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Monday we should get either a filing or a PR talking about the NASDAQ compliance.
Not only that, but corneal scarring is an unmet medical need. Right now doctors can either prescribe steroid injections, or have to perform surgery. With topical eye drops it would make quality of life easier.
That's my biggest consideration for investing in RXII. They are in markets that have a huge unmet medical need.
1.) there is no drug for corneal scarring
2.) there is no drug for retinal scarring in Wet AMD patients
This company will be successful it may take some time but it will be worth it.
Monday morning should have a PR about maintaining uplisting correct? That could also be a nice boost in price. A statement from NASDAQ saying no delisting.
Should be fine. I hope all the catalysts play out well. This time we got Samcyprone phase 2 warts, RXI-109 phase 1/2 retinal scarring macular degeneration, and phase 2 scar results. Plus any potential partnerships.
Gilead has $21 billion in cash, just missed their earnings. They need a new revenue stream. CYDY is just the fix, and they could use their cash to buy it.
Nice so now we got RXII and CYDY together! Sweet
RXi Pharmaceuticals Announces Advancement of its Ophthalmology Franchise with Successful Topical Delivery of sd-rxRNA to the Cornea in an in vivo Corneal Wound Model
http://finance.yahoo.com/news/rxi-pharmaceuticals-announces-advancement-ophthalmology-110200524.html
It's good to see that nobody is shorting Rxi as much anymore, as I stated before they no longer have Tang Capital to help them short the stock. In addition, the float is much smaller now, and smart money knows not to short a low float stock. Especially one with so much news on the horizon. If all the pieces of phase 2 scar data, phase 1/2 retinal scar data, and samcyprone scar data fall into place I expect $10 to $15 afterwards
I'm waiting to see how far it pulls back and will add more accordingly. CYDY should be a winner come June. Best of luck to all
RXi Pharmaceuticals to Webcast First Quarter 2016 Financial Results on Thursday, May 12, 2016
http://www.marketwatch.com/story/rxi-pharmaceuticals-to-webcast-first-quarter-2016-financial-results-on-thursday-may-12-2016-2016-04-27
I didn't see a time line for when it is approved so don't know if the 30 days is accurate, but I did find out that FDA accepts 99.5% of compassionate use IND's filed.
Wasn't the patient nearing the end of the trial? They requested this before the patient reaches the end. Which means the decision should come before the patient is concluded with the trial.
"- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company focused on the development of new antibody therapies for combating human immunodeficiency virus (HIV) infection, announced today that it filed with the FDA a protocol for a compassionate use of PRO 140 to allow a patient who is reaching the end of the Phase 3 combination study to continue treatment with PRO 140 for an extended period of time. "
right in the press release they requested this before the patient reaches the end of the trial. If the FDA agrees to it, the patient will be able to remain on PRO 140 therapy adjunct therapy.
I agree with u, compassionate use shows that the patient is improving in quality of life, and is better off with PRO 140 instead of current HIV therapy. I see no reason why the FDA won't issue compassionate use, especially since PRO 140 is very safe to take, compared to current HIV therapies. I've listed the side effects of other HIV therapy already but they include:
Liver damage
Jaundice
Nausea
vomiting
etc.
Don't worry just load up, the June 20th conference pending good results will send this surging. Right now it will bounce back and forth until it finds footing. But the catalyst is what will drive CYDY higher.
RXi Pharmaceuticals Announces 'Biotech Spotlight' Presentation at the BioNetwork Partnering Summit
http://finance.yahoo.com/news/rxi-pharmaceuticals-announces-biotech-spotlight-110200058.html
RXi Pharmaceuticals to Present at 18th Annual TIDES: Oligonucleotide and Peptides Therapeutics Conference
http://www.marketwatch.com/story/rxi-pharmaceuticals-to-present-at-18th-annual-tides-oligonucleotide-and-peptides-therapeutics-conference-2016-04-25
Because when Rubenfield signed on board he thought the company would advance MANF, Lympro, Eltoprazine. He never saw that the CEO would switch to ESS. First of all ESS is a dermatolgoy indication what does that have to do with Neurology? Parkinson's, Alzheimer's, etc.
Ten years is way too long, I don't think that lady understood how the biotech trials work. If its in phase 2 now, and completing that in phase 2b plus phase 3 you might be looking at 4 years, tack on another year to wait for FDA review so maybe 5 to 6 years depending on progress. 10 years was an overblown statement IMO.
good for you man. I don't blame you, as you would not have recovered anything anyways. Look at this way!
