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Yes that’s correct
Yes we are $$$$$
Yes it was
My fidelity shows 500 million in volume but don’t matter
Half billion traded it’s going to get crazy up in here $$$$$$
Tomorrow going to be interesting $$$
#7 breakout board
Moving up AH
It can close @.065 after it reaches .2 hahah
Bust that move already
Cmon let’s goo
SQUEEZE IT
I believe $$$$
Load up $$$$
Wow almost 100mil
Have faith
Can we get .1
Why you still here lol
Not over yet Mark it $$$$
I hope so enough selling already $$&
Wait for it then BAM $$$
Mms tricking
T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel
Source: GlobeNewswire Inc.
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel. The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.
The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx® Instrument and simultaneously detects six biothreat pathogens, including the organisms that cause anthrax (Bacillus anthracis), tularemia (Francisella tularensis), glanders (Burkholderia mallei), melioidosis (Burkholderia pseudomallei), plague (Yersinia pestis), and typhus (Rickettsia prowazekii). These pathogens have been identified as threats by the U.S. Centers for Disease Control and Prevention and identified as material biological threats under section 319-2(c)(2)(A)(ii) of the Public Health Service Act.
The T2Biothreat Panel is the first and only FDA-cleared product able to simultaneously detect these six high-priority biothreat pathogens, and the only FDA-cleared multi-target biothreat product developed and manufactured by a U.S. owned company. The U.S. clinical evaluation to support the FDA 510(k) submission included testing of the T2Biothreat Panel at MRIGlobal, a Biosafety Level 3 laboratory specializing in biothreat pathogens, and Ochsner Medical Center. The clinical evaluation assessed the sensitivity and specificity of the panel to detect targets in blood samples containing a range of bacterial concentrations. The positive percent agreement for all targets at 1-3 times the limit of detection was 100% for all targets except F. tularensis, which was 94.3%. The negative percent agreement for all six targets in healthy or febrile blood containing no bacteria was 100%.
"The FDA 510(k) clearance for the T2Biothreat Panel marks a major milestone in our collaboration with the U.S. Government, specifically Biomedical Advanced Research and Development Authority (BARDA), and our commitment to protect Americans from the consequences of deliberate or naturally occurring outbreaks of these biothreat pathogens,” stated John Sperzel, Chairman and CEO at T2 Biosystems. “With receipt of the FDA 510(k) clearance, which we believe demonstrates unparalleled sensitivity and specificity in direct-from-blood multi-target biothreat detection, we have immediately shifted our focus to commercialization of the T2Biothreat Panel, which we intend to sell to commercial markets and governments.”
If not treated promptly, infections with the pathogens included on the T2Biothreat Panel can result in mortality rates of 40-90%, according to Medical Aspects of Biological Warfare and The Center for Food Security and Public Health. In the event of a public health emergency involving biothreat pathogens, rapid and accurate diagnostic testing is expected to play a central role in achieving targeted antimicrobial treatment, improving patient outcomes, and minimizing economic impact. The T2Biothreat Panel is able to detect the six aforementioned biothreat pathogens within four hours providing clinicians with the needed information to appropriately treat infected patients.
The six biothreat pathogens detected by the T2Biothreat Panel are identified as biological threats by the U.S. Administration for Strategic Preparedness and Response (ASPR).1 ASPR engages partners through Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) activities to share information and coordinate plans and actions to ensure the nation has and can use medical countermeasures to protect Americans during disasters and emergencies resulting from known and unknown chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases.
This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50119C00053.
