From the SNMMI Frontlines: 5 Takeaways Reshaping Radiopharmaceutical Strategy
Intro
Fresh from the energy of SNMMI 2025, it’s clear the radiopharmaceutical field is accelerating in new, highly strategic directions. This year’s meeting brought a blend of clinical realism, scientific creativity, and regulatory alignment that made it more than a showcase—it was a signal. Here are five key takeaways that matter now for radiopharma innovators navigating development and decision-making in the second half of 2025.
1. FAP Is the New PSMA
Fibroblast activation protein (FAP)-targeting radiopharmaceuticals dominated many translational and imaging sessions. Agents like 68Ga-FAPI and 177Lu-FAP-2286 showed extended retention and superior TME localization in solid tumors, offering theragnostic versatility beyond prostate cancer. FAP’s broad expression profile opens the door to pan-tumor approaches and signals a shift toward stromal-targeting strategies.
Theragnostic Insight: FAP-driven programs may enable more tumor-agnostic designs and justify broader solid tumor enrollment strategies, accelerating clinical signal acquisition. Regulatory teams should prepare early for discussions around biomarker definition and patient selection frameworks, particularly where FAP expression levels vary across tumor types.
2. Alpha Emitters Are Moving from Hype to Infrastructure
SNMMI 2025 featured sustained focus on alpha-emitting radionuclides, reflecting a shift from theoretical promise to practical readiness. Multiple presentations shared tangible manufacturing advances, early human trial results, and GMP supply chain buildouts for agents like actinium-225 and lead-212. These isotopes are now being platformed across solid tumor programs, with increasing integration into early-stage development pipelines. The emphasis has shifted from "why alpha?" to "how fast can we scale?" These discussions reflected the growing consensus that alpha-based therapies may hold the key to treating resistant tumors with minimal off-target toxicity.
Theragnostic Insight: The clinical and operational focus now must include radionuclide logistics, labeling durability, and isotope access planning early in program design. Teams should also consider developing scalable isotope platform strategies to reduce downstream CMC disruptions and increase supply resiliency across programs.
3. Astatine’s Quiet Rise: Building a Case for ²¹¹At in Precision Alpha Therapy
While actinium-225, lead-212, and astatine-211 were all central to the alpha discussions at SNMMI 2025, ²¹¹At stood out for its unique characteristics and growing traction in precision applications. Several SNMMI 2025 presentations and posters spotlighted new radiolabeling methods, centralized production initiatives, and emerging preclinical data supporting astatine’s potential in hematologic and micrometastatic disease.
With its shorter half-life and lower energy profile, astatine may offer a compelling fit for highly localized delivery where long-range alpha emissions pose safety challenges. Yet, key challenges remain in isotope generation, chelation chemistry, and regulatory standardization—areas now receiving focused investment.
Theragnostic Insight: Teams evaluating astatine should engage early with radiochemistry experts and CMC stakeholders to assess production feasibility, labeling consistency, and distribution strategy. As interest in ²¹¹At grows, competitive advantage will depend on operational foresight and strategic isotope integration planning.
4. Imaging-Led Trial Design is Now the Norm
The strongest clinical data presentations were those integrating diagnostic imaging as part of eligibility, enrichment, and response assessment. "See what you treat" is becoming a clinical trial standard, especially for peptide-targeted and small molecule radioligands. This shift enhances patient targeting while enabling earlier go/no-go decisions, standardized site training, and harmonized imaging protocols across multi-center studies.
Theragnostic Insight: Effective execution of theragnostic approaches depends on synchronizing diagnostic and therapeutic steps, a challenge for sites less familiar with radiopharma protocols. Clinical teams should standardize imaging protocols early and plan for centralized reads with QA processes that support regulatory submissions and interim analyses.
5. The Regulatory Climate is Quietly Favorable—If You Engage Early
Across sessions, there was quiet consensus: agencies want to support radiopharma, but they expect strategic clarity. Programs that included pre-IND feedback, dosimetry transparency, and patient safety rationale moved faster and more cleanly through regulatory milestones. A new wave of interest from EMA and Health Canada suggests global alignment opportunities may also be growing.
