Wang v. PTC Therapeutics, Inc.

Updated: October 25, 2017
Status: Ongoing Case

On January 13, 2017, Labaton Sucharow, as co-lead counsel, filed an amended complaint on behalf of the lead plaintiffs in this securities class action against PTC Therapeutics, Inc. (PTC), a biopharmaceutical company. PTC’s lead product is “Translarna,” a treatment for Duchenne muscular dystrophy.

The complaint alleges that throughout the class period, the defendants made false and/or misleading statements and/or failed to disclose: (1) that the company’s New Drug Application (NDA) for Translarna, submitted to the FDA, was not sufficiently complete to permit a substantive review of the application; (2) that the application would not be reviewed nor approved by the FDA; (3) that the impending non-approval of the NDA would have a negative material impact on the company’s operations and prospects; and (4) that, as a result, the defendants’ statements about PTC’s business, operations, and prospects, were false and misleading and/or lacked a reasonable basis.

On August 28, 2017, the court denied the defendants’ motion to dismiss. The court held a scheduling conference on October 25, 2017, and the case is currently in discovery.

The case is Wang v. PTC Therapeutics, Inc., No. 16-cv-1224 (DNJ). The lead plaintiffs are Boston Retirement System and Si Tan Nguyen Trust. Labaton Sucharow represents Boston Retirement System as co-lead counsel. The defendant is PTC Therapeutics, Inc.

The truth started to come to light on February 23, 2016, when the company issued a press release entitled “PTC Receives Refuse to File Letter from FDA for Translarna (ataluren).” The company stated that it received a Refuse to File letter from the FDA regarding the company’s NDA for Translarna because “the application was not sufficiently complete to permit a substantive review,” essentially rejecting the drug without a full clinical review. In response to this news, shares of PTC Therapeutics fell more than 61 percent on unusually heavy trading volume.

The full truth was revealed on February 29, 2016, when the company issued a press release stating that the FDA viewed prior Translarna clinical trials as “negative and do not provide substantial evidence of effectiveness.” PTC Therapeutics’ shares declined an additional 30 percent on March 1, 2016, the next trading day.

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