Today's news is fantastic! When cdx-110 gets approved, off label use for cancers such as head and neck could bring in big revenues.
Any week now phase 3 for cdx-011 will start. However, Celldex's biggest blockbusters will likely be the synergistic drugs shown below.
Celldex has three drugs that can be used for combination therapies. CDX-301, CDX-1127, and CDX-1401. CDX-1401 is already in a combination trial. ARIA is having a great day because of a positive EU opinion. However, the stock is down big from its 52 high because its blood cancer drug has bad side effects. What if its dose could be lowered if it was used in conjunction with CDX-1401? Think about that. The potential combinations of using CDX-301, CDX-1127, or CDX-1401 with other drugs would possibly be in the hundreds. Other companies would pay for such trials in some cases.
Sentiment: Strong Buy
"$100 within 2 years. CLDX is like SGEN and Alexion combined"
Agreed on both points. I still think that CLDX will buy SGEN in a couple of years to round out the platform, though it is distinctly possible they will simply go it fully alone, given the extraordinary depth of the pipeline. We stand at ground level of a monster, here. Feels an awful lot like it felt in AAPL a decade ago. The real run is not too far off.
Will we get a "mystery catalyst" tomorrow? The CLDX execs knew what today's data was going to be. They knew, or had a good idea, of what the doctor was going to say at the presentation. So... why schedule a conference call? No need to amplify what was presented today. Which means (I think) we are going to hear something totally new, probably business-related rather than science-related. GLTA
I would respond to Boston, but it would bump his absurd post back to the top. So I'll do it here. CLDX doesn't need to initiate a PH3 study of CDX-110, it is already in the middle of one. Today's data pretty much confirm that the PH3 result will be positive. The Harvard doctor running the trial, who is not a CLDX employee and has no dog in the fight, said patient outcomes were "exceeding expectations." That's not management spin. Today's news assures CDX-110 approval, when, not if. Once the primary endpoint is reached, 4-6 months for data compilation and NDA submission, followed by 4-6 months for FDA review and approval. That provides a very solid platform on which to begin enrolling a PH3 trial for CDX-011 for triple-negative breast cancer, hopefully now. GLTA
Weight, that is what many have never understood about CLDX. Rindo is still showing the same positive and consistent trends in Glio. Celldex has never said they wanted it all or a shot gun affect it is a very scientific thought out process that will lead to other cancers and indications but first prove the theory with efficacy and it appears both Rindo and 011 are meeting that test. This gives practioners confidence when speaking to patients. This is cancer a very detailed celluar complex issue that can infact change daily so the thought is to attack the key thoughts and not have a wide dissray action that leads to more body breakdown and no build up in the immune process this is the antibody or titer desire, this is what separates immunology or anitbody products from other target focus.
Essentially this data is showing consistency and I would be surprised if this product needs more clinical development after this summer and could be on the market by the end of next year.