finance

Ardelyx Inc

approval

$ARDX what fucking morons are selling it’s approved there are some real dumb fucks involved in this stock good let them get the fuck out. Pussys

$ARDX if we have no approval  you know they are corrupt. .

$ARDX with a 98% chance of fda approval within a few weeks, what is this crap?

Denial of approval of such product  will need a strong justification or presence of significant risk (which is not applicable for Tenapanor as elaborated in the above detailed  
analysis).

but not expecting a ton of juice upon approval 🤞

$ARDX with all due respect, this price action today is embarrassing…nasdaq up 6% we can’t even break $1.30 embarrassing for real… I won’t even be surprised if we get approval next week and we stay stagnant for a bit.

The issue raised was probably one of the only negatives for approval:  The fact that we are using &#39;surrogate&#39; endpoints rather than the correlated clinical outcome.

Tena is already approved for IBS with a solid safety profile, and phosphorus management is a real issue in the CKD community with only binders being available.

insider

One red flag in this company, despite one director buying 1m worth recently, is the low insider ownership.

$ARDX less than one dollar soon insiders doing, given how corrupt the board and CEO are .

$ARDX company doesn’t say anything, insiders don’t buy, stock trades like total crap.

Kind of thing you expect to happen to a stock if the CEO is complicit in a INSIDER Trading SCHEME. .

patient

Those laxatives your taking are not working, you need the full Fleets treatment, a complete system flush.

I still remember listening to the meeting and getting mad at Alikhani, the so called patient&#39;s advocate.

The subsequent increase in intraluminal pressure leads to decreased intestinal blood flow, and in the case of our patient, intestinal ischemia.

They got something that improve the quality of life for dialysis patients and you guys called the trash company.

$ARDX&quot; I am a board-certified nephrologist for 30 years and was very disappointed to say the least by the denial of application of Tenapanor for hyperphosphatemia in patients with CKD.

However, the enrichment strategy did not appear to reliably identify patients who would have a larger treatment response to tenapanor.

As you think about your decision, I’d like to ask you to remember me and the other patients out there like me who are looking for solutions to help them.

Company sitting on the best fundamentals ever to date and we get treated to these stupid 1 liner worthless post.

However when patients get discharged compliance will still remain an issue because nurses and doctors aren’t there watching over them and making sure they take their meds.

trading

Obvious, as hell looking at tape today this trading was far from organic.

↳ Why are you paying to be in a Trading Room?

$ARDX 
With these absurd disconnected 80-100million-share volumes, trading price purely a construction of Dark pool, HFT, MM share-swapping, etc.

In the scientific community as well as in trading feeling get fucked.

reason

what a BS TREE SHAKE by MM&#39;s today was zero reason to let this drop like they did. .

I see no reason to hold or add at this point.

There would be no other reason for the timing.

$ARDX Ok, the only reason to deny our drug is negligible efficacy.

but that the FDA had denied access to for reasons no one understood.

Must be the reason this can’t get past 1.5

There is no reason for it to fall today like this!

He is one of the reasons that the SP stays down.

This is 100% normal and part of the growth of a strong company with excellent fundamentals and an FDA approval coming this year.

$ARDX very good fda news on this conference call

And this is just a beginning, FDA approval will take it to the skies.

Pretty Bullish ER going to give us an update on FDA when and etc. .

If the trend of script numbers is anything to go by, guidance could be way better than Wall Street expects giving us a nice boost before FDA news.

$AKBA within 3  to 4 weeks this stock could be over 2 heading to three like $ARDX .. gsk approval has helped.. fda news, ema opinion/ approval, partnership..

$ARDX when we get fda approval will be shining

This should be seen as a REALLY good thing - because they will need cashflow soon - one would expect - assumption being FDA response is close and production and marketing is about to get kicked up a notch. .

Things to look forward to..  NDA refile announcement, Q4 results, weekly IBSRELA sales increasing now that we are through the holidays, FDA approval, Japan approval, launch of Xphozah.

They just got approval for 1 drug from FDA and things are bot going well there..

news

$ARDX Looking good, would be nice to finish the day in the 4&#39;s 
 
Still waiting on positive news from the company.

$ARDX just keeps doing things well, and good news should arrive soon!

