JMP hosted the call with nephrologist Dr. Goldfarb who said he would utilize sparsentan as second-line therapy following angiotensin-converting (ACE) inhibitors/angiotensin receptor blockers (ARBs)/diuretics./p>
Goldfarb would like a study of at least one year in duration to confirm reduction in proteinuria translates into change in disease progression, notably eGFR and creatinine as markers of kidney disease progression.
The expert cited Keryx Biopharmaceuticals KERX's sulodexide as an example of a development-stage asset that failed such a confirmation in another kidney disease called diabetic nephropathy.
The DUET study has rolled over onto the open-label portion, although the active control irbesartan will not be carried forward, thus it may be difficult to detect a treatment benefit.
"We believe that we will need to wait until year end to determine if the company can convince the FDA that an accelerated approval pathway can meet the agency's needs," analyst Liisa Bayko wrote in a note.
"Our sensitivity analysis shows that the stock currently reflects the sentiment that accelerated approval is unlikely," Bayko added.
At time of writing, shares of Retrophin were up 0.48 percent to $20.91, while the analyst has a price target of $28.
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