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.
Introducing Biotech Briefings
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
Now Available: IPO Guidebook (2025 Edition)
This guidebook offers an overview of the numerous decision points, procedures and vital considerations a company should contemplate before, during and after the IPO process.
Completing an Initial Public Offering (IPO) is a significant milestone for many business owners, executives, directors and stockholders. However, the journey towards going public can be fraught with complexities and unexpected challenges. For companies seeking to raise capital, whether through an IPO or other alternatives, it is critical to understand the road ahead.
Life Sciences 2025 Outlook
The life sciences industry is entering 2025 with a largely favorable set of catalysts for the coming year, but also with some larger risks that will impact companies differently.
FDA to Require Confirmatory Trials Be “Underway” Prior to Accelerated Approval, Per New Draft Guidance
Life sciences companies interested in pursuing accelerated approval should ensure they have a thorough understanding of the complex regulatory landscape and engage in early discussions with FDA regarding their drug development programs.
Executive Email Can Expose Public Companies to Securities Fraud Claim
Pizzuto v. Homology Meds., Inc., No. 1:23-CV-10858, 2024 WL 1436025
(D. Mass. Mar. 31, 2024)
Case Highlight
In a securities fraud action earlier this year, an executive’s statement made in an email to a single research analyst was alleged to be false or misleading. In Pizzuto v. Homology Meds (“Pizzuto”), plaintiffs brought a securities class action complaint against Homology Medicines Inc. (“Homology”), a biopharmaceutical company, alleging that the company’s statements regarding the safety and efficacy of its gene therapy treatment were false and misleading.