) 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
) 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
Concert Pharma carries a Zacks Rank #3 (Hold). A better-ranked
), sporting a Zacks Rank #1 (Strong Buy).
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