What's behind this double-digit move lower? Celldex's shares appear to have gotten caught up in the marketwide downturn last month. The biotech, after all, didn't release any material news to speak of during the course of February.
Celldex and its patient shareholders are currently waiting for the release of glembatumumab vedotin's (glemba) top-line data in triple negative breast cancer (TNBC) patients who overexpress a protein called gpNMB. If successful, the company reportedly plans on filing regulatory applications in both Europe and the U.S. in the second half of 2019. Until this pivotal event happens, however, Celldex's shares are likely to continue trading at the whims of the broader markets.
The good news is that glemba's top-line data appears to be imminent. During the company's recent fourth-quarter earnings call, for instance, management noted that the 203rd progression event required for validation of the primary end point (progression-free survival) had already occurred, leading the study's handlers to prepare for data lock and analysis.
Normally, data lock, cleaning, and analysis take around three to four weeks for a trial of this size. That timeline implies that glemba's top-line data in TNBC will come out somewhere between the end of March to perhaps the beginning of April. Having said that, Celldex's own timeline simply states that the data release will occur sometime before the end of the second quarter.
Regardless of when this seminal event takes place, the data will surely drive a rather dramatic change in the biotech's valuation in short order. If positive, Celldex's shares could potentially double in value. On the flip side, if glemba fails to meet its primary end point, or the data isn't strong enough to permit an accelerated regulatory filing, Celldex's stock may fall by more than 60% (to cash on hand) in a single day.
As such, this speculative biotech is arguably only suited for the most aggressive of investors at this stage. Personally, I plan on being on the sidelines ahead of this binary event, but I may buy shares if the data clearly paves a path toward a near-term regulatory filing. Celldex, after all, should still have a considerable amount of upside potential remaining if glemba turns out to be an important new treatment in the battle against this particularly aggressive form of breast cancer.