Connect with us

Micro Cap Insider

Everyone is Talking About Cellceutix Corp (OTCMKTS:CTIX)

Published

on

Cellceutix Corp (OTCMKTS:CTIX) continues to trade on the comeback trail since hitting a recent low of $1.32 after a SA hit piece came out titled ”Cellceutix: Empty Office, Unviable ‘Science’, Misleading Disclosures, 96% Downside” decimated the share price.

In recent news the Company said it is requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the advancement of the Company’s anti-cancer drug candidate Kevetrin for the treatment of pediatric retinoblastoma.

Retinoblastoma is the most common eye cancer affecting children usually before age 3. It is sight threatening and potentially fatal if not caught early. Occurrence is 250-300 cases per year in the U.S. The tumors arise from the retina, the light sensitive nerve tissue which lines the back of the eye. If caught early and treated it may spare the child from having the eye removed (enucleated) which occurs in late stages to prevent metastasis.

CTIX is one of those legendary stories that we love to report on; from pennies a share back in 2011 to recent highs near $5 CTIX has transformed itself as the top most traded stock on the entire bb’s.

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.

Cellceutix Corp (OTCMKTS:CTIX) is a clinical stage biopharmaceutical company located in Beverly, Massachusetts developing innovative therapies in oncology, dermatology and antimicrobial applications.

CTIX flagship is Brilacidin, a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the “front line” of defense in the human immune system and mange suggest Brilacidin could rival Cubist’s (NASDAQ:CBST) Daptomycin as the antibiotic of primary choice.

CTIX recently announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation for Brilacidin as a new treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ahead of its meeting this month with Cellceutix regarding Cellceutix’s planned Phase 3 trial of Brilacidin for ABSSSI. Brilacidin, the Company’s lead drug in a new class of antibiotics called defensin-mimetics, completed a Phase 2b trial in September showing, amongst other things, a single dose of Brilacidin to be as effective in treatment of ABSSSI as a FDA-approved seven-day dosing regimen of daptomycin.

For more info on CTIX Please Subscribe below, also you should know we have Something Huge Coming

The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.

Among the benefits of QIDP is Fast Track and Priority Review status and a five-period of market exclusivity if approved. Cellceutix acquired Brilacidin last year when they purchased the assets of PolyMedix.

On May 13 CTIX announced financial results for the three months ended March 31, 2015. A detailed report of the third quarter fiscal 2015 has been filed in a Form 10-Q.

Highlights from the quarter ended March 2015 include:

—  The start of the eleventh cohort of patients in the Phase 1 clinical trial of Kevetrin for advanced solid tumors being conducted at Harvard Cancer Center’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. Patients in the completed tenth cohort were administered 450 mg/m2 of Kevetrin. We have found Kevetrin to be extremely well-tolerated, including in one patient who received their first treatment at 750 mg/m2 — the highest dose yet administered and is 75x the initial study dose. Maximum tolerated dose is yet to be determined.

—  Manufacturing of additional quantities of Kevetrin, Brilacidin and Prurisol for planned clinical trials.

—  The release of confidence interval statistics from the Company’s completed Phase 2b trial of Brilacidin, Cellceutix’s lead drug in a new class of antibiotics called defensin-mimetics, for Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The confidence interval statistics reinforced previous data from the trial showing Brilacidin to be comparable to the blockbuster antibiotic daptomycin marketed by Cubist Pharmaceuticals under the brand name Cubicin.

—  Development of formulations of Brilacidin and our “1807” antifungal compounds for otic (ear) infections. The compounds have been shipped to a leading university for ototoxicity testing.

—  $30.0 million stock purchase agreement entered into with Aspire Capital.

—  Applying to list Cellceutix common stock on the NASDAQ Capital Market.

We have a Monster Pick Coming. Subscribe Right Now!

Currently trading at a $207 million market valuation CTIX is down a long way since its $4.93 highs on a well-planned and coordinated short attack on the Company. Up until recently CTIX was the darling of the bb’s running from pennies to $4.93 a share. They are currently fully funded with over $7 million in the treasury. The stock is just now coming into the price range where they will be noticed by the primary players of biotechnology who could be all over this one.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.

