Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced that the independent Data Safety and Monitoring Board (DSMB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 ACT IV study of RINTEGA® (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall survival in patients with minimal residual disease, the primary endpoint of the study, as both the RINTEGA arm and the control arm are performing on par with each other. In the ACT IV study, RINTEGA has performed consistently with prior Phase 2 studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: RINTEGA 20.4 months vs. control 21.1 months). Based on this recommendation, Celldex is discontinuing the study and does not anticipate incurring substantial additional costs related to RINTEGA at this time. All patients on the RINTEGA arm of the ACT IV study, prior Phase 2 studies and existing compassionate use recipients will be offered ongoing access to RINTEGA on a compassionate use basis. Celldex first received the data after market close on Friday, March 4th and is in the process of reviewing the results.
“We are extremely disappointed for patients that the ACT IV study was not successful,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “On behalf of Celldex, I want to express our gratitude to the ACT IV investigators, patients and families who participated in this trial. While this is certainly not the desired outcome, we remain steadfast believers in the power of immunotherapy to transform the future of cancer treatment.”
Celldex currently has seven company-led clinical trials across five product candidates ongoing. The Company expects to report data from a number of these studies over the next three to 18 months, including a registration study in triple negative breast cancer and a number of Phase 1 and 2 cancer immunotherapy combination trials. (Original Source)
Shares of Celldex are collapsing, down nearly 50% in pre-market trading. CLDX has a 1-year high of $32.82 and a 1-year low of $6.25. The stock’s 50-day moving average is $8.08 and its 200-day moving average is $12.73.
On the ratings front, Celldex has been the subject of a number of recent research reports. In a report issued on March 1, H.C. Wainwright analyst Swayampakula Ramakanth initiated coverage with a Buy rating on CLDX and a price target of $25, which implies an upside of 205.3% from current levels. Separately, on February 26, Brean Murray Carret’s Jonathan Aschoff maintained a Buy rating on the stock and has a price target of $24.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Swayampakula Ramakanth and Jonathan Aschoff have a total average return of -25.7% and -11.9% respectively. Ramakanth has a success rate of 17.6% and is ranked #3667 out of 3698 analysts, while Aschoff has a success rate of 31.4% and is ranked #3669.
The street is mostly Bullish on CLDX stock. Out of 5 analysts who cover the stock, 5 suggest a Buy rating . The 12-month average price target assigned to the stock is $28.00, which implies an upside of 241.9% from current levels.
Celldex Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the development, manufacturing and commercialization of immunotherapy technologies for the treatment of cancer and other difficult-to-treat diseases.