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Reversal Sparks on Cellceutix Corp (OTCMKTS:CTIX)

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Cellceutix Corp (OTCMKTS:CTIX) has had a year and a half that investeors would love to forget as the stock has dropped from highs of $4.99 in late 2014 to recent lows of $0.63 a share. The stock has seen a strong reversal off $0.63 lows and has been making strong moves to the upside since.

CTIX is the biotech that rose from pennies to a high of $4.93 last December before the whole thing collapsed. Mako Research published a number of false and misleading hit pieces on Seeking Alpha that are now subject to an ongoing lawsuit as Mako has gone dark.

Cellceutix Corp (OTCMKTS:CTIX) is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships.

Cellceutix was granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company’s novel defensin-mimetic Brilacidin, for the prevention of oral mucositis. Oral mucositis, a common and often debilitating inflammation and ulceration that occurs in the mouth as a side-effect of certain cancer treatments, afflicts approximately 450,000 patients each year in the United States and can affect the course and outcome of cancer therapy. There are no FDA approved drugs for the prevention of oral mucositis.

Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations.

Cellceutix’s anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction.

It all comes back to Cellceutix chief scientific officer, Dr. Krishna Menon; the man is a real whiz; he played key roles in developing two blockbuster cancer drugs; Gemzar and Alimta for Eli Lilly & Co.(NYSE:LLY) back in the late 90’s.

For CTIX he developed Kevetrin which just received Orphan Drug Designation for the treatment of ovarian cancer.. Kevetrin is successful in regulating the p53 pathway that has long been the holy grail of cancer research and big pharma. Industry leaders spent hundreds of millions of dollars trying to achieve what Dr. Krishna Menon has achieved with Kevetrin.

As anyone in the industry knows, regulating the p53 pathway has long been the holy grail of cancer research and big pharma has spent hundreds of millions of dollars researching ways to achieve this with no success thus far. It seems Kevetrin(TM) has accomplished this; extensive preclinical research on Kevetrin shows the re-activation of p53 across a wide spectrum of cancer lines including colon, lung, breast and pancreatic cancers.

If testing is successful, Mr. Ehrlich says the market potential for Kevetrin in treating drug-resistant cancers is worth $5 billion a year. Other cancers could easily represent an additional $5 billion annually, he adds..

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On August 6 of last year Mako Research disclosing they were short published the first of a number of false and misleading hit pieces on CTIX claiming ”Cellceutix: Empty Office, Unviable ‘Science’, Misleading Disclosures, 96% Downside” The articles claimed that Cellceutix’s pipeline of drugs in clinical trials are ineffective and the company is essentially without worth. Over the next 6 weeks Mako Research published 5 more articles on Seeking Alpha all with the aim of decimating CTIX share price before the outfit went dark with the last article published on September 23, 2015.

The Mako Research articles were effective, especially the first one on August 5 causing a sharp drop in CTIX’s share value. Later that day the Rosen Law Firm of NYC announced it is investigating potential securities claims on behalf of shareholders of CTIX resulting from allegations that Cellceutix may have issued materially misleading business information to the investing public. It stated that CTIX had misrepresented the efficacy of its drug candidates Brilacidin, Kevetrin, and Prurisol.

In November the FDA granted Fast Track Designation for the Company’s lead drug candidate Brilacidin-OM. According to the release ”In an ongoing Phase 2 trial, Brilacidin-OM is being evaluated for its safety and efficacy in preventing oral mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer. Seven clinical sites and two satellite sites are currently enrolling patients in the trial, with additional sites expected to open enrollment in the coming weeks.”

On May 10 CTIX announced a corporate update on current operations and upcoming clinical milestones across its pipeline of First-in-Class drug candidates, Prurisol, Kevetrin and Brilacidin, as summarized in our recent Quarterly Report (Form 10-Q), available for download at the link below.

This week Cellceutix anticipates enrolling the final subjects for the Brilacidin 42-day UP/UPS clinical study.

