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FBIO - FDA approval on cancer drug January 6
Anyone know what’s been up with FBIO this past week? I havnt been able to find any news.
Finding Gems in the Biotech Rough: $ATXI, $CKPT, $DERM, $DSS, $FBIO, $MBIO
Finding Gems in the Biotech Rough: $ATXI, $CKPT, $DERM, $DSS, $FBIO, $MBIO
Stocks to watch trading around $1/share: $TLSA, $OLB, $WULF, $FBIO
Promising Stocks around $1/share: $TLSA, $OLB, $FBIO, $WULF
$FBIO, $JUPW -- Two microcaps lifting off from the lows with rising trading volume
Fortress Biotech (NASDAQ:FBIO) Receives New Coverage from Analysts at StockNews.com
63,500 Shares in Fortress Biotech, Inc. (NASDAQ:FBIO) Purchased by Sepio Capital LP
Brokerages Set Fortress Biotech, Inc. (NASDAQ:FBIO) Price Target at $9.60
$FBIO Reports $0.54 per share for Q3FY21, yet price plummets?
$FBIO Interesting price action the last few days.
Fortress Biotech, Inc. (FBIO)- Amazingly never seen this before from Stocktwits
FBIO seems poised for some nice return
7 Penny Stocks That May Not Be Penny Stocks For Long
Mentions
Its definitely luck. You can yolo anything and have 50% chance of losing or making money. The DD you do on pennystocks doesn't actually matter if companies under deliver. Most biotech don't get FDA approval even if their med is proven and would save thousands of lives. Slightest problem with their manufacturing and they get CRL. Look at FBIO.
>I think no risk for this company Er, I'm extremely bullish but there is *definitely* risk. Firstly, there's a risk of dilution: 20% of the float is in warrants priced at $0.83. Secondly, the company might become insolvent (trials and approvals are crushingly expensive). Thirdly, issues unrelated to the drug - like a CRL - might delay approvals, which could be fatal amid cash flow issues and will definitely tank the share price (look at what happened to FBIO). Fourthly, the lead drug might be outperformed by a competitor during development. So far this looks unlikely but it's not impossible. Fifthly, there might not be an economical commercialisation pathway: INTS therapies might command too high a price, need too much rare expertise, or face too many hurdles with insurers to capture a viable portion of the TAM. These are organised from most likely to least likely, in my opinion, but for practical purposes can all be filed under: "who knows?" Maybe INTS has discovered a general application wonder-drug that can carry the price to $50 per share. Maybe they don't relist by December, a reverse split causes algos to flee, cash crunches spook the market, and surprise safety concerns put the nail in the coffin. Who knows?
https://preview.redd.it/vx75mn3m37yf1.jpeg?width=1170&format=pjpg&auto=webp&s=35e56d30bfeafcba0c11008d35df4f33c8536e6e Isn’t this good news for FBIO and DERM?
It's not 50-50, though that's not how probability works. If the outcome is binary, as in this case, approved or not approved (delays, further trials, potential production issues like with FBIO... Let's put all of those under not approved, together with outright rejection) it doesn't mean that the odds of both outcomes are inherently equal. I have no clue what the actual odds are, though. However, since industry insiders seems to be inclined to bet on RVPH instead of against it, I'm paying attention and trying to react quickly enough in case the news are positive.
Just remain confident in your plan, assuming it worked for you in the first place. You can't win every trade and sometimes bad luck comes in bunches. Take a break and be sure not to revenge trade. I just recently blew up half my account on FBIO calls. I was sure that they were getting approved based on their efficacy and with the severity of the disease, safety wasn't an issue. I never would have thought that a company with multiple drugs on the market would be rejected over manufacturing.... I didn't let it get to me and I've more than made the money back just sticking to my same plan. I didn't feel that I need to make drastic moves to make up for that loss, that's how you lose even more.
I generally don't invest in biotech but let me tell you this, it doesn't really matter if everything goes smoothly as announced for the trials (which almost always it doesn't), if FDA finds a little bit of something that doesn't comply with their regulations, its an instant CRL. So think wisely. Same happened with FBIO. It was a proven med which prolongs life expactancy by 14 years but they still got a CRL.
