Long The High Risk Psilocybin Mushroom Therapy Secular Bull RunNot looking for an immediate turn around because Macro-Market conditions and retail risk tolerance is severely negative right now. However, this sector has huge potential to be a bullish meme in years ahead. Think of getting into Pot Stocks 2.0 before the moon pumps
In 2018–19, the United States Food and Drug Administration (FDA) granted breakthrough therapy designation to facilitate further research for psilocybin in the possible treatment of depressive disorders. As of 2020, research on the use of psilocybin indicated it caused hallucinations with inability to establish reality from fantasy, panic reactions, and possible psychoses at high doses.
In November 2020, the U.S. state of Oregon legalized psilocybin for people age 21 and older, and decriminalized possession or use of psilocybin mushrooms for medical conditions, such as depression, anxiety, or PTSD.
Biotech
Allarity priming itself for a pumpAs with most micro biotech companies, I expect the price to continue to fall to the $1 region and then “flatten out” for a while to keep its head just above the minimum listing requirement. It will then probably remain there until it is seemingly forgotten.
Then, in a move to regain compliance (if it falls below $1) we can expect some financial reorganisation on the stocks behalf and possibly a R/S on the cards if things get dire.
If it remains over the minimum listing price, I expect some group of pumpers to catch on to Allarity and we could see a few weeks of growing buzz on social media platforms, followed by some handy articles and a sudden parabolic move upwards on news as FOMO kicks in to the herd.
$AMGN LONG IDEA$AMGN is one of my favorite bio tech stocks as it has solidified its place as a winner over the years. They had a bit of a slowdown and consolidation over the past few years as they didn't have as much involvement with COVID, but certainly didn't lose too much value.
Watch for a 4hr close above $241.50 to send us back to $260+ over next few weeks.
Biotechnology is the next sector to have big runnersI'm looking at Biotechnologies and healthcare sector for my next sector that is going to run beyond the oil industry. Oil is going to die down in the next week or two because the Biden admin will want that to go hush hush. I estimate we will still have one or two more really rallies in the oil industry before we see the whole sector of biotech go nuts. Again just a prediction. I'm broker than the next guy in stocks so follow me if you want to run into crazy stuff.
BCEL is my pick as a great potential for the sector move. It has volume, a low float and looks like it's setting up for crossing over the 200 ma. I don't really like to make those trades before they cross over the 200ma because they haven't officially broken the trend until they are over the 200 ma and sustain it, but BCEL may be a good short term play.
$XBI Monthly approaching buy zoneStarted XBI LEAPS position buying JAN 24 $150 Calls, will continue to add as XBI Biotech has taken a beating, but technically has just found it's way back to the long term upward trendline support zone.
First price target 120, followed by 140 after expecting a bit more downside here.
This is a long term trade idea, for those looking in the short term, there may still be more downside although the R/R favors the long position now IMO.
$XBI Key Levels, Analysis & Targets - Request$XBI Key Levels, Analysis & Targets - Request
Ok, @FlashingGraphs so these would be my targets fo XBI. It sounds like you don’t have an open position yet… I would start around 78.06.
Then if it keeps selling off, then double your position at 62.94
And if it still continues then double again at 45.89. If those 3 hit then you can expect a solid 50% swing from there…
Because of the way the Biotech sector moved in the past two years I could definitely see it making a 3 standard deviation move down like this, in correction. Don’t go in too heavy until you see a clear reversal sign… (such as macD crossing back above 0, and consistent higher lows)
And with that being said I still would start building from Target 1. I hope this helps.
GL & happy swinging…
Biotech in bearish trend50sma has been an important moving average for this ETF.
We see 3 consecutive tests of the 50sma as resistance and a bounce lower.
As we see lower highs and lower lows, the bearish trend is confirmed.
I expect we fail again and test the blue line ($144.5).
