TYME Granted U.S. Patent Claims Treat COVID-19 InfectionsTYME Granted U.S. Patent Claims Covering Use of TYME-19 to Treat COVID-19 Infections
TYME announced that it has received notification that the United States Patent and Trademark Office has granted additional patent claims related to the Company’s metabolomic technology platform. The patent, U.S. Patent No. 10,905,698, is directed to methods for treating COVID-19.
Unlike immune therapies that depend upon the structure of the external virus coat of COVID-19 where the therapy directs its attack, we believe TYME-19 is agnostic to this structure and any mutations to the viral coat.
TYME intends to initiate the appropriate clinical trials to substantiate the safety and efficacy of TYME-19.
TYME-19 is an investigational compound that is not approved in the U.S. for any disease indication.
finance.yahoo.com
Biotechnology
Will ARGX break out ascending channelWill Argenx be Wall streets next Biotech unicorn? I am extremely bullish!
Biotech is booming business. Monoclonal antibodies are revolutionizing pharma industry.
Again great news for Argenx.
01feb2021
launches new global offering to raise funds after 'Go' decisions for CIDP treatment trials
www.argenx.com
www.argenx.com
02feb2021
Argenx raises $1 bln
www.argenx.com
statement showing their product is might be much better than competitors
www.argenx.com
Products are yet to be approved by FDA.
Current products that are currently in clinical trials are:
Efgartigumod
Phase 3 trials submitted for Mystenias gravis/MG (1.4 million patients worldwide)
Phase 3 trials ongoing for Immune Thrombocytopenia/ITP (200 thousand patients worldwide)
Phase 2 trials ongoing for Chronic inflammatory Demyelinating polyneuropathy/CIDP (300 thousand patients worldwide)
Phase 2 trials ongoing for Pemphigus Vulgaris/PV (200 thousand patients worldwide)
This products aims to treat over 2 million patients worldwide. IF this products proves to have a high enough efficacy Argenx wil immediately have hit the jackpot.
Cusatuzumab (in cooperation with J&J)
Phase 2 trials ongoing for Accute Myeloid Leukemia (AML) (incidence 4.3 to 100.000 and a death rate 2.8 to 100.000 which is extremely high)
At some point in our life we all have been confronted with cancer. Sayings like 'it always has to happen to the best of us' don't exist for nu reason. Curing cancer isn't only a billion dollar quest(ion). It's a matter of life and death.
Phase 2 trials ongoing for Higher-risk Myelodysplastic Syndromes (MDS) (approximate prevalence op 150 thousand people affected worldwide)
Cusatuzumab again might work out to become a flagship product product for Argenx.
Argenx pipeline products show immense promise. The company's market cap is still on the low side compared to other pharma companies with working products. Possible upside to be a multiple of the current market cap.
Current market cap. $16.695bln as of 03feb2021
Compared to other biotech companies as of 03feb2021
Alexion Pharmaceuticals $33.84 bln
Regeneron: $52.41 bln
Vertex Pharmaceuticals $54.84 bln
Novo Nordisk $167.60 bln
If Argenx keeps doing great, FDA approves efgartigumod and stock price remains in this ascending channel Stock will double within 2 years time.
ARGX might even break out above this channel coming days
Why SELLAS Life Sciences Is Surging Premarket?Why SELLAS Life Sciences Is Surging Premarket?
SELLAS Life Sciences is captivating investors thanks to its late-stage cancer vaccine
Thanks to some news in December in the biopharma space, SLS stock is racing higher. So what was that news? And what else do you need to know?
its leading candidate Galinpepimut-S is making its way through Phase 3.
This immunotherapy targets the Wilms Tumor 1, which is the leading cancer antigen. Essentially, the company believes that this therapy, which is given via vaccine, reduces the immune response in a patient and has the ability to delay the relapse of cancer. Although SELLAS Life Sciences is testing it for a variety of cancers, it is currently in Phase 3 trials for acute myeloid leukemia.
This lead candidate is where the massive move in SLS stock comes from.
Importantly, SELLAS Life Sciences had some big news of its own in december. While its leading immunotherapy candidate remains in clinical trials, it entered a license agreement with China-based 3D Medicines. Through this deal, 3D Medicines will handle developing and commercializing Galinpepimut-S in mainland China, Hong Kong, Taiwan and Macau. According to a company press release, this could net $202 million in license fees for SELLAS. It also could bring an upfront payment of $7.5 million sometime this quarter.
it looks like another company is responsible for the move in SLS stock.
