AMLX
So I was talking about the Europe final decision being big for the co.. but I realize now there is another trigger due to a very unusual situation...
It seems the first two trials of AMLX's compound for ALS went off so smashingly the FDA did the very rare move of Ok'ing before Phase 3<----
The Co agreed to do Phase 3 and that has not come out yet.<-- catalyst Big Time!
The drug is being sold and it is working patients are staying on it. I mean, could they pull a RAIN on me? Anything is possible but these guys actually are in people's bodies already, I really think the news will be great.
And that will double the stk instantly --it is severely held back here-
This is not a baby bio like Blue or something this is a $40 stk clearly. I think we have a good one here folks.
But last year,
Amylyx Pharmaceuticals(NASDAQ:
AMLX) achieved
FDA approvalfor its ALS drug Relyvrio, despite not having phase 3 clinical trial results. ALS’s severity likely drove the FDA to its decision. Amylyx is
already generating revenuefrom Relyvrio.
The FDA demanded that Amylyx promise to
withdraw the drugif that trial yields negative results. Relyvrio is also approved in Canada on a
conditional basiswhich can be withdrawn based on the trial results. Amylyx faces an uncertain future, which may be causing its stock price to be held back until that uncertainty is resolved.
Besides Relyvrio, Amylyx has
nothing else in clinical trials. But if Relyvrio is an ALS success, it will not only pave the way for the worldwide roll-out, but also bolster the company’s attempts to get Relyvrio approved for other diseases.
The bottom line is that Amylyx has had a big win, but it needs to keep winning to stay in the game. If you like their science and their drug though, this is one of the most promising neurodegenerative biotech stocks to buy.