Press Release

Talphera Secures Key Win in Securities Class Action

May 9, 2024

Palo Alto – May 9, 2024 – Cooley secured a key win on behalf of Talphera (formerly known as AcelRx Pharmaceuticals), a Silicon Valley-based specialty pharmaceutical company focused on the development and commercialization of innovative therapies, in a securities class action lawsuit brought by investors. Lawyers Tijana Brien, Patrick Gibbs, Shannon Eagan, Janelle Fernandes, Greg Merchant, Tiffany Le and Madeleine McNally led the Cooley team representing Talphera.

The lawsuit, first filed in 2021, alleged that Talphera committed securities fraud based on a February 2021 Food and Drug Administration (FDA) warning letter related to two marketing materials for its pain drug, Dsuvia. Two prior times – in September 2022 and July 2023 – Judge Beth Labson Freeman of the US District Court for the Northern District of California issued an order on the investors’ lacking allegations and dismissed their complaint, but gave them leave to amend. 

On May 7, 2024, Judge Freeman issued her final order, granting Talphera’s motion to dismiss with prejudice. Despite the addition of five former employees in the investors’ third amended complaint, Judge Freeman held that the plaintiffs had failed to plead scienter. Importantly, while a number of the former employees opined on the likelihood of certain FDA actions and outcomes, Judge Freeman held that the former employees’ personal opinions about what the FDA might do and their speculation as to whether the company would receive a warning letter from the FDA did not establish scienter. The court also reiterated that mere awareness of certain facts (in this case, the use of allegedly false marketing materials) was insufficient to establish scienter.

Read the order

The case is Sneed Jr. v. AcelRx Pharmaceuticals, Inc. et al. before the US District Court for the Northern District of California (case number 21-cv-04353-BLF).

About Cooley LLP

Clients partner with Cooley on transformative deals, complex IP and regulatory matters, and high-stakes litigation, where innovation meets the law.

Cooley has 1,300+ lawyers across 19 offices in the United States, Asia and Europe, and a total workforce of more than 3,000.

This content is provided for general informational purposes only, and your access or use of the content does not create an attorney-client relationship between you or your organization and Cooley LLP, Cooley (UK) LLP, or any other affiliated practice or entity (collectively referred to as “Cooley”). By accessing this content, you agree that the information provided does not constitute legal or other professional advice. This content is not a substitute for obtaining legal advice from a qualified attorney licensed in your jurisdiction and you should not act or refrain from acting based on this content. This content may be changed without notice. It is not guaranteed to be complete, correct or up to date, and it may not reflect the most current legal developments. Prior results do not guarantee a similar outcome. Do not send any confidential information to Cooley, as we do not have any duty to keep any information you provide to us confidential. This content may be considered Attorney Advertising and is subject to our legal notices.