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She is definitely paid and/or has an extreme negative bias towards PLX clouding her judgment. If you look at her post history, she only starts posting again when bashing PLX.
I always wonder this. I'd like to think it has to do with the sentiment of the stock. That being institutions know sentiment is low and therefore are shadow loading over long periods in preparation of a large move when sentiment is higher. Look at our recent move, the volume average was between 250-500k a day before hand.....but really who knows aha
Are you aware of the current situation with convertible notes, in terms of where the company stands in paying them off?
I’m estimating a run-up I’m starting late 2018/ early 2019. Similar to the run we had with CF (prx-110) in 2017. Honestly, I as well never expected the stock to be at this level but based on price action and volume I believe tutes are loading (high volume accumulation, low volume distribution). Overall I think Protalix will finally pass and stay above $1 in 2019.
Protalix BioTherapeutics (PLX) Granted FDA Fast Track Designation for PRX-102 (Pegunigalsidase Alfa)
Protalix BioTherapeutics, Inc. (NYSE: PLX) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pegunigalsidase alfa, or PRX-102, the Company’s plant cell-expressed recombinant, pegylated, cross-linked a-galactosidase-A candidate for the treatment of Fabry disease. The FDA’s Fast Track designation is a process designed to facilitate the development and expedite the review of drugs and vaccines for serious conditions that fill an unmet medical need.
“We are very pleased that the FDA has recognized the potential for pegunigalsidase alfa to fill an unmet need for Fabry patients,” said Moshe Manor, Protalix’s President and Chief Executive Officer. The data generated in our clinical trials of pegunigalsidase alfa thus far, as well as nonclinical data, as presented to the FDA with Protalix’s application for Fast Track designation, demonstrate that pegunigalsidase alfa has the potential to address an unmet medical need for Fabry patients, such as the prevention of renal failure, improved survivability and a positive impact on quality of life. “We believe that Fast Track designation will help facilitate our development program for pegunigalsidase alfa and may shorten the timelines to an anticipated approval, which will greatly benefit Fabry patients.”
According to the FDA, Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, the purpose being to make important new drugs available to patients earlier. A drug that receives Fast Track designation from the FDA is eligible for some or all of the following:
More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication from the FDA about such things as the design of the proposed clinical trials;
Eligibility for the FDA’s Accelerated Approval and Priority Review, if relevant criteria are met; and
Eligibility for Rolling Review, which allows a drug company to submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the BLA or NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
Fabry disease is a serious, life-threatening condition. It is a disease or condition associated with morbidity that has a substantial impact on survival, day-to-day function, and the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. Fabry disease is an X-linked multisystem lysosomal storage disorder caused by the absence or reduction of a-galactosidase-A (a-Gal-A) activity, which is a lysosomal enzyme that catalyzes the hydrolysis of globotriaosylceramide (Gb3) from oligosaccharides, glycoproteins and glycolipids. The absence or reduction of this enzymatic activity leads to the progressive accumulation of glycolipids, especially Gb3, in capillary endothelial cells, podocytes, tubular cells, glomerular endothelial cells, mesangial cells, interstitial cells, cardiomyocytes, fibroblasts, and neurons. The accumulation of glycosphingolipids (e.g., Gb3) leads to chronic pain, skin lesions, cardiac, deficiencies, and, in particular, renal involvement. End-stage renal failure and cardiomyopathy often lead to early death in Fabry patients. Fabry disease causes substantial reduction in life-expectancy, by an average of 15 years in female patients and 20 years in male patients, compared to the general population.
Pegunigalsidase alfa is currently being studied globally in three phase III clinical trials. Enrollment in each of the trials continues to progress and estimated timelines for top-line data announcements will be announced upon completion of enrollment for each individual trial.
Protalix BioTherapeutics Completes Enrollment in Phase II Clinical Trial of OPRX-106 in Patients with Ulcerative Colitis
CARMIEL, Israel, Nov. 29, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), announced today the completion of enrollment in the Company’s phase II clinical trial evaluating OPRX-106, the Company’s oral antiTNF product candidate, in patients with ulcerative colitis (UC). OPRX-106 is the Company’s proprietary plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc). When administered orally and while passing through the digestive tract, the plant cells function as a natural delivery capsule, having the unique attribute of a cellulose cell wall, which makes them resistant to degradation compared to proteins produced via mammalian cell expression systems. The Company expects to report top-line results from this study in the first quarter of 2018.
“Despite a number of approved treatments for ulcerative colitis, there remains a large unmet medical need in this patient population,” said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer. “We look forward to reporting initial results from our phase II study, which may provide proof of concept data not only for OPRX-106 in the treatment of UC, but also for our oral-delivery protein technology. If successful, OPRX-106 will be the first ever oral protein treatment, as currently there are no other oral recombinant protein treatments available.”