SBFM - Sunshine Biopharma Doing BIG Things!Always DYOR and understand the dynamics of these OTC stocks (known for pump & dump) but the fundamentals here are what will ultimately drive Sunshine Biopharma to return to it's formerly glorious highs but for now, it's relegated to the fractional levels that we see. On it's face, it looks like a no-brainer . . company shedding debt, increasing earnings (still no real profitability) BUT, a recent patent publication and a litany of amazing solutions in the areas of drug-resistant cancers, COVID-19, etc. But don't take my word for it . . check it out . .
sunshinebiopharma.com
Caveat Emptor - The evil corporate empire will probably try to keep this one squashed and on the DL with massive shorting (if I had to guess) and for several reasons
1. Competition
2. Cancer is big business and people that cure it tend to go away quickly
3. Keep the price low with the help of WS peckerwoods for a cheaper acquisition
Again, I don't render professional investment advice, I just read charts and try to tie the fundamentals into a more complete picture. The Fib channel looks attractive in an uptrend, we just got a nice bump up above the 50/200 EMA and we know what kind of price history this beauty has so it's worth an add. I've got a DCA bag and will LTBH it for either a buyout or until the WS woods drive it to zero, whatever the outcome . . no risk, no reward.
Good luck!
Up tnend startThe stock broke through resistance and went to close the gap. The global target is $24. Upside +50%. Trade with a trailing stop.
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VIR - the fundamental playThere is something that market is wrong about. The VIR and its blockbuster drug. This drug earns $1-1.5B per Q.
+ they are clinical stage company with Huuge innovative pipeline in HBV and HIV - treatments and VACCINES!
And market prices them like @#$! while they will earn around their own 1x market cap in 2022 and will sit with so much cash, that the current market cap of a company is HUGE misspricing.
ATOS Weekly Shaping UpWe can see that the weekly chart is showing some exhaustion on the sell pressure. The daily has a bit of a heartbeat today breaking over the 20ema/ma.
Looking to see the weekly SARs flip underneath to support price, and a break over the T Line (EMA8) on the weekly to confirm a trend change.
If there is a solid break, targets (based on current price but will change) would be:
Weekly 20ema - 2.04
Weekly 50ema - 2.53
Weekly 100ema - 3.24
Anything over would just be cream. Unless they finally go phase 3 for endoxifen, but I'm sticking to TA.
BioCryst Pharmaceuticals, Inc ($BCRX)This is very important point for $BCRX, I can see this go either way but my guess is by the end of the week we see $BCRX at $16. I am going to do a more in-depth analysis in the next week.m
$ARDS Target PTs 4.30-6 and higherH.C. Wainwright Bullish on Aridis Pharmaceuticals Covid-19 Antibody Cocktail
Aridis Pharmaceuticals CEO Discusses Monoclonal Antibody Cocktail Protection Against COVID-19 Omicron Variant and Other Viruses in Fox Business Interview
LOS GATOS, Calif., Dec. 21, 2021 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, announced today that Vu Truong, Ph.D., Chief Executive Officer, was interviewed on Varney & Co., hosted by Stuart Varney, on Fox Business.
Key Highlights:
AR-703, one of the components of the AR-701 cocktail, binds to the 'S2' stalk region of coronavirus spike proteins that is responsible for viral fusion and entry into host cells, and binds to the Omicron variant with no loss in affinity as compared to the original Wuhan strain.
In vitro neutralization studies using live coronaviruses showed that AR-701 achieved broad, potent neutralization against all SARS-CoV-2 variants tested, as well as SARS, MERS, and the seasonal 'common cold' betacoronaviruses.
In vivo data with multiple animal challenge models that are widely used to evaluate COVID-19 treatments support AR-701's broad efficacy.
AR-701 is engineered to be long-acting and is expected to provide relevant drug levels for up to 1 year from prophylactic or therapeutic treatment.
Watch the full interview: video.foxbusiness.com
About AR-701
AR-701 is a cocktail of two fully human immunoglobulin G1 (IgG1) mAbs discovered from screening the antibody secreting B-cells of convalescent SARS-CoV-2 infected (COVID-19) patients. AR-701 consists of AR-703 and AR-720 mAbs, each neutralizes coronaviruses using distinct mechanisms of action, namely inhibition of viral fusion and entry into human cells (AR-703) and blockage of viral binding to the human 'ACE2' receptor (AR-720). The two mAbs complement and enhance each other in a synergistic fashion, creating a potent first-in-class cocktail. AR-703 binds to the 'S2' stalk region of spike proteins from betacoronaviruses, including the SARS-CoV2 variants (beta, gamma, delta, epsilon), and binds to the Omicron variant with no loss in affinity compared to the original Wuhan strain. Multiple animal challenge models widely used to evaluate COVID-19 treatments support AR-701's broad efficacy, including:
AR-701 mAbs administered parenterally, either individually or in combination with one another, eradicated SARS-CoV-2 (Wuhan strain) from the lungs of infected mice.
