Bicycle Therapeutics Forges Isotope Empire for High-Stakes 2026

CAMBRIDGE, England & BOSTON – January 12, 2026 – As the pharmaceutical industry watches, Bicycle Therapeutics is gearing up for what could be its most transformative year yet. The clinical-stage company, known for its novel bicyclic peptide (Bicycle®) technology, has laid out an ambitious roadmap for 2026, packed with pivotal clinical trial readouts and key regulatory milestones. Yet, the most audacious move might not be in the clinic, but in the complex world of nuclear logistics, where the company is building a radiopharmaceutical supply chain from the ground up.

Following a year of significant clinical progress in 2025, Bicycle is positioning itself as a dual threat: a developer of innovative cancer-targeting drugs and a vertically integrated powerhouse in the burgeoning field of radiopharmaceuticals. This two-pronged strategy aims to de-risk its future and seize a commanding position in one of oncology's most promising frontiers. The coming months will test this strategy, with a cascade of data releases set to determine the fate of its lead drug candidates and validate its massive investment in nuclear medicine.

Building a Radiopharmaceutical Ecosystem

Perhaps the most striking of Bicycle's recent achievements is its strategic assembly of an end-to-end supply chain for Lead-212 (212Pb), a potent alpha-emitting isotope for targeted cancer therapy. This move directly addresses a critical vulnerability in the radiopharmaceutical market: a fragile and often unreliable supply of medical isotopes.

The industry has seen high-profile examples of these challenges, such as the supply shortages faced by Novartis for its blockbuster 177Lu-based therapy, Pluvicto, where patient demand rapidly outstripped manufacturing capacity. Recognizing this bottleneck as both a risk and an opportunity, Bicycle has forged a series of unique partnerships in the United Kingdom.

Through a 15-year agreement, the UK's Nuclear Decommissioning Authority (NDA) will provide Bicycle with reprocessed uranium from historic nuclear fuel. The UK National Nuclear Laboratory (UKNNL) will then apply its sophisticated extraction methods to isolate the necessary precursor materials. Finally, the US-based specialist SpectronRx will build a bespoke generator to produce the final 212Pb isotope exclusively for Bicycle. This creates what the company calls a “unique radiopharmaceutical capability.”

“By combining these supply collaborations with our proprietary Bicycle technology we have established a unique radiopharmaceutical capability from the identification of Bicycle targeting agents to the potential commercial supply of the radiotherapeutic across multiple radioisotopes,” said Bicycle Therapeutics CEO Kevin Lee, Ph.D. in a recent statement.

This vertical integration could provide a profound competitive advantage, ensuring a stable, long-term supply of a critical therapeutic component and insulating the company from the geopolitical and logistical disruptions that plague the broader market. It’s a long-term bet that transforms Bicycle from a pure drug developer into a company with control over its entire radiopharmaceutical destiny.

Advancing the Attack on Validated and Novel Targets

While its supply chain strategy builds a foundation for the future, Bicycle’s clinical pipeline remains the engine of its near-term value. The company's lead asset, zelenectide pevedotin, a Bicycle® Drug Conjugate (BDC) targeting the well-validated Nectin-4 antigen, made significant strides in 2025. Updated data from the Duravelo-1 trial showed promising anti-tumor activity when combined with pembrolizumab in metastatic urothelial cancer (mUC), a field currently dominated by Seagen and Astellas’s antibody-drug conjugate, Padcev. Bicycle aims to differentiate its candidate with a potentially better safety profile, stemming from its smaller size and renal clearance, which may reduce liver toxicity.

The company is also expanding the drug's potential beyond bladder cancer, initiating new trials in NECTIN4-amplified breast cancer (Duravelo-3) and non-small cell lung cancer (Duravelo-4), with initial data from the breast cancer trial expected in the second half of 2026.

Beyond the validated Nectin-4 target, Bicycle is leveraging its platform to go after cancer targets that have long been considered 'undruggable.' Its Bicycle® Radioconjugates (BRCs) are showing promise against EphA2 and MT1-MMP. The company presented first-in-human imaging data for its EphA2-targeting BRC, providing clinical proof-of-concept for both the target's validity and the platform's utility. Similarly, imaging data for its MT1-MMP-targeting molecule demonstrated precise tumor uptake and rapid systemic clearance, showcasing the technology's ability to deliver radioactive payloads directly to cancer cells while minimizing exposure to healthy tissue.

A High-Stakes Year of Clinical Catalysts

With the strategic groundwork laid, 2026 is poised to be an event-driven, high-stakes year for Bicycle Therapeutics and its investors. The company has scheduled a series of critical data readouts and regulatory updates that will serve as major inflection points.

In the first quarter, the market anticipates a significant update on the potential approval pathway for zelenectide pevedotin in urothelial cancer following meetings with multiple regulatory agencies. This will be closely followed by the announcement of the selected dose for the pivotal Phase 2/3 Duravelo-2 trial, a key step toward potential commercialization. Further data from the Duravelo-1 monotherapy and combination trials are also expected in the first half of the year.

Investors are watching closely. Despite a consensus 'Buy' or 'Hold' rating from analysts, with average price targets suggesting significant potential upside, the company's stock has faced downward pressure over the last year. The upcoming milestones represent clear opportunities to reverse that trend and unlock the value analysts see in the pipeline. However, the inherent risk of clinical development means any setback could have an equally significant negative impact.

Alongside the Nectin-4 program, data readouts are also expected for BT7480, a Nectin-4 and CD137-targeting immune agonist, and BT5528, the BDC targeting EphA2. These results will be crucial in validating the breadth of Bicycle's platform and its multi-pronged strategy against cancer. As the company navigates this pivotal year, its ability to execute clinically and deliver on its ambitious supply chain vision will determine whether it can pedal its way to the forefront of oncology innovation.