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Nymox Pharmaceutical Corporation (NYMX)

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1.4600-0.0900 (-5.81%)
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  • A
    ARC
    Swiss drugmaker Novartis AGhas received breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental treatment for advanced castration-resistant prostate cancer, the company said on Wednesday.
  • l
    lola
    Worth posting again…

    Make sense? I think so…

    2/23/2020
Nymox announces publication on long-term trial results after fexapotide triflutate treatment in early stage prostate cancer 
    • Nymox Pharmaceutical announced that a new peer review report was published today in the World Journal of Urology, documenting the long-term clinical trial results after Fexapotide Triflutate treatment for early stage prostate cancer.
    ◦ Note NYMX announced top-line 5-year results from a study of Fexapotide Triflutate with biopsy confirmed diagnosis of T1c prostate cancer in January 2018 (see linked comments)
    • The Fexapotide (FT) study was started in 2012 and enrolled 147 men with localized Gleason Grade 6 T1c prostate cancer at 28 U.S. clinical investigation sites.
    ◦ Patients were followed with clinical and laboratory evaluations and regular periodic prostate biopsies for up to 5 years.
    ◦ Important clinical highlights from the study include: FT treatment reduced cancer progression (-67.7%) compared to controls (3 years, FT 15mg, p<.02, pooled FT p=.0265) and also reduced (-54.7%) the incidence of surgery, radiotherapy or chemotherapy (4 years, FT 15mg p<.02; pooled FT p=.0374).
    ◦ At 4 years the incidence of surgery, radiotherapy or chemotherapy with increased Gleason grade was significantly reduced (FT 15mg -73.3% p=.0059, pooled FT p=.0064).
    ◦ Results for the high dose (FT 15mg) were superior to the lower dose (FT 2.5mg).
    ◦ Safety data showed no serious adverse events related to FT during the study.

    4/15/2019
Nymox Pharmaceutical Corp provides update on 15-April meeting with the FDA
    • The company announced that it has held its pre-New Drug Application (NDA) Chemistry Manufacturing and Controls (CMC) meeting with the FDA regarding its lead product candidate Fexapotide Triflutate, a novel prostate injectable developed for the treatment of enlarged prostate (Benign Prostatic Hyperplasia, BPH). The purpose of the 15-Apr meeting was to discuss the CMC data package for Fexapotide, an important regulatory requirement prior to the NDA submission. Nymox is pleased to report that it considers the meeting was constructive and positive. The authorities did not raise any serious or unexpected issues with regard to Nymox’s CMC data package, which was submitted prior to the meeting.
    • Mark Staples, Nymox’s VP of Chemistry, Manufacturing and Controls, commented: “We are pleased with the outcome of this important meeting and the feedback we got from the Agency. We believe that the Chemistry, Manufacturing, and Quality Control sections of our NDA filing in the U.S. will provide the technical knowledge base required to fully meet the safety and performance expectations for a commercial therapeutic product. We recognize the fundamental importance of the CMC contribution to an NDA filing and, therefore, consider this meeting an important milestone in our efforts towards successful filing of the NDA for Fexapotide for BPH in the U.S. later this year.”

    10/8/2018
Nymox reports new long-term results from ph.IIb NX03-0040 Fexapotide study in low grade localized prostate cancer
    • All patients in the 78 month study had greater than or equal to 56 months from the time of enrollment, with a range of 56 to 78 months.
    • After 78 months, the data shows that men who received the high dose Fexapotide 15mg single dosage treatment had a 73% reduction in the need for surgery or radiotherapy associated with much more favorable biopsy Gleason results compared to controls (p=.0024).
    • There were 5% patients in the entire Fexapotide group (high dose and low dose) who showed increase in their Gleason primary pattern grade in the 78 month study, compared to controls where the incidence of grade 4 or higher primary pattern was 26.3%, a reduction of 81% (p=.0037).
    • The Company expects to publish full details from this prostate cancer trial in peer review publications as well as participation in upcoming scientific presentations.
  • l
    lola
    The results speak for themselves….

