Antitrust and Competition Life Sciences Year in Review 2025

After four years of unpredictably aggressive—and often controversial—merger review, the expectations were that under the new leadership, the Federal Trade Commission (FTC)’s review of life sciences transactions would return to well-established principles of antitrust analysis. Those expectations have been met so far. With the notable exception of the FTC’s involvement in the bidding war between Pfizer and Novo for Metsera, the agency’s activity in life sciences has been rigorous but consistent with decades of antitrust enforcement precedent.

Observations From the 2026 JP Morgan Healthcare Conference With an Antitrust Lens

2025 was one of the most active years for life sciences M&A activity in recent memory — and certainly since 2019. After a slow start, we saw numerous multi-billion-dollar transactions in the second half of the year, many involving later-stage assets and running the gamut of therapeutic areas:

• Novartis’ $12 billion proposed acquisition of Avidity Biosciences (genetic neuromuscular diseases)
• Merck’s $10 billion acquisition of Verona Pharma (chronic obstructive pulmonary disease maintenance treatment) and $9.2 billion acquisition of Cidara Therapeutics (Phase 3 antiviral for flu prevention)
• Sanofi’s approximately $9.5 billion acquisition of Blueprint Medicines (systemic mastocytosis and oncology pipeline)
• Merck KGaA’s $3.4 billion acquisition of SpringWorks Therapeutics (rare tumor diseases)
• Johnson & Johnson’s $3.05 billion acquisition of Halda Therapeutics (solid tumors, including prostate cancer)
• Genmab’s $8 billion acquisition of Merus (late-stage oncology asset for head and neck cancer)

Notably, life sciences deals are getting done without any unreasonable delays; each of the previously noted transactions cleared after the initial 30-day Hart-Scott-Rodino (HSR) Act waiting period, albeit, in some cases, following a rigorous review.

Metabolic conditions continue to be an area of significant deal activity. In 2024, Madrigal Pharmaceutical’s Rezdiffra became the first approved drug for metabolic dysfunction–associated steatohepatitis (MASH). This prompted M&A activity in the space, which technologically overlaps with or is adjacent to obesity and type 2 diabetes. In July 2025, GSK licensed efimosfermin from Boston Pharmaceuticals for $1.2 billion up front. A few months later, Roche acquired 89bio and its Phase 3 MASH asset for up to $3.5 billion, and Novo Nordisk acquired Akero Therapeutics and its Phase 3 MASH asset for $4.7 billion up front.

Large pharma players were also active in the adjacent obesity space. In March 2025, Roche followed its 2024 acquisition of Carmot Therapeutics (pursuant to which it is still developing CT-388) with a license from Zealand Pharma to develop an amylin analog valued at $3.6 billion. Novo Nordisk entered into a license and collaboration deal with Septerna to explore additional obesity drugs. AbbVie also entered the obesity race in 2025 by licensing an amylin analog from Gubra, while AstraZeneca — which already had multiple assets in development, including an oral, a peptide, and a GLP-1/amylin dual agonist — acquired SixPeaks Bio to bring in an activin receptor type IIA and IIB antagonist (to preserve muscle).

Pfizer made perhaps the most significant moves to shake up the obesity landscape, first by terminating its internal programs — arguably eliminating any antitrust risk in a future obesity-focused deal —and then by signing multiple deals focused on developing obesity drugs that are easier to use and administer than existing market offerings. Specifically, Pfizer reached deals to acquire Metsera and its oral drug candidate for $10 billion and to license Fosun Pharmaceutical’s once-monthly GLP-1 injectable.

In vivo cell therapy was another area of significant competitive business development activity — both by ex vivo cell therapy incumbents and others. The AbbVie/Capstan Therapeutics, Bristol Myers Squibb/Orbital Therapeutics, AstraZeneca/EsoBiotec, Gilead Sciences/Interius BioTherapeutics, and Gilead Sciences/Pregene Biopharma transactions, among others, all involved technologies designed to circumvent the need to reprogram cells ex vivo, which is a laborious and costly process. We expect this trend to continue as preclinical technologies demonstrate their viability in the clinic, potentially disrupting the competitive dynamics in CAR T-cell space and indications beyond oncology.

