SAN FRANCISCO, CA / ACCESSWIRE / August 31, 2023 / Hagens Berman urges Sage Therapeutics, Inc. (NASDAQ: SAGE) investors who suffered substantial losses to submit your losses now.
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Sage Therapeutics, Inc. (NASDAQ: SAGE) Investigation:
The investigation focuses on Sage's disclosures concerning its New Drug Application for the use of zuranolone for treating adults with postpartum depression ("PPD") and adults with major depressive disorder ("MDD").
The accuracy of Sage's disclosures came into question on Aug. 4, 2023, when the company announced that, while the FDA approved zuranolone for treating adults with PPD, the FDA issued a complete response letter rejecting zuranolone's use for treating adults with MDD - the much larger potential market for the drug - citing lack of efficacy.
Investor's Business Daily reported on Aug. 7, 2023 that zuranolone didn't show a statically significant improvement in MDD patients at day 42 of treatment and quoted a Needham analyst who reportedly said "‘[o]ur initial guess is this may be this may be the reason behind the (rejection letter)'" and added, "‘[a]lthough (Sage) management had consistently indicated based on its conversations with FDA that it had sufficient data to support an approval.'"
This news drove a slew of analyst downgrades and a steep decline in the price of Sage shares on Aug. 7, 2023.
"We're focused on investors' losses and whether Sage may have misled investors about its MDD-related data and its communications with the FDA," said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in Sage Therapeutics and have substantial losses, or have knowledge that may assist the firm's investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblowers: Persons with non-public information regarding Sage Therapeutics should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email SAGE@hbsslaw.com.
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SOURCE: Hagens Berman Sobol Shapiro LLP