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Bulls Take Charge of CytoDyn Inc (OTCMKTS:CYDY) as Leronlimab Gains Traction

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CytoDyn Inc (OTCMKTS:CYDY) is moving northbound in recent trading as the Company continues to announce promising results for Leronlimab as a treatment for coronavirus. Last week the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRA’s decision follows several months of its review of CytoDyn’s manufacturing processes and Leronlimab’s safety profile. This comes as CytoDyn has completed its Top-line Report from its randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. FDA, and requested emergency use approval.

CYDY is among the most exciting and dynamic stories on the OTCQB that became the darling of small caps as it skyrocketed to $10 per share from a start point of pennies as its wunderdrug Leronlimab continues to demonstrate significant potential to attack a number of diseases including cancer, HIV and coronavirus (COVID-19). CytoDyn is focused on up-listing its stock to a national exchange which could result in a massive short covering rally.

CytoDyn Inc (OTCMKTS:CYDY) is a late-stage biotechnology company with executive offices in Vancouver, Washington, focused on the clinical development and potential commercialization of Leronlimab (PRO 140), a CCR5 antagonist that continues to demonstrate significant potential to attack a number of diseases including cancer, HIV and coronavirus (COVID-19). Leronlimab has been granted a Fast Track designation by the FDA for two potential indications of Leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. In total Leronlimab has completed 10 clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (Leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

Last week CytoDyn announced it has provided its Top-line Report from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. Food and Drug Administration (FDA), and requested emergency use approval. In addition, CytoDyn sent its Top-line Report of the Phase 2, mild-to-moderate COVID-19 population, to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines. CytoDyn has also been approached by several doctors about a clinical study of leronlimab in long-hauler COVID-19 individuals. The Company is preparing a Phase 3 protocol and will file it as soon as possible.

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CYDY

CytoDyn said it will conduct its Type A meeting in writing in lieu of a teleconference with the FDA. which has agreed to respond to the Company’s questions by September 4, 2020 concerning the additional information the FDA requires to resubmit the Biologics License Application (BLA) for leronlimab as a combination therapy for HIV. Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We completely understand and appreciate the FDA’s meeting schedule during these unprecedented times and are eager to discuss and provide all additional information regarding our recent BLA filing.  Our questions to the FDA were submitted on a Type A meeting request and the Agency’s response to those questions will ensure we have the necessary information we need to resubmit the BLA as soon as possible.”

On August 20 CYDY announced the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRA’s decision follows several months of its review of CytoDyn’s manufacturing processes and leronlimab’s safety profile.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We are very pleased with the MHRA’s confidence in Leronlimab to initiate enrollment of patients in the U.K. for our current CD12 protocol. CytoDyn recently requested “fast track approval” from the MHRA for its completed Phase 2 COVID-19 trial for the mild-to-moderate population, with strong efficacy and safety data. We believe Leronlimab has multiple opportunities for several clinical indications and we are very optimistic about our future based upon how far we have advanced this drug in about 5 years. In addition, we plan to file a BLA for HIV in the U.K. within the next 4 weeks.”

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CYDY is moving northbound since a brief dip below the $3 mark.  Investors are excited as CytoDyn is among the first biotechs to have a drug that ccould be effective in the global fight against coronavirus COVID-19 world epidemic. leronlimab which has been hailed as a possible wonder drug has been found to have significant potential to attack a host of diseases including cancer, HIV and now coronavirus COVID-19. Leronlimab is proving to be a safe and effective drug to treat m/m covid patients and the P2 study subgroup analysis also demonstrated that the patients with more symptoms at baseline (ie: sicker patients), those who received leronlimab had more of a treatment effect than those receiving placebo. This, along with the decrease in SAEs in leronlimab arm compared to placebo, gives us a peek into the S/C results. Last week the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRA’s decision follows several months of its review of CytoDyn’s manufacturing processes and Leronlimab’s safety profile. This comes as CytoDyn has completed its Top-line Report from its randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms to the U.S. FDA, and requested emergency use approval. If the results are better than remdesivir or dexamethasone, pressure will be intense to approve it for sale. Microcapdaily has been reporting on CytoDYn since the stock was $0.25. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.

