- Feldman v. Scynexis, Inc., et al.
- Class Period:March 31, 2023 - September 22, 2023
- Date Filed:November 07, 2023
- Jurisdiction:U.S. District Court, District Court of New Jersey
- Docket Number: 2:23-cv-22082
- Lead Plaintiff Deadline: January 8, 2024
Seek Plaintiff 35
A class action lawsuit captioned Feldman v. Scynexis, Inc., et al., has been filed against Scynexis, Inc. (“Scynexis” or the “Company”) (NASDAQ: SCYX) and certain of the Company’s top executive officers alleging that they violated the federal securities laws. The lawsuit seeks to represent all persons and entities who purchased or otherwise acquired Scynexis securities between March 31, 2023, and September 22, 2023, inclusive (the “Class Period”).
Scynexis is a biotechnology company which is primarily engaged in the development of ibrexafungerp, a broad-spectrum, intravenous (IV)/oral agent for fungal indications. The Company has received approval from the United States Food and Drug Administration (“FDA”) for the use of ibrexafungerp tablets, distributed under the brand name BREXAFEMME® for the treatment of vulvovaginal candidiasis and the reduction in the incidence of recurrent vulvovaginal candidiasis. The Company is also engaged in clinical investigation of ibrexafungerp for the treatment of invasive fungal infections in hospitalized patients and additional pre-clinical and discovery phase investigations.
As alleged in the complaint, on September 25, 2023, before the market opened, the Company reported that, following a recent review of the manufacturing process and equipment at the vendor that manufactures the ibrexafungerp drug substance, the Company became aware of potential cross contamination of ibrexafungerp with a non-antibacterial beta-lactam drug substance. As the Company explained, “[c]urrent FDA guidance recommends segregating the manufacture of beta-lactam compounds from other compounds since beta-lactam compounds have the potential to act as sensitizing agents that may trigger hypersensitivity or an allergic reaction in some people.”
The Company therefore declared it would conduct a recall of BREXAFEMME from the market and place a temporary hold on clinical studies of ibrexafungerp, including a Phase 3 clinical study, until a mitigation strategy and a resupply plan are determined. On this news, the Company’s shares fell $1.13, or 34.14%, to close at $2.18 per share on September 25, 2023, on unusually heavy trading volume. The stock price continued to decline the next trading day by 11.47% to close at $1.93 per share on September 26, 2023, on unusually heavy trading volume.
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: (1) that the equipment used to manufacture ibrexafungerp was also used to manufacture a non-antibacterial beta-lactam drug substance, presenting a risk of cross-contamination; (2) that the Company did not have effective internal controls and procedures, as well as adequate internal oversight policies to ensure that its vendor complied with current Good Manufacturing Practices (GMP); (3) that, due to the substantial risk of cross-contamination, Scynexis was reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies; and (4) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
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If you purchased or otherwise acquired Scynexis securities between March 31, 2023, and September 22, 2023, inclusive, and suffered substantial losses, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page.
You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at email@example.com.
The deadline to apply to the Court to serve as a lead plaintiff in the Scynexis lawsuit is January 08, 2024.