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Interesting. Reduced to a 2.4% stake. Guess that'll be the last we see of them unless CFRX science can turn things around. It can happen.
https://ih.advfn.com/stock-market/NASDAQ/contrafect-CFRX/stock-news/88626941/amended-statement-of-ownership-sc-13g-a
NovAccess Global Announces Filing of Orphan Drug Application for TLR-AD1
Tue, July 19, 2022, 9:00 AM
In this article:
XSNX
+57.8947%
Accelerating on the Path Toward Immunotherapy for Glioblastoma (Brain Cancer)
CLEVELAND, OH / ACCESSWIRE / July 19, 2022 / NovAccess Global Inc. (OTC PINK:XSNX), a biomedical company developing novel immunotherapies for brain tumor patients, today announced the filing of an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for TLR-AD1, a vaccine immunotherapy for the treatment of aggressive brain cancers, including glioblastoma multiforme (GBM) and other high grade gliomas.
GBM is a form of aggressive brain cancer that annually impacts approximately 250,000 people globally and is on the rise in many countries, according to NovAccess scientists and published reports. The market data is more alarming, with GBM accounting for approximately 50% of all malignant brain cancers diagnosed in the United States each year, and more than 10,000 Americans dying from this tumor type annually. Less than 5% of people with this cancer live longer than 5-years after their diagnosis. The global GBM treatment market was estimated to be valued in excess of $2 billion in 2020, with projections for a compounded annual growth rate of more than 8% throughout the remainder of the decade.
"We are very excited to announce the filing of an Orphan Drug application for TLR-AD1 as it may lead to the granting of special status and enable the acceleration of the development of our therapies to treat multiple forms of glioblastomas," said Dr. Dwain Irvin, Chief Executive Officer of NovAccess Global. "The ODD process supports the development and evaluation of new treatments for rare diseases which is a key priority for both the FDA and for NovAccess Global. Receiving this important designation would represent a milestone in the development of TLR-AD1 and would highlight the need for potential new treatment options for patients with aggressive brain cancers which today have no immunotherapy treatment leaving only the option of highly invasive and complicated surgery."
Dr. Irvin continued, "Upon receiving ODD, the product will significantly bolster NovAccess Global's intellectual property portfolio, which presently includes the rights to U.S. patent #US9764014B2 granted under the "Cancer Antigens" category related to the "treatment of cancer using vaccination therapy." We are pleased with the progress we are making toward building out our platform for novel immunotherapy for brain tumor patients."
The FDA's Office of Orphan Products Development grants orphan designation status to investigational drugs and therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides benefits to drug developers which may include assistance in the drug development process, financial incentives to support clinical development, tax credits for clinical costs, exemptions from certain FDA fees and the potential for seven years of post-approval marketing exclusivity.
Sponsors seeking orphan drug designation for a drug must submit a request for designation to the FDA. Orphan drug designation is a separate process from seeking commercial approval or licensing. As such, the receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.
About TLR-AD1
TLR-AD1 is designed to activate anti-tumor immune responses against these brain tumors using immune-activating dendritic cells combined with the patient's own tumor proteins. The resulting dendritic cell vaccines are matured with a proprietary combination of Toll-like receptor (TLR) adjuvants to boost their immune-activating potency beyond current vaccine preparations.
NovAccess Global expects to submit an Investigational New Drug (IND) application to the FDA for TLR-AD1 by the first quarter of 2023. In advance of the IND filing, the Company expects to announce a partnership with a clinical manufacturing organization for vaccine testing and production readiness for phase I-II clinical trials of TLR-AD1.
About NovAccess Global
NovAccess Global is a biomedical company accelerating novel cancer diagnostics and therapeutics. Our goal is to discover, develop and bring to market novel and innovative medicine and medical devices to improve the quality of care for cancer and neurological patients.
