SAN DIEGO--(BUSINESS WIRE)--Robbins LLP reminds investors that a shareholder filed a class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Scynexis, Inc. (NASDAQ: SCYX) securities between March 31, 2023 and September 22, 2023. Scynexis is a biotechnology company that is primarily engaged in the development of ibrexafungerp, a broad-spectrum, intravenous (IV)/oral agent for fungal indications.
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What is this Case About: Scynexis, Inc. (SCYX) Misled Investors Regarding its Quality Control Measures
According to the complaint, 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.
The complaint alleges that during the class period, defendants failed to disclose: (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 (cGMP); and (3) that, due to the substantial risk of cross-contamination, Scynexis was reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies.
Plaintiff further alleges that on Monday September 25, 2023, the Company submitted to the SEC a Form 8-K which reported that, following a recent review by GSK plc (“GSK”) 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 stock fell over 34% to close at $2.18 per share on September 25, 2023, and another 11.47% on September 26, 2023.
What Now: Similarly situated shareholders may be eligible to participate in the class action against Scynexis, Inc. Shareholders who want to act as lead plaintiff for the class should contact Robbins LLP. Plaintiffs must file their lead plaintiff papers by January 8, 2024. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member. For more information, click here.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
About Robbins LLP: Some law firms issuing releases about this matter do not actually litigate securities class actions; Robbins LLP does. A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002. Since our inception, we have obtained over $1 billion for shareholders.
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