On Monday, Piper Sandler reaffirmed its Overweight rating on shares of Tyra Biosciences (NASDAQ:TYRA), with a steady price target of $33.00. The firm's endorsement follows the recent FDA clearance allowing Tyra Biosciences to advance its drug candidate TYRA-300 into the BEACH301 study. This upcoming clinical trial is set to evaluate the treatment in children diagnosed with achondroplasia (ACH) and is slated to commence in the first quarter of 2025.
The BEACH301 study will explore the effects of TYRA-300 across four different dosage levels. It will include both children who have never received treatment and those who have been treated previously. TYRA-300 is designed to selectively target FGFR3, which may permit it to be given at a higher relative dose—up to 50% of the dose used in oncology—compared to the pan-FGFR inhibitor infigratinib, potentially enhancing its effectiveness without raising safety concerns.
Piper Sandler's statement comes in response to investor worries about the safety of the drug, which surfaced last week. The FDA's clearance is seen as a significant endorsement of the drug's safety profile. The analyst's comments also highlighted Tyra Biosciences' plans to submit an Investigational New Drug (IND) application for TYRA-300 in non-muscle invasive bladder cancer (NMIBC) by the end of the year, indicating continued progress in the drug's development pathway.
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