Celldex Therapeutics (NASDAQ:CLDX) Rindopepimut in GBM Looks Promising

Celldex Therapeutics (NASDAQ:CLDX) is expected sometime in the early part of 2011 to finalize a key study for rindopepimut in GBM, which could lead to an SPA.

Needham said, "Looking into 2011, the Company expects to meet with the FDA in early 2011 to finalize a pivotal study for rindopepimut in GBM, which may lead to a SPA, and plans to initiate an international, randomized, placebo controlled Phase 3 trial in 2H11. We believe that rindopepimut has demonstrated consistent efficacy in GBM in three Phase 2 trials and has built a compelling database to support the pivotal trial. With the return of the rights of rindopepimut from Pfizer (N/R), we believe the program may accelerate, as Celldex is fully committed to move rindopepimut forward expediently."

Needham & Company maintains a "Buy" rating on Celldex Therapeutics, which closed Wednesday at $4.18, up $0.04, or 0.97 percent.

Needham Maintains "Buy on Celldex (NASDAQ:CLDX) on Rindopepimut Potential

After unveiling the Phase 2 results concerning cancer vaccine "rindopepimut" at a recent Montreal SNO meeting, Needham reiterated their "Buy" rating on Celldex Therapeutics (NASDAQ:CLDX).

"We believe that the ACT III multicenter data are consistent with two other previously completed Phase 2 trials and further confirm the efficacy of the active immunotherapeutic (cancer vaccine) rindopepimut and support pivotal testing in GBM. The Company expects to meet with the FDA in early 2011 to finalize a pivotal study, which may lead to a SPA, and plans to initiate an international, randomized, placebo controlled Phase 3 trial in 2H11," said Needham.

Celldex closed Monday at $4.30, dropping $0.32, or 6.93 percent. Needham has a price target of $12 on the company.