Microcap biopharma Zalicus (ZLCS) turned itself into a small-cap biopharma today after news that the FDA was giving calcium channel modulator Z160 Orphan Drug designation and shares soared. The company shot up over 30 percent in early trading with more than five times its normal volume. Peaking at just over $1 a share, the company's stock reached a 52-week high and their highest point since they were at $1.48on August 31, 2012.
Orphan Drug designation boosts Zalicus stock
The Orphan Drug designation is given to drugs that the FDA views as being suitable for the treatment of a rare disease and gives the sponsor, in this case Zalicus, access to tax credits for its clinical trials and the opportunity to waive the drug user fee on their marketing application.
"The FDA’s designation of Z160 as having orphan drug status is an important milestone for Zalicus as we continue the clinical development work required for potential FDA approval of Z160," said Mark H.N. Corrigan, MD, Zalicus President and CEO. “We look forward to evaluating and reporting the activity of Z160 in chronic neuropathic pain indications later this year, including postherpetic neuralgia and lumbosacral radiculopathy.”
In order to get Orphan Drug designation, a given drug has to be deemed a novel treatment for a disease that affects fewer than 200,000 patients across the United States.
Z160 shows promise
Zalicus announced that it had completed patient enrollment in two Phase II trials for Z160 earlier this month. The drug is an oral, state-dependent, selective N-type calcium channel modulator that is first in its class. It is intended to selectively target neuronal pain from high-firing neurons. In addition to Z160, Zalicus also has Z944 in its product pipeline, an oral T-type calcium channel blocker.
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