Lets say theoretically someone before the first reverse split of 1 for 150 had 100,000 shares at .05 cents per share average. The first reverse split would bring your share count down to 667 shares.
Now fast forward today, then another reverse split of 1 for 150 would bring you down to 4 shares. So with 4 shares how would you hope to get your money back? If you original investment was 100,000 shares at .05 cents = $5,000. To get your money back with 4 shares the share price would have to get to $1,250 just to make your money back.
This is just to give people a perspective on how these long-term shareholders will get wiped out again in June.
Yes but you can't really blame Dr. Rubenfield, because he was probably deceived by GC as well. Matter of fact, didn't Rubenfield leave Amarantus? I know one of the higher executives left the company after they saw the complete disaster that was ensuing by Gerald. someone find me the link of director/directors leaving please.
JP I love your facts, and I hope by posting them makes you feel better inside. But we already know the company is a scam front for GC and his Father to retire comfortably. Think about this while shareholders have lost so much money, during that same time frame Gerald is living like a King. Nothing he stated would generate revenue has come true.
NuroPro?
Lympro?
Why not advance MANF? why was MANF left by the wayside for ESS? people have to think here,and the truth is that MANF may not be the science everyone had hoped for. I mean if that was as powerful as they say it was why didn't they advanced that first?
Sure now MANF is in pre-clinical stage but if they started working on it 4 years ago it would have already been in phase 1 or phase 2 by now. The company is a shell IMO to fleece investors so executives can live comfortably.
I agree if the data is really good then I expect Gilead to try and buy the company. Either that or partner with it if possible. Gilead stands to lose 44% revenue in the HIV franchise. If they don't act they will lose a lot of revenue. I don't think executives at Gilead are dumb, if they see good results at the conference they will be in talks with Cytodyn. That's a guarantee IMO.
Remember Gilead Sciences is doing 7 presentations on HIV at the conference. Pretty sure they will attend Cytodyn's presentation just to see what's up.
Also to mention the fact that HIV patients lives will be impacted as well. Think about the patients now they have to take 6 to 8 pills everyday for the rest of their lives. If PRO 140 is ultimately approved they only need to do a self injection once a week.
That means the patients can eliminate having to take pills everyday. Quality of life will also be better because of hardly any side effects as well.
Just some of the side effects. I list these major ones but there are others:
TRUVADA can cause serious side effects:
rapid heart rate, increased sweating, tremors, sleep problems (insomnia), feeling anxious or irritable;
severe diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
swelling in your neck or throat (enlarged thyroid), feeling short of breath;
weakness or prickly feeling in your fingers or toes, joint pain;
problems with balance or eye movement, trouble speaking or swallowing;
severe lower back pain, loss of bladder or bowel control;
signs of new infection such as fever, chills, skin lesions, or cough with yellow or green mucus; or
signs of liver damage - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
mild diarrhea. mild nausea or stomach pain;
headache, dizziness, depressed mood;
strange dreams;
mild itching or skin rash; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
I see 2 scenarios for getting higher.
1.) June data at conference for phase 2b adjuvant results
2.) Compassionate Use approved by FDA for patients to continue to take PRO 140.
There are others like Orphan drug status which may give a small boost. And other smaller catalysts.
If all catalysts go well I think we shall see over $2 here shortly
The data in June is new data. They haven't released it yet because they agreed to present it at a medical conference. They have been holding on to the data....
Wow another reverse split this is sad to watch. glad I don't have a position in this. I mean lets says someone held 500,000 shares originally before the first reverse split. The first time they did the 1 for 150 that would give said shareholder 3,333 shares. If they do another reverse split that would bring said example shareholder to 22 shares......
And that's if someone held that many shares 500,000 before the first reverse split. For people holding much less you will be wiped out with 0 shares.
The reason for high short interest before was because of Tang Capital. Since we don't have Tang the short interest won't be as high this time. There will still be short volume as with all biotech stocks, but not as much as when Tang was in.
Tang created the toxic short environment because every preferred share they converted on the market brought down the share price. Subsequent selling of common shares after being convered from preferred put further pressure on the price.
Now, Shortsellers don't have Tang Capital to help them ride it down. It will be riskier for them, and as you say smaller float only 6 mil shares outstanding so it will be dangerous for them in RXII.
