Progenics Pharmaceuticals has an upcoming advisory committee meeting on March 10, 2014. The meeting is regarding Progenics' drug Relistor, for which Progenics is seeking to expand the label in order to include opiod-induced constipation for patients suffering from chronic pain. Relistor has already been approved by the FDA in a different indication, and as such this meeting is solely on whether or not to expand the label for Relistor to include the new indication. This event is very important for the company.
In the event that the label is expanded in order to include OIC patients, then Progenics stands to receive even more revenue from the drug. The drug is currently partnered with Salix pharmaceuticals (SLXP), and the drug is very important to Progenics going forward. It is a very interesting situation though, as investors do not know the exact date that a final FDA decision will be handed down on the drug. The FDA is convening the advisory panel after Progenics appealed an FDA decision to not allow the additional indication. The FDA has indicated that it will act on the appeal after it receives the input of the advisory committee. The fact that the FDA did not want to act without the advisory committee is very telling, as it means that the FDA is actually considering overturning the CRL. Typically FDA appeals are unsuccessful, but it is highly unusual for the FDA to call a panel in order to help decide an appeal so this is an event that has the potential to be the influencing factor in whichever way the FDA ends up deciding to rule. For more information on Progenics I would like to recommend an article by one of my favorite Seeking Alpha authors Scott Matusow, I believe that he does a very nice job covering the drug and its potential for Progenics.
The FDA Advisory Committee decision represents a significant run-up opportunity for the stock, and given the fact that Progenics looks like it may still have room to run, it should be a very interesting consid
Key elements of Molecular Insight's pipeline of targeted radiotherapy and molecular imaging compounds are:
Azedra™ radiotherapy for pheochromocytoma and potential additional indications
Compelling data in a phase 2 registrational trial for pheochromocytoma, an ultra-orphan adrenal tumor indication Is in development under a Special Protocol Assessment with the U.S. Food and Drug Administration using a surrogate marker registrational endpoint Potential for use in neuroblastoma and other neuroendicrine diseases
Trofex™ imaging agent with potential to alter clinical practice in treating prostate cancer
Phase 2 study ongoing in metastatic prostate cancer Highly sensitive and selective radioisotope small molecule targeting PSMA uses technetium-99m for metastatic and localized prostate cancer imaging and detection Designed as an improved imaging agent that identifies cancer cells in soft tissue and bone, where current agents are insufficient
MIP-1466 small molecule therapeutic for metastatic prostate cancer and other PSMA-expressing cancers
Targets the PSMA antigen with a radioactive payload In preclinical development with evidence of dose-dependent enhanced tumor kill and prolonged survival in animal models of human prostate cancer Investigator-initiated study in Germany of men with late-stage metastatic prostate cancer demonstrated tumor reduction for more than 14 days and a greater than 50% decrease in PSA levels in eight of 14 evaluable patients.