Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Sage Therapeutics, Inc. (“Sage” or the “Company”) (NASDAQ: SAGE) securities between April 12, 2021 and July 23, 2024, inclusive (the “Class Period”). Sage investors have until October 28, 2024 to file a lead plaintiff motion.

Investors suffering losses on their Sage investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to howardsmith@howardsmithlaw.com.

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.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) zuranolone was less effective in treating MDD than Defendants had led investors to believe; (2) accordingly, the FDA was unlikely to approve the zuranolone NDA for the treatment of MDD in its present form, and zuranolone’s clinical results for MDD, as well as its overall regulatory and commercial prospects, were overstated; (3) SAGE-718 was less effective in treating MCI due to PD than Defendants had led investors to believe; (4) accordingly, SAGE-718’s clinical, regulatory, and commercial prospects as a treatment for MCI due to PD were overstated; (5) SAGE-324 was less effective in treating ET than Defendants had led investors to believe; (6) accordingly, SAGE-324’s clinical, regulatory, and commercial prospects as a treatment for ET were overstated; and (7) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

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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