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Overview of Tyra Biosciences, Inc.
Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company dedicated to developing next-generation precision medicines. With a focus on precision oncology, FGFR biology, and targeted therapy, the company is pioneering treatments for challenging oncologic indications and genetically defined skeletal dysplasias. At its core, Tyra Biosciences leverages a proprietary drug discovery engine to tackle acquired resistance in cancer therapies and to address unmet medical needs in rare skeletal disorders.
Innovative SNÅP Platform
The foundation of Tyra Biosciences’ approach is its in-house precision medicine platform, SNÅP. This innovative technology allows for rapid and precise drug design through iterative molecular snapshots that accurately predict genetic alterations likely to drive resistance to existing treatments. The platform differentiates the company by enabling the development of drugs that are both highly specific and potentially better tolerated, addressing limitations associated with broader-spectrum FGFR inhibitors.
Clinical-Stage Pipeline and Core Programs
Tyra Biosciences has built a robust pipeline centered on its lead precision candidate, TYRA-300, an oral and highly selective FGFR3 inhibitor. Designed to avoid the toxicities often observed with pan-FGFR inhibition, TYRA-300 is under evaluation for multiple indications. In oncology, its application is primarily in advanced urothelial cancers characterized by FGFR3 gene alterations. Meanwhile, in the realm of skeletal dysplasias, TYRA-300 is being developed for conditions including achondroplasia and hypochondroplasia, with supportive preclinical data and regulatory designations that underscore its potential in addressing rare genetic disorders.
Therapeutic Focus and Market Position
Tyra Biosciences distinguishes itself within the competitive landscape through its targeted focus on FGFR-mediated diseases. By developing drugs that specifically target FGFR3 alterations, the company intends to overcome the frequently encountered challenges associated with acquired resistance. Its dual focus on oncology and rare skeletal dysplasias positions Tyra Biosciences in a unique niche, where precision medicine meets the imperative for improved tolerability and enhanced patient outcomes.
Research, Development, and Strategic Vision
The company’s strategy is built around its ability to translate cutting-edge scientific insight into therapeutic solutions. With an evolving portfolio of clinical-stage programs, Tyra Biosciences emphasizes iterative drug design, deep molecular understanding, and precision targeting. This meticulous approach not only paves the way for improved efficacy and safety profiles in its candidate drugs but also provides a flexible framework to address complex mutational landscapes in cancer and genetic disorders.
Operational Excellence and Future Relevance
Tyra Biosciences continues to advance its clinical programs through precise dose optimization, careful patient selection, and adherence to rigorous regulatory standards. The company’s development programs are structured on a sustainable, long-term basis, ensuring that the information provided remains relevant and evergreen. This emphasis on durable technological innovation and tactical execution underpins its commitment to scientific excellence and operational integrity.
Key Differentiators
- Precision Platform: The SNÅP platform drives the rapid identification and development of targeted therapies.
- Selective Inhibition: TYRA-300 is designed to selectively inhibit FGFR3, reducing off-target toxicities seen in pan-FGFR approaches.
- Diverse Pipeline: The development programs cover both oncology and rare skeletal dysplasias, addressing significant unmet clinical needs.
- Innovative Drug Design: Iterative molecular snapshots enhance the precision of drug design, allowing the tailoring of therapies to specific genetic profiles.
Conclusion
In summary, Tyra Biosciences, Inc. stands at the forefront of precision medicine with its innovative SNÅP platform and a strategic focus on FGFR biology. Its clinical-stage pipeline, led by TYRA-300, exemplifies the company’s commitment to developing targeted therapies that promise improved efficacy and tolerability for conditions with unmet medical needs. Through precise and iterative drug development, Tyra Biosciences is poised to be an informative case study in how targeted molecular strategies can redefine therapeutic approaches in both oncology and rare genetic disorders.
Tyra Biosciences (NASDAQ: TYRA) reported its Q4 and full year 2024 financial results, highlighting significant progress in its precision medicine pipeline. The company ended 2024 with $341.4 million in cash and equivalents, providing runway through 2027.
Key developments include three FDA-cleared INDs for TYRA's precision small molecules, with TYRA-300 advancing to three Phase 2 studies: SURF302 for bladder cancer, BEACH301 for pediatric achondroplasia, and SURF301 for metastatic urothelial cancer. Notably, SURF301 showed promising interim results with 54.5% of patients achieving confirmed partial response.
Financial results show Q4 2024 net loss of $25.6 million compared to $22.8 million in Q4 2023. Full-year 2024 net loss was $86.5 million. R&D expenses increased to $80.1 million for 2024, up from $62.5 million in 2023.
Tyra Biosciences (NASDAQ: TYRA), a clinical-stage biotechnology company specializing in Fibroblast Growth Factor Receptor (FGFR) biology, has announced its participation in four major upcoming investor conferences in early 2025.
The company will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference (February 11-12, virtual), the TD Cowen 45th Annual Healthcare Conference (March 3-5, Boston), the Jefferies Biotech on the Beach Summit (March 11-12, Miami), and the Barclays 27th Annual Global Healthcare Conference (March 11-13, Miami).
Management will engage in fireside chats and one-on-one investor meetings at most events, with presentations scheduled for February 12 at 2:00 PM ET (Oppenheimer), March 3 at 9:50 AM ET (TD Cowen), and March 12 at 8:30 AM ET (Barclays). Live and archived webcasts of the fireside chats will be accessible through TYRA's investor relations website.