Finally, the exponential growth of inbound licenses or acquisitions of preclinical and clinical-stage assets from Chinese sponsors was another area of business development with material impact on future antitrust analyses. Small biotech and large pharma companies based in China are no longer a fringe element of the global life sciences innovation landscape.

M&A Battles Informed by Antitrust Risk Assessment

Amid this overall surge in M&A activity in the life sciences space were two particularly intense battles for acquisition targets. As discussed below, in the cases of both Metsera and Avadel Pharmaceuticals, company boards were forced to evaluate the relative antitrust risk posed by competing bids. These examples illustrate the ongoing importance of antitrust analysis, both at the time of offer(s) and on an ongoing basis as companies consider exit strategies.

Pfizer/Metsera

On September 22, 2025, following a competitive bidding process that began shortly after its February 2025 initial public offering, Metsera announced that it had agreed to be acquired by Pfizer in a deal valued at up to $7.3 billion. Under the agreement, Pfizer would pay $47.50 per share, plus up to an additional $22.50 per share payable through contingent value rights (CVRs) upon clinical and regulatory milestones for Metsera’s GLP-1 obesity treatments.

About a month later, Metsera announced that it was terminating its merger agreement with Pfizer to accept a higher offer from Novo Nordisk that valued the company at up to approximately $9 billion. While Metsera previously rejected a lower offer from Novo during the bidding process due to potential regulatory risks, it determined that Novo’s revised proposal constituted a “Superior Company Proposal” under the Pfizer merger agreement.

The Novo deal involved a unique, two-part acquisition structure rare in public deals. First, upon signing, Novo would pay Metsera a per-share price for non-voting securities representing 50% of the economics of the company, which Metsera would then pay to its stockholders as a dividend. Second, once stockholders and regulators approved the deal, Novo would acquire the remainder of Metsera’s shares and issue CVRs to Metsera’s stockholders as milestone payments. During the pendency of the deal, Novo would provide funding to Metsera for business operations and employee costs, and Metsera would be subject to interim operating covenants.

Because Novo’s acquisition of non-voting securities in the first part of the transaction was not (at least arguably) subject to preclearance under the HSR Act, this deal structure allowed Novo to pay Metsera and its stockholders before undergoing antitrust regulatory review, which could have taken months or years to complete. If the transaction were subsequently blocked on antitrust grounds or otherwise terminated, Metsera stockholders would have still received the upfront consideration and had the option to pursue an alternative transaction (or go it alone).

In response to these developments, Pfizer sued to block Novo’s acquisition of Metsera in the U.S. District Court for the District of Delaware on antitrust grounds. It argued that the deal constituted a “killer acquisition,” as Novo intended not to bring Metsera’s GLP-1 asset to market but instead to slow its development and ultimately to shield Novo from competition.¹

While this lawsuit was pending, Pfizer increased its bid to $10 billion, essentially matching Novo’s bid. While the Metsera board was contemplating both offers, the FTC weighed in, reaching out via a letter and a call to Metsera to communicate its views that the proposed deal with Novo presented material antitrust risk, citing potential violations of “procedural provisions” of the HSR Act.² The FTC’s position on the procedural aspects of the HSR Act may have been driven by its preference for Pfizer as the buyer (Pfizer’s acquisition of Metsera had already cleared HSR review) as much as a belief in its underlying legal position on the HSR reportability issue.³ In any event, with Pfizer meeting Novo’s offer on overall economics, Metsera was left only to compare the relative antitrust risk presented by the two offers. Not surprisingly, Metsera pivoted, ultimately accepting Pfizer’s offer, citing the “unacceptably high legal and regulatory risks” of Novo’s proposal.⁴

The transaction closed on November 13, 2025, shortly after the Metsera board’s decision. Notably, Pfizer had already received early termination from the FTC based on a filing made on the basis of its initial offer.