It will be nice to get a PR on this, but I don't think the PR about a date for data will move the share price much. It's the actual data to be released for phase 3 results that will move the share price.
Plus we got many catalysts coming up anyways:
Orphan drug status for GvHD
Compassionate use acceptance by FDA
phase 2b data at conference in June
and many others.
A lot of short sellers, but holding up quite well. We shall see what happens the rest of the week. I'm more excited about the catalysts coming up in the 2nd half of this year for RXII
RXi Pharmaceuticals Fortifies its Novel RNAi Patent Portfolio with Notice of Allowance for Lead Clinical Candidate RXI-109
http://finance.yahoo.com/news/rxi-pharmaceuticals-fortifies-novel-rnai-110200185.html
Anyone catch the message from the Press release today?
"This patent protection for our novel self-delivering RNAi technology further strengthens our position to generate business and commercial development opportunities in the areas of dermal and ocular scarring as well as other fibrotic indications, such as liver fibrosis".
Look at the end the CEO says potential partnerships with other fibrotic indications such as liver fibrosis. Hint Hint hint.....
I was wondering about today's action. When they do reverse split are most investors barred from buying the first few days? Today's trading was on light volume IMO.
I agree I mean if you are a patient one weekly injection wouldn't be so bad. It is self administered and you get it over with. The rest of the week you go on with your life. You don't have to take 8 to 9 pills everyday in the morning for the whole week.
So far I see support around the $1.18 to 1.19 area. It goes up then comes back down to there. but you are right see if it holds this area before adding. It may be possible for lower entry if the support doesn't hold. I have shares I'm averaging in for long-term until June 20th conference. if Conference moves it a little and not a lot I may even add more.
RXi Pharmaceuticals to Present at the Association for Research in Vision and Ophthalmology 2016 Annual Meeting
http://finance.yahoo.com/news/rxi-pharmaceuticals-present-association-research-110200112.html
Nice news! I look forward to adding more shares before the June 20th conference results!
Three catalysts coming up 2nd half of 2016
phase 2 hypertrophic scar data cohort 3 and cohort 4 -- 6 to 9 months results
Phase 1/2 retinal scarring macular degeneration results
phase 2 samcyrpone data in Warts results
Any potential partnerships - if it can be done by the CEO
They will show the power of the platform through results, just how great those results will be? We will have to wait and see!
If the FDA were truly trying to stop them as you say, they wouldn't ever have let Cytodyn run two phase 3 SPA trials with HIV patients. The FDA welcomes new treatments that can improve patients lives when no other therapy exists. And even if therapies do exist they have more harmful toxic side effects.
After June I could see about $2 to $3 per share. Not all in the same day of the presentation and results. The uptrend should start with consecutive buying lifting the share price.
Thereafter I see positive developments such as phase 3 trial results. The CEO did say on the Conference call that in 4-6 weeks they should be able to give a timeline about when they can unblind the phase 3 results and release them. That should be another confidence booster for the share price.
Plus all the other possible catalysts such as orphan drug designation, compassionate use designation if they get it.
P.S. One more note to add. Gilead has 7 presentations at the ASM Microbe conference about HIV products. Cytodyn has one presentation about their results. If the results are more than amazing, then I can guarantee you Gilead Sciences will be watching this company like a hawk looking at its prey. After all, pending positive results this company would take away 44% of Gilead's yearly revenue stream. NO big pharma would let that happen under their watch.
MY prediction a possible partnership/buyout of Cytodyn would likely happen.
Yah its too bad MANF has been tossed aside like a basket. What happened to starting MANF in retinitis Pigmentosa? Instead the company went for burns, which has nothing to do with neurological disorders such as Alzheimer's, Parkinson's disease etc.
This company is just there to drag shareholders along so Gerald and his father can continue to have a nice paycheck IMO and live comfortably into retirement.
If that were true then the FDA wouldn't let two phase 3 trials run. Look I like good conspiracy theories myself, but that's not the case here. The FDA is allowing two phase 3 trials to run.
As for the breakthrough designation the FDA is always a cautious bunch. YOu see recently two or more biotech stocks get halted for safety issues? ADXS trial was halted for one patient death, until FDA could determine the drug didn't cause the problem.
As for Orphan Drug Status for the phase 2 GvHD trial it is a good thing that there has not been a response. If the FDA was truly not interested in granting the Orphan status they would have already rejected the application 30 days ago.
Therefore I don't agree with your statement!