The phase II clinical trial is a randomized, open label, 2-arm study of OPRX-106 in 19 patients with active mild to moderate ulcerative colitis. Patients have been randomized to receive 2 mg or 8 mg of OPRX-106 protein administered orally, once daily, for 8 weeks. Key efficacy endpoints of the study, in addition to safety, include relevant disease parameters of the drug, including Mayo score and rectal bleeding.
Protalix BioTherapeutics Announces Presentation to be made at the New Horizons in Fabry Disease Conference
Oral Presentation of Long-Term Results from the Phase I/II Open-Label Extension Trial of PRX-102 for Fabry Disease
CARMIEL, Israel, Nov. 20, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX) announced today two-year results from the phase I/II open-label extension clinical trial of pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease will be presented at the New Horizons in Fabry Disease Conference taking place November 24-25 in Prague, Czech Republic.
The oral presentation titled “Enzyme replacement therapies in development – preclinical and clinical data and experience with pegunigalsidase alfa,” will be given by Prof. Raphael Schiffmann, Director, Institute of Metabolic Disease at the Baylor Research Institute, Dallas, Texas, at a session taking place on Friday, November 24 from 4:00 PM to 6:00 PM CET.
Additional details on the conference can be found at http://www.horizons-fabry.com/.
This is not good long term. They need leverage when negotiating with partners. Will delay future announcements imo......
Long wick at .62 (support & bottom) indicate reversal to me.
It bounced hard off .53 which is the 78.6% fib retrace level, using the daily close candles of 1.44 as a high and .29 as low.
Fundamentals continually improve and I will keep adding and averaging down from my .70 avg
Going to test the 200 sma, already broke the 100
Yup, this along with CF conference and Jeffries presentation on June 7th should reinvigorate public interest again!
Protalix BioTherapeutics Announces FDA Approval to Operate its Current Facility as a Multi-Product Facility
CARMIEL, Israel, June 01, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX), announced today that a Supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration (FDA) has been approved by the FDA. Approval of the sNDA allows the Company to convert its manufacturing facility in Carmiel, Israel, from a single dedicated product facility to a multi-product facility.
The facility’s current capacity can serve all of the Company’s current and expected commercial and clinical needs. The Company believes that conversion of the facility to a multi-product facility will serve the Company’s production needs for the anticipated commercialization of pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease together with the current and expected significant increase in the manufacturing of taliglucerase alfa, mainly due to the increased activities in Brazil. The Company expects that the conversion will allow the Company to realize potentially significant operational savings as it progresses towards the anticipated commercialization of pegunigalsidase alfa.
“We have been producing drug substance for our clinical trials of pegunigalsidase alfa in our facility and have already upgraded our manufacturing facility to become a multi-product facility to support the potential manufacturing of both pegunigalsidase alfa and taliglucerase alfa in a commercial scale,” said Moshe Manor, Protalix’s President and Chief Executive Officer. “Given the unique aspects of our ProCellEx® protein expression system, the conversion of the facilities did not entail substantial additional capital expenditures and will allow us to use our capital resources more efficiently in the commercial production of pegunigalsidase alfa, if approved. We are excited to have reached this milestone in our progression towards the commercialization of pegunigalsidase alfa alongside the expected increase in activities in Brazil.”
It's going to bounce off the 100-Day SMA before a new uptrend imo, bid set at .0027
Pumpers gotta pump lol
Morning BCAP, let's churn through these 2 sellers and start building a base at 3 by the end of the week #bullish
Got my 2s filled
BCAP PR OUT...HUGE VOLUME!
BCAP PR OUT...HUGE VOLUME!
Got my lotto ticket here, Berkshire you should check out BCAP aswell!!
Looking to open a starter position here Monday, what's the share structure like?
GACR HUGE MOVE! Thin!
GACR HUGE MOVE! Thin!
Looking good, nice bid support and thin up to .002, very good risk/reward at these levels
GACR Churned! Razor thin ask to .003!!
GACR Churned! Razor thin ask to .003!!
My trading platform let's me trade this today and usually they don't let me trade skulls. If it was assigned this morning then many will still be able to get in until Monday
GACR merger 600% move yesterday, multiday runner
GACR merger 600% move yesterday, multiday runner
Hoping for an opening dip to load up haha this price movement was insane
HUGE TWEET:
working on buying people out.
— Vivalive TV Official (@vivaentgroup) May 10, 2017
Intraday cup and handle setting up!
Bidding 7s, looking like a good early morning churn before an afternoon run
Every OTC stock is a joke, it's just about finding the best joke and riding the momentum lmao
Yup once we're current the chill will be lifted and more buyers can get in!
I highly doubt HempLifeGlobal would partner with a company they didn't deem would be successful....COPPERLAND IS COMING
20Mill on the bid!! Clear that 15mill on the ask and we fly
Not to mention this is all a low volume walk down, bulk of the selling is done
.0005 is the 100-Day SMA, RSI oversold, thin level 2 after .0008 and updated financials mid-May...this thing can pop at any time!!
Little to no selling at these prices, might take 2-3 days to churn through those 8s and then she's clear
Great news!! Funds get in Wednesday Adding more!!