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

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Enveric Biosciences (NASDAQ: ENVB) Pioneering the Future of Anxiety Disorder Treatment

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Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news.

Enveric Biosciences, Inc. (NASDAQ: ENVB) shares surged 78% this morning upon approval of some fantastic news. The United States Patent and Trademark Office has granted them a notice of allowance for their patent application concerning a groundbreaking chemical compound called EB-373. This compound is being developed to address the treatment of anxiety disorders.

The forthcoming patent, titled “C4-Carbonothioate-Substituted Tryptamine Derivatives and Methods of Using,” encompasses claims for the composition of matter of a family of revolutionary prodrug derivatives of psilocin. Enveric’s lead product candidate, EB-373, stands out among these derivatives. A Notice of Allowance signifies that the USPTO has determined that a patent should be granted based on the submitted application.

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Enveric’s commitment to innovation extends beyond EB-373. They have also submitted additional patent applications to the USPTO, exploring psilocin prodrugs with unique crystalline molecular structures. Moreover, they have taken proactive steps to pursue global coverage of the EVM201 and EVM301 Series through companion Patent Cooperation Treaty and non-US national patent applications. Encouragingly, positive International Search Reports and written opinions have been received under the Patent Cooperation Treaty for most of these applications.

Joseph Tucker, Ph.D., Enveric’s director and CEO, underlined the significance of the USPTO’s favorable decision concerning their lead candidate, EB-373. He highlighted the innovative designs of their psilocin prodrugs within the EVM201 series, differentiating them from conventional counterparts like psilocybin. These novel designs hold the potential to deliver more rapid therapeutic effects, precise control, and reduced gastrointestinal side effects. Tucker emphasized that securing a robust intellectual property portfolio for their new chemical entity prodrugs is pivotal to Enveric’s value proposition and integral to their business strategy of developing cutting-edge small-molecule therapeutics to address mental health disorders.

We will update you on ENVB when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening in the markets!

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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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Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) Secure Partnership

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Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) today announced a multi-year collaboration that will use TScan's proprietary target discovery platform.

TScan to Receive $30 Million Upfront With Potential Development and Commercial Milestone Payments of Over $500 Million.

Collaboration Brings Together TScan’s Proprietary Target Discovery Platform and Amgen’s Inflammation Therapeutic Expertise and Research Capabilities

Amgen (NASDAQ: AMGN) and TScan Therapeutics, Inc. (NASDAQ: TCRX) today announced a multi-year collaboration that will use TScan’s proprietary target discovery platform, TargetScan, to identify the antigens recognized by T cells in patients with Crohn’s disease.

All things considered, this is among one of the largest deals you’ll see for a micro-cap biopharma company. As many of you know, companies in this sector of this size and scale are typically not profitable – mainly focusing on R&D until their drug or technology is fully approved/commercially viable. 

The critical thing to note with this deal between TScan and Amgen is that the cash milestones ensure a cash runway for TCRX, potentially even until they become commercially viable and profitable. 

Here’s a breakdown of the press release in layman’s terms, so anyone without background or knowledge in this space can better understand: 

Amgen and TScan Therapeutics are teaming up to find new treatments for Crohn’s disease, a chronic condition that causes inflammation in the gut. TScan has a unique platform called TargetScan that can identify the proteins recognized by the immune system in people with the disease. Amgen will use this information to create new drugs to treat Crohn’s disease.

As part of the deal, TScan will get an upfront payment of $30 million from Amgen and could earn more than $500 million if the collaboration is successful. Amgen will have the rights to develop and sell any new drugs from this partnership.

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Both companies will be responsible for their research costs, and Amgen can expand the collaboration to include another condition called ulcerative colitis. This partnership could lead to new and better treatments for people with Crohn’s disease, who currently have limited options for managing their symptoms.

Here are a couple of blurbs from the management team

“Anti-inflammatory drugs have traditionally been the standard of care for patients suffering from inflammatory bowel disease, but often lack efficacy and durability,” said Raymond Deshaies, Ph.D., senior vice president of Global Research at Amgen. “TScan’s platform provides a best-in-class approach to identify non-conventional drug targets to enable the development of potential first-in-class therapeutics to address unmet medical needs.”

