Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 29

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 29
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, including many major pharmaceutical and biotechnology companies. These treatments consist of small molecule drug products, biologics, cellular therapies, and traditional chemotherapy. 

For TYRA-300 in post-frontline mUC, approved competitors include Janssen Pharmaceutical’s Balversa (erdafitinib), chemotherapy agents and immunotherapy or Padcev for patients not exposed in the frontline. Therapies in development include Eli Lilly’s LOXO-435, an oral, FGFR3-specific inhibitor, as well as multiple next-generation Nectin4-targeted therapies. 

For TYRA-300 in IR NMIBC, no agents beyond intravesical BCG or chemotherapy have been approved. Urogen’s UGN-102, a hydrogel reformulation of mitomycin C, has a PDUFA date scheduled for June 2025. Additional agents in Phase 3 development include Janssen Pharmaceutical’s TAR-210, CG Oncology’s crestostimogene grenadenorepvec and Ferring’s nadofaragene firadenovec.  

For TYRA-300 in high risk NMIBC, beyond Intravesical BCG and chemotherapy instillations, Merck’s Keytruda, ImmunityBio’s Anktiva in combination with BCG and Ferring’s Adstiladrin are approved in BCG-unresponsive high risk NMIBC with CIS, with or without papillary tumors. Additional agents in Phase 3 development include Janssen Pharmaceutical’s TAR-200, CG Oncology’s crestostimogene grenadenorepvec and PD–(L)1 inhibitors including Pfizer’s sasanlimab.

For TYRA-300 in ACH, BioMarin’s Voxzogo is approved for children of any age with open growth plates. Ascendis has disclosed an intent to file an NDA and MAA for TransCon CNP in 2025 and BridgeBio’s infigratinib is still in Phase 3 development.  BioMartin is studying BMN-333, a long-acting CNP in Phase 1 development.

For TYRA-300 in HCH, BioMarin’s vosoritide is in Phase 3 development, BridgeBio’s infigratinib has initiated a run-in for a Phase 2 study and Ascendis has disclosed plans to initiate a clinical study in 2025. BioMarin has also initiated a Phase 2 basket trial for vosoritide in children with Turner Syndrome, SHOX Def