We just published Gibson Dunn’s 2026 Royalty Finance Market Update — a comprehensive analysis of 133 life sciences royalty transactions from 2020 through 2025, totaling $32.7 billion in aggregate value. A few findings stood out to us as genuinely worth flagging for practitioners in the space.
Royalty Finance
One and Done: FDA’s New Single-Trial Default and What It Means for Drug Developers, Investors, and Counsel
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.
MFN Drug Pricing in 2026: Voluntary Deals Are Giving Way to Mandatory Rules — Five Things Life Sciences Companies Need to Know
What began as a series of demand letters in July 2025 has evolved into something significantly more consequential. By February 2026, sixteen of the seventeen largest pharmaceutical manufacturers have signed Most-Favored-Nation (MFN) pricing agreements with the Trump administration, which commit them to Medicaid price parity, MFN pricing on new product launches, and participation in TrumpRx.gov in exchange for three-year tariff immunity and improved regulatory positioning. But as those voluntary deals settle, the Centers for Medicare & Medicaid Services (CMS) has moved to make MFN pricing mandatory for Medicare through two new models: GLOBE (Medicare Part B) and GUARD (Medicare Part D), both published in the Federal Register on December 23, 2025, with a public comment period that closed on February 23, 2026.
2026 Life Sciences Industry Outlook: Royalty Finance
Welcome to Part 3 of our 2026 Life Sciences Industry Outlook series. Today, we are turning to royalty finance transactions in the life sciences industry in 2025 and what to expect in 2026.
Once again, 2025 marked a year of meaningful growth for royalty finance, underscoring the continued evolution of royalty monetization transactions from niche alternatives into established components of the corporate finance toolkit within the life sciences sector. Aggregate transaction value across leading market participants increased to a record level of approximately $6.5 billion, up from approximately $5.7 billion in 2024. While $6.5 billion remains modest when compared with traditional equity or debt markets, the growth trajectory is notable. As recently as the early 2000s, annual aggregate royalty finance transaction value was estimated at less than $200 million per year, highlighting the extent to which royalty financing has relatively quickly become a mainstream funding solution for biopharmaceutical companies.
Article: Royalty Finance Comes of Age
On PrivateFundsCFO.com, Ryan Murr discusses how in a rebounding biotech market, royalty finance can play a far more strategic role, provided it’s executed with disciplined underwriting, smart structuring and a genuine partnership with innovators. Access the article here (free registration required).
Life Sciences Royalty Finance Trends – H1 2025
The numbers for royalty financing transactions in the first half of 2025 look promising, with one commentator going so far to state, “Faced with a bleak equity market and tightening credit, drug developers from Boston to Basel turned to royalty monetization as a lifeline.” (see, https://www.p05.org/royalty-financing-rescues-biopharma-a-h1-2025-global-analysis/)
Gibson Dunn and BCLT Host a Webcast Series on Royalty Finance, the UCC, and Issues of Recharacterization
Gibson Dunn has partnered with the UC Berkeley Center for Law & Technology on a three-part webcast series that discusses issues originally raised in a Law 360 article on royalty financing written by partners Todd Trattner and Ryan Murr.
In the series, partners Todd Trattner, Ryan Murr, Jin Hee Kim, and Jeffrey Krause and associates Kali Jelen, Anthony Hajj, and Michael Farag provide an in-depth exploration of royalty finance, the treatment of synthetics under the UCC, and the risks of a sale of a synthetic royalty being recharacterized as a loan in bankruptcy.
The series is designed to educate biotechnology stakeholders (investors, entrepreneurs, companies, and their attorneys) on best practices for monetizing and investing in a synthetic royalty so that they can embark on such transactions with greater certainty.
To access the series, visit:
- Panel 1 – Royalty Finance: Structures, Trends and Synthetics
- Panel 2 – Synthetic Royalty Financings and the UCC
- Panel 3 – Synthetic Royalty Financings: Risks of Recharacterizing a True Sale (available May 20)
You can watch the series for free using the code “BCLT-GD” at checkout.
Tariffs and Royalties in License Agreements: Key Considerations for Life Science Companies
Recent shifts in international trade policies have led to the imposition of new tariffs prompting life science companies to reassess their license agreements to understand the potential impact of these new tariffs on royalty calculations under such agreements.
Royalty Report: Royalty Finance Transactions in the Life Sciences 2020-2024
This Royalty Report provides an analysis of publicly reported royalty finance transactions for the last five years (2020 to 2024) in the life sciences sector, focusing on both traditional and synthetic royalty transactions. Traditional royalty transactions encompass monetizations of royalties under existing license agreements. Synthetic royalty transactions involve the sale of a portion of future product sales, rather than the sale of an existing future royalty entitlement.
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.