TL;DR
While state-level drug importation programs remain stalled by structural supply chain barriers, the federal government is shifting its focus to an aggressive overhaul of domestic clinical trial regulations. Meanwhile, the clinical pipeline has delivered landmark late-stage victories in immunology, alongside high-profile strategic setbacks in oncology that highlight the risks of complex trial designs.
The Immunology Arms Race Escalates with Late-Stage Phase 3 Wins
Big pharma is locking down dominant positions in the immunology market through high-stakes clinical readouts that validate multi-billion-dollar acquisitions and novel therapeutic pathways.
"These positive Phase 3 induction results for tulisokibart are the first for an anti-TL1A biologic. They represent an important step forward for patients with moderately to severely active ulcerative colitis who – despite available treatments – continue to experience symptoms, and do not achieve clinical remission." — merck-tulisokibart-phase3-ulcerative-colitis
"The final Week 52 data from the VELA program confirm the strength of SLK across most, if not all, metrics that matter in HS: strong early efficacy, sustained and leading improvement over time, a consistent safety profile and great convenience in dosing." — moonlake-sonelokimab-vela-hidradenitis-suppurativa
In June 2026, Merck announced in a press release that its late-stage ATLAS-UC induction study met its primary endpoint of clinical remission, marking the first major clinical victory for an anti-TL1A biologic and validating its $10.8 billion acquisition of Prometheus merck-tulisokibart-phase3-ulcerative-colitis. Around the same time, MoonLake Immunotherapeutics unveiled in a corporate announcement positive fifty-two-week results from its late-stage VELA clinical program for sonelokimab, which demonstrated durable clinical clearance and outperformed historical results of competing therapies moonlake-sonelokimab-vela-hidradenitis-suppurativa. These clinical milestones show that massive premium buyouts are yielding tangible clinical success, while smaller biotechs are successfully carving out spaces with durable data. By targeting dual mechanisms like immuno-fibrosis or utilizing advanced nanobodies, developers are shifting the standard of care from superficial symptom suppression to deep, disease-modifying tissue repair.
What to watch: Watch whether Merck's first-mover advantage in the anti-TL1A space forces competitors like Roche and Sanofi to accelerate their own clinical trials to protect their investments.
Federal Health Agencies Overhaul Clinical Trials to Retain Domestic Leadership
The federal government is aggressively slashing regulatory red tape to prevent clinical research from fleeing to geopolitical rivals like China.
"America should be the best place in the world to develop new medicines, yet we have built a system that drives too much clinical research overseas. Under President Trump's leadership, HHS is launching a coordinated department-wide effort to restore America’s leadership in clinical research, remove unnecessary barriers, and bring more clinical research and investment back to the United States." — hhs-clinical-trials-reform-operation-trialblazer
To counter China's rapid expansion in clinical trial infrastructure, HHS and the FDA launched "Operation Trialblazer" in an official announcement, introducing an Expedited Investigational New Drug pilot program and formalizing a single-pivotal-trial standard to cut development timelines hhs-clinical-trials-reform-operation-trialblazer. While federal authorities previously focused on parallel trade routes to challenge high-cost drug monopolies, this policy shift indicates that domestic clinical trial infrastructure is now being treated as a matter of national security. By deploying advanced artificial intelligence tools and formalizing single-study approvals, the FDA is signaling a willingness to accept higher levels of regulatory flexibility in exchange for keeping high-tech biomedical investment firmly within U.S. borders.
What to watch: Watch how domestic research institutions respond to the FDA's new Expedited Investigational New Drug pilot program and whether it successfully stems the flow of early-stage trials to overseas markets.
Oncology Pipeline Risks Deepen Amid Complicated Trial Designs
The strategy of slicing clinical populations to find efficacy is backfiring as complex trial designs fail to yield statistically significant survival benefits in critical patient subgroups.
"A phase 3 trial for the next-generation multikinase inhibitor in patients with previously treated metastatic colorectal cancer (mCRC) failed to achieve statistical significance on a dual primary endpoint measuring overall survival in a subpopulation..." — exelixis-zanzalintinib-stellar303-colorectal-cancer
In June 2026, Exelixis revealed that its STELLAR-303 trial for zanzalintinib combined with Tecentriq missed its dual primary endpoint of overall survival in the subpopulation of patients without active liver metastases, as reported by Fierce Biotech exelixis-zanzalintinib-stellar303-colorectal-cancer. Exelixis' decision to repeatedly amend its trial protocol to isolate specific patient subgroups shows how drugmakers are scrambling to outmaneuver failed competitor trials, only to run into the same clinical realities. While overall survival in the broad population may still secure an FDA approval, the failure to hit statistical significance in this subgroup weakens the drug's eventual commercial positioning and invites intense regulatory scrutiny over its final label.
What to watch: Watch whether the FDA restricts zanzalintinib's label to exclude the non-liver metastases subpopulation or grants a broad approval despite the missed endpoint during the review leading up to the December target date.
What surprised us
- HHS is willing to use geopolitical competition with China as a lever to bypass traditional clinical trial standards. By launching "Operation Trialblazer" hhs-clinical-trials-reform-operation-trialblazer
, the federal government is explicitly citing China's rapid clinical trial infrastructure expansion as the justification for cutting trial timelines by up to a year. It is a rare moment of overt geopolitical posturing driving domestic drug approval policy, showing that the FDA is ready to formalize a single-pivotal-trial standard to win a regulatory arms race hhs-clinical-trials-reform-operation-trialblazer
- Exelixis' zanzalintinib trial was amended multiple times to chase competitor failures, only to miss its mark anyway. In the STELLAR-303 trial exelixis-zanzalintinib-stellar303-colorectal-cancer
, Exelixis repeatedly altered its primary endpoints—shifting from the overall population to a specific non-liver metastases subgroup after a competitor drug failed, and then back to a dual endpoint setup. This kind of serial protocol-bending shows how desperate oncology drugmakers are to find any statistical win, but the final numerical-only survival benefit in the subgroup shows the limits of trying to engineer success through statistical amendments exelixis-zanzalintinib-stellar303-colorectal-cancer
- MoonLake's sonelokimab outperformed established blockbusters by a wide margin in hidradenitis suppurativa. The final fifty-two-week data showed a clinical response rate that was approximately ten percent higher than historical results of competing therapies moonlake-sonelokimab-vela-hidradenitis-suppurativa. For a smaller biotech, achieving such a "best-in-disease" profile while preparing a single comprehensive BLA that includes adolescent data is an incredibly aggressive play that could completely disrupt the market when it launches moonlake-sonelokimab-vela-hidradenitis-suppurativa.