Between patients already enrolled and those presently in screening, Cellceutix has reached over 70 percent of the anticipated number of trial participants in its Phase 2b trial of Prurisol for the treatment of moderate-to-severe chronic plaque psoriasis.  Interim analysis top-line results

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Currently trading at a $93 million market valuation CTIX has $6 million in the treasury, manageable debt and no revenues to date. The stock was the darling of the bb’s all the way to $4.93 share before the shorts led by Mako Research took it to the woodshed decimated the share price to lows of $0.941. CTIX is the same exciting story it always has been with several drugs in advanced clinical trials sitting on drugs in development that could potentially turn the multi-billion dollar drug-resistant cancers market upside down. The Company also recently announced the FDA granted Fast Track Designation for the Company’s lead drug candidate Brilacidin-OM as well as the conclusion of the last patient visit in its randomized, double-blind Phase 2 trial for Prurisol with top-line data expected in May. We will be updating on CTIX when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CTIX.

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Disclosure: we hold no position in CTIX either long or short and we have not been compensated for this article.

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1 Comment

1 Comment

  1. RZ

    May 15, 2017 at 12:52 am

    Nice article overall. Kevetrin is currently in Phase 2, not Phase 1.

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BioPharma

Cosmos Holdings Inc (NASDAQ: COSM) Huge Short Position Panicks as COSM Rockets Up the Charts

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Cosmos Holdings Inc (NASDAQ: COSM) is rocketing up the charts northbound since reversing off $0.0675 lows earlier this month where we first gave the heads up on COSM at around a dime in our article here. Since than COSM has rocketed northbound recently surpassing $0.60 per share with speculators pointing at $1 as the next stop. In our previous article on COSM on November 13 when COSM was $0.10 we stated: “COSM was trading well over $3 at the beginning of this year but has been heavily shorted since than with current estimates of well over 5 million shares sold short and almost the entire public float sold short. 

While COSM has been heavily shorted into oblivion, the Company is actually doing quite well recently reporting revenues for the 3 months ended September 30 were $12 million. The Company is successfully developing their business recently closing a deal with Iberica, a European Airline, for in flight distribution of their products. The CEO has bought millions of shares at current levels and COSM is beginning to go viral on social media trending on the sub reddit Short Squeeze, Number #1 on Stocktwits and multiple videos being made on YouTube about a massive short squeeze taking place in small caps. 

COSM Friday December 2, 4PM Close Update: COSM had a wild trading day on Friday dropping to $0.42 in the morning before rocketing up to $0.61 highs. This was followed by another drop to the $0.47 range before COSM rocketed up in late afternoon trading, closing at $0.53 on 205 million shares traded. COSM was up 33% on the day on around $110 million in dollar volume. COSM is setup for an enormous week ahead, looking to overtake the $0.845 from Monday and embark on a blue-sky breakout with $1 as the first stop. We gave the heads up on COSM when the stock was below $0.10 per share at the beginning of November. We will be updating on COSM as soon as anything new happens so make sure you are subscribed to Microcapdaily by entering your email in the box below.  

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No alternative text description for this imageCosmos Holdings Inc (NASDAQ: COSM) is a global healthcare group that was incorporated in 2009 and is headquartered in Chicago, Illinois. Cosmos Health is engaged in the nutraceuticals sector through its own proprietary lines of products “Sky Premium Life” and “Mediterranation.” Additionally, the Company is operating in the pharmaceutical sector through the provision of a broad line of branded generics and OTC medications and is involved in the healthcare distribution sector through its subsidiaries in Greece and UK serving retail pharmacies and wholesale distributors. Cosmos Health is strategically focused on the R&D of novel patented nutraceuticals (IP) and specialized root extracts as well as on the R&D of proprietary complex generics and innovative OTC products. Cosmos has developed a global distribution platform and is currently expanding throughout Europe, Asia and North America. Cosmos Health has offices and distribution centers in Thessaloniki and Athens, Greece and Harlow, UK. 

The Number #2 post on the subreddit ShortSqueeze currently is titled: COSM about to test resistance. A pump through $0.66 and lift off to over $1.00 is possible now. 

