TYRA 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• Our in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help us design and predict which product candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. Through this approach, we have built a…

• Our FGFR3 Programs—oral dabogratinib for Urothelial Cancers and Skeletal Dysplasia

• Alterations in the protein receptor FGFR3 are a validated driver in multiple indications with large market opportunities: urothelial cancers and skeletal dysplasia conditions. In urothelial cancer, uncontrolled activation of FGFR3 on the cell surface stimulates cellular proliferation. In skeletal dy…

• We demonstrated initial clinical proof-of-concept results with oral dabogratinib in the SURF301 study, a Phase 1 proof-of-concept study in metastatic urothelial carcinoma (mUC). Oral dabogratinib demonstrated encouraging anti-tumor activity and was generally well-tolerated, with infrequent FGFR2- an…

• We are currently advancing oral dabogratinib in three Phase 2 trials for three outsized market indications: SURF303, evaluating the treatment of low-grade upper tract urothelial carcinoma (LG-UTUC); SURF302, evaluating the treatment of intermediate risk non-muscle invasive bladder cancer (IR NMIBC);…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• Our in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help us design and predict which product candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. We have initially leveraged our SNÅP a…

• Our FGFR3 Programs - Dabogratinib for Skeletal Conditions and Bladder Cancer

• Mutations in the protein receptor FGFR3 are a key driver in two indications with large market opportunities: skeletal conditions and bladder cancer. In skeletal conditions, increased activity of FGFR3 expressed in growth plate chondrocytes (cartilage cells) results in excessive limitation of long bo…

• The current planned clinical development for dabogratinib includes Phase 2 clinical studies for the treatment of pediatric achondroplasia (BEACH301), treatment of low-grade intermediate risk non-muscle invasive bladder cancer (SURF302), our recent expansion into the treatment of low-grade upper trac…

• BEACH301: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating dabogratinib at lower doses (0.125, 0.25, 0.375, 0.50 mg/kg) in children ages 3 to 10 with achondroplasia (ACH) with open growth plates. Prior to initiation of the first two cohorts, the study has commence…

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial report…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

• There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial re…

相对上期新增的文字 · 来源:10-Q · 2026-05-13

• * Intended to satisfy the affirmative defense of Rule 10b5-1(c)

• ** Not intended to satisfy the affirmative defense of Rule 10b5-1(c)

• *** Represents the maximum number of shares that may be sold pursuant to the 10b5-1 arrangement. The number of shares sold is dependent on the satisfaction of certain conditions as set forth in the written plan and the satisfaction of applicable vesting conditions of equity awards.