What: Shares of Omeros Corporation (NASDAQ:OMER), a biophama company developing small-molecule and protein therapeutics for inflammatory diseases and bleeding and nervous disorders, saw its shares climb by as much as 85% today on tremendous volume. This huge upswing was caused by a clinical update for the company's experimental treatment, OMS721, for thrombotic microangiopathies, a family of rare but life-threatening disorders associated with excessive blood clotting.
According to the company, OMS721 has completed its mid-dose testing and is nearing the end of the high-dose phase of the treatment's mid-stage trial as well. What sent shares soaring, though, was the announcement that two patients in the mid-dose group with plasma therapy-resistant aHUS demonstrated clinically meaningful improvements in several areas, such as mean platelet count, mean schistocyte count, mean haptoglobin, and mean levels of LDH. The first patient to complete the high dose regimen of OMS721 showed a marked improvement in several biomarkers as well.
So what: OMS721 is already being used on a compassionate use basis in some regions, and this latest clinical update backs up the drug's efficacy as a treatment for these rare blood disorders. As such, it's looking increasingly likely that OMS721 could be Omeros' second approved product on the market.
Now what: Omeros is reportedly planning on speaking with the FDA soon about the drug's fixed-dose pivotal stage study, set to begin at the cessation of this mid-stage dosing trial. So the good news is that its clinical program is progressing nicely. The bad news is that Omeros is probably going to need to raise funds soon to extend its clinical activities.
Per the second-quarter's figures, Omeros is losing a little over $5.5 million a month at this point, and the recent commercial launch of Omidria doesn't appear to have enough juice yet to reverse this trend before the company's $51 million in cash reserves are exhausted. Put simply, Omeros will probably choose to take advantage of this spike in its share price to raise additional funds, meaning that you may want to avoid chasing this stock following this clinical update.