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Investing.com - H.C. Wainwright has reiterated its Buy rating and $30.00 price target on Tyra Biosciences (NASDAQ:TYRA), representing over 200% upside from the current price of $9.57, following the company’s announcement that the first patient has been dosed in its Phase 2 trial of TYRA-300. According to InvestingPro data, analyst consensus is highly bullish with targets ranging from $28 to $33.
The Phase 2 trial, known as SURF302, is evaluating TYRA-300, a selective FGFR3 inhibitor, in patients with FGFR3-altered low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC). The open-label study will enroll up to 90 patients primarily in the U.S., with initial randomization to treatment with either 50mg QD (Cohort 1) or 60mg QD (Cohort 2). The company’s strong financial position, with a current ratio of 22.78 and minimal debt-to-equity of 0.02, suggests adequate resources to support the trial’s execution.
The trial’s primary endpoint is complete response rate at Month 3, with secondary endpoints including time to recurrence, median duration of response, recurrence free survival, progression free survival, safety, and tolerability. Following a review of efficacy and safety data, researchers may evaluate an additional dosing cohort.
FGFR3 is a frequently altered gene in IR NMIBC, with approximately 70% of low-grade IR NMIBC cases showing activating mutations, making it a potentially important therapeutic target for this patient population.
Tyra Biosciences expects to report initial 3-month complete response data from the trial in the first half of 2026, according to the research note from H.C. Wainwright. While the company currently trades near its InvestingPro Fair Value, subscribers can access 7 additional ProTips and comprehensive financial metrics to better evaluate the investment opportunity.
In other recent news, Tyra Biosciences announced the commencement of its SURF302 Phase 2 clinical trial for TYRA-300, targeting low-grade, intermediate risk non-muscle invasive bladder cancer. The trial aims to evaluate the efficacy and safety of TYRA-300, with plans to enroll up to 90 participants primarily in the United States. The primary endpoint is the complete response rate at three months, with secondary endpoints including recurrence-free survival and safety. Initial data from this trial is expected in the first half of 2026. Additionally, TYRA-300 is set to be evaluated in pediatric achondroplasia in the upcoming BEACH301 Phase 2 study, with dosing anticipated in the second half of 2025.
In related developments, Piper Sandler has assumed coverage of Tyra Biosciences with an Overweight rating and a price target of $33. The firm expressed a positive outlook on TYRA-300, particularly noting its high selectivity for FGFR3, which suggests a potentially safer and more effective profile compared to existing treatments. Piper Sandler also highlighted the promising data for TYRA-300 in treating metastatic urothelial carcinoma and its potential expansion into other conditions. The firm’s endorsement is based on the drug’s promising data and anticipated growth potential in treating achondroplasia and non-muscle invasive bladder cancer.
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