I know I already mentioned it but it seems weird to me that FBIO shoots up 15% today out of nothing with increased $5 call volume, especially since it should be tanking after the FDA rejection. Could be related to other products in their pipeline. Might be worth looking into if there really is something coming.
FBIO is running up... I feel like someone knows something
IXHL, BTAI, and MBOT were huge for me. CHRS was a bust for strategic and financial reasons: an expected short squeeze never materialised because the company used huge cash inflows to pay down debts instead of contributing to an EPS spike. FBIO was almost a bag but their FDA rejection letter was because of non-drug-related issues, so averaging down paid off (for once).
Dans ma tête j’ai un mélange de « est ce que c’est utile et prometteur « et « les résultats financiers « . Du coup sur une Pharma, les recherches pour les cancers, les soins psychiatriques et infantiles « seront priorisés. Le « laser bleu » ne me dit rien du tout. Mais, ces derniers temps je me rends compte que je ne suis pas suffisamment informée sur les « calendriers » des penny Et ça donne , si la FDA a pas validé, un décrochage de l’action terrible. Comme FBIO semaine dernière. Mais bon, je l’aurai gardé, elle donne de très bons dividendes en nov (0,80$) . Voilà, il y a des noms qui jaillissent de ce forum , de nous et aussi d’autres + institutionnalisés mais in finé, on est pas une bande pote qui jouons ensemble au loto en se partageant des numéros . Chacun est seul à lui même quand il appuie sur le bouton Transmettre Ordre? ou Vendre? Mais Ce qui est cool dans ce forum c’est qu’on est quand même comme une bande de pote qui se chauffent entre eux pour se lancer.
I would try really hard to avoid biomedical stocks like IXHL, SHOT, FEMY, or RVPH. Or you would have to be very diligent and proactive in getting out as well as you can when you are at the top. Biomedical stocks usually drop very fast whenever something positive happens as everyone wants to “buy the rumor, sell on the news”, so usually there’s not very stable long term gains on biomedical stocks aside from the big names like NVO or LLY or PFE. Quite a few of us have learned the lesson the hard way with things like OTLK or MBOT or FBIO. Once the catalyst happens, biomedical stocks usually drop and takes a long time to recover again since it takes a lot of effort and capital for a biomedical stock to actually advertise and produce the said development
Thanks, I invested in better things since then. FBIO, and now more recently MLTX when it crashed and has been slowly climbing up. But I'm happy for you guys who stuck here and it paid off! I never wish ill of others and their investments. But sometimes you should sell sooner rather than later, like the people who kept holding ORBS even when it was as high as 75, stabilized at 45 for a few days, but is now currently 8.
Lol FBIO going back up, imagine if my $5 calls are somehow salvaged
That's a very good question, I'm not seeing anything about it right now. If you have any insight please provide it here. From what I saw, FBIO's production facility did not meet current Good Manufacturing Practices, but I could not find any mention of where the facility is located. Could you provide your source for that as well? Would be an interesting case study for RVPH's downside.
I saw that FBIO just tanked because the NDA was rejected due to concerns regarding its production facility in India. For RVPH where is the production site and will the administration's new stance on in-country production stall this?
Averaged down on FBIO and got in on EONR. Still confident NUAI will return to $1.70 but want to maximise my capital in the meantime.
I think so too, especially as paediatric drugs are eligible for huge federal cash boosts. The main thing to watch out for is a rival drug entering development while FBIO sorts itself out.
Going to average down on FBIO or speculate on IXHL if NUAI doesn't dip below $1.7 by the next time I get paid. FBIO's quite a pleasant bag. The complete response letter identified concerns about manufacturing facilities, not the drug itself.
BURU 🤣 Imo, the ones with good fundamentals here are NUAI, NVNI, RZLV, and FBIO
Down $10k on FBIO options, but on the bright side, I'm up $32 on BURU
Buying the RZLV trough offset by FBIO losses, which are officially my first bag.