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

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

ctixpipline

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Featured

IceCure Medical’s (NASDAQ: ICCM) ProSense: A 96.8% Success Rate Revolutionizing Breast Cancer Treatment

Published

on

On October 2nd, 2023, IceCure Medical (NASDAQ: ICCM) shares surged by over 50% following exciting news presented at a major medical event, the European Society of Breast Imaging. Their cutting-edge ProSense® System, designed for minimally invasive cryoablation, is marketed and sold worldwide for its cleared indications in the U.S., Europe, and China. More recently they gained approvals in India, and Brazil and have additional distribution through MC Medical to continue expanding in Europe. More importantly, the latest independent study confirms that the technology is a safe & effective outpatient procedure for breast cancer, with 96.8% success rate.

More Background:

Their system has the potential to revolutionize cancer treatment not only for breast cancer, but also for kidney, bone, and lung cancers. To date, the system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.

During the event, Dr. Lucía Graña-López, a radiologist specializing in breast and women’s imaging, led an independent study. The study explored cryoablation as a viable alternative to surgery for early-stage breast cancer in patients who preferred a non-surgical route. The results were promising, suggesting that cryoablation could be a successful treatment option, particularly for patients hesitant about traditional surgery.

Subscribe to Microcapdaily.com Right Now by entering your Email in the box below.

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

Clinical Study:

The study involved 31 patients with early-stage breast cancer who opted out of surgery, and the outcomes showed that cryoablation was well-tolerated with no major complications. This alternative approach could potentially be a game-changer, especially for breast cancer, which is one of the most prevalent cancers globally. Many patients, particularly older individuals, are seeking less invasive alternatives to surgery, making cryoablation an appealing option.

Dr. Graña-López envisions cryoablation becoming a significant alternative to surgery, particularly for early-stage breast cancer in post-menopausal women. Moreover she believes this technology could reshape how we approach treatment in other indications, particularly for kidney, lung, and thyroid gland cancers.

These results from this independent study are are in line with the ongoing ICE3 study, the largest of its kind in the U.S., set to conclude in early 2024.

We will update you on ICCM when more details emerge, subscribe to Microcapdaily to follow along!

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

Picture by marijana1 from Pixabay

Continue Reading

Featured

T2 Biosystems (NASDAQ: TTOO) Breaks Ground: FDA Clearance, Market Trends, and Healthcare Impact

Published

on

Shares of T2 Biosystems (NASDAQ:TTOO) are soaring up over 20% today on the heels of receiving a 510(k) clearance for its T2Biothreat from the FDA. This unique test directly detects six biothreat pathogens from a blood sample.

Spotting Biothreats Faster:

T2Biothreat Panel is a game-changer, being the first and only FDA-approved product that can spot these critical biothreat pathogens simultaneously. T2 Biosystems proudly stands as the first U.S. company to achieve this milestone, reshaping the field of biothreat detection.

Big Investor Sells:

Interestingly while celebrating this achievement, a significant investor, CR Group (CRG), decided to sell off a substantial chunk of shares. This sell-off, totaling 24.81 million shares, took place between Sept. 20 and Sept. 26. The timing of this sell-off alongside the FDA clearance raises some eyebrows.

Subscribe to Microcapdaily.com Right Now by entering your Email in the box below.

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

New CDC Guidelines:

Regardless of CR Group selling, there still appears to be a massive opportunity according to many retail investors. Following new CDC guidelines, the U.S. government now mandates that all hospitals in the country must adopt rapid testing protocols to combat the sepsis pandemic by 2026, or risk losing Medicare funding.

Buying opportunity of the year!!! Update
byu/den1183 inTTOOstock

T2 Biosystems stands as the exclusive FDA-cleared product capable of achieving 100% accurate sepsis detection within 3 to 5 hours. Anticipating widespread adoption of T2 instruments in hospitals, the CEO foresees significant revenue generation, potentially reaching $1.3 billion annually, given the mandate.

