Well, VBI Vaccines (VBIV) did it. For now, at least. The stock had collapsed in June after it was reported that despite achieving all primary endpoints, two doses of its hepatitis-B vaccine Sci-B-Vac failed to achieve statistical noninferiority to standard of care Engerix-B after three doses for all patients. Despite the fact this was a secondary endpoint that had no bearing on its chances for approval, it sowed doubt in investors as to whether the vaccine could carve out a market share considering competition from Dynavax’s (DVAX) Heplisav-B, which is a two-dose vaccine.
In my previous coverage of these events, which I recommend reviewing for people new to this matter, I posited that Sci-B-Vac still had a chance of overcoming the noninferiority gap in the younger subgroup 18-44, and if so, VBI could be revalued towards where the stock was prior to its big fall. As it turns, Sci-B-Vac did overcome this gap in that subgroup, and VBI shares did in fact regain their prior level, to the point that the stock has regained compliance with Nasdaq minimum price requirements.
VBI put it this way in its press release:
As per the commonly-used statistical margin of non-inferiority for vaccines1, defined as the lower limit of the 95% CI being above -10%, this analysis demonstrated non-inferiority after two doses of Sci-B-Vac® (at day 168) compared with three doses of Engerix-B® (at day 196).
In addition to this, the new data released from a second Sci-B-Vac Phase III trial called CONSTANT passed all primary and secondary endpoints as expected. The primary endpoint was lot-to-lot consistency, which is necessary for vaccines to show consistency in potency and manufacturing. The secondary endpoint was superiority of Sci-B-Vac after 3 doses over Engerix B at 3 doses. These endpoints were a necessity for Sci-B-Vac to have a chance at approval. Without