Alkermes/Avadel Pharmaceuticals

Although it featured fewer twists and turns, a similar battle took place for the acquisition of Avadel Pharmaceuticals, a manufacturer of treatments for sleep- and wakefulness-related disorders. Avadel initially reached an agreement to be acquired by Alkermes on October 22, 2025, which included an initial cash-per-share payment along with a CVR entitling Avadel shareholders to an additional amount upon FDA approval of Avadel’s LUMRYZ product. Alkermes is developing an orexin 2 receptor agonist drug candidate for related indications in narcolepsy and idiopathic hypersomnia.

Avadel subsequently received an unsolicited proposal from H. Lundbeck A/S (Lundbeck). The Avadel board determined that the Lundbeck offer constituted a “Company Superior Proposal” under the terms of its agreement with Alkermes, which triggered Alkermes’ right to counter. Alkermes exercised that option, increasing the value of its offer and modifying certain terms of the definitive transaction agreement (via an amendment) in Avadel’s favor. With these changes, the Avadel board determined that Alkermes’ revised offer was superior and submitted that transaction to its shareholders for approval.

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These M&A examples highlight the importance of detailed (and early) antitrust assessments of potential bidders. Boards will increasingly be called upon to evaluate competing offers across all dimensions, including the speed and certainty of antitrust approval and the allocation of any antitrust risk between the parties. From an even earlier stage, companies should consider conducting antitrust analyses of potential M&A partners. Doing so can inform not just the evaluations of incoming offers but broader consideration of the ideal timing and partner for exit strategies.

Medical Device Challenges

The FTC has a long history of enforcement activity in the medical device space, including litigated challenges to the Illumina/GRAIL and STERIS/Synergy Health deals and numerous consents involving serial acquirers such as Boston Scientific, Medtronic, Johnson & Johnson, and Abbott Laboratories. Its recent litigated challenges to GTCR BC Holdings LLC’s acquisition of Surmodics and Edwards Lifesciences Corporation’s proposed acquisition of JenaValve Technology are continuations of this long-term trend.

GTCR/Surmodics — FTC Fails in Effort to Block Transaction

In the first merger challenge under its new leadership, the FTC filed a complaint in March 2025 to block GTCR’s acquisition of Surmodics, a manufacturer of coatings for medical devices. GTCR drew the FTC’s attention because it had acquired another rival coating manufacturer, Biocoat Holdings LLC, in 2022. The FTC alleged that the merger combined the No. 1 and No. 2 players in the market for outsourced hydrophilic coatings.

Hydrophilic coatings, applied to a medical device by either ultraviolet (UV) curing (i.e., using light) or thermal curing (i.e., using heat), are crucial for the safety and effectiveness of interventional medical devices that must move through the human body with minimal friction, such as stents and catheters. According to the FTC, even though hydrophilic coatings fall into two distinct categories — those cured by UV light and those cured by thermal heating — both are generally effective for the majority of medical devices. For this reason, the FTC alleged that UV-cured and thermal-cured coatings should be part of a single market.

The merging parties attacked the FTC’s allegations on multiple fronts. First, the parties contended that the FTC’s proposed relevant product market was overly broad insofar as it alleged close competition between the parties’ respective products. Citing ordinary-course bidding data and business testimony, the parties argued that thermally cured coatings (GTCR’s legacy product) and UV-cured coatings (Surmodics’ product) do not in fact compete head-to-head because they rarely work equally well for a given medical device.

Second, the parties alleged that the FTC’s market definition was unduly narrow, specifically in its exclusion of (i) in-house self-supply of hydrophilic coatings by medical device manufacturers and (ii) alternative methods such as hydrophobic coatings.

