In a report published Monday, MLV & Co analyst Graig C. Suvannavejh reiterated a Buy rating on Keryx Biopharmaceuticals (NASDAQ: KERX), but lowered the price target from $27.00 to $21.00.
In the report, MLV & Co noted, “KERX reported 1Q results last week, but the main focus was mgmt's comments on the call surrounding outstanding CMC issues with the NDA for lead asset Zerenex (hyperphosphatemia). We hadn't previously been aware of CMC issues, and while KERX has provided add'l data on this (as well as drug-drug interactions, with info on both recently requested by FDA), we were disappointed to hear of this latest update. With the Zerenex PDUFA just one month away (June 7) and mgmt on multiple occasions citing ‘there are no guarantees' (yes, we applaud the transparency), we're feeling a bit less confident in an on-time approval.
"We don't model a delay for Zerenex at this time, but given the increased risk in a potential on-time FDA approval, we now increase the discount rate in our DCF from 17.5% to 20%, and as a result, lower our 1-yr PT to $21 (vs. prior $27, but still 73% upside).”
Keryx Biopharmaceuticals closed on Friday at $12.11.
- Keryx Biopharma Reports Zerenex Phase 2 Results in Non-Dialysis Dependent Chronic Kidney Disease Selected as a Late Breaking Oral Presentation at the Upcoming National Kidney Foundation 2014 Spring Clinical Meeting
- Good News for Keryx - Analyst Blog
- Keryx Biopharmaceuticals Announces EMA Validation of Marketing Authorization Application for Zerenex
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