“We’re excited to apply our target discovery platform to the autoimmunity space,” said Gavin MacBeath, Ph.D., acting chief executive officer and chief scientific and operating officer at TScan. “Our TargetScan platform, which we have now extended to identify MHC class II targets of CD4+ T cells, is well-suited for the discovery of antigens targeted by the immune system in inflammatory bowel disease. We look forward to developing the value of our platform both in this partnership with Amgen and in other autoimmune diseases.”

What’s retail saying?

As per usual, with gains of around 135%, you can probably guess that retail is all over it. Investors practically all over the internet keep their eye on the stock for potential entry points utilizing various day trading techniques. 

Interestingly, some traders are surprised it managed to trade such massive volumes early intraday. If you look at their chart from the prior months, the average volume was relatively minuscule – sometimes trading as low as 5K shares a day.  Compared to the ~27M shares traded at the time of writing, that’s a massive shift.

We will update you on TCRX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening with TCRX.

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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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ContraFect Corp (NASDAQ: CFRX): A Low Float Runner

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On April 27, 2023, shares of ContraFect Corp (NASDAQ: CFRX) skyrocketed by 125% in pre-market trading, which is quite unusual.

On April 27, 2023, shares of ContraFect Corp (NASDAQ: CFRX) skyrocketed by 125% in pre-market trading, which is quite unusual. Although the surge may be linked to the news from the previous day, it is difficult to determine as there was not much movement on April 26.

However, sometimes it only takes the right attention from investors to create such positive rallies. It is worth noting that $CFRX has a low float of 1.53M, which can lead to extreme volatility and provide retail traders an opportunity to make significant gains.

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Summary of latest PR on April 26, 2023

ContraFect Corporation is a clinical-stage biotechnology company developing new treatments for antibiotic-resistant infections. They recently announced that they initiated a Phase 1b/2 study to test the safety, drug disposition, and efficacy of their drug candidate, Exebacase, in patients with chronic prosthetic joint infections (PJI) of the knee. The study is in France and is randomized, double-blind, and placebo-controlled, meaning some patients will receive the drug, while others will receive a placebo. The study will have two parts: Part I will evaluate the drug’s efficacy, safety, and pharmacokinetics at an early six-week time point, while Part II will assess the long-term clinical safety and efficacy of the drug for up to two years. The CEO of ContraFect Corporation is optimistic about the potential of Exebacase to replace the current surgical treatment for chronic PJI, which has not shown significant improvement in clinical outcomes in recent decades.

What are retail traders saying?

https://twitter.com/RealWillTopol/status/1651553835801001986?s=20

It is worth noting that there has been some speculation about the events that have unfolded and the underlying factors that have led to them. 

We’ve observed a subset of traders that capitalize on the volatility by adopting a watchful approach towards stocks, including $CFRX, to generate quick profits. 

However, it is essential to exercise caution when considering following their lead, given the high risk associated with their investment strategies and the prevailing market conditions. While we do not typically recommend emulating their investment decisions, it may be an intriguing endeavor for those willing to assume a certain level of financial risk with funds they can afford to lose.

About ContraFect Corp (NASDAQ: CFRX)

ContraFect is a company that focuses on finding new ways to treat life-threatening infections resistant to antibiotics. Antibiotic-resistant infections are responsible for an estimated 700,000 deaths each year worldwide. ContraFect is developing new medical treatments called DLAs that include lysins and amurin peptides. Lysins are antimicrobial proteins that can quickly kill target bacteria, including those in biofilms, and can work with traditional antibiotics. Amurin peptides can fight many antibiotic-resistant Gram-negative pathogens, including P. aeruginosa, Acinetobacter baumannii, and Enterobacter species. ContraFect believes that lysins and amurin peptides will effectively fight antibiotic-resistant organisms, such as MRSA and P. aeruginosa, which can cause serious infections. The company has completed a Phase 2 clinical trial for their lead lysin candidate, exebacase, designated by the FDA as a Breakthrough Therapy for treating MRSA bloodstream infections, including right-sided endocarditis, when combined with traditional antibiotics.

We will update you on CFRX when more details emerge, so make sure you are subscribed to Microcapdaily to know what’s happening with CFRX.

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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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