Business
Tyra Biosciences Reports Second Quarter 2023 Financial Results and Highlights
-Orphan Drug Designation granted to TYRA-300 for achondroplasia-- SURF301 Phase 1/2 oncology study remains on target; enrollment ongoing in Part B --TYRA-200
About this update from Tyra Biosciences, Inc.
[{"type":"text","content":"-Orphan Drug Designation granted to TYRA-300 for achondroplasia-- SURF301 Phase 1/2 oncology study remains on target; enrollment ongoing in Part B --TYRA-200 Phase 1 study on track; first patient to be dosed in 2H 2023-- Strong cash position of $232.4 million as of Q2 2023-\nCARLSBAD, Calif., Aug. 10, 2023 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, today reported financial results for the quarter ended June 30, 2023 and highlighted recent corporate progress.\n\"TYRA is a precision medicine biotech company focused on large opportunities in FGFR biology, and we continued to advance our pipeline and approach during the last several months,\" said Todd Harris, CEO of TYRA. \"We believe that TYRA-300, our oral FGFR3-selective inhibitor, is potentially a best-in-class agent designed to address unmet needs in oncology and skeletal dysplasias. Our SURF301 oncology study remains on target, and we are pleased to receive Orphan Drug Designation for TYRA-300 in achondroplasia from the U.S. FDA. This is another important milestone in the development of TYRA-300, and we are excited about the opportunity to deliver a new therapeutic option for patients.\"\nSecond Quarter 2023 and Recent Corporate Highlights\nTYRA-300\nGranted Orphan Drug Designation from U.S. FDA for Achondroplasia. In July 2023, TYRA-300, an investigational oral FGFR3-selective inhibitor, was granted Orphan Drug Designation (ODD) for the treatment of achondroplasia. TYRA remains on track to submit an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to enable a Phase 2 study of TYRA-300 in pediatric achondroplasia in 2024.SURF301 Phase 1/2 Study for Oncology is On Target. SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552) is a multi-center, open label study designed to determine the optimal and maximum tolerated doses and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. The study remains on target and enrollment is ongoing in Part A and Part B in Phase 1 of the study at multiple clinical sites in the U.S., Europe, and Australia.TYRA-200\nAdvanced Pr...