- Thinly traded nano cap Opexa Therapeutics (OPXA -22.2%) slumps on more than an 8x surge in volume, albeit on turnover of only 406K shares, as investors reportedly hit the sell button over concerns that Roche's (OTCQX:RHHBY) multiple sclerosis (MS) candidate OCREVUS (ocrelizumab) will hit the U.S. market before Tcelna. If, indeed, this is the reason for the exodus, investors must have been asleep for some time. The FDA's action date (PDUFA) for the BLA is December 28, announced in June. Opexa has not filed its marketing application yet. Top-line data from a Phase 2b study, Abili-T, are expected in Q4.
- An upcoming data presentation may be the real reason for the bearish activity. On October 10, results from Roche's Phase 3 study, ORATORIO, will be presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona. The study involved patients with primary progressive MS. The study met its primary endpoint, a statistically valid reduction in the progression of clinical disability compared to placebo.
- The primary endpoint of Opexa's Abili-T is the percent change in brain volume at Month 24 measured by MRI. The indication is secondary progressive MS. If Roche's ocrelizumab is approved for primary progressive MS, it will be used to treat secondary progressive MS so Abili-T's top-line data need to be impressive.