Theragnostic Insight: Regulatory dialogue should begin early and include considerations such as isotope logistics, site infrastructure, and radiopharmacy support from the outset, as these elements are increasingly standard. Regulatory readiness reviews should be baked into preclinical and CMC timelines and aligned with cross-functional communication strategies.
What This Means for You
SNMMI 2025 provided a clear view into the clinical and operational priorities now defining radiopharmaceutical progress. Radiopharmaceutical development is broadening in scope and showing clearer signs of executional discipline, as seen in advances across oncology, alpha emitter platforms, and next-generation isotopes like astatine-211. This growth calls for deeper cross-functional planning across clinical operations, regulatory strategy, and CMC readiness.
As the field matures, the winning programs will be those that treat logistical, imaging, and regulatory planning not as afterthoughts, but as core pillars of strategy from Day One. Success will depend on early integration of translational imaging, radiochemistry constraints, and cross-border regulatory strategy.
At Theragnostic Insights, we help radiopharmaceutical teams bridge innovation with implementation, turning promising science into programs ready to meet clinical, operational, and regulatory scrutiny. Whether you’re advancing a novel alpha construct or preparing for first-in-human studies with astatine, we offer practical, integrated guidance that aligns scientific potential with clinical execution.
Stay tuned for our next post in this mini-series as we dive deeper into the rise of alpha and Auger emitters, and what they mean for platform builders and clinical teams alike.
References:
[1] UroToday, 2025. SNMMI 2025: WB SPECT/CT Studies Post Lu 177 Therapy. URO TODAY
[2] UroToday, 2025. SNMMI 2025: 18F-Piflufolastat PET/CT in Patients with Biochemically Recurrent Prostate Cancer: A CONDOR Sub-Analysis of Positive Predictive Value in the Prostate/Prostatic Bed Stratified by PSA. URO TODAY
[3] UroToday, 2025. SNMMI 2025: Prognostic Evaluation of an Artificial Intelligence (AI)-based Risk Score for Prostate Cancer on PSMA PET/CT. URO TODAY
[4] UroToday, 2025. SNMMI 2025: Clinical Trial Protocol Update – FLEX-MRT: A Randomized Phase 2 Trial of Flexible and Extended Dosing of 177Lu-PSMA-617 Molecular Radioligand Therapy. URO TODAY
[5] UroToday, 2025. SNMMI 2025: Development of PSMA Targeting Radioligand 161Tb-LNC1011 for Prostate Cancer Theranostics. URO TODAY
[6] UroToday, 2025. SNMMI 2025: Role of 18F-Fluciclovine PET/CT in Patients with Biochemical Recurrence of Prostate Cancer and a Negative PSMA PET/CT. URO TODAY
[7] UroToday, 2025. SNMMI 2025: PSMA-Bisphosphonate Imaging Agent: First Human Study of 68Ga-P17-079 in Prostate Cancer. URO TODAY
[8] UroToday, 2025. SNMMI 2025: Head-to-Head Comparison of mpMRI, PSMA, and GRPR PET/CT for Local Staging of Primary Prostate Cancer: Results from a Prospective, Single-Arm, Single-Center Multimodal Imaging Trial. URO TODAY
[9] UroToday, 2025. SNMMI 2025: Clinical Protocols to Monitor Efficacy of 177Lu-PSMA Radiopharmaceutical Therapy in mCRPC. URO TODAY
[10] UroToday, 2025. SNMMI 2025: Evaluation of PSMA PET/CT Derived Predictors for Treatment Response to 177Lu-PSMA-617: Results from The U.S. Expanded-Access Program. URO TODAY
[11] UroToday, 2025. SNMMI 2025: How About Astatine-211? URO TODAY
[12] UroToday, 2025. SNMMI 2025: Next-Generation PSMA Radioligands "Presentation" - Martin Pomper. URO TODAY
