Celldex Therapeutics, Inc. (NASDAQ:CLDX) shares were up more than 10% in pre-market trading today after the biopharmaceutical company released positive trial results from the Rintega study. The study successfully reached its primary endpoint of progression-free survival at six months in patients.
Rintega, also known as Rindopepimut or CDX-110, is a pipeline treatment for GBM, an aggressive form of brain tumors. The data was presented at the American Society of Clinical Oncology by David Reardon, M.D., who commented, “The results of the [study] are striking because we are observing an extremely rare overall survival advantage that is now translating into long-term survival for a number of patients—something not seen in [GBM]. Importantly, patients… are not only surviving longer, they are experiencing a notable decrease in the need for steroids and the numerous side effects associated with their use.” Furthermore, the treatment was very well tolerated by patients.
Mara Goldstein of Cantor Fitzgerald pointed out that this study was different than previous studies due to its larger population of enrolled patients. Moreover, the new data showed “a statistically significant difference in overall survival at 12 and 18 months.” On June 1, Mara Goldstein reiterated a Buy rating on Celldex Therapeutics with a $38 price target.Following the data released on the GBM study, Goldstein believes that “commercialization [of the drug] is likely.” Goldstein is “awaiting clarity on the registration path for Rintega,” but believes the therapy is heading towards a New Drug Application as it has already been designated as a breakthrough drug. Goldstein concluded, “We continue to like shares of Celldex based on the depth and breadth candidates in numerous clinical trials.”
Mara Goldstein has rated Celldex five times since April 2012, earning a 60% success rate recommending the stock with a +22% average return per CLDX rating. Overall, Goldstein has a 71% success rate recommending stocks with a +17.2% average return per rating.
Separately on June 1, Brean Capital analyst Jonathan Aschoff reiterated a Buy rating on Celldex Therapeutics with a $35 price target after the biopharmaceutical company released positive data from the trial. Aschoff explained, “Despite the relatively forgiving prespecified [primary endpoint] statistics, the trial did formally achieve its primary endpoint but far more importantly, maintained its interim OS benefit when using the 2-sided log-rank test.” Aschoff was also impressed by the steroid reduction in the drug, allowing patients somewhat of a “steroid holiday.” The analyst believes that the OS result is the most compelling factor for FDA Accelerated Approval.
Jonathan Aschoff has rated Celldex five times since November 2013, earning an 80% success rate recommending the stock with a +31.7% average return per CLDX rating. Overall, Aschoff has a 55% success rate recommending stocks with a +8.6% average return per rating.
On average, the top analyst consensus for Celldex on TipRanks is Strong Buy.