Lexaria Provides Guidance on Upcoming R&DLexaria Bioscience Corp. Announces Uplisting to Nasdaq Capital Market and Pricing of $9.6 Million Upsized Public Offering
Lexaria also announced the pricing of an underwritten public offering (the "Offering") of 1,828,571 units, each unit consisting of one share of common stock and one warrant to purchase one share of common stock at a public offering price of $5.25 per unit (all prices in US$).
The shares of common stock and warrants comprising the units are immediately separable and will be issued separately, but will be purchased together. The warrants have an exercise price of $6.58 per share, are immediately exercisable and will expire five years following the date of issuance.
The Company has granted the underwriter a 30-day option to purchase up to an additional 274,285 shares of common stock and/or warrants to purchase up to 274,285 shares of common stock.
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Lexaria Provides Guidance on Upcoming R&D
Lexaria recently closed an oversubscribed financing of US$11 million that has greatly enhanced the Company's ability to conduct applied R&D designed to evidence effectiveness of its patented DehydraTECHTM drug delivery technology across multiple classes of bioactive substances or drugs. In the weeks to come, Lexaria expects to announce many new studies designed to provide initial evidence expected to support further study and commercial exploitation. All studies referenced within this press release are fully funded from existing Company resources.
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Biotehnology
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.
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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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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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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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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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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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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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DBV Technologies rally on Positive FDA CommunicationDBV Technologies Spikes on Positive FDA Communication
DBV Technologies received positive responses from the U.S. Food and Drug Administration regarding its application for a peanut allergy treatment.
The U.S. FDA provided type A meeting requests to the questions the French company submitted in October following its receipt of a complete response letter in connection with its biologics license application (BLA) for Viaskin Peanut DBV712, its once-daily epicutaneous patch to treat peanut allergy in children ages four to 11.
"We are very encouraged by the positive feedback received from the FDA, and we appreciate the clarity provided," said Daniel Tassé, CEO of DBV Technologies. “We look forward to working with our investigators, clinical trial sites, and key stakeholders as we continue in our development of investigational Viaskin Peanut."
DBV says it will address details about a new human factor validation study and additional chemistry, manufacturing and controls data in subsequent communication with the FDA.
"We intend to advance a remediation plan for Viaskin Peanut and work closely with FDA to review protocols and re-file our BLA as soon as possible, so that we can bring Viaskin Peanut, if approved, to patients suffering from peanut allergies," Tassé said.
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Full Commercial Launch of Tigereye(TM) Image-Guided CTO CrossingAvinger Initiates Full Commercial Launch of Tigereye(TM) Image-Guided CTO Crossing Catheter
With the initiation of full commercial launch, current and prospective accounts throughout the US and Germany are now able to order the Tigereye device.
During the fourth quarter of 2020, Avinger conducted a limited launch at 12 clinical centers in the U.S. and Germany. Approximately 50 CTO cases were successfully performed, showcasing Tigereye's advanced clinical capabilities and excellent product reliability in a variety of lesion types and settings.
The limited launch program demonstrated Tigereye's strong clinical results and efficiency across a wide range of PAD cases
"We believe full commercial availability of the Tigereye device will be an important contributor to expanding our revenue growth opportunities in 2021, both in terms of attracting new Avinger user sites and supporting higher utilization per site,"
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Sale of Manufacturing Operations and Global Supply AgreementAcorda Therapeutics Announces Agreement for Sale of Manufacturing Operations and Long-Term Global Supply Agreement for INBRIJA®, Corporate Restructuring, and Enters into "At The Market" Offering Agreement
$80 million up-front payment will substantially increase cash balance
Sale, restructuring and other operating expense reductions will reduce annual operating expenses by approximately $40 million
Total 2021 non-GAAP operating expense guidance expected to be $130-$140 million1
At The Market (ATM) offering allows the sale of common stock at aggregate value up to $15.25 million
Supply agreement will ensure uninterrupted supply of INBRIJA (levodopa inhalation powder) to people with Parkinson’s
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BIOLASE Announces Agreement With DSO Dental Care AllianceBIOLASE Announces Agreement With DSO Dental Care Alliance To Expand Laser Adoption In Dental Offices Across The United States
BIOL announced an agreement with Dental Care Alliance (DCA), one of the largest dental support organizations (DSO) in the United States with more than 330 affiliated practices in 20 states, to expand laser adoption and hands-on training programs in targeted geographies. The Company expects the agreement to lead to a rollout across all DCA offices in 2021.
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This NCNA Penny Stock Could Surge Over 300%, Say AnalystThis NCNA Penny Stock Could Surge Over 300%, Say Analyst
NuCana uses a phosphoramidate chemistry technology called ProTide to create a class of drugs that will surmount the limitations of the existing nucleotide analogs behind many chemotherapy drugs. NuCana’s ProTides have already been used in Gilead’s antiviral drug Sovaldi.
In May of last year, NuCana announced the restart of its Phase III trial on Acelarin, the drug candidate furthest along the company’s pipeline, as a treatment for biliary tract cancers. The study encompasses over 800 patients in 6 countries and is currently ongoing. In November, the company published data described as ‘encouraging’ from the Phase Ib study of the same drug.
While Acelarin is the flagship drug in the pipeline, NuCana has two other prospects under development. NUC-3373 is in Phase I trial as a treatment for solid tumors and colorectal cancers, and NUC-7738 is a second pathway under investigation for applications to advanced solid tumors. Of these three, the colorectal study is the farthest advanced.
5-star analyst Robyn Karnauskas sees the pipeline as key to NuCana’s investor potential.
“We believe investors have overlooked the fact that NCNA is a platform Company that we believe is validated, as defined by the production of clinical products. We like that it has brought 3 products to the clinic, including one novel drug and two improved cornerstone chemos. The data suggest to us that the platform works and can produce better chemos While investors are mostly focused on Acelarin, we believe investors should also focus on NUC-3373, another core to our platform-based thesis that has data expected in 1H2021,” Karnauskas noted.
To this end, Karnauskas puts a $22 price target on NCNA, suggesting the stock has room for 384% growth ahead of it, along with a Buy rating.
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T2SARS-CoV-2™ Panel can detect multiple variants of the SARS-CoVT2 Biosystems T2SARS-CoV-2™ Panel Proves Effective Amid Global Rise in Variants of the SARS-CoV-2 Virus
Panel can detect multiple variants of the SARS-CoV-2 virus, including those most recently identified in the United Kingdom, South Africa, and the U.S.
T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95 percent and specificity of 100 percent.
The T2SARS-CoV-2 Panel provides results in under two hours utilizing an upper respiratory swab sample. The test runs on the Company’s FDA-cleared and fully-automated T2Dx® Instrument, which is capable of performing seven tests simultaneously and up to sixty samples per day.
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Day Traders Lighting Up Reddit Spur Rally in TransEnterixDay Traders Lighting Up Reddit Spur Rally in Tiny Health Stock TRXC
The stock has surged about 180% since the start of the new year. Today’s trading volume was more than 13 times normal. The penny stock garnered a mention in several Reddit forums over the past few days, with one user comparing it with the roughly $95 billion market-cap leader in surgical robotics, Intuitive Surgical Inc.
TransEnterix markets the Senhance surgical system, cleared by the U.S. Food and Drug Administration in 2017. According to the device-maker in an update last week, 10 of the systems were installed in 2020. The Morrisville, North Carolina-based company said it ended 2020 with $17.5 million in cash and equivalents, enough to keep the company afloat into the third quarter.
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