Biotech Briefings

When Should Companies Disclose Drug Safety Risks?

| Posted by Jeff Lombard; Kim Zaneta; Celina Jackson; Topic(s): Clinical Trials; FDA; IPOs; SEC Disclosure; Trends and Insights

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.

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MFN Drug Pricing in 2026: Voluntary Deals Are Giving Way to Mandatory Rules — Five Things Life Sciences Companies Need to Know

| Posted by Ryan A. Murr; Branden C. Berns; Aaron K. Briggs; Melanie E. Neary; John D.W. Partridge; Karen A. Spindler; Topic(s): FDA; Government Regulation; International Trade; License Agreements; M&A; Royalty Finance; SEC Disclosure; Trends and Insights

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.

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2026 Life Sciences Industry Outlook: Regulatory Environment

| Posted by Katlin McKelvie; John D.W. Partridge; Lindsay M. Paulin; Michael J. Perry; Jonathan M. Phillips; Adam M. Smith; Carlo Felizardo; Samantha Sewall; Hui Fang; Jenna Raspanti; Lindsay Bernsen Wardlaw; Topic(s): Antitrust; False Claims Act; FDA; FDA Guidance; Government Regulation; International Trade; Trends and Insights

Welcome to Part 5 of our 2026 Life Sciences Industry Outlook series. Today, we are wrapping up the week with a review of the regulatory environment for life sciences companies in 2025 and our expectations for what 2026 could bring.

In 2025, life sciences companies faced a fast-moving regulatory environment shaped by the Trump administration’s priorities, including deregulation, the use of policy levers to encourage domestic manufacturing and development, and efforts to reduce healthcare costs for American consumers. We expect this unpredictable atmosphere to continue into 2026. In particular, we anticipate regulatory and enforcement developments in FDA regulation, drug pricing and reimbursement, government contracts, tariffs, and antitrust oversight, although specific outcomes and impacts remain difficult to predict.

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2026 Life Sciences Industry Outlook: Collaborations and Licensing

| Posted by Ryan A. Murr; Karen A. Spindler; Carson Zheng; Topic(s): License Agreements; Trends and Insights

Welcome to Part 4 of our 2026 Life Sciences Industry Outlook series. Today, we’re looking at life sciences collaborations and licensing activity in 2025 and what it may signal for 2026.

2025 life sciences licensing activity remained resilient and increasingly sophisticated, with stable deal volume, heightened structural customization, and growing geopolitical and technology-driven considerations shaping how biotechs and large pharmaceutical companies approach partnerships heading into 2026.

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2026 Life Sciences Industry Outlook: Royalty Finance

| Posted by Ryan A. Murr; Karen A. Spindler; Shmuel Giblon; Topic(s): Royalty Finance; Trends and Insights

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.

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2026 Life Sciences Industry Outlook: Capital Markets

| Posted by Branden C. Berns; Ryan A. Murr; Melanie E. Neary; Candice D. Johnson; Nicholas G. Linke; Topic(s): Capital Markets; Trends and Insights

Welcome to Part 2 of our 2026 Life Sciences Industry Outlook series. Today, we are focusing on life sciences capital markets activity in 2025 and expectations for 2026.

The life sciences equity capital markets in 2025 were defined by a stark “tale of two halves,” beginning with intense volatility that effectively shuttered deal activity. The first half of the year was marred by significant market uncertainty, particularly following the “Liberation Day” tariff announcements. This event, combined with regulatory upheaval caused major indices like the XBI and Nasdaq to slide. During this period, the capital markets lay dormant—April saw zero priced biotech IPOs and only four priced follow-on deals, three of which were registered directs.

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2026 Life Sciences Industry Outlook: Mergers and Acquisitions

| Posted by Branden C. Berns; Ryan A. Murr; Melanie E. Neary; Evan Shepherd; Ayushi Sutaria; Maggie Zhang; Topic(s): M&A; Trends and Insights

Welcome to Part 1 of our 2026 Life Sciences Industry Outlook series. We are kicking off the week with a look at  life sciences M&A activity in 2025 and what it may signal for 2026.

M&A activity in 2025 accelerated sharply, marking one of the busiest years on record. Aggregate deal value and the number of announced transactions rose meaningfully from 2024, buoyed by marginally improving financing conditions, greater boardroom confidence, and clearer regulatory expectations in the second half of the year. Mega-cap and upper‑mid‑market deals returned alongside a still‑healthy cadence of bolt‑on acquisitions and other smaller transactions by companies focused on incremental pipeline enhancements and portfolio gaps. Therapeutically, 2025 activity remained anchored beyond traditional oncology into cardio-metabolic (including obesity-adjacent assets) and neuroscience/CNS, while radiopharmaceuticals continued to command strategic interest and autoimmune/immunology remained a steady source of durable, de-risked, later-stage pipeline reinforcements.

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Introducing Our 2026 Life Sciences Industry Outlook Series

| Posted by Branden C. Berns; Ryan A. Murr; Melanie E. Neary; Karen A. Spindler; Topic(s): Trends and Insights

As the life sciences industry kicks off the new year and convenes at the JP Morgan Healthcare Conference this week, we are launching a weeklong Biotech Briefings series highlighting key insights from our 2026 Life Sciences Industry Outlook. Following a pivotal year in which deal activity accelerated and capital markets reopened selectively, the industry enters 2026 with cautious optimism—and a sharper focus on execution.

Throughout the week, we will explore the trends shaping life sciences dealmaking and financing in the year ahead, with posts focused on mergers and acquisitions, capital markets, royalty finance, collaborations and licensing, and the evolving regulatory environment. Together, these perspectives reflect a market characterized by renewed strategic conviction, disciplined capital deployment, and increasing structural sophistication.

We look forward to sharing our views on what biotech executives, investors, and strategic partners should be watching as 2026 unfolds.

Getting Ready for Your Q3 Quarterly Reports: Updated Disclosure Regarding Tariffs and Government Shutdown

| Posted by Aaron K. Briggs; Melanie E. Neary; Xuan Hong Tran; Topic(s): Government Regulation; International Trade; SEC Disclosure; Trends and Insights

As public companies prepare their third quarter Form 10-Q filings, the rapidly shifting policy landscape has created new disclosure challenges for the life sciences sector. The recently announced pharmaceutical tariffs and ongoing government shutdown both carry potential financial and operational implications that warrant close attention. For biotech companies, these developments underscore the need for clear, proactive disclosure around supply chain resilience, pricing exposure, and regulatory uncertainty. In this post, we outline key disclosure considerations to help issuers navigate this evolving environment and manage investor expectations heading into the end of the year.

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