2023 / 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... Read More

CAMBRIDGE, Mass. / Feb 16, 2023 / 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. We have been... Read More

CAMBRIDGE, Mass. / Feb 06, 2023 / 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... Read More

CAMBRIDGE, Mass. / Feb 02, 2023 / 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. The webcast can be accessed on the Investor page of... Read More

Robust pipeline provides potential for long-term value creation, establishing Sage as a leader in brain health Rolling New Drug Application (NDA) submission for zuranolone in MDD and PPD complete, with potential for PDUFA date as early as the third quarter of 2023 if priority review is received and other timelines meet expectations Progressing nine ongoing studies across zuranolone, SAGE-718, SAGE-324 and early pipeline... Read More

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 41 st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 10:30 a.m. PT in San Francisco, 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... Read More

Zuranolone is being evaluated as a short course, rapid-acting, oral medication for major depressive disorder (MDD) and postpartum depression (PPD) 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... Read More