I was worrying about the Pancreatic cancer trial update as the disease is very hard to target and so many companies failed. However the update is much better than I thought. Granted, the patient number is still small. No rationale for the price drop. Wall street is playing game...
It is hard to imagine any of FGEN's pipeline has any issues. Anemia should pass another DSMB review in Apr. Most of FG-3019's trials are in enrollment, so hardly will be any significant setbacks.
But the stock slumps, may be along with shorting thesis on biotech. But this stock is weaker than even the general biotech index.
Will find out soon on the earning report next Monday whether the decline is real or not (anything specific to the company). But don't be surprised that FGEN is doing fine, the price movement is all caused by manipulation.
Looks like all drug companies targeting rare disease should learn from Sarept...Don't do phase 3, that may fail. Use placebo mixed with no harm chemicals, sugar pick 12 patients that is healthy than normal, run subjective testing...Organize and stir the political storm. Job well done. FDA dare not reject this drug...
That is probably the reason that Sarept refused to run a randomized trial on their drug....
Eventually the society and tax payers shoulder the cost. Of course the drug needs to show substantive efficacy.
How are you confident that the drug will work in phase 3 trial based on the poor phase 2 result?
Who can argue Glioblastoma is not a devastating disease? Glioblastoma patients die in 1 year. Celldex has excellent Phase 2 data. I would say Celldex deserve to get pre-approved more than Sarept.
But Celldex's cancer vaccine just failed in phase 3.
Simply hand pick a dozen patients, show plausible result, stir popularism, seek help from politician and demand FDA to get approval. Because it should get approved as long as it doesn't hurt and patients are dying...
run such a trial?
Sarept has forgotton that GSK and PTC Therapeutics all are able to run Randomized Phase 3 clinical trial on their respective DMD drug candidate. PTC Therapeutics is also a small company.
Pre-approve sarept's drug will set a dangerous precedent. There are many devastating disease with high medical need such as ALS, Glioblastoma, Alzheimer's, Pancreatic cancer. Drug developers all need to run placebo controlled phase 3 trials to get approval. It is also unfair to GSK and PTC therapeutics which have a plausible working DMD drug based on phase 2 trials but ultimately failed in phase 3. Who is right? Of course FDA and the panel makes the right decision. Sarept wants to exploit the loophole and try to stir popularism and politics to influence the outcome. They deserve to get failure.
For the cancer vaccine that NONE has ever succeed. It is amazing though...
It is hard to gauge. But the market or some traders may know it is bad based on today's action. If the data is really good, why not announce first? I lean towards data not that compelling (doesn't mean it is bad, but just not that outstanding or clear benefit/risk profile, which is still bad in today's market).
Haha, if you rely on the single arm trial, you will be totally wrong.
I told you that many cancer vaccine has shown excellent OS in the single arm trial, many extending OS by 300%, still fails miserably in the phase 3 trial.
Is there anything special about ARGS's Cancer vaccine technology?
The reason I think this may be overvalued is that all cancer vaccine failed, DNDN's is the only exception, nevertheless still fails commercially.
I can give you a long list of failed cancer vaccine. What makes you confident enough that ARGS's is different. Their phase 2 data is not that exceptional with no controlled arm.
SPA is nothing. Only matters is whether their Phase 3 trial will succeed or not.
This reminds me of CLDX's failed brain cancer vaccine, a personalized EGFR+ brain cancer vaccine, even though has excellent phase 2 data still fails the phase 3 trial.
Argos even don't have an excellent phase 2 data.
To drive this stock from $2 to over $13. Don't know what happened.
But bet on a single arm phase 2 trial and no success story (Dentrice Cell cancer vaccine, DNDN is the only clinical success, but still commercially fail). Interesting to watch...
The second phase 3 trial will take 1 full year, how many of you are confident that Thrombosis SAE or Death will not resurface? I don't think Zafgen really understands what caused Thrombosis but the Data is always there. This company many never understand how Met-AP2 works in the first place to reduce the fat...