I’m actually at peace with FBIO - was always a coin flip. You win some, lose some. No looking back.
FBIO you will be my last ever call option
FBIO - tanked due to FDA given them CRL. Manufacturing issue, and it FDA typically provide another response in 6 month +/- after the issue resolved. Looks like a good dip to buy some and hold. Manage your own risk, and I did not buy before the dip, I bought in when it dip
FBIO got a CRL (no approval) just fyi
Fuck FBIO let's all repeat after me buy rumour sell news buy rumour sell news... might get a tatt saying it so I don't forget
Yeah it’s messed up. One possible thing is FBIO got it late last night and letting us know pre-market, but no matter what it’s kind of messed up to wait this long.
Lol the fact FBIO hasn't said anything yet is making me more and more nervous... Holding $10k in calls I think are going to end up worthless
What actually happened with FBIO?
There's no way that FBIO doesn't explode if they get a priority review voucher - like more than 100% gains simply because the voucher would provide them with more cash than their current market cap
IMO the way to play binary pharma news is in the few weeks before as momentum and anticipation builds. Way too risky to hold through the news itself, seen too many stocks that dump even after good news (re: FBIO)
FBIO for tonight. EONR, too, but it's riskier: a lot of news-sellers.
FBIO approval news should come AH today
Okay, honest DD. I might put some FBIO profits towards this (assuming FBIO keeps climbing).
FBIO going up, hopefully they get approved today🤞
As a recent FBIO buyer, I'm watching very closely to see if investors sell the news.
Approval for a unique drug expected today. Major federal grants could follow because of its field (pediatrics). Under-the-hood, FBIO is also a small fund. It owns big stakes in similar biotechs. Buying FBIO gets you exposure to their performance without risking your capital on multiple stocks.
FBIO is about to blow up
When would FBIO announce PDUFA decision? After hours?
Okay, RZLV was *not* a play. Planning re-entry nearer earnings. Still holding FBIO.
FBIO -8% Seems the market takes it as a bad sign that there is still no news about the approval.
Cash is king today, unless you've got a Mag7 dip to load up on, but FBIO and RZLV are reasonably safe plays that won't keep you staring at your phone.
FBIO (approval for a unique product likely soon), PHIO (multiple cool and successful but not-quite-unique products in the pipe), and RZLV (a binary event imminent but short-seller sleaze lowered the price up front, minimising downside).
How about FBIO? FDA decision is expected to come today!
Where the hell is the FBIO news?
Wishing you all the best, comrade. FBIO has treated me very well.
FBIO before news today anyone?
Who else holding their breath on FBIO tomorrow?
My new plays are FBIO and PHIO. I find FBIO's product likelier to get approval and dominate its market, but PHIO's gene silencing technology is the future and its float far smaller.
FBIO with PDUFA date (ie. FDA approval results for their drug CUTX-101 against Menkes Disease. Will be the first and only FDA approved treatment if approved) set for tomorrow (30th Sept). Article to show deadline date: https://www.fortressbiotech.com/news-media/press-releases/detail/715/fortress-biotech-reports-second-quarter-2025-financial Website for upcoming catalyst for Biopharma companies: https://app.bpiq.com/catalyst-calendar
$5 calls for FBIO? Expiring when? Why will it go up?
FBIO FDA approval tomorrow? is that right? What is the deal with them?
Seriously FBIO of all the stocks out there.
My portfolio is 50% DFLI and 50% FBIO calls right now
Put a second tranche of DFLI profit into FBIO.
You can consider FBIO for tomorrow’s deadline of FDA drug approval.
Are people still holding FBIO for tomorrow?
