According to the law firm press release, Affymax, Inc. is a California-based biopharmaceutical company whose primary drug offering is Omontys (peginesatide) Injection for the treatment of anemia in chronic kidney disease in adult patients on dialysis. The Company has a strategic alliance agreement with Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. (collectively, “Takeda”), to develop and commercialize Omontys. Takeda is also charged as a Defendant in the action.
The Complaint alleges that during the Class Period, Defendants issued materially false and misleading statements regarding the Company’s business practices and financial results. Specifically, the Complaint alleges that Defendants failed to disclose that 2% of patients who were administered Omontys experienced hypersensitivity reactions resulting in anaphylaxis, a serious and life-threatening allergic reaction, a third of which needed medical intervention – and that 0.02% of those administered the drug experienced fatal anaphylaxis reactions. As a result of these false statements, the Complaint alleges that Affymax stock traded at artificially inflated prices during the Class Period, reaching a high of $27.74 per share in intraday trading on October 17, 2012.
Then, on February 23, 2013, Affymax and Takeda announced that the U.S. Food and Drug Administration (“FDA”) was requiring a total recall of the drug due to reports of anaphylaxis, with the FDA calling it a “serious and life-threatening” allergic reaction in the agency’s statement. “Serious and fatal” hypersensitivity reactions had been reported in some patients within 30 minutes of receiving their first doses of the drug by intravenous injection, the FDA said in its statement. On this news, the price of Affymax stock declined by more than 85%, closing at $2.42 per share, down $14.10 per share from the prior night’s close, on unusually high trading volume.
On May 2, 2013, the Plaintiff voluntarily dismissed the case against all Defendants without prejudice pursuant to Fed. R. Civ. P. Rule 41(a)(1)(A)(i) in lieu of other Plaintiffs asserting similar facts and claims.
On May 21, 2013, the Court appointed Lead Plaintiff satisfying the requirements pursuant to Section 211)(a)(3)(13)(iii) of the PSLRA. Lead Plaintiff, pursuant to Section 21D(a)(3)(B)(v) of the PSLRA, selected and retained the law firm of Pomerantz Grossman Hufford Dahlstrom & Gross LLP as Lead Counsel and Glancy Binkow & Goldberg as Liaison Counsel.
On July 22, 2013, lead Plaintiff filed a consolidated amended class action Complaint for violation of the federal securities laws.
On January 21, 2014, the Court issued an Order Granting In Part and Denying In Part Motion to Dismiss Consolidated Amended Complaint.
On February 18, 2014, the Court granted a 90 day stay in this case for the parties to enter settlement discussions. On May 22, the Court issued an order extending this stay until June 20.
On July 2, 2014, the parties entered into a Stipulation of Settlement. This Settlement was preliminarily approved on August 28. On December 12, the Court granted final approval of the Settlement and dismissed this case.