In another post on COSM in the subreddit ShortSqueeze rubio2430 states: “$COSM you cant make this stuff up. this baby is ready for space. the shorts are burying themselves on the daily. constant pr’s, growing fundamentals, no plans on dilutions, dual listing on upstream soon—the list goes on! 

nimble_broccoli replied: Why this is a good play: 

1.) Extremely tiny Marketcap 2.) CEO buying 15’000’000 shares 3.) Good fundamentals, unlike other plays, they actually sell products valued around 10x the valuation. Q1/22 was profitable. 4.) Getting momentum on social media (Reddit Twitter, YT) 

Next catalysts: -Info that they will not be delisted from NASDAQ -Degen and Retail FOMO kicking in -Shorts starting to cover their asses 

In addition, consider this: The stock was somewhere between USD 2 and USD 12 the past ~8 years. Most Hodlers bought back then, do you think they will sell now? Do your own thinking but if one of my stocks dropped 80+ % i d not sell, i d just hope for a miracle or ride it out. Thus, not many regular buy&hold holders of the stock are expected to sell. 

Cosmos operates in the business of full-line pharmaceutical wholesale distribution and serves approximately 1,500 independent retail pharmacies and 40 pharmaceutical wholesalers in Greece region by providing brand-name and generic pharmaceuticals, over-the-counter medicines, vitamins and nutraceuticals. Cosmos invests in technology to enhance safety, distribution and warehousing efficiency and reliability. Specifically, the Company operates a fully automated warehouse system with three robotic systems, two ROWA™ types and one A-frame type, that ensure 0% error selection rate, accelerate order fulfillment, and yield higher cost-efficiency in our distribution center. Cosmos has 3 operating subsidiaries including:

SkyPharm
Sky Pharm SA is headquartered in Thessaloniki, Greece. Sky Pharm trades the excess amounts of about 500 medicines that can be exported within the EU countries. We buy from Greek wholesale pharmaceutical companies and multinational pharmaceutical manufacturers, and export to European markets where demand and prices are substantially higher.
.
DHN
Decahedron Ltd. is a pharmaceutical wholesaler incorporated in the UK in August 2011. It is audited by the MHRA under European GDP (Good Distribution Practices). They are also a full member of the EAEPC and have been audited by TÜV on their behalf.
.
Cosmofarm
Founded in 1994, Cosmofarm is a fully licensed pharmaceutical wholesale company operating in the greater Athens area. The company is approved and authorized by the National Organization for Medicines under Good Distribution Practices to distribute a comprehensive range of pharmaceutical products. Cosmofarm’s core activity is sourcing, procuring, and distributing branded.
.
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COSM

Image

COSM business is strong and Q3 highlights include closing a $7.5M capital raise via public offering and signing an exclusive agreement to market and distribute Nickelodeon’s SpongeBob and PAW Patrol kids’ vitamins in Greece and Cyprus, aiming to reach out 11,000 pharmacies and 120 wholesalers in Greece and 780 pharmacies in Cyprus. They also executed a letter of intent for a strategic co-venture agreement with Smart for Life (SMLF) to cross market products and services in their reciprocal markets. COSM also entered into an LOI to acquire ZipDoctor Inc., and entered into an agreement with Virax Biolabs (VRAX), to become the distributor of Monkeypox Virus Real-Time PCR Detection Kits, having the exclusive distribution rights for Greece and Cyprus, with the opportunity to distribute the test kits across Europe on a non-exclusive basis. SkyPharm officially launched its first Sky Premium Life products on Amazon in the United States. Cosmos targets having all 85 SKUs listed on Amazon by year end. COSM entered into an LOI to acquire Pharmaceutical Laboratories CANA S.A., and another LOI to acquire LIFE NLB, Ltd.’s product portfolio, including Bone-Vio® and Bone-X, related to bone health targeting the human gastrointestinal microbiome. 

