EpiCept Corporation (STO:EPCT; NASDAQ:EPCT), a specialty pharmaceutical company for cancer treatment and pain management, is seeking primary listing status on the Nasdaq OMX Stockholm Exchange. Currently the company has a secondary listing in Stockholm and delisting from The Nasdaq Capital Market might also mean delisting from Stockholm. Primary listing status would give the company Board flexibility in deciding its next move pertaining to stock exchange listing.
In may EpiCept received an extra 180 days to regain complience with Nasdaq Capital Market listing rules. The stock needs to reach a closing bid price of $1.00 or more for a minimum of 10 consecutive trading days before September 30th 2011. Normal course of action in Biotech is to do a reverse split in such a case. The board got sufficient number of votes for the right to do a reverse split the day before yesterday after annual meeting decision on the matter on June 14th was initially adjourned as few votes were lacking.
As far as advancing its pipeline goes, EpiCept received initial FDA comments on Ceplene SPA application, where the FDA made some a new suggestion pertaining to the design of the planned late-stage trial in AML maintenance. The FDA now suggests including an IL-2 monotherapy arm as the control arm.
Ceplene is normally given in conjunction with low-dose interleukin-2 (IL-2). According to EpiCept the agreed upon trial design at a meeting between the company and FDA in October 2010 was to compare Ceplene in conjunction with IL-2 to investigator’s choice (often no treatment). EpiCept will likely meet up with the FDA and retains the right to appeal. Ceplene is approved in the EU as remission maintenance therapy for adult AML patients in first CR.
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