What do I mean? Well, in december we saw a major rally in Greenwich LifeSciences (NASDAQ:GLSI). Ahead of a conference, the company shared promising Phase 2b data on its breast cancer immunotherapy. Importantly, Greenwich LifeSciences is evaluating GP2 as a therapy for patients who have already undergone surgery for breast cancer. And according to the report yesterday, GP2 has reduced the recurrence rate of cancer in trial participants to 0%.
How does this tie into SELLAS Life Sciences? Well, GP2 and Galinpepimut-S are both unique immunotherapies that rely on vaccination as a delivery method. Essentially, both treatments are cancer vaccines. Both treatments are also quite innovative, representing potential advancements in the realm of cancer care. This means that with a more than 2,000% rally from GLSI stock, many investors may be rooting for the same with SLS.
Remember though, this is a tiny company that must continue to navigate clinical trials. Keep an eye on SLS stock, but proceed with caution.
100% Survival Achieved in Osteosarcoma Lung MetastasesMoleculin Announces 100% Survival Achieved in Osteosarcoma Lung Metastases Animal Model
a preclinical study in animals demonstrated a potentially significant therapeutic benefit of Annamycin against metastatic osteosarcoma.
Computerized tomography (CT) scans demonstrated that animals treated with Annamycin exhibited significant suppression of tumor growth and not a single death was observed in the treated animals, whereas significant tumor burden contributed to the rapid death of 90% of untreated animals. While the study continues, as of day 130, the survival rate for animals treated with Annamycin was 100%, compared with only 10% for untreated animals.
Annamycin is a "next generation" anthracycline that has recently been shown in animal models to accumulate in the lungs at up to 34 times the level of doxorubicin, which may account for the 100% survival rate attained in this most recent osteosarcoma lung metastases study.
Moleculin recently announced that the FDA has allowed the Company's request for investigational new drug (IND) status in order to study Annamycin for the treatment of soft tissue sarcoma metastasized to the lungs. In addition, the FDA granted Orphan Drug Designation for Annamycin for the treatment of soft tissue sarcomas.
"We expect that one, and potentially two, clinical trials in sarcoma lung metastases should be up and running this year."
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ANVS401 Improves Cognitive and Functional Outcomes in StrokeAnnovis Bio's Lead Candidate ANVS401 Improves Cognitive and Functional Outcomes in Stroke Mice Study
data showing that a combination treatment using the Company's lead candidate ANVS401 and pifithrin after stroke improved mice locomotor activity and cognitive function more so than treatment with just one or the other agent.
While both treatments yielded improvements in locomotor and cognitive function, the combined ANVS401/PFT- treatment proved able to enhance stroke-induced endogenous neurogenesis and improve the functional recovery in stroke animals. The combined treatment also significantly improved cognitive function more than the single treatment with PFT- alone.
finance.yahoo.com
Simufilam Improves Cognition and Behavior in Alzheimer’s DiseaseCassava Sciences’ Simufilam Improves Cognition and Behavior in Alzheimer’s Disease in Interim Analysis of Open-label Study
- Patients’ Cognition Improved 1.6 Points on ADAS-Cog11 -a 10% mean improvement from baseline to month 6.
- Patients’ Behavior Improved 1.3 Points on NPI, a 29% mean improvement from baseline to month 6.
- Improvements Maintained at 6 Months -
- Results Support Advancing Simufilam into Phase 3 Clinical Program
Next Steps:
Cassava Sciences believes today’s data and prior clinical results support advancing simufilam into a Phase 3 clinical program in Alzheimer’s disease. Initiation of a Phase 3 trial remains on schedule for 2nd half 2021.
Cassava Sciences and the U.S. FDA recently concluded a successful end-of-phase 2 (EOP2) meeting for the simufilam drug development program. Details of the EOP2 meeting will be announced Q1 2021 after official FDA meeting minutes are finalized.
finance.yahoo.com
MMEDF over 3.41OTC name in the cutting-edge field of medical psilocybin is back in the consolidation zone. Can accumulate shares here or wait for the breakout confirmation to play to recent highs.
Should You Buy This Hot Reddit Stock?After GameStop's spectacular short squeeze, investors are now wondering if other heavily shorted stocks that are popular among contrarian Reddit investors, such as CEL-SCI.
As it turns out, discipline becomes paramount when the value of one's holdings goes up so high and so fast.
CEL-SCI is a development-stage biotech that is seeking to develop a novel immunotherapy treatment, Multikine, for head and neck cancer. Despite its noble goals, the company has its fair share of skeptics: Nearly 30% of its shares are shorted.