    • Nymox Pharmaceutical announces that new Phase 3 prospective randomized clinical trial results have confirmed that patients who received fexapotide as their initial treatment for BPH (prostate enlargement) had superior efficacy results as early as 10 days compared to control patients who received placebo or who had prior history of other BPH medical treatments. These new Phase 3 results indicate that fexapotide in these trials was highly efficacious for first-line treatment of BPH.
    • These findings are from analysis of the company's extensive U.S. Phase 3 trials NX02-0017, NX02-0018, NX02-0020 and NX02-0022 including long-term follow-ups that were undertaken from 2009 to 2016. The present prospective randomized trial results are new findings.
    • 390 treatment naive patients with no past treatments for BPH had improvements greater than previously treated BPH patients as early as 10 days post-treatment (p<.02) and at one month (p<.04), 3 months (p<.001), six months (p<.001), one year (p<.01) and at long-term (3.5 years) follow-up (p<.003). The levels of mean change from baseline pre-treatment ranged from 6.49 to 8.88 points improvement in the AUA BPH Symptom Score.
    • These previously untreated patients who received a single injection of fexapotide 2.5 mg also had statistically significant superior improvements compared to patients who received placebo treatments, as early as 10 days post-treatment (p<.001) and at several time points also including the long-term (3.5 years) follow-up extension (p<.001).
    • NYMX's lead drug fexapotide has been found after 7 years of prospective placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease.
    • The study analyzed all cases of prostate cancer that were subsequently diagnosed.
    • The expected rate of new prostate cancer in the U.S. general male population in this age group is in the 5-20% range after 7 years. In the BPH population in published large trials of drugs for the prevention of prostate cancer, the incidence of new prostate cancer cases after 4-7 years has been reported in major studies to be 20-25%.The new data analysis from the Nymox fexapotide study has now shown the statistically significant and very low incidence of 1.3% for prostate cancer in this comparable fexapotide treated BPH population.
    • By comparison, for example in a population of patients with erectile dysfunction treated with PDE5 inhibitor drugs after 4 years the rate of subsequent prostate cancer was 19.5% (and 22.7% in controls) as recently reported in a large U.S. study published in the Journal of Urology (Volume 196; 3, 2016). The quoted study was in a population of middle aged and elderly men without prostate cancer, similar to the Nymox study population
  • l
    lola
    Make sense? I think so…

    2/23/2020
Nymox announces publication on long-term trial results after fexapotide triflutate treatment in early stage prostate cancer 
    • Nymox Pharmaceutical announced that a new peer review report was published today in the World Journal of Urology, documenting the long-term clinical trial results after Fexapotide Triflutate treatment for early stage prostate cancer.
    ◦ Note NYMX announced top-line 5-year results from a study of Fexapotide Triflutate with biopsy confirmed diagnosis of T1c prostate cancer in January 2018 (see linked comments)
    • The Fexapotide (FT) study was started in 2012 and enrolled 147 men with localized Gleason Grade 6 T1c prostate cancer at 28 U.S. clinical investigation sites.
    ◦ Patients were followed with clinical and laboratory evaluations and regular periodic prostate biopsies for up to 5 years.
    ◦ Important clinical highlights from the study include: FT treatment reduced cancer progression (-67.7%) compared to controls (3 years, FT 15mg, p<.02, pooled FT p=.0265) and also reduced (-54.7%) the incidence of surgery, radiotherapy or chemotherapy (4 years, FT 15mg p<.02; pooled FT p=.0374).
    ◦ At 4 years the incidence of surgery, radiotherapy or chemotherapy with increased Gleason grade was significantly reduced (FT 15mg -73.3% p=.0059, pooled FT p=.0064).
    ◦ Results for the high dose (FT 15mg) were superior to the lower dose (FT 2.5mg).
    ◦ Safety data showed no serious adverse events related to FT during the study.

    4/15/2019
Nymox Pharmaceutical Corp provides update on 15-April meeting with the FDA
    • The company announced that it has held its pre-New Drug Application (NDA) Chemistry Manufacturing and Controls (CMC) meeting with the FDA regarding its lead product candidate Fexapotide Triflutate, a novel prostate injectable developed for the treatment of enlarged prostate (Benign Prostatic Hyperplasia, BPH). The purpose of the 15-Apr meeting was to discuss the CMC data package for Fexapotide, an important regulatory requirement prior to the NDA submission. Nymox is pleased to report that it considers the meeting was constructive and positive. The authorities did not raise any serious or unexpected issues with regard to Nymox’s CMC data package, which was submitted prior to the meeting.
    • Mark Staples, Nymox’s VP of Chemistry, Manufacturing and Controls, commented: “We are pleased with the outcome of this important meeting and the feedback we got from the Agency. We believe that the Chemistry, Manufacturing, and Quality Control sections of our NDA filing in the U.S. will provide the technical knowledge base required to fully meet the safety and performance expectations for a commercial therapeutic product. We recognize the fundamental importance of the CMC contribution to an NDA filing and, therefore, consider this meeting an important milestone in our efforts towards successful filing of the NDA for Fexapotide for BPH in the U.S. later this year.”

