Welcome to our dedicated page for Tyra Biosciences news (Ticker: TYRA), a resource for investors and traders seeking the latest updates and insights on Tyra Biosciences stock.
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 (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.
Tyra Biosciences (Nasdaq: TYRA) announced three abstracts for presentation at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) in Barcelona, Spain, from October 23-25, 2024. The presentations include:
1. A late-breaking oral presentation on the preliminary safety and anti-tumor activity of TYRA-300, a highly selective FGFR3 inhibitor, in participants with advanced solid tumors with activating FGFR3 mutations/fusions (SURF301).
2. A poster on the preliminary pharmacokinetic and pharmacodynamic analysis of TYRA-300 from the SURF301 study.
3. A poster on the multicenter, open-label Phase 1/2 study of TYRA-300 in advanced urothelial carcinoma and other solid tumors with activating FGFR3 gene alterations (SURF301).
The abstracts are embargoed until 00.01 hrs CEST on Friday, October 25, 2024.
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