Sneed v. Talphera, Inc.

CourtCourt of Appeals for the Ninth Circuit
DecidedAugust 20, 2025
Docket24-3560
StatusPublished

This text of Sneed v. Talphera, Inc. (Sneed v. Talphera, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sneed v. Talphera, Inc., (9th Cir. 2025).

Opinion

FOR PUBLICATION

UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT

AARON SNEED, Jr.; YAACOV No. 24-3560 MUSRY; DAVID O'GRADY, D.C. No. 5:21-cv-04353- Plaintiffs - Appellants, BLF v.

TALPHERA, INC., formerly known as: AcelRx Pharmaceuticals, Inc.; OPINION VINCENT J. ANGOTTI; PAMELA P. PALMER,

Defendants - Appellees.

Appeal from the United States District Court for the Northern District of California Beth Labson Freeman, District Judge, Presiding Argued and Submitted June 12, 2025 San Francisco, California Filed August 20, 2025 Before: Sidney R. Thomas and Kenneth K. Lee, Circuit Judges, and Roslyn O. Silver, District Judge. *

Opinion by Judge Lee

* The Honorable Roslyn O. Silver, United States District Judge for the District of Arizona, sitting by designation. 2 SNEED V. TALPHERA

SUMMARY **

Securities Fraud

Affirming the district court’s dismissal of a securities fraud action against a pharmaceutical company and its officers, the panel held that plaintiffs failed to adequately plead falsity and did not show a strong inference of scienter under Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5. The pharmaceutical company marketed its under-the- tongue opioid with the slogan “Tongue and Done” in advertisement displays and a speech at an investor conference. Several shareholders sued, alleging that the slogan misled investors because administering the drug was more complex than just “Tongue and Done” and thus its potential market would be more limited. The panel held that plaintiffs did not adequately plead falsity because a reasonable investor would not blindly accept the slogan without considering other information that clarified the context of “Tongue and Done.” The panel concluded that an FDA warning letter objecting to the slogan did not mean that the slogan was necessarily deceptive, given that the court applies a different standard for a reasonable investor than for a medical professional. The panel also held that plaintiffs failed to show a strong inference of scienter.

** This summary constitutes no part of the opinion of the court. It has been prepared by court staff for the convenience of the reader. SNEED V. TALPHERA 3

COUNSEL

Brian P. O'Connell (argued), Diego Martinez-Krippner, and Joshua B. Silverman, Pomerantz LLP, Chicago, Illinois; Jennifer Pafiti, Pomerantz LLP, Los Angeles, California; Jeremy A. Lieberman and J. Alexander Hood II, Pomerantz LLP, New York, New York; Robert V. Prongay and Casey E. Sadler, Glancy Prongay & Murray LLP, Los Angeles, California; for Plaintiffs-Appellants. Patrick J. Hayden (argued), Cooley LLP, New York, New York; Tijana Brien, Patrick E. Gibbs, Janelle M. Fernandes, and Shannon M. Eagan, Cooley LLP, Palo Alto, California; Allison O'Neill, Cooley LLP, San Diego, California; for Defendants-Appellees.

OPINION

LEE, Circuit Judge:

Can a snappy slogan for a potent pharmaceutical be deceptive and lead to liability under our securities laws? Not in this case where the company provided additional disclosures alongside the slogan in materials intended for investors. Talphera, a pharmaceutical company, marketed its under-the-tongue opioid with the slogan “Tongue and Done” in advertisement displays and a speech at an investor conference. Several Talphera shareholders sued alleging that the slogan misled investors because administering the opioid drug is more complex than just “Tongue and Done” and thus its potential market would be more limited. 4 SNEED V. TALPHERA

We affirm the dismissal of this securities fraud lawsuit because the plaintiffs failed to adequately plead falsity under Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5. A reasonable investor would not blindly accept a slogan without considering other information—in the advertising and the speech as well as in SEC disclosures— that clarified the context of “Tongue and Done.” The plaintiffs point to the FDA’s warning letter objecting to the slogan, but that does not mean the slogan is necessarily deceptive, given that we apply a different standard for a reasonable investor than for a medical professional. We also hold that the plaintiffs have not shown a strong inference of scienter: The flimsy evidence of falsity necessarily undermines the ability to show scienter. I. Background A. Talphera develops an under-the-tongue opioid painkiller. Talphera specializes in developing drugs for acute pain management. Previously known as AcelRx, Talphera developed a sublingually-administered—i.e., below the tongue—opioid tablet called DSUVIA. The new drug contains 30 micrograms of sufentanil, a powerful opioid. To reduce the risks of misusing such a potent painkiller, the FDA conditioned the drug’s approval on compliance with an agency safety plan called a Risk Evaluation and Mitigation Strategy (REMS). REMS are generally designed to help ensure safe use of medications with serious safety concerns. The REMS plan for DSUVIA aimed to prevent the unauthorized distribution of the drug outside of healthcare settings. It thus required that patients receive this painkiller only in medically-supervised settings such as hospitals, surgical centers, and emergency departments. SNEED V. TALPHERA 5

The REMS plan contained specific rules underscoring that retail pharmacies cannot carry DSUVIA and that patients cannot use it at home. For example, the REMS required hospitals to “[d]esignate an authorized representative to carry out [a] certification process” to verify the healthcare providers’ compliance with the REMS. The REMS also required healthcare providers to train staff in how to administer the drug and to avoid distribution outside the hospital. And to obtain certification to administer DSUVIA, the healthcare provider needed a license “to carry Schedule 2 opioids[, and to] attest to the fact that they can manage acute opioid overdoses, [by having] either [] Narcan, opioid reversal agents, or other ways to manage the airways.” Despite these risks, DSUVIA still had a major selling point that distinguished it from many other powerful opioids: Patients could receive the drug orally instead of through an IV. This eliminated the need for (and the risks of) frequent redosing. It also allowed the drug to satisfy unmet demand, given the national shortage of IV-administered opioids. B. Talphera uses the slogan “Tongue and Done” at investor conferences. Talphera adopted the slogan “Tongue and Done” to advertise DSUVIA’s desirable sublingual mode of delivery. The company ran all its marketing campaign material through an internal Promotional Review Committee (PRC) to help ensure marketing complied with FDA regulations. That body—which included the company’s scientists, lawyers, and executives—approved the slogan. PRC members and co-defendants Chief Executive Officer Vincent Angotti and Chief Medical Officer Pamala Palmer also favored the slogan. 6 SNEED V. TALPHERA

The “Tongue and Done” slogan soon appeared on marketing materials used at investor conferences. The tabletop display and banner (shown below) appeared at the DSUVIA booth during the Oppenheimer Health Care investors conference in March 2019. The “Tongue and Done” tabletop ad incorporated cautionary language that warned “[p]lease see indication, Important Safety Information, including Limitations of Use and BOXED WARNING at this booth.” The banner ad expressly noted that DSUVIA has a REMS plan and that only a healthcare professional may administer the drug. The banner ad also announced, “WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM . . .” SNEED V. TALPHERA 7

At the Oppenheimer Healthcare Conference, Angotti, the company’s CEO, gave an address promoting DSUVIA. He began the speech by “level set[ting]” when he cautioned “[i]t’s important if you take anything away [] that, you take this away.

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Sneed v. Talphera, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/sneed-v-talphera-inc-ca9-2025.