Hamsters infected with the SARS-CoV-2 (Delta variant) and later treated once with inhaled AR-701 mAbs, either individually or in combination, were protected from disease and weight loss.
Mice infected with the Severe Acute Respiratory Syndrome virus (SARS) were also protected from disease and weight loss with a single inhaled dose of AR-701.
The AR-701 mAbs are engineered to be active for 6-12 months in the blood. AR-701 is being developed as a long-acting intramuscular as well as a self-administered inhaled formulation for the treatment of COVID-19 patients who are not yet hospitalized. AR-701 mAbs were discovered through a collaboration with researchers at the University of Alabama in Birmingham and Texas Biomedical Research Institute (San Antonio, TX).
About Aridis Pharmaceuticals, Inc.
Aridis Pharmaceuticals, Inc. discovers and develops novel anti-infective therapies to treat life-threatening infections, including anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The Company is utilizing its proprietary ʎPEXTM and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture monoclonal antibody (mAbs) for therapeutic treatment of critical infections. These mAbs are already of human origin and functionally optimized for high potency by the donor's immune system; hence, they technically do not require genetic engineering or further optimization to achieve full functionality.
The Company is advancing multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:
Aridis' Pipeline
AR-301 (VAP). AR-301 is a fully human IgG1 mAb targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin and is being evaluated in a global Phase 3 clinical study as an adjunctive treatment of S. aureus ventilator associated pneumonia (VAP).
AR-320 (VAP). AR-320 is a fully human IgG1 mAb targeting S. aureus alpha-toxin that is being developed as a preventative treatment of S. aureus colonized mechanically ventilated patients who do not yet have VAP. Phase 3 is expected to be initiated in 2Q22.
AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients. This program is currently in Phase 2a clinical development in CF patients.
AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that are directed at multiple protein epitopes on the SARS-CoV-2 virus. It is formulated for delivery via intramuscular injection or inhalation using a nebulizer. AR-701 replaces AR-712 as the company's leading COVID mAb candidate.
AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.
AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide.
AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).
$APM Target PTs 7-14 Long term PT 30 and higherAptorum Shares Rise After FDA Orphan Drug Tag For Repurposed Compound For Pediatric Cancer
The FDA has granted Orphan Drug Designation to Aptorum Group Limited (NASDAQ: APM) SACT-1, a repurposed small molecule compound for Neuroblastoma.
Aptorum Group plans to file an Investigational New Drug Application (IND) to commence a Phase 1b/2a trial for SACT-1 in 2022.
Neuroblastoma is one of the most prevailing solid tumor cancers in children, representing 8% - 10% of all childhood tumors, accounting for around 15% of all cancer-related deaths in the pediatric population.
Aptorum received its first US patent regarding SACT-1 repurposed drug for various cancers earlier this week.
The SACT-1 invention provides a composition and method for treating or preventing the growth of cancerous tumors and/or delaying the onset of cancer from tumor-initiating cells.
Price Action: APM shares are up 30.3% at $1.59 during the premarket session on the last check Thursday.
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$PROG Next Target PT 2.25 and higherProgenity, Inc., a biotechnology company, provides develops and commercializes molecular testing products in the United States. It offers Innatal, a noninvasive prenatal screening test offered to women early in pregnancy to screen for chromosome abnormalities, such as down syndrome, trisomy 18, trisomy 13, and sex chromosome disorders through the analysis of cell-free DNA; Preparent that screens for carrier status of hereditary diseases prior to or early in pregnancy; and Riscover, a hereditary cancer screen that analyzes 31 genes associated with inherited risk of 12 types of cancers, including the BRCA1/2 genes for hereditary breast, ovarian, colorectal, endometrial, pancreatic, and other cancer syndromes, as well as for the five genes associated with Lynch syndrome. The company also provides Resura, a noninvasive prenatal test for families at risk for rare single gene disorders; and Preecludia, a preeclampsia rule-out test. In addition, it offers anatomic and molecular pathology tests, and COVID-19 PCR testing services, as well as test products that includes chromosomal microarray for pregnancy loss, which evaluates the genetic cause of miscarriage; maternal serum screening for chromosomal disorders; and preimplantation genetic testing for use with artificial reproductive technologies. Further, the company develops therapeutic solutions for gastrointestinal-related disorders, such as PGN-001, PGN-300, PGN-600, and PGN-OB2. It also owns and operates laboratory. Progenity, Inc. was formerly known as Ascendant MDX, Inc. and changed its name to Progenity, Inc. in November 2013. The company was founded in 2010 and is headquartered in San Diego, California.