    10/8/2018
Nymox reports new long-term results from ph.IIb NX03-0040 Fexapotide study in low grade localized prostate cancer
    • All patients in the 78 month study had greater than or equal to 56 months from the time of enrollment, with a range of 56 to 78 months.
    • After 78 months, the data shows that men who received the high dose Fexapotide 15mg single dosage treatment had a 73% reduction in the need for surgery or radiotherapy associated with much more favorable biopsy Gleason results compared to controls (p=.0024).
    • There were 5% patients in the entire Fexapotide group (high dose and low dose) who showed increase in their Gleason primary pattern grade in the 78 month study, compared to controls where the incidence of grade 4 or higher primary pattern was 26.3%, a reduction of 81% (p=.0037).
    • The Company expects to publish full details from this prostate cancer trial in peer review publications as well as participation in upcoming scientific presentations.
  • B
    Boomer
    I'm starting to feel NYMOX drops clinical trial crumbs to make sure Investors don't Bail.
    Bearish
  • B
    Bruce White
    Action today is nothing more than a dead cat bounce. Or as Bob would say noise
  • l
    lola
    Wtfis….

    Science wins in the end. You can’t refute the data. It works. And provides a major prostate cancer benefit. Most important- it’s extremely safe and zero side effects.
  • B
    Bob
    I think Robo has finally figured this out.
  • M
    Maximum
    I just got a call from some broker out of New York pushing this stock.
    Is this a pump and dumper or legit?
  • B
    Bob
    robo.. now ya talking 2 million volume
  • B
    Bruce White
    Hey Bob what’s you saying now?
  • B
    Bob
    Robo..whats going on?
  • i
    itaintwhatyou
    Was Robinsons share purchase a vote of confidence or a sly move to pump up the share price for the offering? It doesn’t matter. They have the funds to continue and file ($2.9 million FDA NDA fee). It appears the go it alone strategy is still in place which suggests confidence in approval. If the investment community truly believed this was going nowhere the funding would have been at $.25 / share with a gazillon warrants. Somebody just covered their big short position or plans to make money at $2.18 a share - time will tell. I expect this to be the last dilution (other than Averbacks sweet share compensation package) prior to submission - approval.

    Let’s just hope the plan is to sell or license on approval. It’s possible to get a max $ offer if they submit an airtight application that fully establishes the far superior treatment results for BPH including prostate cancer observed benefits. This proof of safety and effectiveness is also the ultimate sales pitch to the marketplace. This has been a long road but everything rides on the filing so they need to get it right. I’ve stopped asking when we are going to get there.
  • B
    Bob
    Average volume. Nothing to see here. You will know there is trouble if the stock price goes down with high volume.
  • B
    Bob
    I hear you Stan. In my mind, however, it doesn't matter if they are delisted at this point. Its a make or break. If Fexo is not approved or approvable we lose our investment. if they file and its approved we make a killing. There is really nothing in between with NYMX.
  • B
    Bob
    see Robo.. noise
  • A
    ARC
    Nymox Pharmaceutical (NYMX) said Thursday it will be filing for marketing approval of Fexapotide Triflutate to treat benign prostatic hyperplasia on or before Sept. 15.
    The drug candidate has completed late-stage development in more than 70 clinical centers in the US, the drug maker said.
  • A
    ARC
    SEC FORM 4
    archive.fast-edgar.com
  • S
    Stan
    Two weeks til the next update, and two things are impacting the stock. First, the Russell 2000 reconstitution is in June, and the first ranking day is May 7. At this market cap, the stock will drop out of the small cap index. I think dealers are already positioning for that, and that's why the stock has been weak. On the positive side, Fex can easily be a $5B-$10B+ drug with only 10%-15% of a market with poor alternatives. I think any hint of real progress should revalue the stock at multiples of today's price, exacerbated by those same dealers scrambling to cover. I bought a little last week and still adding.
  • B
    Bob
    Otherwise the narrative is still on place. Hold..