On February 18, 2026, FDA Commissioner Martin Makary and Vinay Prasad, then-Chief Medical and Scientific Officer and Director of the Center for Biologics Evaluation and Research, published a landmark policy announcement in the New England Journal of Medicine that a single adequate and well-controlled pivotal trial — supplemented by confirmatory evidence — is now the FDA’s default standard for approving novel drugs.[1] The agency’s longstanding practice of requiring two pivotal trials has not been a statutory mandate since 1997: at that time, Congress amended the Federal Food, Drug, and Cosmetic Act to provide that data from one adequate and well-controlled trial and confirmatory evidence can constitute ‘substantial evidence’ of effectiveness.[2] In some therapeutic areas, such as in oncology and rare disease, FDA increasingly has approved drugs on the basis of a single clinical trial, but, as a matter of general agency policy, two trials have been the baseline norm for decades.[3] That norm has now changed.
IPOs
When Should Companies Disclose Drug Safety Risks?
In re BioAge Labs, Inc., Securities Litigation, No. 25-cv-00196, 2025 WL 3038991 (N.D. Cal. Oct. 30, 2025)
Case Highlights
In October 2025, a federal district court dismissed securities claims against a biopharmaceutical company, BioAge Labs, Inc., arising from disclosures in connection with its initial public offering (“IPO”) concerning the safety of the company’s lead drug candidate, azelaprag, which was intended to facilitate weight loss by mimicking the physiological effects of exercise. The court held that the plaintiff failed to plausibly allege that BioAge’s IPO offering documents were misleading because they omitted discussion of a potential liver-related safety risk.
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.
Webcast: IPO and Public Company Readiness: Advance Planning for 2025 and 2026 IPOs – Corporate Governance and ESG Considerations
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.
Webcast: Preparing for Stronger Markets: Considerations for IPO Readiness
As more private companies begin to explore IPOs again after a difficult period in the markets, strong pre-IPO readiness can position companies to more swiftly access IPO market windows when they open. This presentation explores preliminary IPO planning considerations and key issues for private companies thinking about an IPO.