By Ben Fidler, BioPharma Dive
Published September 25, 2026
The biopharmaceutical sector is currently navigating a period of intense transformation, characterized by aggressive pursuit of long-acting delivery platforms, high-stakes litigation, and a steady stream of regulatory approvals that continue to redefine standards of care in diabetes and oncology. As of late September 2026, major players such as Novo Nordisk, Eli Lilly, and Merck & Co. find themselves at the center of critical developments that underscore the industry’s shift toward patient-centric dosing and complex therapeutic combinations.
I. Main Facts: A Convergence of Innovation and Litigation
This week has been marked by significant shifts in the competitive landscape of cardiometabolic and autoimmune disease treatment.
The most notable development involves Novo Nordisk’s strategic pivot toward extended-release therapeutics. By entering into a landmark $1.32 billion (€1.165 billion) licensing agreement with Swedish biotech Nanexa, the Danish pharmaceutical giant is signaling a commitment to revolutionizing the patient experience for those suffering from obesity and Type 2 diabetes. The goal is to move beyond daily injections to regimens that require administration only once a month or once per quarter.
Simultaneously, the regulatory environment remains robust. The FDA has granted approval to Eli Lilly’s once-weekly insulin, Onswik, setting the stage for a high-stakes market battle with Novo’s own weekly insulin, Awiqli. In the oncology space, Merck & Co. continues to extract maximum value from its 2019 acquisition of Peloton Therapeutics, securing yet another indication for its kidney cancer drug, Welireg.
These industry wins are tempered by volatility. Acadia Pharmaceuticals faces a challenging road ahead after its Alzheimer’s psychosis candidate, remlifanserin, narrowly missed primary endpoints, while Nektar Therapeutics has emerged from a long-running legal battle with Eli Lilly with a $90 million verdict—a figure that represents only a fraction of the original damages sought.
II. Chronology of Events
- 2019: Merck & Co. acquires Peloton Therapeutics, bringing the hypoxia-inducible factor (HIF) inhibitor, later branded as Welireg, into its portfolio.
- 2023: Nektar Therapeutics initiates a lawsuit against Eli Lilly, alleging that the latter intentionally undermined their co-developed autoimmune prospect following Lilly’s acquisition of a competing therapy.
- March 2026: The FDA grants approval to Novo Nordisk’s Awiqli, the first once-weekly basal insulin for Type 2 diabetes.
- July 2026: The FDA approves Welireg for adjuvant use in renal cell carcinoma.
- September 24, 2026: A California federal jury delivers a verdict in the Nektar vs. Lilly litigation, awarding Nektar $90 million.
- September 25, 2026: Novo Nordisk announces its partnership with Nanexa; the FDA approves Lilly’s Onswik for Type 2 diabetes.
III. Supporting Data: The Push for Long-Acting Injectables
The deal between Novo Nordisk and Nanexa represents a tactical investment in "PharmaShell," a proprietary drug delivery technology. The financial structure of the agreement—$615 million in upfront payments and milestones, with a total potential value of $1.32 billion—highlights the premium Novo places on reducing treatment burden.
The underlying rationale is simple: adherence. In chronic disease management, particularly for obesity and diabetes, the "pill burden" or the "injection burden" is a primary driver of patient dropout. By targeting five distinct development programs, Novo is betting that quarterly or monthly administration will become the gold standard, effectively locking in patient loyalty and improving clinical outcomes.
This strategy mirrors recent trends. Nanexa’s previous partnership with Moderna, signed in 2025, suggests that the PharmaShell platform is becoming a preferred utility for companies looking to extend the pharmacokinetic profile of their biologics.
IV. Official Responses and Industry Sentiment
The Acadia Dilemma
The situation at Acadia Pharmaceuticals remains the subject of intense scrutiny from Wall Street. While the Phase 2 results for remlifanserin were disappointing, management remains defiant. "The debate is going to be whether there is still a chance that the drug will succeed," noted Stifel analyst Paul Matteis. Despite the "quite modest" efficacy findings, Acadia is moving forward with two Phase 3 trials, citing a favorable safety profile as a mitigating factor. However, the market response—a double-digit decline in share price—indicates that investors remain skeptical of the drug’s commercial viability.
The Nektar-Lilly Verdict
The Nektar vs. Lilly litigation has concluded with a sense of anti-climax. While Nektar successfully proved that Lilly’s actions were detrimental to their partnership, the $90 million award is a far cry from the $1 billion the plaintiff hoped to secure. Legal experts suggest that the discrepancy between the jury’s award and the requested damages reflects a complex jury perception regarding the specific impact of Lilly’s acquisition of Dermira on the joint program. Nektar has indicated that the verdict remains subject to post-trial proceedings, suggesting this saga may have further chapters.
V. Implications for the Future of Medicine
The "Insulin War"
With both Novo’s Awiqli and Lilly’s Onswik now approved, the U.S. diabetes market is entering a new era. The clinical efficacy of these weekly insulins is comparable to traditional daily shots, which means the competition will shift toward pricing, insurance formulary placement, and patient convenience. For clinicians, the ability to prescribe a weekly insulin simplifies the titration process, potentially reducing the rates of hypoglycemia and improving glycemic variability.
Oncology Portfolio Expansion
Merck’s expansion of the Welireg label demonstrates the power of a "pipeline within a product." By incrementally adding indications—from rare genetic conditions to relapsed renal cell carcinoma—Merck is effectively maximizing the return on its 2019 acquisition. The move to combine Welireg with Keytruda in the post-surgery setting is a masterclass in oncology strategy, ensuring that the drug becomes a foundational element of the treatment algorithm for kidney cancer.
The Strategic Value of Technology Platforms
The broader lesson from the week’s news is the increasing value of "delivery technology" over "discovery technology." While traditional drug discovery remains the bedrock of the industry, the ability to successfully re-engineer existing molecules into long-acting, sustained-release formulations is currently where the most significant capital is being deployed. As we look toward the remainder of 2026, we expect to see more mid-to-large cap pharmaceutical companies seek out specialized biotech firms that can help them "evergreen" their portfolios through advanced delivery systems.
A Period of Consolidation
The week’s events suggest that the industry is entering a phase of consolidation and optimization. Litigation, such as the Nektar-Lilly dispute, acts as a deterrent for overly aggressive competitive maneuvers in the future, while regulatory approvals like those for Onswik and Welireg confirm that the FDA is continuing to prioritize therapies that offer either increased convenience or expanded efficacy for underserved patient populations.
As the industry moves into the final quarter of the year, all eyes will be on how these major players integrate their new assets and navigate the fallout from recent legal and clinical developments. The message from the boardrooms is clear: in an era of high-interest rates and intense scrutiny, innovation must be paired with strategic, long-term efficiency to win.
For further analysis on these developments and their impact on the biotechnology sector, stay tuned to BioPharma Dive’s ongoing coverage.
