Trading in biopharmaceutical firm EpiCept (STO: EPCT) has been halted after the company shed 15% of its value on comments from the company’s President and CEO Jack Talley that the company is trying to find a buyer for all of its operations at a reasonable price.
Talley said furthermore that the company’s AML treatment candidate Ceplene faces an uphill battle to be approved in the United States. Ceplene is approved in Europe. The trading halt comes after a request from NASDAQ OMX Stockholm market surveillance unit to provide more information.
This all comes on the heels of an announcement yesterday from the company that the FDA gave it “further encouraging guidance” regarding the the Phase III clinical and nonclinical development and subsequent NDA filing of AmiKet (amitriptyline 4%, ketamine 2%), a prescription topical cream intended for the treatment of chemotherapy- induced peripheral neuropathy (CIPN). Yesterday the stock had reacted very positively to the news.
According to EpiCept, the FDA suggests a 12-week, four-arm, factorial designed trial in CIPN seeking to demonstrate AmiKet’s superiority against placebo, amitriptyline and ketamine. Previously AmKet had been compared against gabapentin, tested in post-herpetic neuralgia pain and in diabetic neuropathy pain. In addition to the proposed four-arm study in CIPN, another two-arm efficacy trial in other peripheral neuropathy condition might broader to drugs label.
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