Tyra Biosciences, Inc.

Tyra Biosciences Reports Initial Phase 2 SURF302 Results Supporting the First Potential Oral Innovation in LG IR NMIBC with Dabogratinib

Tyra Biosciences reported initial Phase 2 SURF302 results for oral dabogratinib in FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer, with a 79% ORR and 64% best-overall-response complete response rate at 60 mg once daily in combined single and multiple marker lesion patients (n=14). In the single marker lesion subgroup that best mirrors the planned adjuvant Phase 3 setting, 60 mg QD delivered a 100% ORR (8/8) and 75% CR as best overall response, while Grade 3 treatment-related AEs occurred in only 4.5% of the 44 safety-evaluable patients with none at the 60 mg dose. Exposure-response analyses showed an 86% ORR among patients above the 2500 ng‧hr/mL AUC threshold versus 58% below it, supporting 60 mg QD for the planned registrational adjuvant study and prompting a new 70 mg QD cohort for the higher-burden ablative setting. Tyra also disclosed that the first patient treated in its Phase 2 SURF303 study in low-grade upper tract urothelial cancer achieved a 3-month complete response, and the company plans to engage health authorities on Phase 3 study design and dose selection.

•1mo ago

Tyra Biosciences Reports Second Quarter 2026 Financial Results and Recent Highlights

Tyra Biosciences reported a Q2 2026 net loss of $45.6 million, or $(0.69) per share, driven by increased R&D expenses of $39.2 million supporting ongoing clinical trials. The company ended the quarter with $353.9 million in cash and marketable securities, which it estimates will fund operations into the second half of 2028. Pipeline milestones remain on track, with initial Phase 2 data from the SURF302 study in bladder cancer expected in September 2026 and safety data from the BEACH301 achondroplasia study anticipated by the end of Q1 2027. Tyra appointed Jonathan Day as EVP of Clinical Development to lead its skeletal dysplasia strategy and amended an ATM agreement with TD Securities to authorize an additional $250 million in share sales.

•2mo ago

Tyra Biosciences Reports First Quarter 2026 Financial Results and Recent Highlights

Tyra Biosciences reported Q1 financial results, ending the quarter with $383.5 million in cash and marketable securities, which provides a runway into the second half of 2028. The company advanced its dabogratinib program by dosing the first patient in the SURF303 study for LG-UTUC, with initial results expected in 2027, and remains on track for data readouts in SURF302 and BEACH301 later this year. Corporate updates included the appointment of Habib Dable to the Board of Directors and the strengthening of the balance sheet with $147.9 million in net proceeds from an at-the-market offering.

•5mo ago