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Unlocking Potential: Biodexa Pharmaceutical’s (NASDAQ: BDRX) MTX110 Study Progress Triggers Trading Frenzy

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Biodexa Pharmaceutical’s (NASDAQ: BDRX) shares have shown substantial volatility during today’s trading session, experiencing gains of nearly 150% at various points. Biodexa specializes in the development of treatments for brain cancer. More importantly, the company recently completed the enrollment and treatment phase for nine children participating in a study involving their lead asset, MTX110.

 

Allow us to provide a simplified explanation of the announcement, to enhance your understanding of the company’s efforts to improve clinical outcomes for primary and metastatic brain cancers.

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About MTX110 Clinical Trial:

In this particular study, the enrolled children, aged between 4 and 17 years, underwent radiation therapy as per standard medical practice. After that, they had surgery to implant a special catheter and a programmable pump directly into their tumors. The purpose of this implant is to deliver a drug called MTX110 into the tumor site. Out of the nine patients, eight have received two infusions of MTX110 via a technique called convection-enhanced delivery (CED), with different concentrations of the drug being tested.

The important update is that there have been no reports of serious side effects or toxicities related to the use of MTX110 in this study. The drug has been well-tolerated by the patients.

The study aims to evaluate the safety and effectiveness of MTX110 in treating children with DMGs, which is a highly challenging and life-threatening disease. The survival rate for patients with DMGs is very low, and current treatment options are limited. The results of this study are expected to be made public in early 2024, providing valuable information about the drug’s impact on the disease.

Insights from Retail Investors:

As previously mentioned, Microcap stocks often have a limited number of available shares, commonly referred to as a “tight” or “low” float. In the case of $BDRX, they recently underwent a reverse stock split because their stock price fell below the minimum bid compliance standard on NASDAQ. This reverse split was significant, with a ratio of one-for-eighty (1-80), and was effective on July 5th, 2023. Consequently, the number of shares available for trading decreased substantially, leading to a significant increase in trading volatility. It’s worth noting that $BDRX has one of the lowest floats we’ve observed on NASDAQ, with only 220.22k shares available for trading. Many Retail investors would consider this a “Nano-float”. Given the circumstances, it’s understandable that stocks like this can experience highly significant price fluctuations, attracting a large number of investors seeking quick gains through short-term trading strategies.

 

 

 

About Diffuse Midline Gliomas (DMGs):

DMGs is a type of brain tumor that occurs in the middle part of the brain. It cannot be surgically removed and mostly affects children. The average survival rate is around 9 to 11 months, and most patients die within a year of diagnosis. The current treatments, such as chemotherapy, are not very effective because the drugs have difficulty reaching the brain. About 1,100 people worldwide are diagnosed with DMG each year.

About MTX110:

MTX110 is a modified form of a drug called panobinostat. It is designed to be delivered directly to the tumor site through a catheter system, bypassing the blood-brain barrier. This allows for high concentrations of the drug to be delivered to the tumor while minimizing side effects. MTX110 is being studied for its effectiveness in treating recurrent glioblastoma, pediatric DMG, and recurrent medulloblastoma. Previous studies have shown promising results in laboratory tests using DMG and glioblastoma cells.

About Phase 1 Clinical Trials: 

The primary goal of a Phase 1 clinical trial is to assess the safety and tolerability of a new drug or treatment in a small group of participants. Phase 1 trials are the earliest stage of human testing and usually involve a relatively small number of healthy volunteers or patients. The main objectives of Phase 1 trials are:

Safety: Phase 1 trials aim to identify any potential side effects or adverse reactions associated with the treatment. Researchers closely monitor participants for any negative effects and determine the dose levels that can be tolerated.

Dosage determination: These trials help determine the appropriate dosage range for further studies. Researchers may administer different doses to participants to evaluate the drug’s pharmacokinetics (how the drug is absorbed, distributed, metabolized, and eliminated by the body) and determine the optimal dose for further investigation.

Pharmacokinetics and pharmacodynamics: Phase 1 trials assess how the drug is processed in the body, including its absorption, distribution, metabolism, and elimination. They also evaluate how the drug interacts with the body’s cells and affects the targeted disease or condition.

Preliminary efficacy: Although Phase 1 trials primarily focus on safety, they may also provide initial data on the treatment’s effectiveness. Researchers may evaluate early signs of efficacy or measure biomarkers to determine if the drug is having the desired effects.

Overall, the main goal of a Phase 1 clinical trial is to gather essential information about the drug’s safety profile, establish an appropriate dosage range, and lay the groundwork for further studies in subsequent phases (Phase 2 and Phase 3) to evaluate the treatment’s efficacy and potential benefits.

Conclusion:

Biodexa Ltd (NASDAQ: BDRX) has achieved another significant milestone with its lead asset, MTX110. The limited number of available shares following their stock split has resulted in rapid stock movement, attracting investors seeking quick profits from potential substantial gains. According to their presentation deck, there are several important upcoming milestones and catalysts to monitor in the coming months. These include the release of Phase 1 ‘203 study data in DMG, submission of Phase 2 IND in DMG, the publication of MAGIC-G1 study cohort A PFS data, and the initiation of the Phase 2 study in DMG.

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

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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.

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

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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.

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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.

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

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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.

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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!

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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.

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Femasys’ (NASDAQ: FEMY) FemaSeed Receives FDA Nod: A Game-Changer for Infertility Treatment

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Femasys Inc. (NASDAQ: FEMY) hit a massive milestone and saw shares soar by a whopping 346%. The reason? The United States Food and Drug Administration (FDA) has given the thumbs up for the commercialization of FemaSeed, a game-changing option for artificial insemination aiming to boost the natural fertilization process.

FemaSeed:

It’s a breakthrough treatment for infertility, designed to carry sperm right to where conception happens in a woman’s fallopian tube. This breakthrough could change the game in infertility treatments by offering a less invasive option compared to heavy hitters like in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), potentially reducing the risk of complications during the procedure.

Kathy Lee-Sepsick, Femasys’ founder and CEO, is beyond excited about the FDA’s green light for FemaSeed. She highlights how this could be a game-changer in providing infertility treatments that are less of a burden. The FDA clearance is a testament to successful teamwork with the FDA and a major step forward in making this new technology available to those struggling with infertility.

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The rising numbers of infertility cases in the United States (about 10 million women, as per the Center for Disease Control) show how crucial it is to have accessible and effective infertility treatments. FemaSeed is ready to meet this need by offering an affordable and efficient option for those dealing with infertility.

Here’s an interesting tidbit: FemaSeed works in harmony with FemVue, Femasys’ FDA-cleared diagnostic device. FemVue lets doctors perform an in-office ultrasound assessment of the fallopian tubes, helping diagnose infertility even before going for FemaSeed.

But wait, there’s more! Femasys isn’t just about FemaSeed. They’re also charging ahead with FemBloc, their lead candidate for permanent birth control in late-stage clinical development. Their commitment is to provide accessible solutions for women’s health, covering unmet needs with a range of innovative in-office products.

In a nutshell, Femasys is all about empowering women and couples facing fertility challenges. Their aim? To provide cost-effective and less invasive infertility treatments, backed by innovative diagnostic solutions. With this FDA clearance for FemaSeed, Femasys is a step closer to achieving this mission and leaving a lasting impact in the realm of women’s healthcare.

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

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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.

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