1. https://aspr.hhs.gov/PHEMCE/Pages/Threats.aspx
About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, the T2Bacteria® Panel, the T2Candida® Panel, the T2Resistance® Panel, the T2Biothreat™ Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Cauris™ Panel, and T2Lyme™ Panel, as well as next-generation products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers. For more information, please visit www.t2biosystems.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the ability of the T2Biothreat Panel to simultaneously detect six biothreat pathogens, product demand, the ability of the T2Biothreat Panel to protect Americans from the threat of deliberate or naturally occurring outbreaks of biothreat pathogens, and our ability to sell the T2Biothreat Panel to commercial markets and Governments, as well as statements that include the words “expect,” “may,” “should,” “anticipate,” and similar statements of a future or forward-looking nature. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406
This one is way overdue for a run IMO
Anything goes in penny land $$$$
Moleculin Announces New Positive Independent Report of No Cardiotoxicity in Annamycin
Source: PR Newswire (US)
– Annamycin continues to demonstrate no evidence of cardiotoxicity to date, now in a total of 62 subjects across three of the Company's Annamycin clinical trials
– Next generation anthracycline, Annamycin, has demonstrated both safety and promising early activity across multiple clinical studies with potential to be an effective treatment across multiple oncology indications
HOUSTON, Sept. 18, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced it has received a new independent assessment for the absence of cardiotoxicity in subjects treated with Annamycin. Data from the following subjects were made available to an expert in chemotherapy who is affiliated with a leading cancer research institute in assessing cardiotoxicity. After review of this data, the independent expert concluded that there was no evidence of cardiotoxicity:
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)
The first cohort of 3 subjects (190 mg/m2) of its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB106). clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587;
Cohort 4a (360 mg/m2) in the Phase 1B portion of the Company's ongoing U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB-107), comprised of 3 subjects. clinicaltrials.gov: NCT04887298; and
14 subjects in the Phase 2 expansion Recommended Phase 2 Dose (RP2D) (330 mg/m2) of the ongoing U.S. Phase 1B/2 MB-107 clinical trial.
This brings the total reviewed by an independent expert to 62 subjects covering 4 separate clinical trials in the U.S. and in Europe.
The data made available included left ventricular ejection fraction (LVEF) as determined by echocardiograms, ECHO strain imaging, and Troponin levels. "ECHO strain imaging" is a method in echocardiography (medical ultrasound) for measuring regional or global deformation (contraction or beating) of the myocardium (heart muscle). By strain rate imaging, the simultaneous function of different regions can be displayed and measured. Cardiac health biomarkers such as blood Troponin levels are considered an indicator of potential long-term heart damage.
"We continue to be encouraged by the potential of Annamycin, especially with the reports from this expert covering 62 subjects. This additional independent report of additional datasets provides further validation in the absence of cardiotoxicity," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Annamycin continues to establish itself as a non-cardiotoxic anthracycline, even in subjects who have received far more than the lifetime maximum cumulative anthracycline exposure established by the FDA. In fact, 53 of the 62 subjects evaluated have been taken over the lifetime maximum of 450 mg/m2 and one of them as high as 3420 mg/m2. Our growing body of positive data for Annamycin continues to bolster our confidence in our belief that Annamycin is truly a 'next generation' anthracycline, especially in light of the growing efficacy data that we have previously reported in the treatment of STS lung mets and AML. We remain focused on advancing our Annamycin development programs and ultimately, addressing the medical unmet needs of people with difficult to treat cancers and viruses."
Annamycin is the Company's next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Annamycin is currently in development for the treatment of STS lung metastases (STS lung mets) as well as both first line therapy and therapy for relapsed or refractory acute myeloid leukemia (AML), and the Company believes the drug may have the potential to treat additional indications.
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company's lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of COVID-19 and other viruses, as well as cancer indications including brain tumors, pancreatic and other cancers.
For more information about the Company, please visit www.moleculin.com and connect on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
Thinking about it
Maybe wash rinse repeat
More like a dumper
Not happening sorry
Si much for $2 lol
Ouch don’t look good here
Yeah I sold also @ .37 not liking it today Il be back if it goes lower
Creeping back up
You might be correct
On September 14, 2023, Moleculin Biotech, Inc. (the “Company”), issued a press release which announced its abstract has been accepted for poster presentation at the 2023 CTOS Annual Meeting being held November 1-4, 2023 in Dublin, Ireland
Looks good here $$$$$
Novo Integrated Sciences’ IoNovo for Kids Granted Registration Number and Regulatory Approval by Turkey’s Ministry of Health
Source: Business Wire
Partners with NOYEM Global Foreign Trade and Consultancy Inc. for Distribution in Turkey
Novo Integrated Sciences, Inc. (NASDAQ: NVOS) (the “Company” or “Novo”), today announced that its IoNovo for Kids pure iodine oral spray has been granted a registration number and received regulatory approval by Turkey’s Ministry of Health as a dietary supplement determined to be safe, effective, of high quality, and eligible for sale in Turkey. With this registration, Novo’s two IoNovo Iodine related products have full approval for distribution and sale throughout Turkey.
