|Healthcare Review: ImmunoCellular Therapeutics, Stemline Therapeutics, DaVita HealthCare, Ampio Pharmaceuticals, Celldex Therapeutics|
|By Staff and Wire Reports|
|Monday, 25 November 2013 15:24|
ImmunoCellular Therapeutics ($IMUC) rallies hard after Cedars-Sinai provides an update on a study of ICT-107 in glioblastoma multiforme.Eight of sixteen patients survived for longer than five years post-diagnosis.Six patients were progression free at five years.Four patients are still free of disease with "good quality of life at lengths from 65.1-82.7 months following diagnosis."
Stemline Therapeutics ($STML) enjoys a strong session after announcing late Friday evening that the results of a clinical trial of SL-701 in low-grade glioma were being presented at a Meeting of the World Federation of Neuro-Oncology. The company says an abstract shows the vaccine is "well-tolerated and induced specific and sustained immune responses against its brain tumor targets."Additionally, STML says the results show "patients with a high magnitude of immunologic responsiveness experienced prolonged progression free survival."
The good news is that Medicare rates will not be decreased next year, when most thought rates would be down," DaVita HealthCare's ($DVA) group VP LeAnne Zumwalt says, reacting to the final CMS Medicare ESRD rule for 2014."The bad news is ... that Medicare dialysis rates will be flat in 2014 and 2015 in an environment of increasing expenses," Zumwalt adds.
In light of the rule, DVA provides the following guidance for FY14: Enterprise operating income, $1.675-1.85B; operating income for dialysis services and related ancillary businesses, $1.425 to $1.54B; operating income for HCP, $250 to $310M.
Ampio Pharmaceuticals ($AMPE) is trading 6.6% lower premarket. Likely behind the move is TheStreet's Adam Feuerstein who, in a response to an article by SA contributor Brian Wilson, says the company "slipped in" new disclosures regarding Optina in the prospectus for its most recent financing. According to Feuerstein, the company's disclosure that "the FDA has previously indicated that a Phase 3 trial may be necessary following the current trial" is quite a change of pace from the language present in AMPE's March 10-Q."The FDA has never approved a drug for DME based on a 12-week clinical trial," Feuerstein says.
On Sunday, Celldex Therapeutics ($CLDX) reported interim data from ReACT. The company says the results "demonstrate promising clinical activity" in patients with brain cancer. So far, it appears investors are not impressed, as the shares are trading lower by 7% in premarket action. Traders may be attempting to draw some conclusions about the rindopepimut study based on the reported p-values (as highlighted here yesterday): OS, p=0.16; PFS, p=0.47.