What happened
Shares of Anavex Life Sciences (AVXL -7.34%) were surging 44.9% higher as of 11:09 a.m. ET on Friday. The huge jump came after the company reported the results Thursday evening from a phase 2b/3 clinical study evaluating Anavex 2-73 (blarcamesine) in treating early Alzheimer's disease.
So what
Clinical results nearly always serve as key catalysts -- either positive or negative -- for biotech stocks. That's especially the case with stocks of companies that don't have any products on the market yet. Anavex is such a company. Its Anavex 2-73 is one of only two clinical-stage candidates in the biotech's pipeline.
The oral Anavex 2-73 therapy met the primary and secondary endpoints of the trial, with patients receiving the therapy experiencing statistically significant improvement in cognition. Anavex said that the candidate's safety profile also appeared to be relatively good.
However, those positive results might not be as great as they seem. Anavex's handling of the clinical study has come under attack by some observers. As a case in point, longtime biotech reporter Adam Feuerstein with Stat+ News wrote on Friday morning that the results were a "spin job." He accused Anavex of "making basic math errors" and "using nonsensical statistical tests," among other allegations.
Now what
Anavex should soon get a chance to make its case about the quality of its latest clinical results. The company says it plans to meet with regulatory authorities to discuss the phase 2b/3 data to "determine next steps." Anavex also intends to submit the clinical trial data to a peer-reviewed medical journal for publication.
