UPDATE: Stifel Reiterates, Lowers Price Target On Egalet Corp As Filing Delay Is Likely

In a report published Wednesday, Stifel analyst Annabel Samimy reiterated a Buy rating on Egalet Corp (NASDAQ: EGLT), but lowered the price target from $20.00 to $18.00.

In the report, Stifel noted, “Egalet reported results from its 15mg PK study of Egalet-001 compared against MS-Contin, which just missed bioequivalence (BE) criteria. Results met criteria for average total exposure (area under the curve, AUC) (90% CI: 91.01-99.42%) but was outside of the confidence interval for its peak, Cmax (90% CI: 78.99-88.47% outside 80-125%). Recall last month, EGLT announced mixed results from the 100mg PK study of Egalet-001, for similar reasons. Given BE results for both the 15mg and 100mg dosages were near-misses, management plans to schedule a meeting with FDA 4Q14 to discuss the path forward. For now, it has planned a large scale Phase 3 trial, but holds out continued hope that FDA will accept their mixed BE data.

"Conducting a large Phase 3 trial to demonstrate efficacy, a process which management is confident the data already supports, will delay Egalet-001 NDA filing to mid-2016 and launch likely to 2017. With respect to cash, EGLT has $66mn and could require another round of financing unless it receives milestone payments from its partnered program.”

Egalet Corp closed on Tuesday at $9.31.