Sage Therapeutics, Inc. (NASDAQ: SAGE) Securities Fraud Class Action

LEAD PLAINTIFF DEADLINE IS OCTOBER 28, 2024.

If you have suffered losses and would like to discuss your rights, please fill out this form or you may contact Jonathan Naji, Esq. at (484) 270-1453 or via e-mail at info@ktmc.com.

Case Background:
As relevant here, in collaboration with Biogen Inc. (“Biogen”), the company is developing zuranolone (SAGE-217/BIIB125), a neuroactive steroid for the treatment of postpartum depression (“PPD”) and major depressive disorder (“MDD”); SAGE-718 (dalzanemdor), an oral, oxysterol-based positive allosteric modulator of the N-methyl-D-aspartate (“NMDA”) receptor for the treatment of mild cognitive impairment (“MCI”) due to Parkinson’s Disease (“PD”); and SAGE-324 (BIIB124), an oral investigational drug for the treatment of essential tremor (“ET”).

On August 4, 2023, Sage issued a press release announcing that the FDA had only approved the SAGE-217/BIIB125 NDA insofar as it sought SAGE-217/BIIB125 as a treatment for adults with PPD and had “issued a Complete Response Letter (CRL) for the [NDA] for [SAGE-217/BIIB125].in the treatment of adults with MDD” because “the application did not provide substantial evidence of effectiveness to support the approval of [SAGE-217/BIIB125] for the treatment of MDD,” advising that “an additional study or studies will be needed” for that additional indication.  On this news, the price of Sage common stock declined $19.35 per share, or approximately 53.6%, from a close of $36.10 per share on August 4, 2023, to close at $16.75 per share on August 7, 2023.

On April 17, 2024, Sage issued a press release and announced that a Phase 2 study of SAGE-718 as a treatment for MCI due to PD “did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily [SAGE-718] versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV (WAIS-IV) Coding Test score at Day 42,” and that, “[b]ased on the data, the Company does not plan any further development of [SAGE-718] in PD.”  On this news, the price of Sage common stock declined $3.06 per share, or approximately 19.6%, from a close of $15.63 per share on April 16, 2024, to close at $12.57 per share on April 17, 2024.

Then, on July 24, 2024, Sage issued a press release and announced that a Phase 2 study of SAGE-324 as a treatment for ET “did not demonstrate a statistically significant dose-response relationship in change from baseline to Day 91 based on the primary endpoint, The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Item 4 (upper limb) total score, in participants with ET”; that “there were no statistically significant differences demonstrated for any dose of SAGE-324 versus placebo in the change from baseline to Day 91 on the TETRAS PS Item 4 Total Score or the TETRAS Activities of Daily Living (ADL) Composite Score”; and that, “[g]iven these results, Sage and Biogen will close the ongoing open label safety study of SAGE-324 in ET and do not plan to conduct further clinical development of SAGE-324 in ET.”  On this news, the price of Sage common stock declined $2.70 per share, or approximately 20.6%, from a close of $13.08 per share on July 23, 2024, to close at $10.38 per share on July 24, 2024.

The complaint 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 misrepresented and/or failed to disclose that: (1) SAGE-217/BIIB125 was less effective in treating MDD than Defendants had led investors to believe; (2) accordingly, the U.S. Food and Drug Administration (“FDA”) was unlikely to approve a SAGE-217/BIIB125 new drug application for the treatment of MDD in its present form, and SAGE-217/BIIB125’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’ statements about the company’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.

What is a Lead Plaintiff?

A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case.  Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.