BLUE: Up 88% AH on FDA approval? Could be something worthwhile to someone

Ticker: BLUE

Just came across this - I am by no means good at DD, but I suppose I’d share just in case someone was interested in a potential play.

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I am not seeing a lot here and it seems to be tumbling down to zero. What caught your eye with it?

definitely gaining traction here. I’m going to look more into it after work today and will update later.

Quick update during lunch break so nothing too in depth.

Pros: 2 unanimous recommendations from the FDA for approval of their therapies, should have an official decision on approval or not by Mid august/early September.

Cons: they seem to be in a very difficult cash position. Looks like they currently have around 396 million with an estimated 400 million cash burn for this year. They recently stated they will need addition financing in upcoming periods, going so far to say that if they fail to get additional capital that it may force them to delay or even cancel commercial launch following any approval. I’m unaware of any current offerings but I’m assuming one would be coming soon if this continues to pump.

With that being said it seems to have a good chance of getting approval and looks like it would be the first of its therapies out of any company to do so. Worth a gamble in my opinion. Looking to get in on a pullback for August/September calls to ride the momentum up to the approval decision. Will update later when I have more time to dig deeper.

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Lmao well that didn’t take long. I still believe this has potential and will look to enter calls on a pull back for their possible approval in Aug/September.

No idea if anyone is still following this ticker but I took profit on all my august/September calls around that spike to 7 and will hold all November calls… still expecting approval by next Friday but at this point that is most likely priced in and if you took calls when this was first posted you should be up significantly… will look to reposition for the next approval decision in September after the first is announced…. The biggest risk (assuming the first drug is not denied) now is that there is a clinical trial hold for the second drug and I do not believe it will get approval from the FDA if that hold remains into the decision mid September. So either the second decision will get pushed to a further date or it gets denied outright. The latter of which I do not think will happen due to the unanimous decision from the advisory board for approval of said therapy… best case scenario is the hold is lifted soon which would most likely lead to approval of their second drug which, again, is expected mid September… do not chase this play but I still believe there is room for this to run, possibly even get a BO down the road… I’m looking to add to my November position on a pullback “IF” the first drug is approved…

Blue halted for news. Approval/denial incoming…

Looks like BCBS will now cover their newly approved drug. A big bear case here was that the therapy was too expensive and that no insurance company would cover it, looks like that is not the case anymore. Back in my original position to play the run up to their next drug approval in September. We need to see the clinical hold on this trial lifted in the coming weeks or else I will most likely exit the play because I do not think they will get approval with that hold in place. However I believe the hold will get lifted and drug approved based on unanimous ADCOM vote for approval of said drug.

FDA approval for their second therapy targeting kids with CALD was announced last night. This is great news for the families of those suffering with this horrible life ending disease. With that being said it is extremely rare, affecting around 50 kids a year. Bluebird bio is planning on treating as many as they can but state that it will most likely be around 10 per year. They have yet to establish a price for this therapy but for reference their last gene editing therapy that was approved a month ago is going for over 2million a person… Both these therapies “should” start bringing in much needed revenue by the end of this year. In the short term both these FDA approvals have come with a priority review voucher (PRV) worth 100+million each. In a recent fireside chat with the CEO he states that with both PRVs, both therapies, and the current at the market offering ongoing they have enough money to last into 2024. The next big milestone for BLUE will be their submission for their gene edition therapy for sickle cell disease, expected in Q1 of 2023. This is where the huge potential for this company lies. Gene editing therapies are becoming popular again and I believe that BLUE will most likely either partner with a major pharma company or get bought outright to bring their sickle cell therapy to market (if approved).

For me this is now going to be a long term hold for shares and I’ll be selling my remaining call options into whatever pop we get on Monday morning (if there is one). The daily chart seems to be making the dreaded Batman symbol and paired with a “sell the news” event that I’m sure will be coming this week we may go back to test the 4-4.5 area. Might even switch to short term puts to play the sell off if I can get good fills. Either way if you’re looking to play this now I wouldn’t touch calls and wait for consolidation before getting any shares. This is now a long term swing, I don’t really see a big move upwards in stock price until we get closer to their sickle cell BLA submission early 2023. Will most likely follow along with the biotech ETF XBI until their next catalyst.