It’s a tale as old as time for many small- and mid-cap biotech companies…you file a new Form S-3 shelf registration statement in connection with your Form 10-K filing in late February or March and are eager to do a shelf takedown after some promising investor meetings. The SEC confirms that it is not reviewing the Form S-3 and you are able to go effective, but wait! As a non-WKSI, you must have your proxy information on file (either through Part III of your Form 10-K or by filing your proxy within 120 days of year end) in order to take your Form S-3 effective and begin using the shelf. Companies have historically had three choices to resolve this dilemma: (i) quickly pull together a Form 10-K/A to include Part III information in the Form 10-K filing, (ii) accelerate the proxy filing timing or (iii) wait until the proxy is on file. Options (i) and (ii) will put unwanted pressure on the legal and finance teams and under option (iii) each passing day could mean the difference between an equity raise and losing interested investors.
Life Sciences Securities Litigation Insights: Even Marketing Materials Can Subject Issuers to Securities Fraud Claim
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.
Key Takeaways: Life Sciences 2025 Outlook: Capital Markets Webcast (March 19)
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.
Introducing the Royalty Finance Tracker
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.
Key Takeaways: Life Sciences 2025 Outlook: Royalty Finance Webcast (March 12)
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.
SEC Expands Confidential Submission for Form S-1 Filings: New Rules Enhance Fundraising Options for Life Sciences Companies
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.
Join us: Life Sciences 2025 Outlook: Capital Markets Webcast (March 19)
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.
The Latest Pay-to-Play Non-Circumvention Provisions in the NVCA Model Documents and Considerations for Private Biotech Companies
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).
Navigating the Impact of Emergency Tariffs on Biotech Manufacturing with Chinese Counterparties
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.
FDA in Flux: What Life Science Companies Should Expect as the Agency Undergoes Staffing Changes
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.