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.
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Biotechnology
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.
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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.
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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.”
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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
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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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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
Sorrento could surge 275% in 2021, Here is why...H.C. Wainwright analyst Ram Selvaraju rates SRNE a Buy along with a $30 price target, which implies a 275% upside from current levels.
Factors behind the optimistic outlook:
1. Sorrento has a stake in two cell-based immunotherapy companies that could “drive value in Sorrento shares over the coming months.”
2. the analyst highlights Sorrento’s “burgeoning portfolio of assets spanning three distinct therapeutic areas (non-opioid pain management, oncology and COVID-19).”.
3. two rapid COVID 19 detection tests; COVI-STIX, for which the company filed for Emergency Use Authorization (EUA) in the U.S. in December, and COVI-TRACE, which Selvaraju claims could come in handy at any mass gathering event.
“We believe that the incentive to facilitate the large-scale and indeed ubiquitous deployment of the COVI-TRACE test is extremely high and governments worldwide may seek to implement this in their respective regions,” the 5-star analyst opined.
4. Other Covid-19 candidates include COVIGUARD - a SARS-CoV-2 neutralizing antibody, COVI-AMG - an affinity-matured version of the COVIGUARD neutralizing antibody, a neutralizing antibody cocktail named COVI-SHIELD and COVIDTRAP, an ACE2 receptor decoy, intended to imitate the mammalian ACE2 receptor that acts as the primary portal for the SARS-CoV-2 virus to penetrate human cells.
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Oppenheimer Analyst Says buy, following of some positive dataOppenheimer 5-star Analyst Says BioNano Genomics is ready to Execute in 2021.
the latest move was decidedly upbeat. In Wednesday’s session, the stock took off to the tune of 40% following the publication of some positive data.
article which made side-by-side comparisons between Bionano’s optical genome mapping platform Saphyr and PacBio's HiFi chemistry revealed that Saphyr had the upper hand on several metrics.
Across 32 different human genomes, PacBio technologies found only 72% of the large SVs (structural variants) that Bionano’s optical genome mapping (OGM) detected.
Saphyr was also found to be better at locating indels in regions correlated to neurodevelopment.
Additionally, Saphyr appears to be more cost effective. The platform’s estimated cost of $500 per genome coming in far below the $10,000-20,000 per genome when HiFi and SMRT sequencing are put into action.
Oppenheimer’s Kevin DeGeeter believes the data should help Saphyr make further inroads in the “large SV research market.” The analyst views 2021 “largely as an execution year.”
We expect the data to support broader adoption of Saphyr for de novo sequencing and research applications. the 5-star analyst said.
“Furthermore, we expect 2021 to be an important year for adoption of Saphyr for clinical cytogenetics market based on a series of positive recent publications... Based on our current assessment of the competitive landscape, we do not believe long-read sequencing technologies can replicate Saphyr's performance and cost structure for digital cytogenetics testing.”
Accordingly, DeGeeter reiterated an Outperform (i.e. Buy) on BNGO shares, along with a $1.5 price target. The implication for investors? Strong upside of 113% .
Two other analysts have thrown the hat in with a BNGO review recently, one saying Buy and the other recommending a Hold -- all add up to a Moderate Buy consensus rating. Meanwhile, the average price target stands at $1.42, implying gains of 101% could be in the cards over the next 12 months.
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FDA identifies "Assay Kit" able to detect SARS-CoV-2 mutationsU.S. FDA Lists Applied DNA’s Linea™ COVID-19 Assay Kit as 1 of Only 2 EUA-Authorized Tests Able to Detect S-Gene Mutation Found in SARS-CoV-2 U.K. Variant (B.1.1.7)
(FDA) published a safety communication (the "Communication") that identifies the Company’s Linea™ COVID-19 Assay Kit (the "Assay Kit") as one of only two tests marketed under the FDA’s Emergency Use Authorization (EUA) that are potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7). According to recent publications, the B.1.1.7 variant has been identified within the United States and may be associated with an increased risk of transmission of the virus that causes COVID-19.
Based on analysis conducted by the Company and FDA, one of the two S-gene targets (S1 and S2) of the Assay Kit has significantly reduced sensitivity in the presence of certain S-gene mutations, including a mutation found in the B.1.1.7 variant.
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ATRA growth potentialAtara Biotherapeutics , Inc. (Nasdaq: ATRA ), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T- cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases
"Atara made significant progress in 2020 and is well-positioned for a strong 2021," said Pascal Touchon, President and Chief Executive Officer of Atara. "As the most advanced allogeneic T-cell therapy company, nearing initiation and subsequent completion of a rolling BLA for our lead product candidate tab-cel®, we are making key investments in commercial infrastructure to ensure delivery of this potentially transformative therapy to patients in dire need. Atara also anticipates significant progress throughout 2021 on ATA188 for progressive MS with multiple data read-outs and, after recent productive interactions with the FDA, is poised to expand enrollment in the RCT and conduct an interim analysis in H1 2022."
