Lawsuit filed for Investors with losses from shares of Sage Therapeutics, Inc. (NASDAQ: SAGE)

An investor, who purchased shares of Sage Therapeutics, Inc. (NASDAQ: SAGE), filed a lawsuit over alleged violations of Federal Securities Laws by Sage Therapeutics, Inc. in connection with certain allegedly false and misleading statements.

Investors who purchased shares of Sage Therapeutics, Inc. (NASDAQ: SAGE) have certain options and for certain investors are short and strict deadlines running. Deadline: October 28, 2024. NASDAQ: SAGE investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Cambridge, MA based Sage Therapeutics, Inc., a biopharmaceutical company, develops and commercializes brain health medicines. The Company is developing, inter alia, zuranolone (SAGE-217/BIIB125), a neuroactive steroid for the treatment of postpartum depression ("PPD") and major depressive disorder ("MDD"), in collaboration with Biogen Inc. ("Biogen"); SAGE-718 (dalzanemdor), an oral, oxysterol-based positive allosteric modulator of the N-methyl-D-aspartate receptor for the treatment of, inter alia, 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"), also in collaboration with Biogen.

In May 2022, Sage Therapeutics, Inc announced that it had initiated a rolling submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for zuranolone in the treatment of MDD. In June 2022, Sage announced that, rather than filing separate NDAs for zuranolone in the treatment of MDD and PPD, as originally intended, it would instead submit a single NDA seeking approval of zuranolone for the treatment of both MDD and PPD (the "Zuranolone NDA"). In December 2022, Sage announced the completion of the rolling submission of the Zuranolone NDA to the FDA.

On August 4, 2023, Sage Therapeutics, Inc disclosed that the FDA had only approved the Zuranolone NDA insofar as it sought zuranolone as a treatment for adults with PPD and had "issued a Complete Response Letter 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 April 17, 2024, Sage Therapeutics, Inc disclosed 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 dalzanemdor [SAGE-718] versus placebo on the Wechsler Adult Intelligence Scale Fourth Edition-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."

Then, on July 24, 2024, Sage Therapeutics, Inc disclosed 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 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."

Shares of Sage Therapeutics, Inc (NASDAQ: SAGE) declined from $28.26 per share on January 12, 2024, to as low as $7.70 per share on August 12, 2024.

The plaintiff claims that between April 12, 2021 and July 23, 2024, the defendants made false and/or misleading statements and/or failed to disclose that zuranolone was less effective in treating MDD than Defendants had led investors to believe, that 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, that SAGE-718 was less effective in treating MCI due to PD than Defendants had led investors to believe, that accordingly, SAGE-718's clinical, regulatory, and commercial prospects as a treatment for MCI due to PD were overstated, that SAGE-324 was less effective in treating ET than Defendants had led investors to believe, thataccordingly, SAGE-324's clinical, regulatory, and commercial prospects as a treatment for ET were overstated, and that as a result of all the foregoing, the Company's public statements were materially false and misleading at all relevant times.

Those who purchased shares of Sage Therapeutics, Inc. (NASDAQ: SAGE) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.