$ARDX LOL, soon Xenopah News  😁 
Stay in, or buy

$ARDX good news coming man let’s goooooo

application

$ARDX I am thrilled that the chairwoman of our Adcom gave monotherapy a thumbs up.

Better than money in the bank with soon resubmission and approval 2-6 months later!

So glad that I bought before ADCOM meeting.

$ARDX This company is sitting on a mountain of great fundamentals.. 40++ medical patents ,,, 40+ more in application status 1 drug approved IBSRELA 1 drug almost aproved XPHOZAH a kidney drug that could pull an annual billion dollar + revenue.

bull

🎉

Have a great evening bulls and longs. 🍻🍻🍻

Hold strong bulls we’re not going anywhere 😤

$ARDX I’ll see you bulls in the 3.90s today 😤

$ARDX wow and just like that there’s no more bulls 🤣🤣🤣

A close above 4 will be huge for the bulls

Cheers and see you all tomorrow bulls and longs. 🍻

$ARDX  Looks like a bull flag on the daily morning here.

$ARDX $APRN $BLBX Have a great night, Bulls and Bull-ettes! !

SELLAS Life Sciences Group Inc

buying

$SLS  I wont be buying anymore shares until the CEO can show is company is worth at least 150m marketcap 
 
Look at the 3 year chart be warned the CEO is a scam artist and a liar

You are better off hoarding cash vs buying into a company where the staff sells free shares and does not deserve pay raises during a economic crisis/recession.

$SLS  No one should be buying in at these prices though.

$SLS SERIOUSLY STOP FUCKING RUNNING ALL THE BUYING OTC DARK POOL!!!

This MM is refusing to honor order flow, they are refusing to move the price higher when buying comes in, they are dictating price direction and that&#39;s not their fucking job.

HOW THE FUCK DID THEY JUST FILL 24k BUYING VOLUME AND NOT A SINGLE $.01 MOVE!!!!

but buying inflow and a 5K buy order and yet POS MM will not let it fucking go!! !

Gfh009 is a joke and will ruin this stock until 3d meds sees fda approval for aml gps.

16/16 
In all 3 Options GPs gets FDA approval due to QOL, venclexta, onureg, oralAz - all Cr1 salvage agents are highly toxic.

This concerns me, we get the dreaded not statistically relevant ruling from the FDA.

- OUTRIGHT LIE saying THEN 52 weeks - PURE BS 
- OUTRIGHT LIE saying THEN patients need to Die 
Co is now on RECord Reiterating 80 Events, patient deaths in Q1Q2 
That is the fda green light moment.

announcement

You fucked up and shorted NCI non dilutive funding announcement and patients living longer news.

$SLS they supposedly hired a lawyer fill time and this was never announced .

The shorts feeling the pain on their announcement.

$SLS For those predicting some big announcement from Sellas on the 14th at the Regal symposium, you are going to be terribly disappointed.

investor

What a freaking smack in the face to investors.

Angelos has intentionally screwed the long term investor.

$SLS I find it arrogant that SLS would even investors were concerned about their SIVB exposure.

but after doing an offering and the way the market is, the company should be giving some communication,  otherwise you are showing you really don&#39;t care about long term  investors,  personally  I&#39;m not impressed with the way it&#39;s been handled.

$SLS This is a JOKE and the JOKE is on the real investors ☹️

$SLS SLS investors have two problems now.

If you’re an experienced investor and you buy this scam, you deserve to lose you your investment.

$SLS No one should buy  in to this unless you are new investor.

They need to communicate and support their investors and shareholders.

Scary that I bought 2 years ago 9000 shares $6.50 average price to see this today just seems like he doesn’t care at all for investors why would he?

Burns may be is the real person in charge, living comfortably with 3-4 finance people working for him.

It will be a game changer to your finances as well if you can be patient enough to hold for commercialization.

The only thing that may be noteworthy is they hired a few more finance people to help manage future offerings.

Good job Angelo’s👍🏻 burns really deserved the promoting last year, heavy job to make 4 finance people look busy for a company with zero revenue.

A 300% gain in less than a month - and this time sis has plenty of cash in the tank to keep on running to the FDA green light.

$SLS my vote is get GPS green lighted for FDA approval and ramp this company up for M&amp;A.  GPS and GFH009 are high potential assets

Really is a great set up here - Get the FDA Green light and collect $50M plus another $25M warrants at $5.40.