$PSTIBiotechnology Company Pluristem, and Israel’s Largest Food Producer Tnuva, Launch Landmark Collaboration to Establish Cultured Food Platform
Eyal Malis, CEO, Tnuva Group
Collaboration uniquely combines Pluristem’s technological expertise in mass-scale, cost-effective, consistent cell production with Tnuva’s power multipliers in consumer-packaged goods, research and development (R&D), consumer branding marketing, and sales and distribution with the goal to accelerate time to market
Tnuva Group is Israel's largest food conglomerate, founded 96 years ago, with over $2 billion dollars in annual revenues
The collaboration aligns with Pluristem’s strategy of leveraging its cell-based technology platform in key partnerships
Pluristem to host online investor and analyst call on January 11 at 9:00 am EST (4:00 pm IST)
HAIFA, Israel, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI) (“Pluristem” or “the Company”), a leading biotechnology company, and Tnuva Group (“Tnuva Group" or “Tnuva”), Israel’s largest food producer, (together, “Parties”) today announced the launch of an innovative collaboration to develop, manufacture and commercialize cultured cell-based products for the food industry. The collaboration started with the incorporation of a new company (“NewCo”), that will receive exclusive, global, royalty bearing licensing rights to use Pluristem’s proprietary technology, intellectual property and knowhow, to be used in the field of cultured meat.
Tnuva Group will invest $7.5 million in NewCo, according to a pre-money valuation of $40 million, with the option to invest up to an additional $7.5 million over a period of 12 months following the closing. NewCo will use its own funding and resources to promote its mission with a dedicated management team and staff, and Pluristem will support the establishment, research and development activities of NewCo pursuant to a services agreement. Tnuva will provide the R&D platform to develop consumer products and will receive preferred marketing rights of any developed NewCo’s products in Israel.
Pluristem has the industry-leading capacity to design, develop, and manufacture cells for commercial use. Over the last two decades, the Company developed a proprietary three-dimensional (3D) expansion platform that can produce high-quality cells in a cost-effective manner with batch-to-batch consistency. According to both Parties’ estimates and plans, NewCo intends to present its technology Proof of Concept in 2022, with the goal of launching its first raw cultured meat product in 2023.
As part of the collaboration, the Parties may expand the collaboration to include cultured dairy and cultured fish products by establishing separate, new ventures.
Haim Gavrieli, Chairman of Tnuva Group: “Our collaboration with Pluristem is part of the execution of Tnuva Group’s strategy and vision. Tnuva strives to lead the alternative protein industry in Israel and to continue to expand in the industry on a global scale. We chose to collaborate with Pluristem because we believe it owns one of the most advanced cell production technologies in the world. We expect the collaboration between the companies to revolutionize the cultured food industry and develop the next generation of alternative proteins.”
Zami Aberman, Chairman of Pluristem: “Both Parties are leading companies in their fields, each with proven experience and tremendous capabilities, and the collaboration between us holds vast potential to lead towards a better future for the food industry. The collaboration with Tnuva supports Pluristem's strategy to establish partnerships that leverage its cell-based technology platform. As we embark on this collaboration with Tnuva, Pluristem is still dedicated to its core business of developing cell therapy products."
Yaky Yanay, CEO & President of Pluristem: "Over the years, Pluristem has developed one of the most advanced cell manufacturing platforms. During the last year, we made our strategy more precise, with the goal of leveraging our technology and expertise through partnerships and collaborations. Today, we are proud to join forces with a market leader, Tnuva Group, as they bring 96 years of experience in consumer food brands and innovation to the table. We believe that Tnuva’s and Pluristem’s vast experience will support fast and effective development of large-scale cultured meat products, relying on our existing infrastructures and talented teams. This collaboration is the first showcase of Pluristem’s intention to expand its business to verticals that need superior cell expansion proprietary technologies."
