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Showing posts with the label IONIS

Trade: IONIS Pharmaceuticals (IONS)

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Today was a wild day for Ionis.  After FDA results for a competing drug failed to show signs that it was effective enough to prevent competition for FCS in the mix, IONS was up over 10% at varying points during the day.  I was contemplating selling some, given I was finally back in the green on the stock.  However, there was a PDUFA meeting coming on Thursday for the approval on Volanasorsen on the radar and I didn't want to try to sell out and hope to get back in to maximize gains (typically after a big jump, the stock sells off for a couple days).  Then after the bell, the stock was halted as the FDA issued a Complete Response Letter (CRL) notifiying their holding company Akcea that they have rejected their drug Walivra on serious concerns on safety with antisense oligonucleotide drugs.  This puts the upcoming PDUFA in some jeapordy and the future PDUFA for Inotersen in serious jeapordy (due to the fact it suffered a death related to platelet issues), sign...

Stock Analysis: Ionis Pharmaceuticals (IONS)

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Notes: Stock Ratings: 1 = buy at current stock prices, 2 = buy on a 5-10% dip in stock price, 3 = sell on a 5-10% increase in stock price, 4 = sell at current stock prices to raise cash.  Ratings are based upon 12-18 month outlook on stock direction and not necessarily related to moves I make due to financial positioning. Yesterday Ionis Pharmaceuticals posted an update on its 2 Phase 3 studies regarding their anti-sense therapy for TTR.  In short, the FDA put a hold on the start of the study for the FCA version of the therapy (for heart-related TTR), which is being operated by Glaxo-Smith Klein (GSK), while the FAP version (for neurological-related TTR) continues on its normal path.  This news event caused the stock to go down over 13% at one point yesterday before it closed down over 10%.  Today it was down another 2%, presumably related to this news.   Traditionally, an FDA hold is a bad thing for biotech companies as it indicates an issue in a tes...