---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-021953"
form_type: "8-K"
ticker: "TYRA"
cik: "0001863127"
company_name: "Tyra Biosciences, Inc."
filed_at: "2024-02-01T23:59:59+00:00"
generated_at: "2026-06-06T11:35:33.100282+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA grants Rare Pediatric Disease Designation to Tyra Biosciences' TYRA-300 for achondroplasia

## Summary
- FDA granted Rare Pediatric Disease Designation to TYRA-300, an oral FGFR3 inhibitor, for achondroplasia.
- If NDA approved, Tyra may receive a Priority Review Voucher (PRV) that can be sold or transferred.
- Company plans to submit IND in H2 2024 for a randomized Phase 2 trial in children with achondroplasia.
- RPD Designation is for diseases affecting <200,000 in US and primarily individuals under 18 years.

## SEC filing metadata
- accession: 0001193125-24-021953
- form_type: 8-K
- ticker: TYRA
- cik: 0001863127
- company_name: Tyra Biosciences, Inc.
- filed_at: 2024-02-01T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1863127/000119312524021953/0001193125-24-021953-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1863127/000119312524021953/d674967d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-021953
- JSON: https://secwatch.observer/filing/0001193125-24-021953.json
- Plain text: https://secwatch.observer/filing/0001193125-24-021953.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.