NovAccess Global is currently developing a cancer vaccine therapy that enhances the patient's immune response against brain tumors. Our Company has a novel immunotherapeutic approach to treat brain tumor patients with glioblastoma multiforme, the most common adult brain tumor with a 15-month median survival after diagnosis. Our patented technology is designed to combine a dendritic cell-based immunotherapeutic approach with a unique combination of Toll-like receptor (TLR) adjuvants, TLR-AD1, to help promote an enhanced immune response against the patient's tumor. Our platform technology focuses on enhancing the patient's immune cells to fight their unique cancer by utilizing the antigens specific to the patient's tumor. The Company owns a cancer vaccine, which is a medication that stimulates or restores the immune system's ability to fight existing cancer by strengthening the body's natural defenses against the cancer cells. It is a meaningful technology that could significantly improve the quality of life and prognosis for the many people who suffer from brain tumors. For more information, please visit novaccessglobal.com.
Forward-Looking Statement
This email and its attachments contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may," "future," "plan" or "planned," "will" or "should," "expected," "anticipates," "draft," "eventually" or "projected." You are cautioned that such statements are subject to a multitude or risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in the Company's disclosures or filings with the Securities Exchange Commission and/or OTC Markets, Inc. You are further cautioned that penny stocks and stocks of smaller companies like NovAccess, Inc. are inherently volatile and risky and that no investor should buy this stock unless they can afford the loss of their entire investment. The Company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date thereof.
Investor Relations Contact:
Jordan Darrow
Darrow Associates
631-766-4528
jdarrow@darrowir.com
SOURCE: NovAccess Global Inc.
View source version on accesswire.com:
https://www.accesswire.com/708956/NovAccess-Global-Announces-Filing-of-Orphan-Drug-Application-for-TLR-AD1
Looking to head back into the .20's. Get'r done!!
$$$$$$$GET THERE $SNGX!$$$$$$$
Watching the reset. Told you this a great swing play stock.
I'm ready! Alerts set, summertime fun so no need to babysit.
Just filled a few more .1489. been accumulating over the last couple weeks.
Risk/reward is off the charts here imo. Negligible resistance thru to .25 then the fun starts thru the .30's & .40's. Cuts that, this'll be looking for the $ imo. This sees the right news? Forget the charts!!!
INPX daily
Citigroup Maintains Buy on Lexicon Pharmaceuticals, Raises Price Target to $20
6:51 am ET July 1, 2022 (Benzinga) Print
Citigroup analyst Yigal Nochomovitz maintains Lexicon Pharmaceuticals (NASDAQ:LXRX) with a Buy and raises the price target from $18 to $20.
Latest Ratings for LXRX DateFirmActionFromTo
Jan 2021WedbushDowngradesOutperformNeutral Jan 2021JP MorganUpgradesUnderweightNeutral Dec 2020CitigroupUpgradesNeutralBuy
View More Analyst Ratings for LXRX
View the Latest Analyst Ratings
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
BooDog maintains that this is still an excellent swing play bio. At least till their next data set.
Mine was in my IRA. Watching LII's and the chart for the dead cat bounce. Figure if the rest of their pipeline even has a chance it'll stll be a long time before this sees over the $ again. The data suggests that they still may be able to tweak a bit here and there and make another go of it. We'll see that possibility in a month or so.
The company plans to provide further details regarding the development of exebacase following completion of its own analysis of the accrued study data.
While I may not stick around to find out I may keep an eye on it for the future. IMO, they have a good team put together that has pretty good potential for the future.
Edit: This also on a day that the market gets the crap kicked out of it. The bounce may not be till tomorrow. Took some .54's.
News: On July 8, 2022, Synthetic Biologics, Inc. (the “Company”) was notified of the clearance of the safety evaluation period by the first patient that had been dosed in the investigator sponsored Phase 1 clinical trial evaluating VCN-01 (NCT05057715), an intravenous oncolytic adenovirus, in combination with mesothelin-directed lentiviral transduced human chimeric antigen receptor modified T cells (huCART-meso) for patients with pancreatic and serious epithelial ovarian cancers. VCN-01 was developed by Synthetic Biologics’ wholly-owned subsidiary VCN Biosciences, SL.