Last week COSM announced its Sky Premium Life luxury food supplement brand will be sold on Ronda, the official inflight magazine of the airline company Iberia of BRITISH AIRWAYS group. Ronda is available free of charge to the over 10 million passengers who fly Iberian Airlines annually. Iberia Airlines, majority owned by British Airways, has a fleet of 147 aircrafts and engages in over 600 daily flights. 

https://twitter.com/nxtplse/status/1597365583934545920

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Currently trading at a $36 million market valuation COSM os is 92,008,281 the Company recently reported Q3 Revenues of $12 million down a bit from the same time last year due to a high variation in FX differences between EUR and GBP to USD. COSM was trading over $4 this time last year however OS has increased substantially since then.  COSM is an exciting opportunity in small caps; the stock was shorted into oblivion and currently there are minimum 5.8 million shares short and was way oversold to pennies and it looked as if it would definitely get delisted by the Nasdaq however, led by able CEO Grigorios Siokas, Cosmos is fighting back. Mr. Siokas continues to buy more COSM at current price levels, putting his money where his mouth is as COSM rockets towards $1 which is now just a day and half away if the stock continues up at the same trend.  We will be updating on COSM when more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in COSM either long or short and we have not been compensated for this article.

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BioPharma

Cosmos Holdings Inc (NASDAQ: COSM) Heating Up as Co Looks to Take on Massive 5 million Share Short Position

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Cosmos Holdings Inc (NASDAQ: COSM) is making a rapid move up the charts since recent reversing off $0.0675 lows. The stock was trading well over $3 at the beginning of this year but has been heavily shorted since than with current estimates of well over 5 million shares sold short and almost the entire public float sold short. COSM is quickly emerging as the latest short squeeze at the top of speculators watch lists and is currently trending on stocktwits and the sub reddit ShortSqueeze on Reddit. 

The Company is fighting back against the shorts and planning a lawsuit and CEO Grigorios Siokas recently put his money where his mouth is when he bought 12,500,000 shares of the stock at $0.12 average for about $1.5 million. While in danger of being delisted from the Nasdaq if they don’t get the stock price back over $1 by the end of November the Company is doing well recently reporting its first ever net income on $13,208,504 in revenues for the 3 months ended June 30, 2022. Cosmos is also acquiring ZipDoctor Inc. from American International Holdings Corp (AMIH) 

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Cosmos Holdings Inc (NASDAQ: COSM) is an international healthcare group that was incorporated in 2009 and is headquartered in Chicago, Illinois. On August 2, 2022, the Company filed a Fictitious Firm Name Certificate in Nevada to do business under the name Cosmos Health, Inc. and will seek shareholder approval at its annual shareholders meeting scheduled for December 2, 2022 to amend its Articles of Incorporation for the name change. Cosmos Health is engaged in the nutraceuticals sector through its own proprietary lines of products “Sky Premium Life” and “Mediterranation.” Additionally, the Company is operating in the pharmaceutical sector through the provision of a broad line of branded generics and over-the-counter (“OTC”) medications and is involved in the healthcare distribution sector through its subsidiaries in Greece and UK serving retail pharmacies and wholesale distributors.  

Cosmos operates in the business of full-line pharmaceutical wholesale distribution and serves approximately 1,500 independent retail pharmacies and 40 pharmaceutical wholesalers in Greece region by providing brand-name and generic pharmaceuticals, over-the-counter medicines, vitamins and nutraceuticals. Cosmos invests in technology to enhance safety, distribution and warehousing efficiency and reliability. Specifically, the Company operates a fully automated warehouse system with three robotic systems, two ROWA™ types and one A-frame type, that ensure 0% error selection rate, accelerate order fulfillment, and yield higher cost-efficiency in our distribution center. Cosmos has 3 operating subsidiaries including:

SkyPharm
Sky Pharm SA is headquartered in Thessaloniki, Greece. Sky Pharm trades the excess amounts of about 500 medicines that can be exported within the EU countries. We buy from Greek wholesale pharmaceutical companies and multinational pharmaceutical manufacturers, and export to European markets where demand and prices are substantially higher. The …
DHN
Decahedron Ltd. is a pharmaceutical wholesaler incorporated in the UK in August 2011. It is audited by the MHRA under European GDP (Good Distribution Practices). They are also a full member of the EAEPC and have been audited by TÜV on their behalf. They import and export branded, generic and …
Cosmofarm
Founded in 1994, Cosmofarm is a fully licensed pharmaceutical wholesale company operating in the greater Athens area. The company is approved and authorized by the National Organization for Medicines under Good Distribution Practices to distribute a comprehensive range of pharmaceutical products. Cosmofarm’s core activity is sourcing, procuring, and distributing branded

https://twitter.com/ChairmanOtc/status/1590877348752420866

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COSM

ImageOn August 22 Cosmos provided a business update and reported financial results for the second quarter and six months ended June 30, 2022. Revenues were $13,208,504 for the 3 months ended June 30, 2022 compared to $14.8 million for the same period last year. 