Eyal Malis, CEO of the Tnuva Group: "Tnuva Group has decades of experience developing and marketing innovative products for the Israeli market. Tnuva leads the alternative protein market in Israel and has recently taken its expertise globally. Just as Tnuva made the field of alternative proteins accessible to every Israeli home, we intend to make cultured food products available to all. The collaboration between two proven pioneers in their fields, each of which with proven experience and tremendous abilities, can create a better future for the food industry.”
Alternative meat is one of the fastest growing industries in the world and is estimated to be a $140 billion market by 20301. Affordable cultured food will require mass-produced, high-quality cells at competitive costs.
Pluristem to host online investor and analyst call on January 11, 2022 at 9:00 am EST (4:00 pm IST). Click here to register: veidan.activetrail.biz
About Tnuva Group
Tnuva Group is the largest food producer in Israel, as well as the Israeli leader in the field of alternative dairy and protein products. Tnuva Group has annual revenues of over $2 billion, 6,000 employees in 32 sites country wide. The Tnuva brand can be found in almost every home and every meal in Israel, with the country's largest distribution network for chilled and frozen products, including a wide range of dairy products, meat, eggs, fish, frozen vegetables, pastries and frozen and chilled food. Tnuva holds Israel's leading and most loved food brands in Israel, with approximately 4 million of Tnuva Group's products sold daily.
Tnuva takes part in the establishment of advanced food tech platforms in Israel, including 'FRESH START,' an innovative food tech incubator in Northern Israel with the goal of future development of the Israeli food industry. The incubator, established in collaboration with the Israel Innovation Authority, Tempo Beverages Ltd, the investment platform Our Crowd, and the American investment fund Finistere, specializes in locating and accompanying groundbreaking Israeli food technologies. Tnuva also supports innovative startups food companies, and academic researchers in Israel. Tnuva has recently signed a know-how licensing agreement with Swiss retail giant "Migros", under which Tnuva will help the Swiss company produce dairy alternatives.
About Pluristem
Pluristem is pushing the boundaries of science and engineering to create cell-based products for commercial use. The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating ischemia, damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. The Company’s manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system. Pluristem’s method is uniquely accurate, cost-effective, and consistent from batch to batch. The collaboration with Tnuva supports Pluristem’s strategy to establish partnerships leveraging Pluristem’s cell-based technology platform.
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the expected contributions of each of the Parties with respect to the collaboration and NewCo, the expected timing of the presentation of the proof of concept and the goal for the timing of the launch of the first cultured meat product, the potential benefits to be realized by the collaboration and the potential for expanded collaboration with respect to cultured dairy and cultured fish products. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluristem or NewCo or the collaboration: changes in technology and market requirements; either may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; their products may not be approved by regulatory agencies, their technology may not be validated as they progress further and their methods may not be accepted by the scientific community; they may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with their processes; their products may wind up being more expensive than they anticipate; results in the laboratory may not translate to equally good results in real clinical settings; their patents may not be sufficient; their products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem, NewCo or the collaboration to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
Photocure $PHO setting up for IHS?An average Q3 report for Photocure today giving some selling action, painting up the framework for a nice inverted head & shoulders formation within the long uptrend of the stock.
$ENSC SR -133Ensysce Biosciences Announces First Cohort Dosing in Bioequivalence (BE) Study of Novel “TAAP” Opioid
BE Study of PF614 Provides Critical Step toward FDA Approval
SAN DIEGO, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Ensysce Biosciences, Inc. (“Ensysce” or the “Company”) (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company with two novel technology platforms designed to provide relief for those suffering with severe pain while protecting against abuse and overdose, announced today the initiation and first dosing in the Bioequivalence (BE) trial of the novel Trypsin Activated Abuse Protected (TAAP) Opioid, PF614.
The BE study follows the successful completion of the multi-ascending twice daily dosing study of PF614 and will compare PF614 versus OxyContin in subjects in both fasted and fed states. This data will be critical to understand future prescribing criteria for PF614. If successful, upon completion of the BE study the Company believes that the data will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval. This pathway allows reference to available safety and clinical data from an approved product, and the BE data established by this study will move PF614 closer to registration.
