Investigation Announced for Sage Therapeutics (SAGE) Investors

Author: Dylan Bailey Updated: 09-11-2024 07:58 PM

Sage Therapeutics Under Investigation

Recent developments surrounding Sage Therapeutics, Inc. (NASDAQ: SAGE) have triggered an investigation by law offices representing affected investors. This move comes as the company faces scrutiny over significant drops in its stock value linked to announcements regarding its drug applications and study results.

The Impact of FDA Approvals

In a significant disclosure, Sage Therapeutics revealed that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for zuranolone strictly for the treatment of postpartum depression (PPD). However, the FDA issued a Complete Response Letter (CRL) for the application intended for treating adults with major depressive disorder (MDD), citing insufficient evidence of effectiveness. This led to a drastic fall in the stock price, plummeting $19.35, representing a 53.6% decrease, with shares closing at $16.75 shortly after the announcement.

Consequences of Clinical Study Results

The fallout continued on April 17, 2024, when Sage shared disappointing outcomes regarding a Phase 2 study of SAGE-718, aimed at treating mild cognitive impairment due to Parkinson's disease. The study failed to meet its primary endpoint, indicating no significant differences between the treated group and the placebo. Consequently, Sage announced it would halt any further development of SAGE-718, resulting in another significant drop in stock value—down by $3.06, or 19.6%, closing at $12.57.

Further Challenges with Sage-324

As if the news could not worsen, on July 24, 2024, Sage disclosed results from a Phase 2 study of SAGE-324 for essential tremor. The findings revealed a lack of statistically significant dose-response relationships, prompting the company to cease ongoing studies and discuss halting further development. The market reacted swiftly, and Sage's stock price dropped by $2.70, or 20.6%, settling at $10.38 per share.

Investors' Rights and Support

The implications of these announcements have raised serious concerns among investors regarding their rights and interests. Those who have purchased Sage securities and wish to understand their legal options are encouraged to reach out to the Law Offices of Howard G. Smith. Howard G. Smith, Esquire, is available for inquiries regarding these recent developments.

Conclusion and Contact Information

The Law Offices of Howard G. Smith are committed to assisting investors who may be impacted by these significant shortcomings. Investors can contact them directly for further information regarding their rights or any questions regarding the situation. The law office is situated at 3070 Bristol Pike, Suite 112, with a direct phone number at (215) 638-4847.

Frequently Asked Questions

What prompted the investigation into Sage Therapeutics?

The investigation is a response to significant stock price drops following the company's disclosures about FDA approvals and clinical study results.

What were the consequences of the FDA's response to Sage's drug applications?

The FDA's issuance of a Complete Response Letter for zuranolone's application for MDD contributed to a drastic drop in the company's stock price.

How did the Phase 2 study results affect Sage's stock?

Disappointments in the results of Phase 2 studies for SAGE-718 and SAGE-324 resulted in substantial stock price declines, negatively impacting investor confidence.

What should investors do if they have concerns about Sage Therapeutics?

Investors concerned about their holdings in Sage Therapeutics should contact the Law Offices of Howard G. Smith for guidance and to discuss potential legal options.

Where can I find more information about the investigation?

Investors can reach the Law Offices of Howard G. Smith directly by phone for more details regarding the investigation and related inquiries.

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