Multikine is CEL-SCI's only late-stage candidate. The experimental therapy is going through the final stages of phase 3 data collection and statistical analysis, with results expected any day. Multikine's phase 3 clinical trial has been going on for a decade, even though it was supposed to conclude in December 2015. The discrepancy between the actual and estimated trial completion time has caused CEL-SCI to become a contested stock.
All of this matters because large-cap biotechs can acquire development-stage competitors that successfully bring just one immuno-oncology therapy to market for more than $20 billion. CEL-SCI's market cap is just about $850 million, so the stock would without a doubt become a multi-bagger if it can bring Multikine past the finish line. Likewise, since it only has about $40.5 million in assets and negligible revenue, it will likely trade down to zero if Multikine disappoints.
www.fool.com
This Penny Stock NMTR Could soar 462% in 2021The company’s development pipeline features drug candidates under investigation as treatments for short bowel syndrome (SBS) and celiac disease (CeD), two conditions that are both dangerous and difficult to treat.
9 Meters’ flagship product, Larazotide, is in Phase 3 development for the treatment of CeD. CeD affects about 1% of the population, yet there are no approved therapies. Top-line data from the study is expected in the second half of 2021.
Furthermore, this past December, the company announced that it had entered an agreement with EBRIS, the European Biomedical Research Institute of Salerno, to investigate Larazotide as a potential treatment for respiratory complications due to COVID-19.
The other major drug in the company’s pipeline is NM-002, for SBS. The company has recently announced positive Phase 1b/2a results, with a measurable impact on disease symptoms from a compound that was well-tolerated by patients.
ne of these NMTR bulls is Truist’s Srikripa Devarakonda. Citing Larazotide as a key component of his bullish thesis, the analyst noted, “We acknowledge investors are likely to see a pivotal trial in a tough-to-crack Celiac disease program as high risk despite encouraging Ph2b data. We model $705M/$353M in peak unadjusted/adjusted sales and see potential upside of 400% - 1650% from positive Ph3 readout.”
finance.yahoo.com
COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 TrialNovavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial
First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants
Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK).
Novavax also announced successful results of its Phase 2b study conducted in South Africa.
Significant progress on PREVENT-19 Clinical Trial in US and Mexico
finance.yahoo.com
ADMA Technical Analysis 🧙ADMA Biologics Inc is a United States-based biopharmaceutical company. It is engaged in the manufacture, marketing and development of specialty plasma-derived biologics. The operating segments of the company are ADMA BioManufacturing segment; Plasma Collection Centers segment; and Corporate segment. The Plasma Collection Centers segment consists of three FDA-licensed source plasma collection facilities located in Georgia. The company's ADMA BioManufacturing segment reflects the company's immune globulin manufacturing and development operations in Florida.
If you understand the idea,🎯 press a thumb up! 👍 Have a question? Don't be shy to ask! 🤓 Interested to study how to analyze charts, follow me!
Acquisition of Quellis Biosciences Inc.+private placementCatabasis Pharmaceuticals Announces Acquisition of Quellis Biosciences Inc.
Acquisition Includes QLS-215, a Potential Best-in-Class Monoclonal Antibody Inhibitor of Plasma Kallikrein in Preclinical Development for the Treatment of Hereditary Angioedema
Concurrent with the acquisition of Quellis, Catabasis entered into a definitive agreement for the sale of Series X convertible preferred stock (the "Series X preferred stock") in a private placement to a group of institutional accredited investors.
Catabasis expects to use the proceeds from the private placement primarily to enable the completion of IND-enabling studies, Phase 1a, and Phase 1b/2 clinical trials for the lead program QLS-215 in hereditary angioedema (HAE), a rare, debilitating and potentially life-threatening disease.
Catabasis expects to file an Investigational New Drug application for QLS-215 in the first half of 2022 and plans to initiate a Phase 1 clinical trial with initial results anticipated by the end of 2022. Subsequently, Catabasis expects to initiate a Phase 1b/2 trial in patients affected by HAE in 2023 with initial results anticipated by the end of 2023.
About the Transactions
finance.yahoo.com
entry at 1.25?a team less than 20 works on the development of recombinant proteins for the treatment of gastrointestinal diseases.
Vistagen (VTGN): My opinion NASDAQ:VTGN This isn't financial advice (hell no). I like this stock. The company has potential. This is a nice buying opportunity in non-expert opinion. So, I'm scooping up before their phase 3 trials.