$SLS In addition to GPs FDA approval for AML secondary Remission patients - Gps + Keytruda/Checkpoint Inhibition is also best in class for Ovarian cancer patients.

- Gps FDA Approval only a matter of time and is worth $8B in Market Value to Big Pharma  
- SlS current market cap of $.067B 
Best Short term investment any of us will find for a long. time.

Great Set Up here - $25M total incoming in Q1/2, Then another $50M when Gps gets the FDA green light - usually that is when small bios need to raise cash, and shorts can cover -- Ange Has them Over a barrel.

I think the share price will be climbing all along the approach to the FDA green light.

2,500% to 5,000% Upside in this ahead of the Fda Green light for Gps, as the first immunotherapy to treat 20,000 AML remission patients.

His 25-year experience, with global drug/biologics approvals and Breakthrough Therapy Designation with FDA, will be of immense value to our organization, especially as 2023 will be a pivotal year for our Company - welcome Andrew!

It reported positive outcomes in pleural mesothelioma patients, including:
Improved survival: Study patients lived around 11 months.

* Best Available Therapy offers 6-8 months of Overall Survival  
* All pooled Regal patients, BAT and Gps combined, is 16 months.

* Best Available Therapy offers 6-8 months of Overall Survival 
* All pooled Regal patients, BAT and Gps combined, is 16 months.

Now phase 3 trial is showing similar results to date where patients are living longer after Galinpepimut-S up to 1.5 year longer is a breakthrough for AML patients.

- Best available treatment 6-8 months of os.

- Cured GPS patients, continue to elongate the OS curve in Gps favor every day that goes by.

$SLS NCT update, nice…
They target 140 patients in 110 investigational sites.

$SLS With news on its way, the confidence built in the science, fear factor is gone.

$SLS No breaking news here regarding Sellas, and its well above my understanding,

$SLS good news, at the current rate and the ridiculous prices, in about a month you can buy this company for free.

My guess is that they generated ~3m revenue through the EAP, which would be really great news.

This is a rare opportunity that you know the news is grossly good(it convinced in investor(s)) and still have the chance to load and make 50 to 100% in .month or so.

plenty of upside if there is positive news.

$SLS they picked a great day for this news. lol

So much for this offering being good news.

Positive trial data/results supported with bullish news and sentiment! 4.

trial

PROC data are excellent compared to any combo trials.

But yesterdays paper also has me considering, if there isn&#39;t a deal with $mrk or $BMY or some other CPI BP  
--- That data is Best In Class - best in clinic, best in trial too.

The nation’s best means the O&#39;Neal Comprehensive Center in Alabama have access to the latest therapies, cutting-edge clinical trials and the expertise needed to treat their cancer.

Gps is doing what it has done in every single trial and its the reason Patients are living 3 fold longer than patients on best available treatments.

Treatment with GFH009 resulted in 90 to 100 percent cancer inhibition at dose levels equivalent to those already demonstrated to be safe in patients in the ongoing Phase 1 trial with no viable cancer cells at the highest dose levels.

Mannkind Corp

vehicle

Needing more of the SAME ACTIVE ingredient means your delivery is less precise.

We don’t have enough electricity as is, and nobody has brought up the fact electric stoves are extremely inefficient transferring heat.

$MNKD the worst President in everyone’s lifetime, 🤡Joementia, at the beginning of his shitshow cancelled the Keystone XL pipeline requiring all that oil to be shipped in trucks and trains.

share

That is the reason MNKD share price has suffered lately.

$MNKD My biggest complaint is Management has been handed all these shares and really has no skin in the game.

All while leaving the share price of Mannkind at a pathetic 0.89 pre-split.

$MNKD SVB, the first thing that should happen is every single corporate officer that sold shares should be arrested minimally for fraud, handcuffed and placed in general population awaiting trial.

He may be so arrogant that he announce he&#39;s giving the board and himself a raise and free shares.

Still own my pre split shares and at a big paper loss!!!

It is problematic when every catalyst seems to have little effect on the company&#39;s share price and its perception in the market.

Last year, they paid only 50% of their dividend and that was $1.25 per share (absolutely insane).

The CEO has no backbone, thus the company has no backbone and, by consequence, the share price has no backbone.

but was horribly inefficient and required higher dosing to get mediocre Cmax.

