No sweet dingus, the FDA didn't approve it today. An advisory panel voted that the FDA should approve it, but that isn't the same thing. The approval comes later.
IMHO, it has potential to hit 52 WH high tomorrow it has strong tail winds to hit TP of $179 before 2Q ER date.
PCYC has already been taken out. It would be really nice if ESPR is taken out by AMGN.
Sentiment: Strong Buy
So much unknown about what can happen with long term us of Evolocumab on autoimmune diseases. What are the off target effects which will be observed? I am sure this has not been studied in heterogeneous populations. A clear risk benefit model will be required to position for the right patient candidate. Clearly a break thru product for FH however, with lot of unknowns to be considered first line for broad population. I sure the cost of therapy will be an added barrier.
There was no reason for the sell off yesterday and today. Remember this stock trades at very low volumes and any bid/ask separation will cause the stock price to move either up or down in wild swings. The majority of float is owned by institutions and funds alike. They do not want the stock price to go any lower and will support it tomorrow. Tomorrow we should have a larger volume trading day. Probably 5-7 million shares.
If the FDA approved the REGN/SNY drug then I dont see why AMGN would not also be approved tomorrow. The two drugs I believe are basically identical and for the same disease. I think it will be approved and AMGN should move back up to last week's range of $157-$160
The below.mentioned FDA comments ahead of tomorrow's meeting to review AMGN's Repatha make me nervous. Granted, I think the FDA has concerns about REGN's Praluent; but REGN isn't offering a larger once-per-mont option. It sounds like AMGN's larger once-per-month dose (which I thought would be an advantage over REGN) is not seen by the FDA as a big plus. I'm long AMGN and will ride out the volatility, but I think things might get bumpy.
"In its briefing documents, the FDA noted that both dosing regimens (140 mg once every 2 weeks/Q2W and 420 mg once monthly) of Repatha resulted in a statistically significant reduction in LDL-C (“bad” cholesterol) of approximately 60% after 12 and 52 weeks of treatment.
But concerns have been raised regarding the appropriate patient population likely to benefit from this drug given the lack of safety and efficacy data for the 420 mg Q2W dose since this dosing regimen could potentially be used in children aged 12 years or older. Moreover, the FDA recommended that, if approved, potential safety issues, including pancreatitis, serious renal disorders and a possible increased incidence of new onset diabetes in certain patients should be adequately addressed in the drug's labeling and appropriately monitored by health care providers. The regulatory agency also mentioned that these issues should be comprehensively assessed in ongoing studies."
volatility will likely increase. the AMGN drug will get the FDA vote for approval (similar to REGN). the next round of news from the FDA will be a decision on usage guidelines, and I'm not sure when that news will break. until the dust clears and we know exactly how large the patient population is volatility will be the norm.
after hours trading on AMGN has gotten back to $153-$154, but we may see lower prices before things go higher. AMGN may also be halted tomorrow. no news on that item as of yet.
yep the FDA verdict is the news driven event. I didn't think we would have this much chop ahead of the news though.
I can't find any breaking news as of yet, so people are selling purely based on rumor and fear. I'm a buyer, but want to wait for some news first. Things could uglier before they stabilize.