Bicycle Therapeutics reports Q3 2026 results, orphan drug status for nuzefatide in pancreatic cancer

Bicycle Therapeutics plc said that in September 2026 the FDA granted nuzefatide orphan drug designation for the treatment of pancreatic cancer.¹ The designation applies to investigational therapies intended to treat rare diseases affecting fewer than 200,000 patients in the United States.¹ Under the designation, the company said it could receive tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and the potential for seven years of market exclusivity upon regulatory approval.¹

Bicycle said it is enrolling patients in a Phase 2 trial evaluating nuzefatide's efficacy, safety, and pharmacokinetics in adult patients with recurrent pancreatic ductal adenocarcinoma, with further updates expected in 2027.¹

On its radioligand program, the company said it continues to work on its Bicycle Radioconjugate molecules and expects to begin its first company-sponsored radioligand clinical trial for BT1702, an MT1-MMP-targeting BRC, in the second half of 2027.¹

For zelenectide pevedotin, a Nectin-4 targeting candidate, Bicycle said it converted the Duravelo-2 trial to a randomized Phase 2 study in May 2026 and deprioritized the program for internal development.¹ The company said it expects to report Duravelo-2 survival data from the randomized Phase 2 trial in previously untreated patients with metastatic urothelial cancer in the second half of 2027.¹

On finances, Bicycle reported cash and cash equivalents of $469.9 million as of September 30, 2026, compared to $628.1 million as of December 31, 2025.¹ The company attributed the decline mainly to cash used in operations, including payments for clinical program activities.¹ Bicycle said it expects its cash to fund operations into 2030, according to the release's summary of expected runway.