secwatch.observer — SEC 8-K summary
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Issuer:     Tyra Biosciences, Inc. (TYRA)
CIK:        0001863127
Form:       8-K
Filed at:   2024-10-28T23:59:59+00:00
Accession:  0001193125-24-244590
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Tyra Biosciences receives FDA clearance for Phase 2 trial of TYRA-300 in achondroplasia
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- FDA cleared IND for TYRA-300 Phase 2 trial (BEACH301) in children with achondroplasia ages 3-10.
- BEACH301 is multicenter, open-label, dose-escalation/dose-expansion with two cohorts (naïve and prior therapy), up to 10 per dose level.
- Primary endpoints: safety/tolerability and annualized growth velocity; secondary: height z-score, proportionality, PK.
- First patient dosing expected Q1 2025; also plans IND for TYRA-300 in NMIBC by year-end 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1863127/000119312524244590/0001193125-24-244590-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1863127/000119312524244590/d895225d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-244590

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer