According to the law firm press release, the complaint charges Chelsea and certain of its officers and directors with violations of the Securities Exchange Act of 1934. Chelsea is a biopharmaceutical company that has been developing the drug Northera ("Droxidopa") for use in treating neurogenic orthostatic hypotension ("NOH") in patients with primary autonomic failure, including Parkinson's disease.
The complaint alleges that during the Class Period, defendants issued material misstatements and omissions concerning the safety and efficacy of Droxidopa for patients with NOH. Specifically, defendants failed to disclose, among other things: (i) the results of the Phase III testing of Droxidopa for patients with NOH; (ii) the post-marketing events in Japan (where Droxidopa has been approved for the same indication since 1989); and (iii) the likelihood of FDA approval of Droxidopa for patients with NOH in light of the known adverse material facts concerning Droxidopa. These false and misleading statements resulted in the artificial inflation of the market price of Chelsea common stock during the Class Period.
On February 13, 2012, defendants announced the that FDA had provided Chelsea with a briefing document that the FDA staff had prepared for the February 23, 2012 Advisory Committee meeting and that it had raised questions concerning Droxidopa’s risk-benefit analysis. On this disclosure, Chelsea stock dropped from $4.99 per share to $3.11 per share. Then, on February 21, 2012, the FDA publicly released the briefing document that had been provided to Chelsea on February 13, 2012. The FDA recommended that Droxidopa for patients with NOH not be approved for use in the United States, stating that Droxidopa had not demonstrated durable effectiveness in clinical trials and showed worrisome safety signals in test results and in post-marketing cases in Japan. As a result, on February 21, 2012, the market price of Chelsea common stock dropped again, closing at $2.64 per share.
Plaintiff seeks to recover damages on behalf of all purchasers of Chelsea common stock during the Class Period (the “Class”).
On May 9, 2012, the Court issued an Order granting the motion to consolidate cases.
On August 16, 2012, the Court issued an Order appointing lead plaintiff and approving the selection of lead counsel. On October 5, the lead plaintiff filed a consolidated complaint.
On October 9, 2013, the Court issued an Order granting the defendants' Motion to Dismiss with prejudice. A Clerk's Judgment was entered in accordance with this Order. On November 8th, Lead Plaintiff filed a Notice of Appeal of the above Judgment.
On March 16, 2015, the Court of Appeals vacated the district court's judgment and remanded this case for further proceedings.
On August 26, 2015, the Court issued an Order denying defendants' Motion to Dismiss.
On May 27, 2016, the parties filed a Stipulation of Settlement. The Settlement was preliminarily approved by the Court on June 1. On September 19, the Court granted final approval of the Settlement and entered Final Judgment.