This development drastically alters the landscape, potentially influencing the stock’s trajectory positively. With the ongoing surge in manufacturing hires and likely acceleration in orders, coupled with potential government contracts or international sales, many beleive T2 Biosystems presents an undervalued opportunity for investors.

What Borrowing Costs Tell Us:

Another interesting indicator to look at is the cost to borrow (CTB) fee. In terms of TTOO’s case, the stock has seen a massive surge in CTB fees, indicating a high demand from short sellers. When compared to the average CTB fee for other stocks, it’s pretty drastic. While this is typically not a very positive sign, retail investors seem to be buzzing with interest, given there also could be a potential short squeeze if enough buying comes in to trap the shorts.

Better News for Patients:

But let’s not forget the real impact and that’s what TTOO can do for patients. @ChengKeki a user from Twitter also shared an article about Butler Memorial Hospital and their approach to Sepsis. The hospital came up with a 2 step approach to expedite patient care.  They’re utilizing the Beckman Coulter automation line to identify changes in a person’s blood cells that might indicate the development of sepsis. Which apparently has only been used in Europe and they’re the first in the US with the technology. Then shortly after, they use T2 Biosystems panels that as you know, quicken the process from 36 hours, to just 3-5 hours.

Catching sepsis quickly is crucial because it’s a life-threatening condition that rapidly progresses throughout your body and can lead to death if not promptly diagnosed and treated. Sepsis occurs when the body responds improperly to an infection, causing widespread inflammation and potentially damages multiple organ systems. Early detection allows for immediate medical intervention.

Conclusion:

T2 Biosystems is hitting major milestones, not only in the market but in improving critical healthcare processes. The company is also a major hit with retail investors and continues to trade an astronomical amount of shares daily, the current average is ~115M shares. The FDA approval and its implications, along with the positive shift in sepsis diagnosis, showcase T2 Biosystems’ growing role in healthcare. Keep an eye on how this progresses—it’s exciting for both investors and patients alike.

We will update you on TTOO when more details emerge, subscribe to Microcapdaily to follow along!

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

Picture by jarmoluk from Pixabay

 

Continue Reading

BioPharma

Organogenesis (NASDAQ: ORGO): Latest Developments and Future Growth Prospects

Published

on

Organogenesis Holdings (NASDAQ: ORGO), a top regenerative medicine company dedicated to advanced wound care, surgical, and sports medicine solutions, gains over 30% during intraday trading and after hours combined after their latest release. According to the release, three Medicare Administrative Contractors (MACs) decided to withdraw certain coverage rules that were meant to start on October 1. These rules related to products for treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU).

More Background:

Organogenesis serves a range of clients, from hospitals and wound care centers to doctors’ offices. The MACs’ initial rules, set on August 9, caused concern. They specified that covered products must be particular types of skin substitutes. Unfortunately, this excluded five products from Organogenesis, impacting their financial outlook.

Fast forward, the MACs pulled back these rules just in time, preventing potential harm to Organogenesis. Even before these rules, the company was facing challenges. In the second quarter, revenue was slightly down compared to the same period last year. Despite this, the company is doing better than the previous year in a six-month comparison.

Subscribe to Microcapdaily.com Right Now by entering your Email in the box below.

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

Gary S. Gillheeney, Sr., the head of Organogenesis, expressed deep gratitude for the MACs and the Centers for Medicare & Medicaid Services (CMS). He praised their thoughtful consideration of stakeholder concerns and putting patients first. This decision will positively affect the lives of many.

He also thanked the stakeholders, including doctors, patient advocacy groups, and various associations. Their unified support played a vital role in challenging these rules, considering the potential harm they could cause patients. Their advocacy shed light on the possible negative health outcomes and treatment disparities, especially for those with higher rates of diabetes and related conditions. Their collective efforts made a significant difference.

We will update you on ORGO when more details emerge, subscribe to Microcapdaily to follow along!

Subscribe to Our 100% Free Penny Stock Newsletter. We Have Something Big Coming!

Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

Picture by Parentingupstream from Pixabay

Continue Reading

Trending

© All rights reserved.

Sign up now for our 100% FREE Penny Stock Newsletter

Privacy Policy. we will never share your email with anyone.