Biotech Briefings

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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M&A Thirty Days into the Government Shutdown: First Transaction to Close That Launched During the Shutdown

| Posted by Ryan A. Murr; Bradley P. Smith; Branden C. Berns; Melanie E. Neary; Topic(s): Government Regulation; M&A; Trends and Insights

Thirty days into the U.S. government shutdown, most federal agencies are operating with only “essential” personnel. The SEC and FTC are running with minimal staffing, authorized to take only limited actions. At the SEC, no registration statements have been declared effective since the shutdown began, and a backlog of more than 1,000 filings is expected to await review once operations resume.

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Trump’s 100% Pharma Tariffs: Manageable for Large Pharma; Challenging for Biotechs

| Posted by Ryan A. Murr; Pamela Lawrence Endreny; Terrell Ussing; Karen A. Spindler; Branden C. Berns; Melanie E. Neary; Ryan Rott; Topic(s): Government Regulation; International Trade; Trends and Insights

On September 25, 2025, President Trump announced 100% tariffs on imported branded or patented pharmaceuticals, effective October 1, 2025, unless the importing company is building U.S. manufacturing capacity (defined in President Trump’s announcement as “breaking ground and/or under construction”). The policy is being advanced under Section 232 “national security” authority.

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White House, HHS, and FDA Launch a “Crackdown” on “Deceptive” Direct-to-Consumer Prescription Drug Advertising

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

The White House, the Department of Health and Human Services (HHS), and the Food and Drug Administration (FDA) have announced that FDA has initiated “sweeping reforms” and “aggressive enforcement” to address “deceptive” and “misleading” direct-to-consumer (DTC) prescription drug advertising.

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What Life Sciences Companies Should Know About the New Trade Fraud Task Force

| Posted by Adam M. Smith; Samantha Sewall; Topic(s): Government Regulation; International Trade; Trends and Insights

On August 29, 2025, the Department of Justice (DOJ) launched the Trade Fraud Task Force that will coordinate efforts between DOJ’s Civil and Criminal Divisions and the Department of Homeland Security (DHS) to bring enforcement actions against importers who unlawfully evade tariffs and other customs duties, as well as against parties who unlawfully import prohibited goods.[1] This is the latest sign that, amid legal battles over the legality of President Trump’s tariffs, DOJ remains deeply committed to using all available legal tools to police customs and tariff compliance.  It is also the latest example of this Administration’s top-down approach to generating investigative targets.

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Life Sciences Royalty Finance Trends – H1 2025

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

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/)

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Expanded QSBS Benefits: What Biotech Founders Need to Know After the “One Big Beautiful Bill” Act

| Posted by Eric B. Sloan; Matt Donnelly; Kamia Williams; Bree Gong; Topic(s): Government Regulation; Tax; Trends and Insights

Why this matters for biotech start-ups

Raising capital for drug discovery often pushes early-stage biotech companies above the gross asset limit for qualifying for the U.S. federal income tax benefits associated with qualified small business stock (“QSBS”). The law commonly referred to as the One Big Beautiful Bill Act (the “OBBBA”), signed into law on July 4, 2025, lets founders and other investors greater access these tax savings—potentially reducing their tax bill by millions when the company is sold.

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