Latest news with #TyraBiosciences
Yahoo
08-07-2025
- Business
- Yahoo
Tyra Biosciences Doses First Patient in Phase 2 Study of TYRA-300 in Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)
-TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC- -Initial 3-month complete response (CR) data expected to be reported in 1H 2026- CARLSBAD, Calif., June 30, 2025 /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, announced today that the first patient has been dosed in the Phase 2 SURF302 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC). TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to minimize the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for FGFR3 gatekeeper mutations. FGFR3 is a frequently altered gene in IR NMIBC, with ~70% of low-grade IR NMIBC showing activating mutations. "Our goal is to develop TYRA-300 as the first once-daily oral treatment designed to reduce disease recurrence, as well as surgical procedural intervention and intravesical therapy, for people living with IR NMIBC," said Dr. Erik Goluboff, SVP of Clinical Development at TYRA. "We believe we are well-positioned to contribute meaningful advancements to the field of bladder cancer with SURF302, and we anticipate that the clinical data will offer valuable insights with the potential to enhance patient outcomes." SURF302 (NCT06995677) is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with TYRA-300 at 50 mg once daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability. "I am excited that the Phase 2 trial evaluating oral TYRA-300 in IR NMIBC is now underway," said Dr. Tom Jayram, Director of the Advanced Therapeutics Center at Urology Associates in Nashville, TN. "IR NMIBC is a challenging disease for urologists and patients alike, with the potential for recurrence, progression, and the morbidity of multiple procedures for disease surveillance. Selective FGFR inhibitors are an exciting new option in this disease space that can allow a personalized approach to bladder cancer. TYRA-300 is an investigational, daily oral tablet that has shown encouraging preliminary safety and efficacy in an early phase trial and has the potential to be a paradigm shift in how urologists can treat bladder cancer." TYRA-300 will also be evaluated in pediatric achondroplasia in the BEACH301 Phase 2 study, which is open for enrollment and for which the Company now expects first child dosing in the second half of the year. About Non-Muscle Invasive Bladder Cancer In the United States, it is estimated that there are more than 730,000 people living with bladder cancer. Many of these patients have intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and experience recurrence episodes throughout the course of their disease. Treatment for IR NMIBC and disease recurrence is a surgical procedure called transurethral resection of bladder tumor (TURBT) combined with intravesical-administered chemotherapy. Repeat TURBT procedures and intravesical-administered chemotherapy can impact patients' quality of life and overall health, leading to a significant unmet medical need for better tolerated therapeutic options. TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC. About TYRA-300 TYRA-300 is the Company's lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia that has demonstrated interim clinical proof-of-concept results in metastatic urothelial cancer (mUC). TYRA-300's planned clinical development includes three Phase 2 clinical trials: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for mUC. Please visit the Patients page of our website for more information on our clinical trials. About Tyra Biosciences Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA's expertise in FGFR biology has created a differentiated pipeline with three clinical-stage programs in targeted oncology and genetically defined conditions. The Company's lead precision medicine stemming from SNÅP, TYRA-300, is a potential first-in-class selective FGFR3 inhibitor that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for FGFR3 gatekeeper mutations. TYRA-300's planned clinical development includes three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial cancer. TYRA is also developing TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: expected reporting of data from the SURF302 study and the timing thereof; the design and goals of the SURF302 study; the potential to develop next-generation precision medicines and for TYRA-300 to be a first-in-class, once-daily oral treatment, and the potential safety and therapeutic benefits of TYRA-300; the expected timing and phase of development of TYRA-300, including the expected timing of dosing for the BEACH301 study in pediatric achondroplasia; and the potential for SNÅP to develop therapies. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: potential delays in the commencement, recruitment, enrollment, data readouts and completion of clinical trials and preclinical studies; results from preclinical studies or early clinical trials not necessarily being predictive of future results; interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of TYRA-300; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; our dependence on third parties in connection with manufacturing, research and preclinical testing; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for TYRA-300 or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Amy Conrad aconrad@ View original content to download multimedia: SOURCE Tyra Biosciences Sign in to access your portfolio
Business Insider
12-06-2025
- Business
- Business Insider
Tyra Biosciences up 3% as RA Capital increases stake to 22.4%
In a regulatory 13D/A filing, RA Capital disclosed that it has increased its stake in Tyra Biosciences (TYRA) to 22.4% from 20.1% reported in March. Shares were up 3% at $10.50 at the conclusion of the afterhours session. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Yahoo
09-05-2025
- Business
- Yahoo
One Tyra Biosciences Insider Raised Stake By 284% In Previous Year
From what we can see, insiders were net buyers in Tyra Biosciences, Inc.'s (NASDAQ:TYRA ) during the past 12 months. That is, insiders acquired the stock in greater numbers than they sold it. While we would never suggest that investors should base their decisions solely on what the directors of a company have been doing, logic dictates you should pay some attention to whether insiders are buying or selling shares. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. The Chief Financial Officer Alan Fuhrman made the biggest insider purchase in the last 12 months. That single transaction was for US$152k worth of shares at a price of US$16.00 each. So it's clear an insider wanted to buy, even at a higher price than the current share price (being US$10.07). It's very possible they regret the purchase, but it's more likely they are bullish about the company. To us, it's very important to consider the price insiders pay for shares. Generally speaking, it catches our eye when an insider has purchased shares at above current prices, as it suggests they believed the shares were worth buying, even at a higher price. Alan Fuhrman was the only individual insider to buy during the last year. The chart below shows insider transactions (by companies and individuals) over the last year. If you want to know exactly who sold, for how much, and when, simply click on the graph below! Check out our latest analysis for Tyra Biosciences There are always plenty of stocks that insiders are buying. If investing in lesser known companies is your style, you could take a look at this free list of companies. (Hint: insiders have been buying them). Looking at the total insider shareholdings in a company can help to inform your view of whether they are well aligned with common shareholders. Usually, the higher the insider ownership, the more likely it is that insiders will be incentivised to build the company for the long term. Tyra Biosciences insiders own about US$20m worth of shares. That equates to 4.2% of the company. While this is a strong but not outstanding level of insider ownership, it's enough to indicate some alignment between management and smaller shareholders. There haven't been any insider transactions in the last three months -- that doesn't mean much. But insiders have shown more of an appetite for the stock, over the last year. Overall we don't see anything to make us think Tyra Biosciences insiders are doubting the company, and they do own shares. So these insider transactions can help us build a thesis about the stock, but it's also worthwhile knowing the risks facing this company. When we did our research, we found 2 warning signs for Tyra Biosciences (1 doesn't sit too well with us!) that we believe deserve your full attention. Of course Tyra Biosciences may not be the best stock to buy. So you may wish to see this free collection of high quality companies. For the purposes of this article, insiders are those individuals who report their transactions to the relevant regulatory body. We currently account for open market transactions and private dispositions of direct interests only, but not derivative transactions or indirect interests. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
