Radiopharmaceutical Industry Update: Q1 (2026)

The first quarter of 2026 brought a convergence of regulatory, policy and supply chain developments affecting radiopharmaceuticals. From sweeping Nuclear Regulatory Commission (NRC) deregulatory initiatives to the Trump administration’s Section 232 tariff proclamation — which carves out a conditional exemption for “nuclear medicines” — the operating environment for radioligand therapy and theranostic platforms is evolving rapidly. Meanwhile, transformative investments in actinium-225 production signal a broader commitment to advancing next-generation cancer treatments.

For private equity investors with portfolio exposure to radiopharmaceuticals, these developments present both opportunities and execution challenges.

I. Regulatory Developments

NRC Regulatory Reform Under Executive Order 14300
In Q1 2026, the NRC accelerated a wholesale revision of its regulations under Executive Order 14300, signed by President Donald Trump on May 23, 2025, which directed the NRC to reform its regulatory framework to promote efficiency and reduce unnecessary burden. Three rulemakings were completed during the quarter: the Sunset Rule, which establishes automatic expiration of regulations not affirmatively retained and became final on Jan. 8, 2026; a proposed rule Streamlining Contested Adjudications in Licensing Proceedings (March 3, 2026); and the Revision of Fee Schedules for FY 2026 (proposed March 12, 2026).

Of most consequence for radiopharmaceutical portfolio companies, the NRC announced two upcoming proposed rules with direct sector impact:

• Reducing Barriers to Medical Use Licensing (10 CFR Part 35)
  This proposed rule, anticipated in Q2 2026, would amend NRC regulations to reduce barriers to medical use licensing by enabling more efficient and predictable licensing, increasing flexibility and easing administrative burden. It will incorporate a prior rulemaking on emerging medical technologies, including rubidium-82 generators. Affected entities include all NRC, Agreement State and Master Materials License medical licensees and permittees. For PE-backed radiopharmaceutical companies, streamlined medical use licensing could accelerate site activations and reduce compliance costs associated with new treatment locations.
• Modernizing NRC Regulations for Byproduct Material Use (10 CFR Parts 30, 31, 32, 34, 39, 70)
  Also anticipated in Q2 2026, this proposed rule would modernize decommissioning financial assurance requirements for sealed and unsealed radioactive materials — directly relevant to radiopharmaceutical manufacturing and Contract Development and Manufacturing Organization facilities that handle therapeutic isotopes. Both rules are classified as deregulatory actions expected to result in cost savings to NRC and industry stakeholders.

Separately, on March 30, 2026, the NRC published its final rule codifying the new 10 CFR Part 53, a risk-informed, technology-inclusive licensing framework for commercial nuclear plants. While Part 53 is primarily directed at advanced reactor licensing, its implications for the isotope supply chain are significant: Accelerated reactor deployment under Part 53 could expand domestic production capacity for medical isotopes, including Mo-99 and Lu-177, by enabling new reactor designs optimized for isotope production to reach the licensing stage more efficiently.

CDER Guidance Agenda (February 2026)

The FDA’s Center for Drug Evaluation and Research published its updated Guidance Agenda in February 2026, signaling several priority initiatives that warrant close tracking through Q2 and the remainder of the year. Most notably, CDER signaled its intent to publish a new draft guidance on Radiation Dosimetry for First-in-Human Studies of Positron Emission Tomography Drugs, which — together with the existing 2025 draft guidance on dosage optimization for oncology therapeutic radiopharmaceuticals — would complete a more coherent dosimetry framework spanning the diagnostic (PET) and therapeutic halves of the theranostic pair, with material implications for IND-enabling packages, first-in-human protocol design and the radiation-safety assumptions sponsors must defend in pre-IND meetings.

