Biotech Briefings

Gibson Dunn and BCLT Host a Webcast Series on Royalty Finance, the UCC, and Issues of Recharacterization

| Posted by Todd J. Trattner; Ryan A. Murr; Topic(s): Royalty Finance

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, looking at synthetic royalties, 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:

You can watch the series for free using the code “BCLT-GD” at checkout.

“Deal Lawyers Download” Podcast: Shell Companies and Reverse Mergers

| Posted by Ryan A. Murr; Branden C. Berns; James Moloney; Topic(s): Reverse Mergers

Listen to Ryan Murr, Branden Berns, and James Moloney discuss reverse mergers and how recent actions by the SEC have influenced the ways that reverse mergers are structured and the implications of those actions for those companies considering a reverse merger on the “Deal Lawyers Download” podcast produced by DealLawyers.com.

Listen here (subscription required).

Missed PDUFA Targets: Context, Concerns, and the Case of Stealth BioTherapeutics

| Posted by Branden C. Berns; Katlin McKelvie; Carlo Felizardo; Topic(s): FDA

The FDA’s commitment to timely drug approvals under the Prescription Drug User Fee Act (PDUFA) has been a cornerstone of its regulatory framework. Historically, the agency has maintained a high success rate in meeting its PDUFA goals; however, a handful of delays will typically occur each year for largely idiosyncratic reasons. Since 2021, when the FDA experienced delays due to challenges during the COVID-19 pandemic, the FDA has generally met or exceeded 90% of its review performance goals for new drug applications (NDAs) and biologics license applications (BLAs). However, recent regulatory upheaval at the FDA has prompted discussions of a potential decline in the previously reliable response rates and the implications for biotech companies and patients awaiting new therapies.​

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Impact of Current and Proposed Tariffs on Pharmaceutical Products

| Posted by Adam Smith; Samantha Sewall; Hui Fang; Topic(s): International Trade; Trends and Insights

Pharmaceutical products from China continue to be subject to the fentanyl-related emergency tariffs (20%) and are expected to be subject to national security tariffs to be announced under Section 232 of the Trade Expansion Act of 1962, despite the recently announced “exemption” from the so-called “reciprocal tariffs” announced on April 2, 2025. We expect the Section 232 investigation to move quickly, and we advise companies to take prompt proactive steps to assess the tariff impacts. Our trade team stands ready to assist clients in navigating the fast-developing tariff landscape.

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FDA’s Roadmap to Reducing Preclinical Animal Safety Studies: Six Things to Know

| Posted by Katlin McKelvie; Carlo Felizardo; Topic(s): FDA; FDA Guidance; Trends and Insights

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a new initiative to explore ways to reduce preclinical animal safety studies for human drugs and biological products, beginning with an approach to allowing the use of “New Approach Methodologies” (NAMs) in lieu of animal testing for eligible investigational monoclonal antibodies.[1] The agency’s plan marks a significant departure from decades of agency practice, in which life sciences companies developing novel therapeutic products typically have conducted a number of safety studies, including pharmacological and toxicological studies, in various species before progressing to the clinical phase. Below are six key points for life sciences companies to know about FDA’s plans to incorporate NAMs into preclinical evaluations for human drugs and biologics.

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FDA’s User Fee Programs at a Crossroads: User Fee Deadlines and Funding at Risk

| Posted by Katlin McKelvie; Carlo Felizardo; Topic(s): FDA

Gibson Dunn is closely monitoring developments and is prepared to help companies consider and address the implications of potential changes to FDA’s funding structure and authorities, including through regulatory counseling, agency and legislative engagement, and litigation.

Following recent mass layoffs at the Food and Drug Administration and growing criticism from senior administration officials of FDA’s user fee funding programs, the life sciences industry can expect significant changes to both FDA’s ability to meet medical product user fee deadlines and the future of the user fee programs more broadly.

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Royalty Report: Royalty Finance Transactions in the Life Sciences 2020-2024

| Posted by Todd J. Trattner; Ryan A. Murr; Topic(s): Royalty Finance; Trends and Insights

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.

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Opening the Window for S-3 Effectiveness Post-10-K Filing

| Posted by Melanie E. Neary; Branden C. Berns; Topic(s): Capital Markets; SEC Updates; Trends and Insights

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.

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