Novo has partnered with NOYEM Global Foreign Trade and Consultancy Inc. (NOYEM), a Turkish entity with over 25 years of experience in the sale and distribution of pharmaceutical and medical device products. Phase 1 of NOYEM’s plan provides for 3 separate distribtuion and sales channels including (i) doctors at over 100 different institutions in approximately 40 different cities across Turkey including govermental, university, and private hospitals; (ii) pharmaceutical wholesalers that serve approximately 15,000 pharmacies; and (iii) e-commerce platforms including Turkey’s largest e-commerce platform with approximately 30 million active members.
For decades, the global medical community has recognized Iodine as an essential micronutrient that assists the thyroid to produce T3 and T4 hormones needed for a healthy metabolism, immune system, increased energy levels, and cognitive development, Additionally, Iodine is known to promote healthy skin, nails, and hair. IoNovo Iodine is directly absorbed into the bloodstream through a precise oral spray dosage without interacting with the oral micro-biome or any bacteria or viruses. All of Novo’s IoNovo products are designed to be delivered via oral spray which is proven to be significantly more effective in absorption than pill or gel capsules.
About Novo Integrated Sciences, Inc.
Novo Integrated Sciences, Inc. is pioneering a holistic approach to patient-first health and wellness through a multidisciplinary healthcare ecosystem of services and product innovation. Novo offers an essential and differentiated solution to deliver, or intend to deliver, these services and products through the integration of medical technology, advanced therapeutics, and rehabilitative science.
We believe that “decentralizing” healthcare, through the integration of medical technology and interconnectivity, is an essential solution to the rapidly evolving fundamental transformation of how non-catastrophic healthcare is delivered both now and in the future. Specific to non-critical care, ongoing advancements in both medical technology and inter-connectivity are allowing for a shift of the patient/practitioner relationship to the patient’s home and away from on-site visits to primary medical centers with mass-services. This acceleration of “ease-of-access” in the patient/practitioner interaction for non-critical care diagnosis and subsequent treatment minimizes the degradation of non-critical health conditions to critical conditions as well as allowing for more cost-effective healthcare distribution.
The Company’s decentralized healthcare business model is centered on three primary pillars to best support the transformation of non-catastrophic healthcare delivery to patients and consumers:
First Pillar: Service Networks. Deliver multidisciplinary primary care services through (i) an affiliate network of clinic facilities, (ii) small and micro footprint sized clinic facilities primarily located within the footprint of box-store commercial enterprises, (iii) clinic facilities operated through a franchise relationship with the Company, and (iv) corporate operated clinic facilities.
Second Pillar: Technology. Develop, deploy, and integrate sophisticated interconnected technology, interfacing the patient to the healthcare practitioner thus expanding the reach and availability of the Company’s services, beyond the traditional clinic location, to geographic areas not readily providing advanced, peripheral based healthcare services, including the patient’s home.
Third Pillar: Products. Develop and distribute effective, personalized health and wellness product solutions allowing for the customization of patient preventative care remedies and ultimately a healthier population. The Company’s science-first approach to product innovation further emphasizes our mandate to create and provide over-the-counter preventative and maintenance care solutions.
Innovation through science combined with the integration of sophisticated, secure technology assures Novo Integrated Sciences of continued cutting-edge advancement in patient-first platforms.
For more information concerning Novo Integrated Sciences, please visit www.novointegrated.com.
Twitter, LinkedIn, Facebook, Instagram, YouTube
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, or the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts included in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by words such as "believe," “intend,” "expect," "anticipate," "plan," "potential," "continue," or similar expressions. Such forward-looking statements include risks and uncertainties, and there are important factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These factors, risks, and uncertainties are discussed in Novo’s filings with the Securities and Exchange Commission. Investors should not place any undue reliance on forward-looking statements since they involve known and unknown uncertainties and other factors which are, in some cases, beyond Novo’s control which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects Novo’s current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to operations, results of operations, growth strategy and liquidity. Novo assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. The contents of any website referenced in this press release are not incorporated by reference herein.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230913295756/en/
Chris David, COO & President
Novo Integrated Sciences, Inc.
chris.david@novointegrated.com
(888) 512-1195