Dr. William Schmidt, Chief Medical Officer of Ensysce, commented, “We continue to be encouraged by our progress towards bringing our lead ‘next generation’ opioid to market. The completion of this study will be a critical milestone for Ensysce and a major step toward providing safer options for doctors and patients.”
Commenting on the Company’s progress, Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, stated, “As we enter 2022 with strong progress across our clinical stage pipeline, we are looking forward to the data from this BE study in the second quarter of the year to position PF614 as our first commercial candidate. We believe that we have the foundation in place to realize our mission of bringing a unique pipeline of products onto the market and helping the millions who experience severe pain.”
PF614 is designed as an abuse protective agent with trypsin-activated abuse protection (TAAP). TAAP chemical modification inactivates the active ingredient in Ensysce’s opioids products including PF614 and provides abuse protection, resistance to manipulation and other forms of recreational drug abuse. This study will build on the safety and pharmacokinetic results of the initial Phase 1 and 1b studies and is designed to improve the understanding of how PF614 compares to currently available commercial products.
As previously announced, the clinical study is PF614-102 entitled “A Phase 1b, Randomized, 2-Part Single-Center Study to Evaluate the Pharmacokinetics (PK) and Safety of Multiple-Ascending Oral Doses (MAD) of PF614 and the Food Effect and Bioavailability/BE of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects.” The study is being conducted by Matthew Johnston, MD, PRA Health Sciences, Salt Lake City, Utah.
About Ensysce Biosciences
Ensysce Biosciences San Diego, CA is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR™) platforms, the Company is in the process of developing a new class of powerful, tamper-proof opioids that prevent both drug abuse and overdoses. Ensysce’s products are anticipated to provide safer options to treat severe pain and assist in preventing deaths caused by opioid abuse, reducing the human and economic cost. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.
$IMRNImmuron stock rockets after funding by U.S. DoD of new research agreement
Shares of Immuron Ltd. IMRN, +46.18% rocketed 49.6% in active premarket trading Wednesday, after the Australia-based biopharmaceutical company said it received an award of AUD$6.2 million ($4.5 million) from the U.S. Department of Defense to evaluate Travelan for military use. Trading volume spiked to 1.3 million shares, compared with the full-day average of about 60,500. The award is aimed at testing the efficacy of a single larger dose regimen of Travelan for the treatment of moderate to severe diarrhea upon challenge with enterotoxigenic Escherichia coli (ETEC). "This new project expands our clinical development program and represents the first of several significant clinical trials which the Company expects to undertake with the US Military in 2022," said Immuron Chief Executive JErry Kanellos. "The new funding is testament to the value proposition our hyperimmune bovine polyclonal colostrum technology offers to benefit the US Military as well as the civilian international travelling population." The stock has tumbled 30.1% over the past three months while the iShares Biotechnology ETF IBB, -1.11% has declined 7.2% and the S&P 500 SPX, +0.28% has gained 8.3%.
$KPRX Target PT 2 and higherKiora Pharmaceuticals to Provide 2022 Business Outlook at the H.C. Wainwright Bioconnect Virtual Conference
Salt Lake City, Utah--(Newsfile Corp. - January 5, 2022) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) will participate in the H.C. Wainwright Bioconnect Virtual Conference January 10-13, 2022. Brian Strem, Ph.D., President and Chief Executive Officer, will provide an outlook for the business and its pipeline of treatments for ophthalmic diseases.
The corporate presentation will be available on-demand and accessible from the Company's Investor Relations website starting Monday January 10, 2022 at 7:00 am Eastern Time.
About Kiora
Kiora is a clinical-stage biotechnology company developing and commercializing products for treating ophthalmic diseases. KIO-301 is a molecular photoswitch that has the potential to restore light perception in patients with inherited and/or age-related retinal degeneration. KIO-101 is a next-generation, non-steroidal, immuno-modulatory and small molecule inhibitor of Dihydroorotate Dehydrogenase ("DHODH") with best-in-class picomolar potency and a validated immune modulating mechanism (blocks T cell proliferation and proinflammatory cytokine release) designed to overcome the off-target side effects and safety issues associated with other DHODH inhibitors. In addition, Kiora is developing KIO-201, a modified form of the natural polymer hyaluronic acid, designed to accelerate corneal wound healing. For more information, please visit www.kiorapharma.com.
