CARLSBAD, Calif. - Tyra Biosciences, Inc. (NASDAQ:TYRA), a biotech firm specializing in precision medicines for Fibroblast Growth Factor Receptor (FGFR) related conditions, announced the FDA's clearance of its Investigational New Drug (IND) application for TYRA-300. This approval sets the stage for a Phase 2 clinical trial targeting achondroplasia in children, a common form of dwarfism.
TYRA-300, an oral FGFR3-selective inhibitor, aims to address the limitations of current treatments, which include daily injections that provide only modest improvements. The drug is designed to avoid toxicities linked to the inhibition of other FGFRs and is also under evaluation for metastatic urothelial cancer.
The upcoming BEACH301 study will involve children aged 3 to 10 with open growth plates and will be conducted at multiple global sites. It will assess the safety, tolerability, and impact on growth velocity to determine optimal dosing. The study will also explore changes in height, body proportionality, and pharmacokinetics, with additional assessments on functional outcomes and quality of life.
Tyra Biosciences' CEO, Todd Harris, highlighted the significance of IND clearance for the achondroplasia community, expressing optimism about TYRA-300's potential to improve growth velocity and achieve meaningful clinical benefits. The company is preparing to initiate the BEACH301 study and commence dosing in the first quarter of 2025.
Previously, the FDA granted TYRA-300 Orphan Drug Designation in July 2023 and Rare Pediatric Designation in January 2024 for achondroplasia treatment. Tyra Biosciences continues to engage with the achondroplasia community as it advances its clinical development program.
Achondroplasia affects an estimated 1 in 15,000 to 40,000 children born worldwide, with approximately 250,000 individuals affected globally. The FGFR3 G380R mutation is responsible for nearly all cases of the condition. TYRA-300's selective inhibition of FGFR3 holds promise for addressing the underlying genetic cause of achondroplasia.
This news is based on a press release statement from Tyra Biosciences.
In other recent news, Tyra Biosciences, a pharmaceutical company, has made significant advancements in its clinical trials and financial outlook. The company received approval from the FDA to proceed with a Phase 2 trial of its investigational drug TYRA-300 for achondroplasia treatment. The study aims to enroll up to 10 participants per dose level across two cohorts and will assess the drug's safety and its impact on annualized growth velocity.
Tyra Biosciences has also reported positive results from its SURF-301 Phase 1/2 trial of TYRA-300 in metastatic urothelial carcinoma, leading to H.C. Wainwright raising the price target to $32. Preliminary results showed a 55% objective response rate for TYRA-300, surpassing the expected rate of 36%, which reaffirmed TD Cowen's Buy rating on the company's shares.
In financial developments, Tyra Biosciences has entered into an agreement with Boxer Capital, LLC and RA Capital Healthcare Fund, L.P. to exchange existing shares for warrants. The company's revenue is projected to grow to approximately $2.5 billion by 2035, according to Piper Sandler's estimates.
Tyra Biosciences has also received upgrades from BofA Securities, Piper Sandler, H.C. Wainwright, and Oppenheimer, with price targets ranging from $30 to $33. Finally, the company has made significant appointments, including Doug Warner as its new Chief Medical Officer and the addition of Susan Moran, M.D., M.S.C.E., and S. Michael Rothenberg, M.D., Ph.D., to its board as independent directors. These are part of the recent developments at Tyra Biosciences.
InvestingPro Insights
As Tyra Biosciences (NASDAQ:TYRA) advances its TYRA-300 drug for achondroplasia treatment, investors may find additional context from InvestingPro data and tips valuable.
The company's market capitalization stands at $1.16 billion, reflecting investor optimism about its potential in the precision medicine space. This optimism is further supported by the stock's impressive performance, with a 98.82% price total return over the past year and a 39.95% return over the last six months.
However, it's important to note that Tyra Biosciences is not yet profitable, with an adjusted operating income of -$95.45 million over the last twelve months. This is consistent with many early-stage biotech companies investing heavily in research and development. An InvestingPro Tip highlights that analysts do not anticipate the company will be profitable this year, which is typical for firms in the clinical trial phase.
On a positive note, another InvestingPro Tip reveals that Tyra holds more cash than debt on its balance sheet, providing financial flexibility as it progresses through clinical trials. This strong liquidity position is crucial for biotech companies navigating the lengthy and costly drug development process.
Investors should be aware that the stock has experienced volatility, with a 22.7% decline over the past week. This fluctuation underscores the importance of staying informed about clinical trial progress and regulatory decisions, which can significantly impact biotech stock prices.
For those seeking a deeper understanding of Tyra Biosciences' financial health and market position, InvestingPro offers 10 additional tips, providing a comprehensive view of the company's prospects as it moves forward with its promising TYRA-300 drug candidate.
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