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Life Sciences Securities Litigation Insights: Even Marketing Materials Can Subject Issuers to Securities Fraud Claim

March 25, 2025 | Posted by Ryan A. Murr; Branden C. Berns; Jeff Lombard; Jessica Valenzuela; Brian M. Lutz; Craig Varnen; Monica K. Loseman Topic(s): Securities Litigation

Case Highlights:

On May 7, 2024, a federal district court dismissed securities fraud claims brought against a pharmaceutical company related to a marketing slogan used to promote the company’s drug.  At issue in Sneed v. AcelRx Pharms., Inc. (“Sneed”)[1], was AcelRx Pharmaceuticals, Inc.’s (“AcelRx”) marketing slogan, “Tongue and Done,” used to promote its FDA-approved drug DSUVIA, an opioid painkiller.  AcelRx had presented the “Tongue and Done” slogan on its website, among other places, to highlight the ease of administering DSUVIA (i.e., sublingually) compared to other opioid painkillers, which are administered either orally (which requires a patient’s ability to swallow) or via intravenous injection.

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Key Takeaways: Life Sciences 2025 Outlook: Capital Markets Webcast (March 19)

March 24, 2025 | Posted by Ryan A. Murr; Branden C. Berns; Melanie E. Neary; Anika Gidwani Topic(s): Capital Markets; Trends and Insights

Melanie Neary, Branden Berns, and Ryan Murr of Gibson Dunn, along with Bud O’Hara of Jefferies, hosted a Life Sciences 2025 Outlook: Capital Markets webcast on Wednesday, March 19, 2025, breaking down capital market trends, deal activity, and industry expectations for life sciences in 2025.

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Introducing the Royalty Finance Tracker

March 19, 2025 | Posted by Todd J. Trattner; Ryan A. Murr; Topic(s): Royalty Finance; Trends and Insights

Dear friends and colleagues,

We are excited to introduce the Gibson Dunn Royalty Finance Tracker (https://www.gibsondunn.com/royalty-finance-tracker/) in conjunction with the launch of Biotech Briefings, where we have compiled all publicly announced royalty finance transactions amongst the most active funds that have occurred since January 1, 2020.

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Key Takeaways: Life Sciences 2025 Outlook: Royalty Finance Webcast (March 12)

March 18, 2025 | Posted by Todd J. Trattner; Ryan A. Murr; Topic(s): Royalty Finance; Trends and Insights

Todd Trattner and Ryan Murr of Gibson Dunn and Doug Prescott of TD Cowen hosted a Life Sciences 2025 Outlook: Royalty Finance webcast on Wednesday, March 12, in which they provided an integrated outlook on royalty finance in the life sciences industry, identifying trends and uncertainties that will shape the year ahead.

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SEC Expands Confidential Submission for Form S-1 Filings: New Rules Enhance Fundraising Options for Life Sciences Companies

March 17, 2025 | Posted by Branden C. Berns; Hong Tran; Topic(s): Capital Markets; SEC Updates; Trends and Insights

The Securities and Exchange Commission (SEC) has expanded confidential submission privileges for Form S-1 filings, benefiting many life sciences companies. As of March 3, 2025, public companies, including those that became public through reverse mergers and those subject to “baby shelf” limitations, can now submit draft registration statements for confidential review.

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Join us: Life Sciences 2025 Outlook: Capital Markets Webcast (March 19)

March 13, 2025 | Posted by Ryan A. Murr; Branden C. Berns; Melanie E. Neary; Topic(s): Capital Markets; Trends and Insights

You’re invited! Please join Ryan Murr, Branden Berns and Melanie Neary of Gibson Dunn and Bud O’Hara of Jefferies for a Life Sciences 2025 Outlook: Capital Markets webcast on Wednesday, March 19 from 1 – 1:45 pm ET / 10 – 10:45 am PT. We will provide an integrated outlook on capital markets in the life sciences industry, identifying trends and uncertainties that will shape the year ahead.

Register Here

The Latest Pay-to-Play Non-Circumvention Provisions in the NVCA Model Documents and Considerations for Private Biotech Companies

March 12, 2025 | Posted by Mark Goldman; Sam Shapiro; Topic(s): ECVC; Trends and Insights

The National Venture Capital Association (NVCA) recently updated its model equity financing documents to reflect changes in law and market norms. One update particularly relevant in the life sciences context is the temporary suspension of a preferred stockholder’s right to convert its preferred stock into common stock during the period prior to completion of a financing round with a “pay-to-play” component (see Section 4.1.1 of the model Certificate of Incorporation available here and excerpted below).

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Navigating the Impact of Emergency Tariffs on Biotech Manufacturing with Chinese Counterparties

March 10, 2025 | Posted by Samantha Sewall; Lindsay Bernsen Wardlaw; Adam Smith; Branden C. Berns; Topic(s): Government Regulation; International Trade; Manufacturing; Trends and Insights

The recent imposition of emergency tariffs on products from China and Hong Kong has raised significant concerns for biotech companies, particularly those considering or currently engaged in manufacturing contracts with Chinese entities. This post aims to provide an overview of the recent emergency tariffs targeting China and their potential implications for the biotech industry.

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FDA in Flux: What Life Science Companies Should Expect as the Agency Undergoes Staffing Changes

March 4, 2025 | Posted by Katlin McKelvie; Carlo Felizardo; Topic(s): FDA; Government Regulation; Trends and Insights

The beginning of the second Trump administration has been marked by significant—and often sudden—efforts to shrink the federal workforce and replace agency leadership to establish and deliver on a new set of priorities. In the past weeks, the administration has pursued a deferred resignation program,[1] terminated employees both in leadership and on probationary status,[2] and announced plans for a forthcoming government-wide reduction in force.[3] The U.S. Food and Drug Administration (FDA) has not been immune to these changes.

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Introducing Biotech Briefings

March 3, 2025 | Posted by Branden C. Berns; Aaron K. Briggs; Jane M. Love, Ph.D.; Mary Beth Maloney; Ryan A. Murr; Melanie E. Neary; John D.W. Partridge; Karen A. Spindler; Eric J. Stock; Todd J. Trattner; Stephen Weissman; Topic(s): Trends and Insights

Dear friends and colleagues,

We are excited to introduce Biotech Briefings, providing Gibson Dunn’s commentary and perspectives on the legal, business, and regulatory issues shaping the life sciences industry.

From groundbreaking developments in biopharma, medical devices, and diagnostics to the evolving landscape of IP, FDA and SEC regulation, Biotech Briefings delivers timely insights for companies, investors, and industry stakeholders.

Stay tuned for expert analysis on:

  • Key FDA, FTC & SEC developments
  • M&A, financing & strategic partnerships
  • Market dynamics shaping investment & innovation

We invite you to follow along for actionable insights at the crossroads of law, business, and science.

The Gibson Dunn Life Sciences Team

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Editors

Branden C. Berns

Lindsay Bernsen Wardlaw

Aaron K. Briggs

Gustav W. Eyler

Hui Fang

Carlo Felizardo

Mark Goldman

Charlotte Jacobsen

Jin Hee Kim

Jeff Lombard

Jane M. Love, Ph.D.

Mary Beth Maloney

Katlin McKelvie

James Moloney

Ryan A. Murr

Melanie E. Neary

John D.W. Partridge

Lindsey D. Schmidt

Samantha Sewall

Sam Shapiro

Adam Smith

Karen A. Spindler

Eric J. Stock

Hong Tran

Todd J. Trattner

Stephen Weissman

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