Greg Siokas, Chief Executive Officer of Cosmos Health, stated, “We increased our profitability for the first half of 2022 due to the increase of gross profit margin to 14.2% from 11.5% for the respective period of 2021. This increase is attributed mainly to the organic growth of our proprietary nutraceutical brand, Sky Premium Life® (“SPL”). We achieved positive income from operations of $0.2 million for the first half of 2022 compared to a loss of $3.1 million in the same period last year and positive EBITDA of $0.8 million for the first half of 2022 compared to a loss of $2.8 million for the same period last year. Gross profit increased by 23.0% to $3.7 million for the six months ended June 30, 2022. We continue to carefully manage expenses and reduced operating expenses by nearly 43.7% and 41.9% for the three and six months ended June 30, 2022, respectively. During the quarter, we launched a new premium line of nutritional supplements, Mediterranation. The Mediterranation line uses organic herbs and plant extracts such as crataegus, hibiscus, dittany of Crete, oregano, mastic and kritamos, found in specific regions in Greece and the Mediterranean. These unique formulations contain a proprietary blend of vitamins and minerals and are made with the highest quality raw materials. There is high demand among consumers for supplements that utilize high quality Mediterranean ingredients, such as polyphenols, which possess antioxidant and anti-inflammatory properties. We expect the launch of the Mediterranation line will further enhance our growth strategy and we look forward to expanding the product line into new global markets through our growing distribution channels. We also launched our SPL products on Amazon Singapore and are in the process of launching on Amazon United States and Amazon Canada in the third quarter of 2022. These new markets provide an untapped growth opportunities and new audiences for our proprietary SPL brand. Our goal is to grow our portfolio of branded nutraceuticals and reach up to 150 SKUs by the end of 2022.” 

Earlier this year Cosmos announced an LOI to acquire ZipDoctor Inc. from American International Holdings Corp (AMIH). AMIH will continue to manage all aspects of the day-to-day operations of ZipDoctor including product development, marketing, and operational support. ZipDoctor Inc., is a direct-to-consumer subscription-based telemedicine platform, that expects to provide its customers affordable, unlimited, 24/7 access to board certified physicians and licensed mental and behavioral health counselors and therapists. ZipDoctor’s online telemedicine platform will be available to customers across the United States and offers English and Spanish coverage with virtual visits taking place either via the phone or through a secured video chat platform. 

On October 17, 2022, Cosmos entered into a Securities Purchase Agreement with certain institutional investors (the “Purchasers”), pursuant to which the Company agreed to issue and sell, in a public offering, an aggregate of $7,500,000 of securities, consisting of (i) 62,500,000 shares of Common Stock, (ii) pre-funded Warrant in lieu of shares of Common Stock, and (iii) warrants to purchase 125,000,000 shares of Common Stock (the “Common Warrants” and collectively with the Pre-Funded Warrants, the “Warrants”).  Under the terms of the Purchase Agreement, the Company agreed to sell one share of its Common Stock or a Pre-Funded Warrant and two Common Warrants for each share of Common Stock or Pre-Funded Warrant sold at a unit price of $0.12.  For each of 15,662,603 Pre-Funded Warrant sold in the Offering, the number of shares of Common Stock offered were decreased on a one-for-one basis. 

https://twitter.com/AirGoodman24/status/1591938222548189186

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Currently trading at a $10 million market valuation COSM is the latest potential short squeeze at the top of speculators watch lists. With $35 million in current liabilities and an inability to collect on accounts receivables that currently stand at over $25 million COSM stock has lagged even as the Company reports its first ever net income on $13,208,504 in revenues for the 3 months ended June 30, 2022. The short position on COSM has grown to well over 5 million shares short and currently the entire public float is sold short. Now that the cat is out of the bag and the stock is surging northbound COSM short squeeze should be at the top of small cap speculators watch lists. We will be updating on COSM when more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in COSM either long or short and we have not been compensated for this article.