Third, the parties devoted significant time to the FTC’s market share methodology. In alleging that the parties had a combined share of more than 50%, the FTC relied primarily on “legacy revenue,” often derived from older contracts that were automatically renewed. The parties argued that more recent win-loss information, which showed lower combined shares, provided a more accurate view of current competitive conditions.

Along with these substantive arguments, the parties also moved forward unilaterally shortly before trial with a plan to divest part of Biocoat’s hydrophilic coatings business to a third party (i.e., Integer Holdings Corporation) with significant development and manufacturing experience in an adjacent space.

In a telephone hearing on November 11, 2025, U.S. District Court for the Northern District of Illinois Judge Jeffrey I. Cummings denied the FTC’s request for a preliminary injunction, finding for the parties on several of the key issues previously noted. With respect to market definition and market shares, the court identified multiple flaws in the FTC’s case, citing, among other things, (i) its failure to include self-supply in the relevant market, (ii) undue reliance on historical revenue data as a market share measurement as opposed to more recent outcomes, and (iii) lay testimony about the lack of head-to-head competition between the products at issue. Perhaps most importantly, the court credited the parties’ proposed divestiture, finding that it would “sufficiently mitigate[] the merger’s effect, such that it is no longer likely to substantially lessen competition.”

The ruling is the latest in a series of losses by the FTC and DOJ in cases in which they have been forced to “litigate the fix.” While the agencies have attempted to persuade judges to evaluate the original (i.e., pre-divestiture) transaction as part of its core liability finding, and then examine the divestiture at the remedies stage, courts have yet to follow this course. Instead, courts consider the divestiture in the liability phase, a considerable advantage for the merging parties insofar as it places the burden on the agencies to show that the transaction as modified by the divestiture substantially lessens competition rather than requiring the merging parties to show that the divestiture is sufficient to negate any anticompetitive effects.

Edwards/JenaValve — FTC Secures Preliminary Injunction

On January 9, 2026, the U.S. District Court for the District of Columbia granted the FTC’s petition for a preliminary injunction, blocking Edwards’ proposed acquisition of JenaValve. This case arose from Edwards’ simultaneous acquisitions of JenaValve and JC Medical, the only two companies conducting clinical trials in the United States for transcatheter aortic valve replacement (TAVR) devices designed to treat aortic regurgitation (AR). While Edwards’ acquisition of JC Medical had closed (and was under the HSR reporting threshold), its acquisition of JenaValve was paused for regulatory review. Ultimately, the court found a reasonable probability that the Edwards/JenaValve transaction violates Section 7 of the Clayton Act and, accordingly, enjoined the transaction pending conclusion of the FTC’s administrative trial.

The decision is notable for its careful consideration of several life sciences–specific factors in the context of Section 7 and merger analysis, including (i) the FDA’s rigorous and extended review timeline and the resulting uncertainty of outcomes (i.e., approval); (ii) the competitive relevance of ex-US products; (iii) the nature and extent of innovation competition, particularly between pre-commercial assets; and (iv) the inherent limitations of smaller life sciences firms with respect to development, approval, and commercialization.

The case involved two assets at the pre-commercial stage — the parties’ respective TAVR-AR products undergoing clinical trials in the United States. The FTC alleged that the relevant product market was limited to the research, development, and commercialization of TAVR-AR devices in the United States (with the parties being the only two companies in clinical trials for TAVR-AR products) and excluded, among other things, (i) surgical aortic valve replacement (SAVR) devices, the only FDA-approved treatment for AR currently on the market; (ii) off-label use of other TAVR devices; and (iii) approved and commercialized TAVR-AR products from other jurisdictions (including Europe and China). In finding in favor of the FTC, the court reasoned that SAVR devices merited exclusion from this product market since they could only be used in procedures deemed highly invasive and thus were unsuitable for many high-risk patients. Off-label use of TAVR devices routinely produced poor outcomes in AR patients and were excluded from the product market on that basis.

