Civitas Therapeutics Inc. filed with the U.S. Securities and Exchange Commission (SEC) for an initial public offering (IPO). No terms were given in the filing, but the total is up to $86.25 million. The company plans to list on the Nasdaq Global Market under the symbol CVTS when it starts trading.
The underwriters for the offering are J.P. Morgan, Cowen and Company, Bank of America Merrill Lynch, and Oppenheimer.
Civitas is a biopharmaceutical company founded in 2009 and focused on developing and commercializing transformative therapeutics using its ARCUS technology. The company’s initial focus is treating OFF episodes, the unpredictable re-emergence of symptoms, in patients with Parkinson’s disease.
The standard of care for the treatment of symptoms of Parkinson’s has been oral levodopa (L-dopa) for more than 40 years. Although in standard application, L-dopa has a wide variability in the timing and amount of absorption into the bloodstream. CVT-301, the company’s lead product, was developed for a rapid delivery of L-dopa to combat these OFF episodes, orally in the form of an inhaler. It has already completed a Phase 2b clinical trial with positive results, and Civitas is planning to move forward to Phase 3.
Civitas had this to say about its lead product:
We expect to initiate our pivotal Phase 3 clinical trial for CVT-301 by early 2015. Based on our discussions to date with the United States Food and Drug Administration, or FDA, we believe that CVT-301 will qualify for review through the 505(b)(2) pathway, which would allow for an abbreviated pathway to approval in the United States.
The approximate amounts for the use of proceeds were not disclosed, but the intentions are in-line with the company’s strategy to rapidly develop CVT-301 for its Phase 3 clinical trials among other programs.