The agenda also lists a potential revised draft of PET Drugs — Current Good Manufacturing Practice (CGMP). This potential revision has been on CDER’s annual list since 2017 and would be the first substantive refresh of the PET cGMP framework in years. Whenever the update occurs, it will likely comment on or attempt to address longstanding concerns by industry about inconsistent FDA interpretation of existing cGMP requirements during inspections and when reviewing applications/supplements on Part 212 flexibility (e.g., precursor identity testing). Also of interest are revised guidance documents addressing: (1) Expedited Programs: Fast Track, Breakthrough Therapy, and Priority Review; (2) Master Protocols for Drug and Biological Product Development; and (3) Master Protocols for Drug and Biological Product Development.

II. Presidential Proclamation — Section 232 Tariffs on Pharmaceuticals

On April 2, 2026, President Donald Trump issued a Section 232 proclamation imposing a 100% ad valorem duty rate on imports of patented pharmaceuticals and their associated ingredients (including APIs and key starting materials), with reduced rates of 20% for companies operating under Commerce-approved onshoring plans; 15% for products of Japan, the EU, Korea and Switzerland/Liechtenstein; and 10% for UK products. Tariffs take effect July 31, 2026, for the 17 large drugmakers listed in Annex III of the proclamation — which includes most sponsors of approved and pipeline radioligand therapies — and Sept. 29, 2026, for all other importers.

The most consequential provision for the nuclear medicine industry is clause (3)(d), which establishes a 0% tariff rate for “nuclear medicines” as one of several enumerated specialty categories. Critically, the exemption is not automatic: it applies only when the secretary of commerce, in consultation with the U.S. trade representative and the Department of Health and Human Services, affirmatively determines that the product is either sourced from a jurisdiction with a trade and security framework agreement under Executive Order 14346 or meets an urgent U.S. health need. The proclamation does not define “nuclear medicines” and does not specify qualifying HTSUS codes, leaving open significant interpretive questions about whether the term reaches finished radiopharmaceutical drug products only or also extends to unlabeled precursors and cold-kit components, bulk radioisotopes and target materials, and specialty manufacturing equipment such as cyclotrons and hot cells.

III. Manufacturing and Isotope Supply Chain

Novartis’s $23 Billion U.S. Manufacturing Expansion

Novartis continued to execute on what is a particularly ambitious radioligand therapy manufacturing buildout in the industry’s history. In Q1, the company announced a new 35,000-square-foot RLT facility in Winter Park, Florida, to serve the southeastern United States, joining the existing Novartis network in Indiana, New Jersey and California. Novartis then announced the company’s fifth U.S. facility, a 46,000-square-foot RLT manufacturing site in Denton, Texas, with construction expected to begin in 2026 and full operations by 2028. These investments are part of Novartis’s previously announced plan to invest $23 billion in U.S.-based infrastructure over five years, which accelerated in the context of the Trump administration’s tariff policies on pharmaceutical imports.

Actinium-225 Supply Chain Investments

Actinium-225 (Ac-225), the alpha-emitting isotope widely viewed as the next frontier in radioligand therapy, saw transformative supply chain developments in Q1 2026:

• TerraPower Isotopes (March 17, 2026)
  The Bill Gates-founded company announced a $450 million investment to build a 250,000-square-foot cGMP Ac-225 manufacturing facility in Philadelphia’s Bellwether District. Combined with capacity expansion at its Everett, Washington, site, the investment is expected to increase production capacity 20-fold. The facility is expected to commence production in 2029. Pennsylvania invested $10 million in the project.
• NorthStar Medical Radioisotopes (Jan. 6, 2026)
  NorthStar confirmed it is routinely producing commercial-scale, non-carrier-added Ac-225 using electron-accelerator technology at its Beloit, Wisconsin, campus. A Drug Master File submission is planned for Q2 2026. NorthStar represents the first commercial-scale producer of Ac-225 using this production method.

These developments are critical for investors evaluating the alpha-emitter pipeline. The transition from beta-emitting (lutetium-177) to alpha-emitting (actinium-225) radiopharmaceuticals represents a fundamental shift in the sector’s trajectory, and companies with secured Ac-225 supply will hold a significant competitive advantage.

