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CARLSBAD, Calif. - Tyra Biosciences, Inc. (NASDAQ:TYRA), a clinical-stage biotech company with a market capitalization of $572 million, has dosed the first child in its Phase 2 clinical study evaluating dabogratinib for the treatment of achondroplasia, the most common form of dwarfism. InvestingPro analysis shows the company maintains a strong financial position with more cash than debt on its balance sheet, though it’s currently burning through cash as it advances its clinical programs.
The BEACH301 trial will assess the company’s oral FGFR3-selective inhibitor in children ages 3 to 10 with achondroplasia who have open growth plates. The study includes both treatment-naïve participants and those who have received prior growth-accelerating therapy, with initial results from the safety sentinel cohort expected in the second half of 2026. Wall Street appears optimistic about the company’s prospects, with analyst price targets ranging from $28 to $33, suggesting significant upside potential from the current trading price of $10.24.
Achondroplasia affects approximately 1 in 15,000 to 40,000 children at birth, with an estimated 250,000 individuals affected worldwide. The condition is caused by an FGFR3 gene mutation in approximately 99% of cases and can lead to health complications including spinal stenosis, sleep apnea, and disproportionate short stature.
"Dabogratinib is the only oral, FGFR3-selective inhibitor in clinical development for achondroplasia," said Doug Warner, Chief Medical Officer of Tyra Biosciences. "It is designed as an easy-to-take oral option, offering an improved administration approach for children and their families."
The BEACH301 study will enroll up to 10 participants per dose level across multiple sites globally. Primary objectives include assessing safety and tolerability while evaluating changes in annualized growth velocity to determine optimal dosing for further development.
The U.S. Food and Drug Administration has granted both Orphan Drug Designation and Rare Pediatric Disease Designation to dabogratinib for the treatment of achondroplasia.
Tyra Biosciences developed dabogratinib using its proprietary SNÅP platform, which the company states enables precise drug design through iterative molecular analysis to predict genetic alterations that may cause resistance to existing therapies.
This article is based on a press release statement from Tyra Biosciences.
In other recent news, Tyra Biosciences has announced the dosing of the first patient in its Phase 2 trial for TYRA-300, targeting low-grade, intermediate-risk non-muscle invasive bladder cancer. The trial, known as SURF302, is an open-label study aiming to enroll up to 90 participants, primarily in the United States, to assess the efficacy and safety of TYRA-300. Participants will be randomized to receive either 50 mg or 60 mg of the drug daily, with potential additional dosing cohorts based on initial data reviews.
Additionally, H.C. Wainwright has reiterated its Buy rating on Tyra Biosciences, maintaining a price target of $30. Piper Sandler has also assumed coverage of the company with an Overweight rating, raising the price target to $33. The firm expressed optimism about TYRA-300, particularly its potential in treating metastatic urothelial carcinoma and possibly expanding into other conditions. Analysts from Piper Sandler highlighted the drug’s high selectivity for FGFR3, which may offer a safer and more effective treatment compared to existing options. These developments reflect growing interest and positive sentiment from the investment community regarding Tyra Biosciences’ ongoing research and development efforts.
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