Forward-Looking Statements
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's products, including KIO-101, KIO-201 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2021 or described in Kiora's other public filings. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law.
$NLSP Target PTs 2.39-3 and higherNLS Pharmaceutics Announces Patent Issuance in the United States for its Mazindol Extended-Release Formulation
Key patent now granted in major markets including the U.S., Europe, Canada & South Korea
Patent claims cover use of the Company's lead product candidate, Quilience® (mazindol ER) in both attention deficit hyperactivity disorder (ADHD) & narcolepsy
STANS, SWITZERLAND / ACCESSWIRE / January 4, 2022 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that the United States Patent and Trademark Office (USPTO) has granted the Company U.S. Patent No. 11207271, entitled A MAZINDOL IR/SR MULTILAYER TABLET AND ITS USE FOR THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD). The patent covers oral formulations containing immediate-release and sustained-release layers of mazindol and their use in treating attention deficit disorders (ADD or ADHD), related deficit of alertness or decline of vigilance, or excessive daytime sleepiness including narcolepsy or idiopathic hypersomnia.
"Our intellectual property estate has been significantly strengthened since our initial public offering in February 2021, putting NLS in a solid position as we anticipate reporting Phase 2a results for Quilience® (mazindol ER) to treat narcolepsy in the first quarter of 2022," said Alex Zwyer, Chief Executive Officer of NLS. "We now have issued patents in major markets including the U.S., Europe, Canada, and South Korea covering our extended-release formulation of mazindol. These recently issued patents augment the Orphan Drug Designations that have been granted for Quilience® in both the U.S. and Europe. Most patients with narcolepsy remain unsatisfied with current treatment options, and we believe that Quilience® has potential to fill a major need in the market given mazindol's history of safety and evidence of effectiveness in treating the symptoms of narcolepsy. We remain focused on bringing this treatment option to patients suffering from narcolepsy and potentially other sleep-wake disorders as soon as possible."
About NLS Pharmaceutics Ltd.
NLS Pharmaceutics is a Swiss clinical-stage biopharmaceutical company led by an experienced management team with a track record of developing and repurposing product candidates to treat rare and complex central nervous system disorders. The Company's lead product candidate, Quilience® is a proprietary extended-release formulation of mazindol (mazindol ER) and is being developed for the treatment of narcolepsy. Mazindol is a triple monoamine reuptake inhibitor and partial orexin-2 receptor agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. NLS has initiated a phase 2 program in the U.S. evaluating Quilience® in adult subjects suffering from narcolepsy. Previously, NLS successfully completed a phase 2 study in the U.S. evaluating Nolazol® (mazindol controlled-release) in adult subjects suffering from ADHD. The study met all primary and secondary endpoints and Nolazol® was well-tolerated. Quilience® has received Orphan Drug Designations both in the U.S. and in Europe for the treatment of narcolepsy. Up to one-third of narcoleptic patients are also diagnosed with ADHD.
Safe Harbor Statement
This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses the timing of the reporting of its reporting of the Phase 2a results for Quilience® (mazindol ER) to treat narcolepsy and that Quilience® has potential to fill a major need in the market. These forward-looking statements and their implications are based on the current expectations of the management of NLS only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS's products may not be approved by regulatory agencies, NLS's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS's process; NLS's products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS's patents may not be sufficient; NLS's products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading "Risk Factors" in NLS' annual report on Form 20-F filed with the Securities and Exchange Commission (the SEC"), which is available on the SEC's website, www.sec.gov.
AEZS European approval to market MacrillenAEterna has a variety of new products in its pipeline.
Macrilen, for example, is the first and only FDA-approved oral test for the diagnosis of Adult Growth Hormone Deficiency.
AEterna received European approval to market Macrillen.
Dr. Christian Strasburger: "Clinical studies have demonstrated that macimorelin is safer and much simpler to administer than the current methods of testing for insulin-induced hypoglycemia, and is well-tolerated by patients and reliable in diagnosing the condition.”
I think AEZS is a sleeping giant.
My price target is $1.25.