With respect to ex-US competitors, the defendants went to great lengths to argue that these companies were well-positioned to enter the US market given their possession of extensive clinical data and approvals from other jurisdictions with rigorous approval regimes. In finding that these companies did not belong in the relevant product market (i.e., they were not to be considered competitors for purposes of the antitrust analysis), the court relied principally on the FDA’s process and its past consideration of ex-US data. Specifically, the court found that the FDA did not generally view clinical data from other countries as persuasive, particularly with respect to high-risk devices, and instead routinely insisted that parties generate US-specific data to support FDA approval. More broadly, the court considered the FDA’s premarket approval process to be a “significant barrier to entry” even for foreign-approved devices seeking to commercialize in the US.⁵

In addition to this consideration of foreign competition, the court’s ruling endorsed a purely pre-commercial, innovation market.⁶ Although the parties contended that TAVR-AR devices could not constitute their own market because no TAVR-AR device is currently approved for commercial sale in the United States, the court concluded otherwise. In doing so, the court looked to the FTC and DOJ’s updated Horizontal Merger Guidelines to find recognition that a reduction in innovation competition, or a reduction in incentives to innovate, could constitute an actionable substantial lessening of competition. Put another way, if a merger could be said to reduce the incentive to innovate, the court was comfortable defining a relevant market exclusively around “products that would result from that innovation if successful, even if those products do not yet exist.”⁷ By the same token, the court concluded that the “FTC should not be expected to wait until one of [the] devices is commercialized to bring [a] challenge.”

Particularly relevant to life science companies, the court acknowledged that a market defined around innovation, and in this case specifically regarding two products still very much in the development process, involves a prediction about future regulatory outcomes. On this point, the defendants presented evidence that the chance of both products getting approved was less than 50%, which they argued made it too speculative to support Section 7 liability. Although the court conceded that it was possible that either or both parties’ products never receive FDA approval, the judge found that Section 7 necessarily required a “predictive judgment” rather than a decision based on certainties and that, in any event, the transaction would give control over both products and thus a monopoly so long as either was approved.

In considering the effects of the transaction, this case did not feature the usual set of commercial indicators of close competition (e.g., price decreases, supply increases). Instead, the court analyzed the parties’ development activities in the pre-commercialization phase. In finding that the parties were in fact close competitors and had been motivated by that competition, the court cited evidence that each party had attempted to develop product features to increase its commercial appeal (e.g., expand valve sizes to cover a broader range of patient populations and patient indications), achieve faster speed to market, secure better and more clinical trial sites and desirable principal investigators, and deliver superior clinical outcomes such as mortality rates and valve anchoring failure. The court pointed to the existence of the other party as a key driver of these initiatives.

As part of their rebuttal case, the defendants argued that the transaction created significant efficiencies that, once credited, would tilt the overall case in their favor. Here, the defendants relied on arguments commonly made in life sciences transactions, specifically that (i) the seller lacked the financial resources and expertise to successfully bring its product to market if left on its own and (ii) Edwards’ superior R&D, manufacturing, and sales capabilities would increase the chances of the acquired product achieving FDA approval and ultimately reaching patients. While the court observed JenaValve’s financial constraints and manufacturing limitations, it was not convinced that these weaknesses were “so severe” as to render JenaValve unable to compete or that the proposed transaction was JenaValve’s only partnership or M&A option. In doing so, the court followed both the Horizontal Merger Guidelines and previous Section 7 decisions in setting the bar very high for establishing cognizable efficiencies.

As life sciences firms consider future M&A activities, this case contains multiple lessons worth taking away. While antitrust practitioners routinely consider pipeline overlaps as part of their pre-merger analyses, the formal judicial recognition of pre-commercial, innovation-only markets found here makes such analyses even more important. Further, parties should factor in the FTC’s discrediting of ex-US players and line drawing even within the FDA approval process (i.e., considering only those products in clinical trials as competitors). Finally, firms should anticipate that uncertainty regarding ultimate approval or commercialization of their assets or those being acquired may not be sufficient to fend off government challenges. In other words, the FTC may not tolerate the mere risk of one company possessing directly competing assets in the future, even if the likelihood of both surviving the FDA’s approval process is low.