The Phase 1, open-label, non-randomized trial, which is the first clinical trial of VCN-01 being conducted in the US, is designed to evaluate the safety and feasibility of intravenously administered VCN-01 in combination with mesothelin-directed lentiviral transduced huCART-meso cells in a 3+3 dose design for patients with pancreatic or serous epithelial ovarian cancers. VCN-01 will be administered at a single dose of 3.3x1012 vp (cohort 1) or 1 x 1013 vp (cohort 2) followed by a single dose of 5x107 huCART-meso cells on Day 14. The trial may also evaluate the safety of a different sequence of administration for these two investigational products at the same dose levels used in cohort 1.
https://ih.advfn.com/p.php?pid=nmona&article=88593706
CFRX down 76% pre market. News after hours yesterday sent it tumbling.
It's not a dead end for them but certainly a set back. Could see a decent dead cat bounce but in todays bio world it'll take some time (a year at least imo) to stabilize for enough confidence to find the money again.
In other words, a small ouch for me. I had just started taking small bites to take a chance on interim data. A loss of a few hundred instead of a few thousand. News posted right after close and NONE of my alerts went off.
https://finviz.com/quote.ashx?t=CFRX
Right at close. Of course.
Looks like the volume is still trying. See if this can get back to the .30's, soon.
Possible $ land again too.
This could push back over $4 before the fun even begins.
LXRX daily
When only a few are even paying attention.
That's a lot of $2.50's. Hope it works!
A wee dip. This puppy is a swinger!
Catalysts getting closer here.
Clinical testing of HyBryte™ has yielded consistently positive results. It works by applying fluorescent light to topical synthetic hypericin, and in a Phase 3 study it showed a rapid treatment response in six weeks and sustained responses after twelve and eighteen weeks that produced significant improvement for half of the trial participants. Soligenix anticipates submitting a new drug application (NDA) to the FDA for HyBryte™ to treat CTCL in H2 2022.
The trials have been so effective that Soligenix is now exploring a second disease indication, with synthetic hypericin (SGX302), for the treatment of psoriasis. A Phase 1/2 pilot study was previously conducted to demonstrate proof of concept and a Phase 2a clinical trial is being initiated later this year. According to Fortune Business Insights, the global psoriasis treatment market is projected to reach nearly $40.6 billion in the next five years.
A fat taste of volume buying would be good right about here. .86
I haven't been over there in years.
“While we are keenly focused on continued enrollment in our Phase 3 trial of exebacase and the upcoming interim futility analysis from the study, we continue to amass evidence of the potential utility of exebacase against antibiotic resistant staphylococcus infections in a variety of clinical contexts,” commented Roger Pomerantz, M.D., ContraFect’s Chairman, CEO and President. “And together with our presentations at ECCMID earlier this year, these data further underpin the foundation of our direct lysin agent platform, and the potential for these agents to provide patients with meaningful improvements in clinical outcomes of antibiotic resistant infections.”
https://finance.yahoo.com/news/presentations-asm-microbe-conference-demonstrate-113000599.html
Potential continues to grow here imo.
Looks to be getting interesting here. Nice looking charts imo.
Took a bite of CFRX 2.88. HEPA looks to be basing in the .50's. Volume surge on INPX.
Happy 4th of July weekend!!
Interesting volume surge.
Awesome. For real.
Might see a bit of a short squeeze. Possibly.
Watching the LII's. The chart doesn't suggest a short squeeze imo, but it was looking like some short covering. Get this puppy back over the $$!!
Like to see this party get started!! EXCELLENT!!
I was just looking at RMED about an hour ago. Didn't look like it could cut resistance and didn't want to buy this high up. They did a split not long ago so if anything happens it could move on air pretty easily.
