Concert Pharmaceuticals (CNCE) announced the successful conclusion of its end-of-phase II meeting with the FDA on its pipeline candidate, CTP-499. The candidate is being developed for treating patients suffering from diabetic nephropathy, a disorder related to kidney functioning. Concert Pharma stated that diabetic nephropathy is the primary cause of end-stage renal disease.
Concert Pharma’s meeting with the U.S. regulatory body concluded on a positive note with the latter agreeing to the company’s phase III development plan regarding CTP-499. However, the favorable outcome of the meeting failed to convince investors with the company’s stock price declining 2.36% to $9.12 per share on Jul 8.
The FDA while guiding the company on its impending phase III program on the candidate was flexible in its approach. As per the FDA, the biopharmaceutical company can either conduct two studies or a single one to evaluate the candidate across two doses compared to placebo. A reduction in the rate of progression of renal disease following treatment with CTP-499 compared to placebo was decided as the end point of the phase III program in the meeting. Concert Pharma said that it will submit a request for a Special Protocol Assessment to the FDA by Dec 31, 2014.
Apart from CTP-499, Concert Pharma’s pipeline includes candidates like CTP-354 and VP-786. The company along with partners like Avanir Pharmaceuticals (AVNR) and Jazz Pharmaceuticals (JAZZ) is working hard to develop the pipeline. We believe the pipeline at Concert Pharma must deliver as it currently has no approved product in its portfolio. We expect investor focus to remain on updates regarding Concert Pharma’s pipeline, particularly CTP-499.
Concert Pharma carries a Zacks Rank #3 (Hold). A better-ranked stock is Actelion (ALIOF), sporting a Zacks Rank #1 (Strong Buy).