Tyra Biosciences, Inc. is a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer. Its proprietary in-house discovery platform, SN?P, enables the rapid and precise refinement of structural design through iterative molecular SN?Pshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA is developing a pipeline of selective inhibitors of the Fibroblast Growth Factor Receptor (FGFR) family members, which are altered in approximately 7% of all cancers. The company was founded by Daniel Bensen and Todd Harris on August 2, 2018 and is headquartered in Carlsbad, CA.
相关临床试验
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3 进行中
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成立时间
2018
进行中（未招募）
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42.9%
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- Tyra Biosciences reported initial Phase 2 SURF302 results for oral dabogratinib in FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer, identifying 60 mg once daily as the dose for its planned adjuvant strategy. - In single marker lesion patients (n=8), dabogratinib 60 mg QD achieved 100% overall response rate and a 75% best overall complete response rate, while combined single and multiple lesion patients (n=14) showed 79% ORR and 64% CR. - Safety was favorable with no Grade 4 or 5 events, no clinically significant hyperphosphatemia, nail or ocular toxicity, and no dose reductions or treatment-related discontinuations at 60 mg. - Despite the efficacy signal, Tyra shares fell roughly 20-22% as the 64% complete response rate missed the 70% benchmark analysts had set, and the company now plans a 70 mg cohort for the ablative setting.
- Tyra Biosciences was added to the S&P Biotechnology Select Industry Index on December 13, 2025, marking a significant milestone for institutional recognition. - The company's investment thesis centers on its focused FGFR3 pipeline and SNAP platform, with key clinical milestones expected for TYRA-300 and dabogratinib. - Despite zero revenue and rising losses, the biotech has strengthened its operating and regulatory leadership team to advance its therapeutic programs. - Index inclusion and recent insider share sales highlight growing institutional attention while the company faces ongoing funding challenges and clinical execution risks.
- Ascendis Pharma's TransCon CNP awaits FDA approval on November 30 as a weekly treatment for achondroplasia, competing directly with BioMarin's daily Voxzogo injections. - Phase II data showed TransCon CNP achieved 5.42 cm per year growth velocity versus 4.35 cm for placebo, while Voxzogo demonstrated 1.57 cm improvement over placebo in Phase III trials. - The global achondroplasia market represents over $5 billion opportunity with 24,000 eligible patients, though Voxzogo currently captures only 17% market penetration. - Alternative approaches targeting the root cause include BridgeBio's oral infigratinib, which uniquely improves body proportionality unlike CNP-based therapies.
• The FDA has cleared Tyra Biosciences' IND application for TYRA-300, allowing a Phase 2 trial in low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC). • The SURF302 trial will evaluate the safety and efficacy of TYRA-300, an oral FGFR3-selective inhibitor, in patients with FGFR3-altered NMIBC. • The open-label study will enroll up to 90 patients, with the primary endpoint being the complete response rate at 3 months, with patient dosing expected in Q2 2025. • TYRA-300 is also being investigated in metastatic urothelial carcinoma (mUC) and pediatric achondroplasia, showing promising initial efficacy and tolerability.
- Tyra Biosciences reported positive interim Phase 1/2 data for TYRA-300 in metastatic urothelial cancer (mUC), with a 54.5% confirmed partial response rate in FGFR3+ patients. - The FDA cleared the IND for TYRA-300's Phase 2 study in pediatric achondroplasia (BEACH301), with the first patient expected to be dosed in Q1 2025. - TYRA-300 is also on track for a Phase 2 IND submission for non-muscle invasive bladder cancer (NMIBC) by the end of 2024, expanding its clinical development. - The company appointed Doug Warner, MD, as Chief Medical Officer and reported a cash position of $360.1 million, expected to last through at least 2026.
• Tyra Biosciences' oral FGFR3 inhibitor TYRA-300 is advancing in development for metastatic urothelial carcinoma and other solid tumors, with projected annual revenue of $63 million by 2036. • The drug candidate, developed using Tyra's proprietary SNAP platform, aims to overcome resistance to existing treatments and provide deeper responses in targeted oncology. • Despite promising projections, Tyra Biosciences reported increased operating losses, from $58.9M in 2022 to $79.9M in 2023, reflecting ongoing R&D investments.
• TYRA Biosciences reported positive interim results for TYRA-300 in metastatic urothelial cancer (mUC) from the SURF301 Phase 1/2 study, demonstrating notable anti-tumor activity. • The company's IND was cleared for a Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301), with plans to initiate the study in Q1 2025. • TYRA-300 is also on track for a Phase 2 IND submission for non-muscle invasive bladder cancer (NMIBC) by the end of 2024, expanding its clinical development. • Doug Warner, MD, was appointed as Chief Medical Officer, bringing extensive experience in oncology and skeletal disease drug development to Tyra Biosciences.
• TYRA-300, a selective FGFR3 inhibitor, demonstrates encouraging anti-tumor activity in heavily pretreated metastatic urothelial carcinoma patients. • Interim Phase I/II SURF301 trial results show a 54.5% partial response rate in patients receiving at least 90 mg of TYRA-300 daily. • The disease control rate reached 100% in patients given at least 90 mg of TYRA-300, with a favorable safety profile observed. • TYRA-300 aims to address the unmet need for a more tolerable FGFR3 inhibitor compared to pan-FGFR inhibitors like Balversa.
• The FDA has cleared Tyra Biosciences' IND application for TYRA-300, an oral FGFR3-selective inhibitor, to proceed with a Phase 2 trial in children with achondroplasia. • The BEACH301 trial will be a multicenter, open-label, dose-escalation/expansion study evaluating TYRA-300 in children aged 3-10 with achondroplasia. • TYRA-300 has received Orphan Drug and Rare Pediatric Designations from the FDA for treating achondroplasia, highlighting its potential impact on this rare condition.
• TYRA-300, a selective FGFR3 inhibitor, demonstrates promising antitumor activity in patients with metastatic urothelial cancer harboring FGFR3 alterations, with a 54.5% partial response rate at doses of 90 mg or higher. • The SURF301 trial's early results indicate that TYRA-300 is well-tolerated, with fewer of the adverse effects commonly associated with pan-FGFR inhibitors, offering a potentially improved safety profile. • Pharmacokinetic analysis suggests that a dose of 90 mg daily provides adequate FGFR3 target coverage, supporting its selection as the optimal dose for achieving the desired therapeutic effect in this patient population. • This investigational drug represents a potential next-generation targeted therapy, offering improved precision medicine for urothelial cancer patients, with the aim of enhancing both survival and quality of life.
