Health and Healthcare

Is This the Start of the Final Implosion at Celldex?

Chris Lange

Published: March 7, 2016 11:40 am

Last Updated: January 13, 2020 12:17 pm

Celldex Therapeutics Inc. (NASDAQ: CLDX) got burned in Monday’s regular trading session and ultimately saw its shares fall by over 50%. The reasoning behind this? The independent Data Safety and Monitoring Board (DSMB) has determined that Celldex’s late stage Rintega study will not reach statistical significance for overall survival in patients with minimal residual disease.

This company needs to figure out something quick because the stock has been under fire for a while now, and it’s starting to look like a race to zero. So far in 2016, the stock is down nearly 50%, not even counting this move on Monday. And even over the past 52 weeks, the stock is down about 90%.

The DSMB came to this conclusion based on a preplanned interim analysis that both the Rintega arm and the control arm are performing on par with each other. In the ACT IV study, Rintega performed consistently with prior Phase 2 studies, but the control arm has significantly outperformed expectations.

Based on this recommendation, Celldex has decided to discontinue 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 4, and is in the process of reviewing the results.

Anthony Marucci, co-founder, president and CEO of Celldex, commented:

We are extremely disappointed for patients that the ACT IV study was not successful. 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.

The company mentioned at the end of its release that it currently has seven company-led clinical trials across five product candidates ongoing.

Shares of Celldex were trading down over 50% at $3.99 Monday morning, with a consensus analyst price target of $31.27 and a 52-week trading range of $3.70 to $32.82.