RBC Capital notes that Applied Therapeutics (APLT)’ PDUFA for govorestat is tomorrow, November 28th, though given that the day falls on a holiday, there is some uncertainty around when a potential decision could be announced. The firm’s analysis of PDUFAs that fall on weekday federal holidays shows that 100% of approvals get announced ahead of holidays and the only CRL was announced after – suggesting that if govorestat were to be approved, one would likely hear sometime today. Recall that RBC had previously done a similar analysis of PDUFAs that fell on weekends, and its conclusion had been that approvals are more likely to come prior to the PDUFA date with the vast majority of CRLs announced after. The firm caveats that sample sizes for holiday PDUFAs are small, but together with its weekend analysis, the firm continues to believe that good news typically tends to come early, and that if govorestat is not approved by today, that there could be a higher chance the drug may receive a CRL. RBC has an Outperform rating on the shares with a price target of $12.
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