Bicycle Therapeutics Posts Narrower Q3 Loss, Wins FDA Orphan Drug Status for Pancreatic Cancer Drug

Bicycle Therapeutics plc (BCYC) reported third-quarter 2026 results and said it received FDA Orphan Drug Designation for nuzefatide pevedotin, an EphA2-targeting Bicycle Drug Conjugate being evaluated in a Phase 2 trial for recurrent pancreatic ductal adenocarcinoma. The company expects further clinical updates on the program in 2027. The designation offers development incentives including potential tax credits for qualified clinical trial costs, exemption from certain user fees and up to seven years of market exclusivity after approval. Bicycle also expects to start its first company-sponsored radioligand trial for BT1702 in the second half of 2027 and to report survival data then from the Phase 2 Duravelo-2 trial of zelenectide pevedotin in metastatic urothelial cancer; that program has been deprioritized for internal development. Collaboration revenue rose to $34.1 million from $11.7 million, mainly on recognition of remaining revenue from the terminated Bayer Consumer Care AG collaboration. Net loss narrowed to $10.5 million, or $0.15 per share, from $59.1 million, or $0.85 per share. R&D expenses fell to $33.4 million from $58.4 million. Cash stood at $469.9 million as of September 30, 2026, with runway expected into 2030. BCYC traded at $3.78, down 2.58%.