Cancer vaccine stocks soar on Dendreon panel vote Friday March 30, 1:34 pm ET By Toni Clarke
BOSTON (Reuters) - Shares of cancer vaccine makers soared on Friday after an advisory panel to the U.S. Food and Drug Administration recommended approval of a product made by Dendreon Corp. (NasdaqGM:DNDN - News) ADVERTISEMENT
The surprise ruling paves the way for approval of the first ever cancer vaccine and provides a vote of confidence in a field that has been dogged by failure and investor skepticism.
"This is a significant step not just for Dendreon but for the industry as a whole," said Steve Brozak, an analyst at WBB Securities. "However, it remains to be seen what the practical application will be and how physicians will adopt it."
Dendreon shares more than doubled to $13.54 by midday from $5.22 at Thursday's close after reaching as high as $18.05.
If the FDA follows its panel's advice, which it usually does, Dendreon vaccine Provenge will be the first to directly spur the immune system into attacking cancer -- an approach that is attracting growing interest among drugmakers big and small.
Therapeutic vaccines are designed not to be given before a disease develops but to prevent the disease from progressing once it has been diagnosed.
Antigenics Inc. (NasdaqGM:AGEN - News) was up 8.1 percent to $2.14, Cell Genesys Inc. (NasdaqGM:CEGE - News) up 23.4 percent to $4.32, Genitope Corp. (NasdaqGM:GTOP - News) up 8.6 percent to $4.03 and Favrille Inc. (NasdaqGM:FVRL - News) up 19.5 percent to $3.13.
MAY BE CONTINGENT
Earlier this week, France's Sanofi-Aventis SA (Paris:SASY.PA - News) signed a deal with Oxford BioMedica Plc (LSE:OXB.L - News) for the rights to the British biotech firm's experimental cancer vaccine, TroVax.
Some analysts, including Jonathan Aschoff of Brean Murray Carret & Co., say the FDA will not approve Dendreon's vaccine outright but will issue the company an "approvable" letter, which means approval would be contingent on certain factors such as results from other trials.
"We maintain our belief that Dendreon is banking more on the dire need for safer prostate cancer therapies, given the large and growing incidence of the disease, and less on the merits of its trials' results," Aschoff said in a research note.
While the risks for cancer vaccines remain high, Provenge is the first ever to be reviewed by an FDA advisory panel, and while the data from Dendreon's trial did not fully establish efficacy, the panel ruled that there was sufficient evidence to warrant approval.
The FDA's response was greeted enthusiastically by rivals.
"We are encouraged by the fact that the FDA has shown some flexibility in the way data is interpreted from a cancer vaccine trial," said Garo Armen, chief executive of Antigenics, whose cancer vaccine Oncophage failed a late-stage trial in kidney cancer.
The company plans to release updated data from the trial in June.
Cancer vaccines are made using various different methods.
Dendreon, for example, makes its vaccine by taking blood, separating a patient's dendritic cells, which are part of the immune system's cellular army, processing them to be able to target a protein fragment expressed on prostate cancer cells, and activating the immune system to kill the cell.
Antigenics, by contrast, takes cancer tissue following surgery, extracts certain proteins that activate the immune system and injects the enriched protein back into the body through the skin.
(Additional reporting by Ben Hirschler in London)
WOW!!! THIS IS A NICE LONG TERM STOCK!!!!
Posted by BIG * B*U*C*K*S on :
Meanwhile, Biomira Inc. shares rose 12 cents, or 11.4 percent, to $1.17 on the Nasdaq. The company is developing compounds to treat a variety of cancer types, with Stimuvax as its lead product candidate. Its partner on that drug is German drug maker Merck KGaA.
BIOM is the ticker for it
Posted by Machiavelli on :
long term stock? .. ahh no... this one gapped up too high ... it has nowhere to go now but down for a massive "correction" ...
Posted by BIG * B*U*C*K*S on :
up 12% today
Posted by IMAKEMONEY on :
12% DONT FEED MY DOG.
Posted by BIG * B*U*C*K*S on :
???
Posted by Machiavelli on :
let's put it this way... yes.. it was up 10.60% to be exact not 12%.. and only reason it is up that much today is because people are desperately trying to keep the price up and to stop it from letting it go down from short sellers....
Posted by T e x on :
well, that's still "the market," eh?
Mach, given the "market is always right," are you saying you see TA/chart indicators in flux/disagreement?
Posted by Jo4321 on :
Monday, April 02, 2007 4:46:59 PM ET JMP Securities
NEW YORK, April 2 (newratings.com) - Analysts at JMP Securities reiterate their "strong buy" rating on Dendreon Corp (DNR.FSE), while revising their estimates for the company. The target price has been raised from $12 to $20. In a research note published on March 30, the analysts mention that Center for Biologics Evaluation and Research (CBER) panel has unanimously voted in favour of the safety and efficacy of the company’s Provenge’s BLA for the treatment of late-stage prostate cancer. The analysts believe that the FDA would grant Dendreon an approvable letter for Provenge going forward. The EPS estimate for FY07 has been reduced from -$0.49 to -$1.15. The EPS estimate for FY10 has been raised from $0.84 to $1.27.
Posted by Machiavelli on :
I'm never a fan when a stock gaps up that high as it did on friday Tex... when it gaps so high it usually will come crashing down for a correction... all markets correct themselves eventually : real estate, gas, oil, and of course stocks.... right now people are putting too much faith in this one and holding or buying more... my guess and i could be wrong but i think the MM's will short it sooner or later... and the ones who don't follow rule #1 : don't fall in love with a stock... will keep holding or buying more while the MM's manipulate it and short it ... the "lovers" will be left holding the bag... but like i said.. i could be wrong... let's watch it in the next few days... I just hope people are smart enough to put stop/losses and lock in their profits...
Posted by abram on :
JMP dropped their "strong buy" rating to , "neutral". Extending a patients life 3 to 5 months is a roll of the dice. Not proof.