EDSA to Study Investigational Drug as Potential Rescue TheraphyEdesa Biotech to Study Its Investigational Drug as Potential Rescue Therapy
EDSA has received regulatory approval from the U.S. Food and Drug Administration (FDA) and Health Canada to add a sub-study to its ongoing Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of Acute Respiratory Distress Syndrome (ARDS) - the leading cause of death in COVID-19 patients. The sub-study will evaluate the drug as a potential rescue therapy for critically severe COVID-19 cases.
This sub-study will allow us to potentially expand the use of EB05 to critically ill patients suffering from profound, medically refractory COVID-19 respiratory failure," Dr. Nijhawan said.
finance.yahoo.com
Significant and Rapid Reduction in Hepatitis B Surface AntigenInitial Data from Ongoing Phase 1 Trial of VIR-3434 for Chronic Hepatitis B Virus Infection Demonstrates Significant and Rapid Reduction in Hepatitis B Surface Antigen
Data from the first blinded cohort of eight patients, two of whom received placebo and six of whom received a single dose of 6 mg of VIR-3434, showed that six of eight patients achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients.
Additional data will be submitted for presentation at an upcoming medical conference. A Phase 2 trial combining VIR-3434 with Vir’s HBV-targeting siRNA, VIR-2218, is expected to commence in the second half of this year.
finance.yahoo.com
the world's first Phase 3 oral insulin studyOramed Doses Patients Across Multiple Sites in Phase 3 Oral Insulin Study
Randomization of patients in the world's first Phase 3 oral insulin study conducted under FDA approved protocol
Announced today that randomization of patients in its first Phase 3 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D) is under way. The study is being conducted in accordance with U.S. Food and Drug Administration (FDA) approved protocols.
Efficacy data will become available after all patients have completed the first 6-month treatment period.
finance.yahoo.com
SYMJEPI Products Now Available in the WalgreensSYMJEPI Products Now Available in the Walgreens Prescription Savings Club, with the Lowest Prices for Epinephrine Products
ADMP) today announced that its SYMJEPI® (epinephrine) Injection products are now available to members of the Walgreens Prescription Savings Club program, for a discounted price of $99.99 for a two-pack, the lowest price offered for epinephrine products through the Walgreens Prescriptions Savings Club, and the lowest price for epinephrine devices on the market1.
finance.yahoo.com
AzurRx BioPharma Announces First Two Patients DosedAzurRx BioPharma Announces First Two Patients Dosed in Phase 2b OPTION 2 Extension Study of MS1819 in Cystic Fibrosis Patients
Due to enrollment in the initial crossover trial being ahead of schedule, we are given an opportunity to thoroughly explore optimal doses and capsule types that will help guide our future development plans for MS1819 in a Phase 3 program. In the meantime, we will continue our preparation for a successful FDA meeting later this year.”
Topline data results for this study are anticipated in Q1 2021, as enrollment remains strong.
finance.yahoo.com
AditxtScore™ Immune Monitoring Service Operational on February 1AditxtScore™ Immune Monitoring Service Will be Operational on February 1st
Company Plans to Offer Service through Channel Partners
The initial application of the platform will be AditxtScore™ for COVID-19 which has been designed to provide a more complete assessment of an individual’s infection and immunity status with respect to the SARS-CoV-2 virus.
We’re currently in discussions with labs, hospitals and other channel partners around the world interested in incorporating AditxtScore™ into their offerings.
finance.yahoo.com
Obalon Therapeutics Surges On News Of Merger With ReShape LifeObalon Therapeutics Surges 75% On News Of Merger With ReShape Lifesciences
ReShape Lifesciences Inc. to Merge With Obalon Therapeutics, Inc. to Expand Weight Loss Product Offering
ReShape Lifesciences, a weight-loss solutions company, entered into a merger agreement with Obalon Therapeutics, under which ReShape and Obalon will combine in an all-stock transaction.
Under the agreement, which has been unanimously approved by the boards of both companies, existing ReShape stockholders will have majority ownership of the combined company.
Obalon will be renamed ReShape Lifesciences Inc. and will trade under the NASDAQ ticker symbol "RSLS."
The current directors and officers of ReShape will comprise the board of directors and executive management of the combined company.
www.nasdaq.com
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Nasdaq Biotechnology vs IXICNasdaq Biotechnology Index vs Nasdaq Composite Index presented Long-, Mid- and Short-term trend.
nano-sphere health possible buypossible bullish divergence? super high risk speculation - there is a future in biotech and finding anything that will be profitable in this industry will most likely be a unicorn in the end