Having a higher dose doesn’t mean anything when it doesn’t translate into improved efficacy and outcomes, which is the case here with Yutrepia’s inferior clinical trial outcomes and PK data.

$MNKD the administration and hierarchy of the mnkd corp could be a classic textbook case study at the college level for corporate greed, malfeasance, and management failure. .

$MNKD $LQDA 

Yutrepia Clinical Trial treatment related serious adverse events: 

Four patients experienced a severe treatment‐related AE during the trial.

price

$MNKD Look at the 6 &amp; 3 month charts, speaks for itself where this stock price is headed-DOWN!

The markets have performed horribly under Biden, and his policies have harmed the country and MNKD stock price.

That would definitely take UTHR stock price down.

When i set my order, automatically someone increase the price lol. .

$MNKD The problem with LQDA is that while this patent dispute goes on, it depresses UTHR stock price and along with it MNKD as DPI is put into question.

$MNKD this is sweetness here, hey how about sweetening our price a bit. ty

bear

$MNKD  
 
Never engage (including tagging) these professional trolls, that is how they make their bones.

$MNKD We are in a bear market in my opinion.

Not a finance advice, hold your shares!! !

MNKD and Al Mann deserve a whole lot of credit for the hardwork they put into getting a revolutionary Dry Powder Inhaled Delivery System, Manufacturing and a game changing insulin Afrezza FDA Approved.

With all the good things that have happened for MNKD, 2 FDA approvals and the deal with UTHR and this is where the stock price is.

Excellent scripts this  week amongst all 3 of our FDA approved products!

Explanation, Technosphere is a known and safe incipient as defined by the FDA and its use as such in drug delivery is now a known and accepted incipient!

It is now at $24 a share on news it received a favorable thumbs up from the FDA on a  phase 2 drug result.

We have 3 FDA approved drug revenue streams, lots of cash, &amp; a solid partnership with more coming.

Here at Mannkind we have…
-3 FDA approved drugs
-Revenue increasing quarter over quarter.

revenue

* Annual revenue grew 32% to  
   almost $100M vs 2021!

$MNKD I will continue to accumulate all the shares I can because of growing revenues, growing profits, and growing cash for many quarters and years to come.

* Afrezza annual net revenue 
   increased by double digits  
   every yr last 5 yrs to $43M+ 
* Afrezza Pediatric study  
   completion will upsurge sales  
    in this market!

$MNKD 

﻿Afrezza

First ten weeks of this year = $18.83 million 

First ten weeks of last year = $14.05 million

which represents 33.95% growth year-over-year

Plus, by then MNKD may have another large revenue stream and potentially others in the works.

$MNKD 
With the company being in the best position it ever has been as revenues continue to increase quarter over quarter it won’t take long before we are sitting at a new 52 week high! Cheers!🍸

Revenues are going to increase significantly.

$MNKD sustainable growing revenue streams…only a matter of time!

* UTHR has the highest rev &amp;  
    most profitable year ever  
    owing to Tyvaso DPI (T-DPI)!

They LOVE the CEO &amp; he can do no wrong. ..

$MNKD Long &amp; Strong as long as it takes.

market

That same pattern happened in October and the market had a decent run up.

The only thing I am confident about is its going to be much higher going into next year regardless of the market.

$MNKD holding up well in this bear market

$MNKD Well the markets are certainly impressed with the 950 Afrezza scripts. GO!!!

$MNKD Regardless of today or maybe even the next few months, MNKD has a lot of positives that should drive it higher when the market stops throwing out the baby with the bathwater.

Top Stocks matching your search for "finance fda"

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ARDX

Ardelyx Inc

23.58%

$3.35 - $4.14

SLS

SELLAS Life Sciences Group Inc

-63.99%

$3.61 - $1.30

Dec, 13, 2022

Nov, 5, 2022

Divihomes is Now Live

MNKD

Mannkind Corp

-21.71%

$5.25 - $4.11

Dec, 1, 2022

ARDX

Ardelyx Inc

23.58%

$3.35 - $4.14

SLS

SELLAS Life Sciences Group Inc

-63.99%

$3.61 - $1.30

Dec, 13, 2022

Nov, 5, 2022

Nov, 2, 2022

Sep, 30, 2022

MNKD

Mannkind Corp

-21.71%

$5.25 - $4.11

Dec, 1, 2022