CARLSBAD, Calif. - Tyra Biosciences, Inc. (NASDAQ: TYRA), a biotechnology firm with a market capitalization of $840 million specializing in precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology, has received clearance from the U.S. Food and Drug Administration (FDA) to move forward with a Phase 2 clinical trial for its drug candidate TYRA-300. According to InvestingPro data, the company's stock has delivered a strong 24% return over the past year, reflecting investor confidence in its pipeline development. The trial will focus on treating low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC).
The investigational drug TYRA-300 is a selective inhibitor designed specifically to target FGFR3 mutations, which are commonly found in NMIBC. The drug aims to provide an effective treatment option while minimizing the toxicities associated with inhibiting other FGFRs. InvestingPro analysis shows the company maintains a strong financial position with a remarkable current ratio of 29.55 and more cash than debt on its balance sheet, providing ample runway for clinical development. The Phase 2 study, known as SURF302, will be an open-label trial assessing the efficacy and safety of TYRA-300 in patients with FGFR3-altered IR NMIBC. The trial will enroll up to 90 participants across multiple sites in the United States.
Dr. Erik Goluboff, an experienced urologic oncologist with over three decades in the field, has been appointed as Senior Vice President of Clinical Development at TYRA to lead the clinical program. His background includes roles at Genentech/Roche and AstraZeneca (NASDAQ:AZN), as well as academic positions at Columbia and Mount Sinai.
The SURF302 study will explore two different dosing regimens, with the possibility of adding a third cohort following a review of initial efficacy and safety data. The primary outcome of the trial will be the complete response rate at three months, with secondary outcomes including time to recurrence and overall safety.
Doug Warner, TYRA's Chief Medical (TASE:PMCN) Officer, expressed the significance of the FDA's IND clearance as a crucial step toward addressing the urgent need for better tolerated treatments for NMIBC. Dr. Goluboff also highlighted the potential of TYRA-300 as a compelling treatment option for IR NMIBC.
TYRA-300 is also being evaluated for other conditions, including pediatric achondroplasia and metastatic urothelial carcinoma. The company's proprietary SNÃ…P platform has enabled the rapid design and development of this and other precision medicine candidates.
This press release statement confirms that the first patient dosing for the SURF302 study is expected to commence in the second quarter of 2025. Wall Street appears optimistic about TYRA's prospects, with analyst price targets ranging from $28 to $33 per share. Discover more detailed financial insights and 6 additional ProTips for TYRA with a subscription to InvestingPro, including comprehensive analysis of the company's financial health and growth potential.
In other recent news, Tyra Biosciences has made significant strides in its clinical trials and financial prospects. The company's drug candidate, TYRA-300, has received FDA approval to proceed with a Phase 2 trial aimed at treating achondroplasia. Analysts from UBS and H.C. Wainwright have shown confidence in Tyra Biosciences, with UBS initiating coverage with a Buy rating and a price target of $28.00, while H.C. Wainwright adjusted its price target to $30 from $32, maintaining a Buy rating.
Piper Sandler also reaffirmed an Overweight rating on Tyra Biosciences shares, indicating continued confidence in the company's prospects. According to UBS, the market is currently pricing Tyra Biosciences' shares with an expectation of approximately $100-200 million in 2035 sales for oncology and $300-400 million for growth disorders. However, UBS's risk-adjusted estimates are considerably higher, at around $350 million for oncology and $650 million for growth disorders.
These recent developments underscore UBS's confidence in Tyra Biosciences' long-term revenue potential driven by its innovative drug development. The company maintains a strong financial position with a current ratio of 29.55 and more cash than debt on its balance sheet. In addition, Tyra Biosciences plans to submit an Investigational New Drug application to commence a Phase 2 trial in achondroplasia and initiate a Phase 2 study in non-muscle invasive bladder cancer.
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