Law Offices of Howard G. Smith announces an investigation on behalf of Sage Therapeutics, Inc. (“Sage” or the “Company”) (NASDAQ: SAGE) investors concerning the Company’s possible violations of federal securities laws.

On August 4, 2023, Sage disclosed that the U.S. Food and Drug Administration (“FDA”) had approved the New Drug Application (“NDA”) for its postpartum depression (“PPD”) and major depressive disorder (“MDD”) drug, zuranolone, only as a treatment for adults with PPD and had “issued a Complete Response Letter (CRL) for the [NDA] for zuranolone in the treatment of adults with MDD” because “the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD,” advising that “an additional study or studies will be needed” for that additional indication. On this news, Sage’s stock price fell $19.35, or 53.6%, to close at $16.75 per share on August 7, 2023, thereby injuring investors.

Then, on April 17, 2024, Sage disclosed that a Phase 2 study of SAGE-718 for the treatment of mild cognitive impairment (“MCI”) due to Parkinson’s Disease (“PD”) “did not meet its primary endpoint” of demonstrating significant differences between participants treated with the drug versus placebo, and thus, “[b]ased on the data, the Company does not plan any further development of [SAGE-718] in PD.” On this news, Sage’s stock price fell $3.06, or 19.6%, to close at $12.57 per share on April 17, 2024.

Then, on July 24, 2024, Sage disclosed that a Phase 2 study of Sage-324 for the treatment of essential tremor (“ET”) “did not demonstrate a statistically significant dose-response relationship in change from baseline to Day 91 based on the primary endpoint” and “there were no statistically significant differences demonstrated for any dose of SAGE-324 versus placebo[.]” Due to the results, the Company stated that it would close the ongoing study and did “not plan to conduct further clinical development of SAGE-324 in ET.” On this news, Sage’s stock price fell $2.70, or 20.6%, to close at $10.38 per share on July 24, 2024, thereby injuring investors further.

If you purchased Sage securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847 or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.

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