Skiadas v. Acer Therapeutics Inc., 2020 WL 3268495 (S.D.N.Y. June 16, 2020)

On June 16, 2020, Judge Gregory Woods of the Southern District of New York granted in part and denied in part a motion to dismiss an action against Acer Therapeutics Inc. and certain of its executives regarding disclosures made in offering documents prior to the Company’s submission of a New Drug Application (“NDA”) for EDSIVO, a drug that treats Vascular Ehlers-Danlos Syndrome (“vEDS”).  Plaintiff allege that when the FDA declined to approve the drug, Acer’s stock dropped.


Continue Reading S.D.N.Y. Partially Dismisses Claims Against Pharmaceutical Company, But Allows Claim Regarding Misleading Statements About Upcoming NDA for Rare Tissue Disorder To Proceed

Nguyen v. Endologix, Inc., 2020 WL 3069776 (9th Cir. June 10, 2020)

On June 10, 2020, the Ninth Circuit affirmed the dismissal of a putative securities fraud class action brought against a medical device corporation, Endologix, Inc., and certain of its officers, regarding statements concerning the FDA’s likelihood of premarket approval of the Company’s aneurysm sealing product, Nellix. The Court held that plaintiff failed to allege facts giving rise to a strong inference of scienter (i.e., fraudulent intent) and thus failed to adequately plead a claim for securities fraud.


Continue Reading Ninth Circuit Affirms Dismissal of Action Regarding Statements Concerning Likelihood of FDA Premarket Approval of Aneurysm Sealing Device

In re Celgene Corp. Sec. Litig., 2019 WL 6909463 (D.N.J. Dec. 19, 2019)

On December 19, 2019, Judge John Michael Vazquez of the District of New Jersey partially denied a motion to dismiss a putative securities class action complaint filed against biopharmaceutical company Celgene and certain of its executives.

Plaintiff’s allegations relied heavily on purported information from former Celgene employees, consultants, and scientists, and arose out of Celgene’s statements concerning three drugs that Celgene was developing as revenue replacements for its blockbuster multiple myeloma drug, Revlimid, which has a patent set to expire in 2022.  Judge Vazquez analyzed allegations relating to each drug in turn.


Continue Reading District Court Judge Partially Dismisses Claims Against Celgene, But Allows Allegations Regarding Misleading Statements About Sales Projections and FDA Approval to Proceed

Dougherty v. Esperion Therapeutics, Inc., 905 F.3d 971 (6th Cir. 2018)

A recent Sixth Circuit opinion demonstrates the critical importance of accurately describing interactions with the FDA when making statements on that topic.

In Dougherty v. Esperion Therapeutics, Inc., the Sixth Circuit held that plaintiffs adequately pleaded the scienter element (i.e., fraudulent intent) of their securities fraud claims against Esperion, a clinical stage pharmaceutical corporation, and its CEO, and reversed the district court’s order granting a motion to dismiss.


Continue Reading Unanimous Sixth Circuit Reverses Dismissal, Finding Plaintiffs Plausibly Alleged Defendants Knew Statements Summarizing FDA Meeting Were False