This is very promising, FBIO have pharmaceutical products on the market already, and multiple things in the pipeline. This is for menkes disease in pediatrics, a very rare disease for which there is currently no drug available, so its a first of its kind. according to a biopharmacy website the probability is actually 85%. Yes, DUPFA approve only 1 in 6 application's but this application was given a priority review which gives it a further positive catalyst. Set a Stop Loss, go in with a small amount and then if approved, buy some more. Keep an eye on the company’s website for news or stocktitan before the stock halt is removed (halted to allow the result to be published) The price has moved 119% in 3 months! NFA
Let’s all not forget FBIO this week 😌
FBIO PDUFA on Sep 30 - negative is if there is no approval (personally think the lack of alternative treatments for a disease that kills little children kind of puts it as a sure thing) FUBO merger approval shareholder meeting on Sep 30 - almost 100% guaranteed for the vote to pass, waiting for DOJ approval after is more tricky but definitely a quick scalp can be made next week
FBIO owns Cyprium, there is almost no difference. Majority of the financial benefit flows to FBIO.
The voucher goes to Cyprium Therapeutics, which is a subsidiary of Fortress Biotech (FBIO). So idk how much we benifit im sure we will
FBIO (Fortress Biotech) There’s a PDUFA approval deadline set for 30th September 2025 for their treatment of Menkes Disease. It will be the first FDA approved treatment if approved. Phase 3 clinical results are good. This drug (CUTX-101) was given Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug Designations. Because of the Rare Pediatric Disease designations, companies that get a drug approved with that designation will also be awarded with a Prority Review Voucher. This voucher can be used for a different drug to expedite FDA review or sold off (on average price between $100mil to $150mil). Like all biotech stocks and penny stocks, there’s a little gamble involved, but potentially this maybe 1.5x to 3-4x this week. Or like how the stock market works, sell the news.
pstv and atch are my mains But I'm holding NVNI and FBIO for potential long term gains
If DFLI, FBIO, NVNI and especially RZLV tank next week I may have to sell panties and feet picks. I went all in🙏🙏🙏
ATYR failed the clinical trial which is not the case with FBIO. They have already proven efficacy. Thats why approval is estimated around %80.
I agree for ATCH, not sure about FBIO
FBIO and ATCH for next week. 🤠 Check it out.
Any opinions on FBIO right now?
how do we feel about FBIO? no one really talks about it in the lounge but it has a big catalyst coming up
Surprised nobody mentioned FBIO, last run up before PDUFA on 30 Sep
Current opinions on FBIO going into next week?
If you guys really wanna gamble, $FBIO fda approval coming up next Tuesday… 70% approval
FBIO was next on my radar. I was thinking of rolling into that after PSQH. But looking how high up it already is over the past month - and how badly PSQH just went for me on today's big announcement - I'm a bit uncertain now. Do want to ask - what has you convinced of its value?
FBIO and NVNI have a catalyst on the 29th and 30th of sept. RZLV also have a highly anticipated earning 1st okt.
Next week is going to be a make or break for my portfolio RZLV, FBIO and NVNI. Especially afraid for FBIO since the atyr debacle
On another topic, $FBIO has a pretty good FDA approval coming up Sept 30th! Their solution for Menkes disease is the 1st in the market and have a 75% chance of approval and analyst predict a $10 to $15 price target. Plus the chart looks juice bullish...
Holding both til at least end of month. Still buy FBIO dips, but not expecting a huge price jump. FBIO pretty much priced in.
Anybody still holding NVNI OR FBIO how we feeling?
biotech stocks with catalysts soon: LRMR - Phase 2 FBIO - PDUFA approval for first Menkes disease treatment on Sept 30th
Personally, I'm holding PSQH right now. Got in at 2.54 yesterday morning. I don't know if I'd recommend trying to get in now when we're already up about 30-40% since Monday's close, but there's supposed to be a big announcement today with some important individuals. After this, I'm looking at FBIO going into next week, and then I might look at CYCU after that.
$FBIO just had a big dip and about to rise and moon again
FBIO. Their drug, CUTX-101, is being developed to treat Menkes disease, and there are currently no FDA-approved therapies to treat this! Their upcoming potential catalyst is the FDA PDUFA approval for their CUTX-101 drug on September 30, 2025.
Really considering buying 2k worth of stocks of FBIO. Anyone know any reasons not to?
don’t forget PDUFA approval for FBIO expected on the 30th!
FBIO - short squeeze possible and 6 days to PDUFA. Let's go.