NEW YORK (
) -- Biotech run-up traders should pay attention to
(ANAC - Get Report)
over the next few weeks as the company readies phase III clinical trial results in January.
Anacor is a developer of anti-fungal, antibiotic and anti-inflammatory products, including its lead drug tavaborole, a topical solution for treating fungal infections of the nails and nail bed (onychomycosis.) Tavaborole is supposed to minimize side effects seen with competing drug such as Penlac and Lamisil while achieving similar or even better efficacy.
Given the near-term timeline for phase III results in January, Anacor shares should run to the upper $5 to low $6 range. Other phase III catalyst stocks --
-- have been strong gainers recently. Anacor, by comparison, is trading closer to its 52-week low of $4.50 per share and below the October stock offering at $6 per share. This dilution, however, should mean Anacor won't be raising any money before the phase III results of tavaborole are released next month.
Anacor expects to have $45 million in cash at year end, sufficient to fund its business through a planned approval filing for tavaborole in mid-2013.
There is a high probability for success in the tavaborole phase III clinical trials versus placebo, based on the results of previously conducted phase 2 clinical trials. Additional confidence can be gained by looking at the objective endpoint of eradicating nail fungal infections -- this is not subject to placebo effect or subjective bias.
Tavaborole is currently being evaluated in two pivotal Phase III clinical trials with results from the first trial expected in January and results from the second trial expected approximately six weeks later (March estimate.) Both sets of data will support a planned New Drug Application (NDA) to the FDA in mid-2013 based on guidance from the most recent quarterly update in early November.
In addition, the Company recently disclosed through it completed two Phase 1 safety trials (including a heart rhythm or QT study and repeat skin exposure test) as part of preparations for a planned NDA filing next year.
Run-Up traders who would like to exit safely before data would want to close their positions in Anacor before the end of the year to avoid holding into data.
Messier has no position in Anacor.