That $4.00 low near the open today wasn't real-- it was just a sucker punch (600+ share sale) to see if any scared retail investors would panic sell. It didn't work.
They're going to initiate IV form for Status Epilepticus trial soon. And they claim that their preliminary data shows ganax to be far superior to allopregnanolone. And then transition to pills. Read their press release.
That right there will be worth a billion $$.
Everything/anything before that is gravy. Even if there a trial failure before that time--which I doubt-- we're good.
Yes, sage 547 is allopregnanolone, their proprietary formulation. But there is a commercially available "regular" non-patented formulation. This of course is a negative for SAGE if their drug gets approved. Will people use generic "black market" online formulation instead? I doubt it, but it's a concern for them.
Even if there is downward pressure all year from a dropping IBB (if it occurs), my hope is that the share price re-sets higher after every milestone reached, such as positive lymphoma and/or DM trial results and GSO launch. I think that's possible even in this environment.
Yes... He's the deal:
1) Ganax works well in kids. So the reasearcher gets the center to now initiate trials on adults with the non- proprietary option available (allo) with a high chance for success. It could make her and the center look great, become a superstar at the meetings
2) Ganax does poorly. I'm that case, she would never start allo trial in adults. It's throwing good money after bad
3) Ganax has glimmer of hope. She would then likely start Allo for kids for a very narrow primary endpoint, perhaps one of the secondary end points that ganax did well in. I too doubt she would do that in adults. But it is possible.
My best guess is #1.
Because UCDavis can't use Ganaxolone. Marinus owns it (a good thing). They've already run their fragile X trial with it. So the investigator has no choice but to use allopregnanolone, which is commercially available.
Ok, I glanced at the message board this AM, couldn't stay away after all, I guess.
Absolutely right. The UCDavis lead investigator (Randi Hagerman I think) tipped us all off. She saw what ganax did for kids with Frag X and now starts a new trial on her own to prove if the similar but non-proprietary allopregnanolone also works for adults. Very bullish.
VA... It's a low volume price decline. No one is bailing, including me. We're good.
I'm taking a week off from stocks and message boards, since I'm already vested and don't plan on buying or selling for a while, even if Fragile X results are announced.
The technicals here (and almost every biotech) are a train wreck. Every indicator says sell.
The fundamentals here, however, are excellent, based on sound science, and positive clues such as the impressive new hires in December, Oppenheimer comments, and clues that Fragile X results might be good.
Anyway, I have found it helpful in the past to take breaks periodically. I could sure use one now in this rough market!
Yes FLXN is a good buy here too.
Funny, other than IDRA, I've got a completely different list of bio stocks that I follow as compared to last year. I used to follow CYTR, SYN, SNTA, MNKD, KERX, GALE, and MACK. I've crossed all of them off my list, although MACK has great potential, and perhaps KERX is a good buy now.
Yes, I wouldn't touch that stock. Something isn't right with NVIV.
Even with IDRA, I am not totally confident with -8400. Lymphoma trial is high risk. Same with PM/DM. I think you need to own now at the current great price but also keep dry powder just in case 8400 fails, and then load the boat completely. (I am gun-shy now about cancer and immunology trials, with recent failures in SNTA, THLD, XOMA and others.)
MRNS, IDRA, FOMX, and XNCR are my favorites now. Maybe EDGE too.
Biotrader-- I think Idera is a powerhouse in the making, but it'll be a long slog, especially in the cancer and immunology space. The GSO platform will be amazing.
On the other hand, I love the simplicity of MRNS. Their drug is an analogue of a natural chemical in our brain, so likely very safe with no surprise adverse events. Second, it's in a good biotech space now--CNS-- perhaps the biggest unmet need, which includes epilespy, not to mention depression and other indications. Third, it has relatively short, quick, quantifiable trials... either it stops seizures or it doesn't. Easy to recruit too. Compare that to the cumbersome NVIV, for example. Fourth, it has orphan status-- longer patent, etc. Fifth, it likely has many possible uses-- look at SAGE trials to get an idea. Get approval for one use, and it'll be used off-label for all others. Also, Fragile X-- which I expect to be positive-- is a bonus. Much higher incidence than Fabry's (look at FOLD) and DMD ( look at SRPT). Imagine what positive results will do to out share price.
Well, Bio, I don't think we'll get another QE. The Fed is hell-bent on raising interest rates more this year, no matter what. They're at war with Wall Street and won't give in. That's my guess. They want to show who's boss.
Anyway, even in a bad market, a few select biotechs could do fine if they report good results and are
priced right. Investors still know that they are practically the only lottery ticket left that can make good money. But you have to stick with low market cap ones that have more upside than downside potential (like MRNS and IDRA), as opposed to the KITE's out there.
I listen to oldies on satellite radio while driving every day. Nothing makes me smile more than when an EWF song is played. Their music had an unmatched joy. And I've heard that their concerts were amazing. They could really rock.
Jeremy Grantham in his just released quarterly newsletter doesn't believe we are ready for the BIG correction yet. He expects a blow-off top first. He doesn't predict the short term low in our current drop, but he expects the low energy and commodity prices to be a great tailwind which will creat surprise growth and the S&P to surge to at least 2300 before "the BIG correction". (Perhaps the blow-off top will occur after euphoria from a GOP presidential victory, peaking in 2017)
Just one person's opinion.
Another way to look at it: Within the last year, IBB went from 400 down to 251 (so far), but the XBI went from 91 down to 46, close to 50% down! Small cap bios have been hit harder and are nearer the bottom than the bigger bios.