Tyra Biosciences (Nasdaq: TYRA) has appointed Adele Gulfo to its Board of Directors. Gulfo brings nearly three decades of executive leadership experience in pharmaceutical development and commercialization from companies including Pfizer, AstraZeneca, Viatris, and Sumitomo Pharma.
Most recently, Gulfo served as CEO of Sumitomo Pharma America's Biopharma Commercial Unit, overseeing portfolios in oncology, rare disease, urology, CNS, and Women's Health. Her notable achievements include leading Pfizer's $12B+ U.S. primary care business unit and playing key roles in launching successful drugs like LIPITOR® and CRESTOR®.
The appointment aims to strengthen TYRA's development of precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology, particularly as the company advances TYRA-300 for non-muscle invasive bladder cancer.
Tyra Biosciences (Nasdaq: TYRA) announced the acceptance of two abstracts for presentation at the 2025 ASCO Gastrointestinal Cancers Symposium in San Francisco. The first presentation covers TYRA-200, featuring a multicenter, open-label, first-in-human study for advanced intrahepatic cholangiocarcinoma and other solid tumors with FGFR2 gene alterations. Dr. Robin Kate Kelley from UC San Francisco will present this study.
The second presentation focuses on TYRA-430, described as the first reversible FGFR4/3 inhibitor designed to address challenges in FGF19-driven hepatocellular carcinoma treatment, to be presented by Dr. Ronald Swanson. Both presentations are scheduled for January 24, 2025, from 11:30 AM to 1:00 PM PST.
Tyra Biosciences (NASDAQ: TYRA) has received FDA clearance for its IND application to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC). The company has appointed Dr. Erik Goluboff as SVP of Clinical Development to lead this program.
The Phase 2 study, SURF302, will evaluate TYRA-300, an oral FGFR3-selective inhibitor, in up to 90 participants across multiple U.S. sites. Participants will be randomized to receive either 50mg or 60mg once-daily doses. The primary endpoint is complete response rate at three months, with secondary endpoints including time to recurrence, duration of response, and safety measures.
TYRA-300 targets FGFR3, which is altered in 60-80% of IR NMIBC cases. The first patient is expected to be dosed in Q2 2025. The drug will also be evaluated in two other Phase 2 studies: BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial carcinoma.
Tyra Biosciences (Nasdaq: TYRA), a clinical-stage biotechnology company specializing in Fibroblast Growth Factor Receptor (FGFR) precision medicines, has announced its participation in two major investor conferences. CEO Todd Harris will present at the Jefferies London Healthcare Conference (November 19-21st, 2024) with a fireside chat on November 19th at 2:00 pm GMT, and at the 36th Annual Piper Healthcare Conference (December 3-5th, 2024) in New York with a presentation on December 4th at 10:30 am ET. Management will participate in one-on-one investor meetings at both events. Webcasts will be available on TYRA's website.
Tyra Biosciences (Nasdaq: TYRA), a clinical-stage biotechnology company, reported its Q3 2024 financial results and corporate highlights. Key points include positive interim clinical proof-of-concept results for TYRA-300 in metastatic urothelial cancer (mUC) from the SURF301 Phase 1/2 study. The company received IND clearance for a Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301) and plans to submit an IND for a Phase 2 study in non-muscle invasive bladder cancer (NMIBC) by year-end 2024.
Tyra also advanced its TYRA-200 and TYRA-430 programs and appointed Dr. Doug Warner as Chief Medical Officer. Financially, Tyra reported a net loss of $24.0 million for Q3 2024, with increased R&D and administrative expenses. The company holds $360.1 million in cash and equivalents, expected to fund operations through 2026.
Tyra Biosciences received FDA clearance for its IND application to proceed with BEACH301, a Phase 2 clinical trial of TYRA-300 in pediatric achondroplasia. TYRA-300 is the first oral FGFR3-selective inhibitor well-tolerated in clinical studies. The trial will evaluate children ages 3-10 with achondroplasia, enrolling up to 10 participants per dose level in treatment-naïve and previously treated cohorts. The study aims to assess safety, tolerability, and changes in growth velocity. First patient dosing is expected in Q1 2025. TYRA-300 received both Orphan Drug and Rare Pediatric Designations from the FDA for achondroplasia treatment.
Tyra Biosciences announced promising interim clinical data for TYRA-300, their investigational oral FGFR3-selective inhibitor, in treating metastatic urothelial cancer (mUC). In patients receiving ≥90mg daily doses, 6 out of 11 (54.5%) achieved confirmed partial response, with 100% disease control rate. The study included 41 heavily pre-treated patients, with 44% receiving ≥3 prior therapies. TYRA-300 demonstrated favorable safety results across all doses, showing infrequent FGFR2/FGFR1-associated toxicities. Only 4 serious adverse events (10%) were reported, with one dose-limiting toxicity of grade 3 diarrhea at 90mg daily.
Tyra Biosciences (Nasdaq: TYRA) announced it will host a conference call and webcast on October 25, 2024 at 8:00 am ET to present interim clinical results of TYRA-300 from the SURF301 Phase 1/2 study in metastatic urothelial cancer (mUC). The data will be presented at the 36th EORTC-NCI-AACR Symposium in Barcelona, Spain. Dr. Gary Steinberg from Rush University Medical Center will join TYRA's management team for the presentation and Q&A. The webcast will be accessible through TYRA's investor relations website, with telephone participation available through pre-registration.
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