It’s been a roller-coaster couple of days for Advanced Cell Technology Inc. (OTC:ACTC), which watched aghast as its stock took an unexplained plunge yersterday, only to rebound and then some today after the company announced a European approval.
The European Medicines Agency’s Committee for Orphan Medicinal Products granted the Marlborough, Mass.-based company a positive decision on its human embryonic stem cell-derived retinal pigment epithelial cells for treatment of Stargardt Macular Dystrophy, a genetic disease that causes progressive vision loss.
The news comes a day after ACTC shares took a 20 percent dive, dropping from 15 cents to 12 cents apiece. That prompted the company to issue a statement saying it knew of "of no business, clinical or financial reason for the stock’s recent significant decline," and added that its "two Phase I/II clinical trials … including a Phase I/II trial in patients with dry age-related macular degeneration, are proceeding as scheduled."
The stock recovered yesterday to close back up at 15 cents and is currently trading at 16 cents, up about 7.6 percent since the opening bell.
The next step for the company’s Stargardt’s disease treatment would be winning orphan drug designation from the European Commission. The designation would provide regulatory and financial incentives to the company to facilitate the development and commercialize the treatment. The EC defines orphan drugs as "therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union," according to ACT. The FDA granted orphan drug designation to the same treatment last year.
The company plans to release news about its clinical trials later this month in a regulatory filing with the federal Securities & Exchange Commission.
In January, ACT won a $25 million commitment from investment firm Socius Capital Group and landed FDA clearance for its investigational new drug application to initiate the Phase I/II study macular degeneration study.