Scynexis, Inc.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired Scynexis, Inc. (“Scynexis” or the “Company”) (NASDAQ: SCYX) securities during the period from March 31, 2023 through September 22, 2023, inclusive (the “Class Period”). Investors have until January 8, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Scynexis develops and distributes intravenous drugs for treatment of serious and life-threatening invasive fungal infections in humans.
On September 25, 2023, Scynexis reported that it became aware of potential cross contamination of ibrexafungerp with a non-antibacterial beta-lactam drug substance at the vendor that manufactures ibrexafungerp. The Company disclosed that, according to FDA guidance, failure to separate these compounds may trigger hypersensitivity or an allergic reaction in some people. As a result, Scynexis declared it would conduct a recall of BREXAFEMME from the market and place a temporary hold on clinical studies of ibrexafungerp until a mitigation strategy and a resupply plan are determined. On this news, the price of Scynexis shares declined by $1.13, or approximately 34.14%, from $3.31 per share to close at $2.18 on September 25, 2023.
The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose that: (i) the equipment used to manufacture ibrexafungerp was also used to manufacture a non-antibacterial beta-lactam drug substance, presenting a risk of cross-contamination; (ii) 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 (iii) due to the substantial risk of cross-contamination, Scynexis was reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies.
Scynexis develops and distributes intravenous drugs for treatment of serious and life-threatening invasive fungal infections in humans.
On September 25, 2023, Scynexis reported that it became aware of potential cross contamination of ibrexafungerp with a non-antibacterial beta-lactam drug substance at the vendor that manufactures ibrexafungerp. The Company disclosed that, according to FDA guidance, failure to separate these compounds may trigger hypersensitivity or an allergic reaction in some people. As a result, Scynexis declared it would conduct a recall of BREXAFEMME from the market and place a temporary hold on clinical studies of ibrexafungerp until a mitigation strategy and a resupply plan are determined. On this news, the price of Scynexis shares declined by $1.13, or approximately 34.14%, from $3.31 per share to close at $2.18 on September 25, 2023.
The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose that: (i) the equipment used to manufacture ibrexafungerp was also used to manufacture a non-antibacterial beta-lactam drug substance, presenting a risk of cross-contamination; (ii) 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 (iii) due to the substantial risk of cross-contamination, Scynexis was reasonably likely to recall its ibrexafungerp tablets and halt its clinical studies.