Celldex Therapeutics, Inc. (NASDAQ:CLDX) has kept the market waiting for the results of the interim study involving its cancer immunotherapy Rintega. The drug is the most advanced in Celldex’s portfolio and could make or break the stock in the next few months or even weeks. A team of independent monitors are conducting the interim tests analysis of the drug. The results of the analysis are expected to be announced anytime, being early 2016 in Celldex’s words.
Results of the interim study will determine the next steps in the development of the cancer immunotherapy. Uncertainty regarding the results of the interim analysis is what has contributed to the volatility in Celldex shares on top of general market volatility we are now experiencing. Pressure on the stock appears to be increasing as the announcement of the interim study results approaches. Shares of Celldex have declined more than 46% YTD, largely because of the uncertainty and perhaps pessimism around Rintega.
If independent monitors are satisfied that Rintega has a statistically significant benefit, it would definitely be good news for Celldex. The company could then proceed with the remaining tests and that could also increase the chances of regulatory approval of the drug.
However, if the interim analysis concludes that Rintega has little effect, it would be back to the drawing board for Celldex in terms of drug candidates. Rintega reported positive results in terms of survival back in November on brain cancer patients, so the steep decline of Celldex shares may be unwarranted and only related to weakness in biotech shares in general in January.