Biotech Briefings

Now Available: IPO Guidebook (2025 Edition)

| Posted by Topic(s): Capital Markets; IPOs; Trends and Insights

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.

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Executive Email Can Expose Public Companies to Securities Fraud Claim

| Posted by Branden C. Berns; Jeff Lombard; Topic(s): Securities Litigation

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.

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Webcast: M&A Insights: Earn-Outs, New HSR and Investment Rules, and Fraud Liability

| Posted by Branden C. Berns; Topic(s): M&A; Trends and Insights

Join us for a 45-minute briefing covering several M&A practice topics. The program is part of a series of quarterly webcasts designed to provide quick insights into emerging issues and practical advice on how to manage common M&A problems. Steve Glover, a partner in the firm’s Global M&A Practice Group, acts as moderator.

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Webcast: IPO and Public Company Readiness: Advance Planning for 2025 and 2026 IPOs – Corporate Governance and ESG Considerations

| Posted by Aaron K. Briggs; Topic(s): Capital Markets; IPOs; Trends and Insights

Please join us for a briefing where we explore corporate governance and ESG considerations in preparing for an Initial Public Offering (IPO) and becoming a public company. We delve into state-of-the-art corporate governance policies and practices that companies should implement in connection with the IPO process, ensuring alignment with market practices and evolving trends. Attendees will gain insights into investor and proxy advisor expectations, key issues under Delaware law and stock exchange listing standards.

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Federal Circuit Decision in Allergan v. MSN

| Posted by Jane M. Love, Ph.D.; Topic(s): Delaware Law; M&A

On August 13, 2024, the Federal Circuit issued a precedential decision on the issue of obviousness-type double patenting (ODP) and patent-term adjustment (PTA) in Allergan USA, Inc. et al., v. MSN Laboratories Private Ltd., et al., No. 24-1061 (Fed. Cir. Aug. 13, 2024).  While the decision also addressed other issues, this update focuses on summarizing the Court’s holding on the ODP issue.

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FDA Issues Overdue Guidance on Diversity Action Plans in Drug and Device Clinical Trials – What You Need to Know

| Posted by Katlin McKelvie; Topic(s): Clinical Trials; FDA Guidance

This update provides key takeaways on the new draft guidance and Diversity Action Plan requirements, including when the new requirements will go into effect, the types of clinical studies that require submission of a Diversity Action Plan, whether FDA intends to issue waivers for the requirements, and the consequences of failure to submit a Diversity Action Plan.

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Delaware Court of Chancery Opines on the Meaning of “Commercially Reasonable Efforts” in a Pharmaceutical Earn-Out Provision

| Posted by Ryan A. Murr; Karen A. Spindler; Todd J. Trattner; Topic(s): Delaware Law; M&A

Observations and drafting suggestions for CRE terms in merger agreements, licenses, and royalty purchase agreements.

On April 30, 2024, the Delaware Court of Chancery held that the buyer in a life sciences merger and its successor had not breached their contractual obligations under an earn-out provision to use commercially reasonable efforts (“CRE”) to achieve regulatory approvals for a pharmaceutical product. In Himawan, et al. v. Cephalon, Inc., et al., Vice Chancellor Glasscock found that the merger agreement’s definition of CRE for purposes of the earn-out provision, which referred to the efforts of a company with substantially the same resources and expertise as the buyer, required the Court to analyze whether a reasonable actor faced with the circumstances would continue to pursue the development of a drug that had failed to meet one of its co-primary endpoints in an earlier clinical trial.[1]

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