Nice move for EVFM!!!
It's ALIVE! Soligenix Announces Successful Protection using a Bivalent Thermostabilized Filovirus Vaccine
Thu, June 23, 2022, 7:30 AM
Bivalent vaccine provides 100% protection in non-human primates against both Sudan ebolavirus and Marburg marburgvirus
Only subunit (protein) vaccine platform shown to protect against potentially lethal Ebola and Marburg viruses
https://finance.yahoo.com/news/soligenix-announces-successful-protection-using-113000288.html
Analyst
Target Price
Stock Rating
Action
Latest Report
News
TipRanks Analyst Ratings Sorted by date: ascending
analyst
Stephen Brozak
WBB Securities
StarStarStarStarStar
target
$7.00
ranking
Buy
analystAction
Upgraded
date
15 days ago
articletooltip
Click this button to read the definition of [object Object]
analyst
Vamil Divan
Mizuho Securities
StarStarStarStarStar
target
$9.00
ranking
Buy
analystAction
Reiterated
date
a month ago
articletooltip
Click this button to read the definition of [object Object]
analyst
Roanna Ruiz
SVB Securities
StarStarStarStarStar
target
$9.00
ranking
Buy
analystAction
Reiterated
date
a month ago
articletooltip
Click this button to read the definition of [object Object]
analyst
Jason McCarthy
Maxim Group
StarStarStarStarStar
target
$9.00
ranking
Buy
analystAction
Reiterated
date
a month ago
articletooltip
Click this button to read the definition of [object Object]
analyst
Louise Chen
Cantor Fitzgerald
StarStarStarStarStar
target
--
ranking
Buy
analystAction
Reiterated
date
a month ago
article
Overall...
9 out of 10
Outperform
Watching this dip very carerfully. And taking advantage if it lets me.
Seeing a half way decent support level here on the DJIA weekly.
https://finviz.com/futures_charts.ashx?t=YM&p=w1
I think it cracks though once the Fed does its thing.
I guess we're backing the clock up. We've been here before. The worst news is always on Fridays near/after close. Especially banks and other fins.
Good luck out there!!
Watch Mondays action. Up 1200 points on the DJIA or continue the down slope.
Good thing us squirells know how to hide our nuts!!
REV may be the next dead cat bounce.
https://www.marketwatch.com/story/u-s-stock-futures-wobble-as-investors-await-cpi-data-11654849394
https://www.bloomberg.com/news/articles/2022-06-10/revlon-plunges-after-report-it-s-preparing-a-bankruptcy-filing?srnd=markets-vp
Doesn't matter. Nothing goes straight up or straight down. Even when there's heavy dilution theres still opportunity if you stick to your rules. I.E. tight stop loss. And follow your buy signals on the charts.
And don't be greedy.
Of course there's also the chance this finds a partner. Right now that chance may be worse than playing the power ball.
So 12 to 30% gains are nothing to you? This is pinky land. Who dad's pinks?
Looks playable again to me.
Makes one wonder. And I didn't even watch their presentation.
Meeting postponed. Need more votes.
https://finance.yahoo.com/news/sonnet-biotherapeutics-announces-adjournment-annual-132500222.html
Ned to double check that I voted. And certainly would be voting "NO" on the RS of course.
The right news puts this back over the $$!! :)
BXRX .74. Gets some volume it just may make a move.
BXRX daily
Here's the 1.50's. So predictable. Major dilution all the way back down.
Message in reply to:
Thinking this should go pretty quickly to the 1.55 bottom.
Good to see this! Further strengthening the pipeline!!
https://finance.yahoo.com/news/soligenix-receives-us-patent-allowance-113000570.html
The Annual Meeting will reconvene at 9:00 a.m. Eastern time on May 18, 2022 and will continue to be held virtually at www.virtualshareholdermeeting.com/BXRX2022.
$10M and now another $2M??
See if they actually finish something!
Nice work picking up the .0006's!