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BioPharma

Anavex Life Sciences Corp (NASDAQ: AVXL) On Watch as Biotech to Present Results for its Phase 2b/3 Trial for blarcamesine for Alzheimer’s Disease

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Anavex Life Sciences Corp (NASDAQ: AVXL) is an exciting biotech small cap caps targeting the holy grail of medicine; Alzheimer’s disease and other neurodegenerative diseases. The Company is at a pivotal point and will present results from its phase 2b/3 trial for blarcamesine for Alzheimer’s disease at the CTAD conference in San Francisco on December 1st; a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options. More on the phase 2b/3 trial in the conclusion of this article. 

On November 7 AVXL announced the U.S. Food and Drug Administration’s (FDA) has granted Orphan Drug Designation (ODD) to ANAVEX®2-73 (blarcamesine) for the treatment of Fragile X syndrome. Fragile X syndrome (FXS) is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and 1,088,500 worldwide.1 At present, there is no approved treatment for Fragile X syndrome. 


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Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer.

Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy.

The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation.

Microcapddaily first reported on AVXL on April 2, 2015 after AVXL had reversed off $0.15 lows on the OTCQB stating at the time: “Currently trading at a $12.8 million market valuation AVXL does have $7 million in the treasury and is fully funded going forward. Now that the stock has made a significant reversal off $0.15 after years of steady decline and the Company is presenting promising preclinical data for both ANAVEX 2-73 and ANAVEX 3-71, Investors are giving AVXL another look.

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AVXL

On November 7 AVXL announced the U.S. Food and Drug Administration’s (FDA) has granted Orphan Drug Designation (ODD) to ANAVEX®2-73 (blarcamesine) for the treatment of Fragile X syndrome. Fragile X syndrome (FXS) is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and 1,088,500 worldwide.1 At present, there is no approved treatment for Fragile X syndrome. 

The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. Anavex Life Sciences’ product portfolio platform includes drug lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease dementia, Parkinson’s disease and Rett syndrome and ANAVEX®3-71 for schizophrenia, frontotemporal dementia, and Alzheimer’s disease. 

AVXL CEO Christopher U Missling stated: “The Orphan Drug Designation highlights the potential to expand the therapeutic profile of ANAVEX®2-73 into the largest portion of autism spectrum disorder, Fragile X syndrome. We look forward to working with the Fragile X syndrome community to rapidly advance ANAVEX®2-73 as a potential treatment for Fragile X syndrome while we continue to expand late-stage clinical investigation of ANAVEX®2-73 as part of its precision medicine platform technology for both neurodevelopmental and neurodegenerative indications.” 

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AVXL is quickly emerging as one of the most exciting stocks in small caps targeting the holy grail of medicine; Alzheimer’s disease and other neurodegenerative diseases. Alzheimer’s is among the top 10 leading causes of deaths in the United States.  As we have always said here at Microcapdaily on AVXL the Company has got everyone’s attention; AVXL is sitting on drugs in development that could potentially disrupt several billion-dollar markets. Anavex will present results from its phase 2b/3 trial for blarcamesine for Alzheimer’s disease at the CTAD conference in San Francisco on December 1st; a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options. In a past trial, Anavex’s blarcamesine modified mild Alzheimer’s disease in some patients at 148 weeks. At higher concentrations, 4 out of six individuals with mild Alzheimer’s disease or mild cognitive impairment improved at 57 weeks and 3 of these six individuals retained these improvements at 109 weeks. If these numbers hold up in the larger trial and blarcamesine meets safety requirements, the FDA could grant the drug accelerated approval. AVXL was a big runner that saw a historic rise starting in 2014 when we first covered it below $0.20 when it was trading on the OTCQB to over $30 per share on the NASDAQ during the summer of 2021. We will be updating on AVXL when more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in AVXL either long or short and we have not been compensated for this article

 

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