Core Insights - Tyra Biosciences reported positive interim clinical proof-of-concept results for TYRA-300 in metastatic urothelial cancer (mUC) and received IND clearance for a Phase 2 study in pediatric achondroplasia [1][5] - The company appointed Doug Warner, MD, as Chief Medical Officer, enhancing its leadership team [10] - As of Q3 2024, Tyra had cash, cash equivalents, and marketable securities totaling $360.1 million, providing a strong financial position for ongoing and future clinical trials [12][19] Clinical Development Highlights - Interim data from the SURF301 Phase 1/2 study showed that at a dose of ≥ 90 mg once daily, 54.5% of patients with FGFR3+ mUC achieved a confirmed partial response, with a 100% disease control rate [3] - The company plans to expand the clinical development of TYRA-300 into non-muscle invasive bladder cancer (NMIBC) and aims to submit an IND application for this indication by the end of 2024 [4] - The FDA cleared the IND application for a Phase 2 clinical trial of TYRA-300 in children with achondroplasia, expected to begin in Q1 2025 [5] Financial Performance - For Q3 2024, Tyra reported a net loss of $24.0 million, compared to a net loss of $21.2 million in Q3 2023 [11][20] - Research and development expenses increased to $22.7 million in Q3 2024 from $19.3 million in the same period of 2023, driven by ongoing clinical trials [11] - General and administrative expenses rose to $5.9 million in Q3 2024 from $4.7 million in Q3 2023, primarily due to increased personnel-related costs [11] Pipeline and Research Initiatives - TYRA-300 is being evaluated in the SURF301 study for both oncology and skeletal dysplasias, with a focus on achieving best-in-class status [13][15] - The company is also advancing TYRA-200, an FGFR1/2/3 inhibitor, in a Phase 1 study for advanced solid tumors [14] - TYRA-430, an FGFR4/3-biased inhibitor, has received IND clearance for a Phase 1 study targeting advanced hepatocellular carcinoma and other solid tumors [9]

– TYRA-300 is the first oral FGFR-3 selective inhibitor to be well-tolerated in clinical studies –– First child with achondroplasia expected to be dosed in Q1 2025 –CARLSBAD, Calif., Oct. 28, 2024 /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 U.S. Food and Drug Administration (FDA) cleared its I ...

On Thursday, Tyra Biosciences, Inc. TYRA released clinical proof-of-concept data for TYRA-300 in patients with metastatic urothelial (mUC) cancer from its ongoing SURF301 Phase 1/2 study. These data will be presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to avoid the toxicities associated with the inhibition of FGFR1, FGFR2, and FGFR4 while being agnostic for the FGFR3 ga ...

CARLSBAD, Calif., Oct. 23, 2024 /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, today announced that it will host a conference call and webcast on October 25, 2024 at 8:00 am ET to share interim clinical results of TYRA-300 from the SURF301 Phase 1/2 study in metastatic urothelial cancer (mUC). These data will be presente ...

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BofA Securities has upgraded Tyra Biosciences TYRA, a clinical-stage biotechnology company focused on developing next-generation precision medicines. The company's initial focus is on improving small molecule drug discovery and development in targeted oncology and genetically defined conditions. The company has a pipeline of four preclinical candidates. In July, Tyra Biosciences announced preclinical proof-of-concept results with TYRA-300 in hypochondroplasia (HCH), the most common form of dwarfism. TYRA-30 ...

-Dr. Warner brings over twenty years of proven clinical development leadership to TYRA having successfully led global development and secured approvals for medicines across oncology and skeletal disease- CARLSBAD, Calif., Sept. 10, 2024 /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 the appointment of Dou ...

Tyra Biosciences, Inc. (TYRA) closed the last trading session at $20.59, gaining 2.5% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $26.33 indicates a 27.9% upside potential. The average comprises six short-term price targets ranging from a low of $22 to a high of $33, with a standard deviation of $3.78. While the lowest estimate indicates an increase of 6.9% from the current pri ...

- SURF301 Ph1 initial results and ACH IND submission expected in 2H24 - - Reported preclinical proof-of-concept with TYRA-300 in HCH, demonstrating increases in long bone length and binding against the HCH altered protein - - IND cleared for TYRA-430, an FGFR4/3 biased inhibitor for HCC - - Announced Chief Medical Officer transition plan; search for an external candidate underway with guidance from Science & Technology (S&T) Committee of the Board, including recent additions Dr. Susan Moran and Dr. S. Micha ...

Core Insights - Tyra Biosciences, Inc. announced preclinical proof-of-concept results for TYRA-300, an investigational oral FGFR3 selective inhibitor, in hypochondroplasia (HCH) at the 6th Annual Achondroplasia & Skeletal Dysplasia Research Conference [1][2] Company Overview - Tyra Biosciences is a clinical-stage biotechnology company focused on developing next-generation precision medicines targeting FGFR biology, utilizing its in-house precision medicine platform, SNÅP, for rapid drug design [4] - The company is based in Carlsbad, California, and aims to address large opportunities in targeted oncology and genetically defined conditions [4] Product Development - TYRA-300 has shown promising preclinical results in increasing long bone length and improving growth plate function in a hypochondroplasia mouse model [6][7] - The drug targets the FGFR3 gene, which is commonly mutated in HCH, with no current approved therapeutic options available [6] - The company plans to submit an Investigational New Drug (IND) application in the second half of 2024 to initiate a Phase 2 clinical study in pediatric achondroplasia [2][7] Clinical Study Insights - In preclinical studies, TYRA-300 demonstrated significant increases in the length of various bones in FGFR3 mutated mice, including femur (3.70%), tibia (3.75%), humerus (3.22%), and ulna (5.03%) [9] - The drug also increased the size of the foramen magnum by 5.88% in the same model [9] - TYRA-300 is currently being evaluated in a multicenter, open-label Phase 1/2 clinical study for advanced solid tumors, aiming to determine the recommended Phase 2 dose and evaluate preliminary antitumor activity [7]