Nyrada (ASX:NYR) received supportive written feedback from the US Food and Drug Administration (FDA) on its pre-investigational new drug (IND) meeting request for Xolatryp, with no major issues identified, according to a Tuesday filing with the Australian bourse.

Xolatryp is being developed to protect the heart tissue from damage.

The FDA deemed the nonclinical safety data, proposed clinical design, cardiac safety monitoring, and chemistry, manufacturing and controls package generally adequate to support the planned phase 2a PROTECT-MI trial in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention, while requesting additional information to complete the IND submission, the filing said.

The FDA said that a future fast-track designation request could be appropriate, depending on the design of a subsequent phase three trial, per the filing.

The company remains on schedule to file its US IND in the first half of 2027 while accelerating recruitment for the PROTECT-MI trial, the filing added.