Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 89

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 89
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 the RPD drug for which the voucher was awarded is not marketed in the U.S. within one year following the date of approval. 

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We have obtained a RPD designation for TYRA-300 for the treatment of ACH, however, there is no guarantee that we will be able to obtain a priority review voucher, even if TYRA-300 is approved by the FDA for use in ACH patients. For example, the FDA may determine that an NDA, even if ultimately approved, does not meet the eligibility criteria for a priority review voucher, including for the following reasons: 

•the product no longer meets the definition of a RPD;

•the product contains an active ingredient (including any ester or salt of the active ingredient) that has been previously approved in another marketing application;

•the application does not rely on clinical data derived from studies examining a pediatric population and dosages of the drug intended for that population; or

•the application is approved for a different adult indication than the RPD for which the product is designated

Moreover, Congress included a sunset provision in the statute authorizing the RPD priority review voucher program.  Under the current statutory sunset provisions, after September 30, 2024, the FDA may only award a voucher for an approved RPD product application if the sponsor has RPD designation for the product candidate, and that designation was granted by December 20, 2024. After September 30, 2026, FDA may not award any RPD priority review vouchers. 

We have conducted, and may continue to conduct, clinical trials for certain of our product candidates outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.

We have conducted, and may continue to conduct, one or more of our clinical trials for our product candidates outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to certain conditions imposed by the FDA. Where data from foreign clinical trials are intended to as the sole basis for marketing approval in the United States, the FDA will not approve the application on the basis of foreign data alone unless those data are applicable to the U.S. population and U.S. medical practice; the trials were performed by clinical investigators of recognized competence; and the data are considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an