• Beta-Alpha Transition
  Beta-emitting isotopes, which have dominated the radioligand therapy landscape for the past decade, deliver targeted radiation over a relatively longer path length (approximately 0.5-12 mm), making them effective for larger tumors but less precise for micrometastatic disease. Alpha-emitting isotopes, by contrast, deliver high-energy particles over a much shorter range (50–100 μm), enabling more potent cytotoxic effects with reduced off-target damage to surrounding healthy tissue. Clinically, alpha emitters have demonstrated enhanced efficacy in treating patients who have progressed on beta-emitting therapies, driving regulatory and commercial interest. Technologically, advancements in chelation chemistry — particularly the development of stable chelators capable of binding alpha emitters to targeting molecules — have addressed earlier concerns about radiochemical stability and safety. These scientific and clinical advantages, combined with expanding production capacity, position alpha-emitting radiopharmaceuticals as the next frontier in precision oncology.

IV. Medicare Reimbursement Policy

The U.S. Centers for Medicare & Medicaid Services (CMS) CY 2026 OPPS-ASC Final Rule, effective Jan. 1, 2026, introduced several consequential provisions for radiopharmaceutical reimbursement:

• Tc-99m Domestic Production Add-On
  CMS finalized a $10 per-study-dose add-on payment for domestically produced Tc-99m doses, defined as Tc-99m generated from Mo-99 that was both irradiated and processed in the United States. This incentive aligns with broader national security objectives around domestic isotope production.
• Diagnostic Radiopharmaceutical Reimbursement
  CMS continued to use mean unit cost (MUC) methodology rather than average sales price (ASP) for separately payable diagnostic radiopharmaceuticals, setting the per-day cost threshold at $655 for 2026. Industry stakeholders, including the Society of Nuclear Medicine and Molecular Imaging (SNMMI), advocated for ASP-based reimbursement, arguing that MUC-based calculations are derived from stale data and imprecise cost-to-charge ratios.
• ASP Reporting
  Voluntary ASP reporting for diagnostic radiopharmaceuticals continues in 2026, though CMS signaled its intent to explore mandatory ASP reporting and ASP-based payment in future rulemaking cycles.

Q2 2026 Outlook: Issues to Watch

• Section 232 Implementation and Commerce Department Guidance
  Look for guidance on the scope of the nuclear medicines exemption, onshoring plan criteria and MFN pricing agreement pathways.
• NRC ACMUI Spring Meeting
  The U.S. Nuclear Regulatory Commission’s Advisory Committee on the Medical Uses of Isotopes (ACMUI) convened April 20 and 21, 2026, to address several developments of note to stakeholders in the nuclear medicine and radiopharmaceutical sectors. Key agenda items included subcommittee recommendations on implementing the ADVANCE Act of 2024 — the bipartisan legislation directing the NRC to modernize its regulatory framework and conduct licensing “in a manner that is efficient and does not unnecessarily limit” civilian nuclear energy technologies — within the medical-use context, review of draft staff guidance on licensing the use of alpha-emitting nuclides in radiopharmaceutical therapy, recommendations on the application of AI and deep-learning technologies to NRC medical oversight, and proposed rulemaking on modernizing physical protection requirements for category 1 and category 2 quantities of radioactive material.
• NRC Deregulatory Rulemaking
  Proposed rules on Reducing Barriers to Medical Use Licensing and Modernizing Byproduct Material Use regulations are expected in Q2 2026. Final rules under EO 14300 are required by November 2026.
• FDA PET cGMP 212 NPRM
  The FDA is expected to publish a Notice of Proposed Rulemaking in May 2026 to amend the current good manufacturing practice (cGMP) regulations under 21 CFR Part 212 governing positron emission tomography (PET) drugs. The proposed rule would remove a reference to an outdated United States Pharmacopeia chapter and streamline manufacturing requirements to cover the production, quality assurance, holding and distribution of all PET drugs, including investigational and research PET drugs.