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Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company based in Carlsbad, CA, focused on developing next-generation precision medicines that target significant opportunities in Fibroblast Growth Factor Receptor (FGFR) biology. The Company leverages its proprietary precision medicine platform, SNÅP, to enable rapid and precise drug design through iterative molecular SNÅPshots that predict genetic alterations likely to cause acquired resistance to existing therapies.
Tyra’s lead product candidate, TYRA-300, is an investigational oral FGFR3-selective inhibitor aimed at treating cancer and skeletal dysplasias, including achondroplasia. TYRA-300 is currently being evaluated in a multi-center, open-label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors). SURF301 is designed to determine the optimal and maximal tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate its preliminary antitumor activity. TYRA-300 has demonstrated positive preclinical results in skeletal dysplasias, and Tyra expects to submit an Investigational New Drug (IND) application to the FDA for a Phase 2 clinical study in pediatric achondroplasia in 2024.
Another key product in development is TYRA-200, an investigational oral FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations for the treatment of cancer. TYRA-200 is currently undergoing evaluation in a multi-center, open-label Phase 1 clinical study, SURF201 (Study in Previously treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors). SURF201 is designed to determine the optimal and MTD and RP2D of TYRA-200 and to evaluate its preliminary antitumor activity.
Tyra has recently achieved significant milestones, including the FDA granting Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation to TYRA-300 for treating achondroplasia. The Company is also actively presenting research findings at major scientific congresses such as the American Society for Bone and Mineral Research (ASBMR) and the American Society of Human Genetics (ASHG).
In 2024, Tyra secured approximately $200 million in funding via a securities purchase agreement with institutional and accredited investors, led by RA Capital Management. This financial boost strengthens Tyra's balance sheet as the company advances its clinical development programs and leverages the SNÅP platform for discovering new drug candidates.
Tyra Biosciences' vision is to provide novel therapeutic options for patients with unmet medical needs by developing best-in-class precision medicines. Their ongoing research, clinical trials, and financial stability position them well to achieve this goal.
Tyra Biosciences announced promising preclinical results for TYRA-300, an oral FGFR3 selective inhibitor, in treating hypochondroplasia (HCH).
Presented at the 6th Annual Achondroplasia & Skeletal Dysplasia Research Conference, the data showed TYRA-300 increased long bone lengths by up to 5.03% and skull size by 5.88% in mouse models, compared to vehicle-treated mice. The results support the potential of TYRA-300 as a best-in-class agent for FGFR3-related skeletal dysplasias like HCH.
The company plans to submit an Investigational New Drug (IND) application for achondroplasia (ACH) in the second half of 2024, aiming for a Phase 2 study in pediatric ACH.
Tyra Biosciences (Nasdaq: TYRA), a clinical-stage biotechnology firm specializing in precision medicines for FGFR biology, will participate in several investor conferences. On May 28-29, 2024, CEO Todd Harris will join a fireside chat at TD Cowen's Oncology Innovation Summit. The company will engage in one-on-one investor meetings at the Jefferies Global Healthcare Conference on June 5-6, 2024. Additionally, Harris will present on June 12, 2024, at the Goldman Sachs Global Healthcare Conference, with further investor meetings scheduled. Webcasts of these presentations will be available on Tyra's Investor page.
Tyra Biosciences, a clinical-stage biotechnology company, reported financial results for Q1 2024, with $382.5 million in cash and marketable securities. Recent highlights include progress on TYRA-300 in oncology and achondroplasia, new board appointments, and completion of a $200M private placement financing. The company continues to advance its pipeline and expects to report SURF301 Phase 1 initial results in 2H24.
Tyra Biosciences, a clinical-stage biotech company, appointed Susan Moran, M.D., M.S.C.E. and S. Michael Rothenberg, M.D., Ph.D. as independent directors, replacing Isan Chen, M.D. Both new directors bring extensive expertise in FGFR3 biology and oncology. Dr. Moran has a background in clinical trials and product development, while Dr. Rothenberg has experience in clinical care and drug development. The changes aim to advance the company's precision medicine candidates, particularly TYRA-300 for skeletal dysplasias and oncology.
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