EU and UK Update

Looking back on 2025, life sciences remained a priority sector for both EU and UK authorities. In the EU, industrial-policy messaging went hand-in-hand with active antitrust enforcement. In the UK, the Competition and Markets Authority (CMA) focused on how market conduct affects clinical decision-making and market access, including through communications directed at healthcare professionals. In a similar vein, the European Commission (EC) launched its “Choose Europe for life sciences” strategy, an initiative aimed at making Europe “the world’s most attractive place for life sciences by 2030.” The strategy seeks to strengthen Europe’s life sciences ecosystem, improve market access, and encourage uptake of innovation. It also sits alongside the EC’s broader “Competitiveness compass,” which stresses the importance of robust competition enforcement — including in antitrust, mergers, and the EU Foreign Subsidies Regulation. Both initiatives showed competition agencies’ intense interest in ensuring a level playing field in the life sciences space, including through the policing of product messaging and scientific communications.

Looking ahead to 2026, companies should expect these trends to accelerate. The EC is likely to test the boundaries of disparagement-based theories of harm, particularly in concentrated therapeutic areas in which communications shape prescriber behavior. The CMA, meanwhile, is expected to continue scrutinizing how commercial practices influence clinical choice and National Health Service (NHS) purchasing, with a growing emphasis on real-world evidence, digital promotion, and the role of artificial intelligence–enabled decision tools. Across both jurisdictions, firms should anticipate closer coordination between industrial-policy initiatives and enforcement priorities, as well as more detailed requests for internal scientific, medical, and marketing materials in investigations. based theories of harm, particularly in concentrated therapeutic areas where communications shape prescriber world evidence, digital promotion, and the role of AI enabled decision tools. Across both jurisdictions, firms should anticipate closer coordination between industrial policy initiatives and enforcement priorities, as well as more detailed requests for internal scientific, medical, and marketing materials in investigations.

Landmark Pharma Disparagement Cases and EC Dawn Raids Reveal Enforcement Priorities

A major theme in 2025 was the evolution of disparagement — potentially misleading or negative messaging about rivals’ products — into a recognized theory of harm for abuse of dominance cases.

In May 2025, the UK CMA closed its investigation into Vifor Pharma concerning communications about Pharmacosmos’ Monofer relative to Vifor’s own product, Ferinject. Without admitting liability, Vifor offered a package of binding commitments, including a financial payment to the NHS and corrective communications intended to address statements that the CMA believed could have misled healthcare professionals.

These UK developments built on prior EU action. In July 2024, the EC accepted commitments from Vifor addressing similar concerns within the EU, including corrective-messaging requirements and ongoing monitoring.

Likely motivated by similar policy concerns, the EC carried out unannounced inspections (often called “dawn raids,” the first step in formal fact-finding) at Sanofi’s offices in France and Germany in September 2025. The EC stated that it was examining suspected abuse of dominance, focusing on alleged “exclusionary practices” that may constitute “anticompetitive disparagement” in the market for seasonal flu vaccines. While inspections do not “prejudge the outcome,” they highlight the EC’s willingness to pursue cases when a dominant firm’s communications might hinder its rivals’ abilities to compete.

The Vifor outcomes in the EU and UK, coupled with the EC’s vaccine-sector inspections, confirm that competition authorities increasingly view product communications, safety statements, and scientific positioning as potential vehicles for exclusionary conduct. When a company holds market power, messaging that may influence clinical behavior or impede a competitor’s access to healthcare professionals can attract antitrust scrutiny, even if the boundary between commercial communication and scientific debate appears fluid. These key developments in 2025 demonstrate how competitiveness and industrial-policy ambitions continued to operate in parallel with conventional competition law enforcement. sector inspections.