Monroe1
4 일 전
Thanks for the history lesson which supports some analysts currently remarking about our CytoDyn;
Cytodyn Inc Stock (CYDY) Forecast
The Cytodyn Inc (CYDY) stock price forecast for the next 30 days is generally positive, with an average analyst price target of $0.9960, representing a +346.65% increase from the current price of $0.223. The highest analyst price target is $1.0583, and the lowest is $0.9338.
https://stockscan.io/stocks/CYDY/forecast
Long-term CYDY price forecast for 2025, 2030, 2035, 2040, 2045 and 2050
Based on our analysis about Cytodyn Inc financial reports and earnings history, Cytodyn Inc (CYDY) stock could reach $5.1574 by 2030, $15.38 by 2040 and $13.87 by 2050. See the projected annual prices until 2050 of the Cytodyn Inc stock below:
Cytodyn Inc (CYDY) is expected to reach an average price of $9.1981 in 2035, with a high prediction of $10.19 and a low estimate of $9.2096. This indicates an +4024.72% change from the last recorded price of $0.223.
Cytodyn Inc (CYDY) stock is projected to chart a bullish course in 2040, with an average price target of $14.50, representing an +6400.68% change from its current level. The forecast ranges from a conservative $14.51 to a sky-high $15.38.
Our analysts predict Cytodyn Inc (CYDY) to change +8934.14% by 2045, soaring from $9.2116 to an average price of $20.15, potentially reaching $21.18. While $9.2116 is the low estimate, the potential upside is significant.
Cytodyn Inc (CYDY) stock is expected to climb by 2050, reaching an average of $12.63, a +5564.26% change from its current level. However, a wide range of estimates exists, with high and low targets of $13.87 and $11.39, respectively, highlighting the market's uncertainty.
NOT FACTORED IN IS THE BUY OUT OR MERGER. IMO, THIS LONGTERM OUTLOOK IS FAR SHY EVEN WITH ONLY A PARTNER OR TWO. A BREAKTHROUGH WITH HIV AND FIBROSIS AND WE COULD BE AT THIS 2035 $10 PPS AVERAGE IN 2-3 YEARS WITH LICENSING AND PARTNERS THE FUTURE IS ANYTHING BUT PREDICTABLE EXCEPT WE ARE GOING UP. MY GRANDKIDS WILL REMEMBER THIS INVESTMENT.
docj
4 일 전
Anything can happen even for CYDY being on the OTC market. Partial credit to Biostocktraderbyday for this info:
Several biotech companies that initially started as over-the-counter (OTC) stocks or smaller companies have gone on to become major players in the pharmaceutical and biotech industries. These companies often gained success by developing breakthrough treatments and seeing their stock prices soar. Here’s a list of some noteworthy companies that began in OTC markets but eventually became more prominent:
1. Amgen (AMGN)
OTC Origins: Originally started in 1980 as a small biotech company, trading under various names before going public.
Success: Amgen is one of the largest biotechnology firms in the world. Their blockbuster drugs, such as Enbrel (for autoimmune diseases) and Neulasta (for cancer patients), have driven immense financial success.
Stock Price Performance: Over the years, Amgen’s stock price has risen significantly, becoming a staple of biotech investing.
2. Gilead Sciences (GILD)
OTC Origins: Gilead started as a small biotech company and traded on the OTC market in its early days in the 1990s.
Success: Gilead revolutionized the treatment of HIV and hepatitis C with drugs like Sovaldi and Harvoni. Later, its acquisition of Kite Pharma helped establish it in the CAR-T cancer therapy space.
Stock Price Performance: After gaining approval for key drugs, Gilead’s stock price surged, and it became one of the most valuable biotech companies.
3. Regeneron Pharmaceuticals (REGN)
OTC Origins: Founded in 1988 and initially traded as a smaller entity.
Success: Regeneron has had huge successes with drugs like Eylea (for eye diseases) and Dupixent (for asthma, eczema, and other inflammatory conditions).
Stock Price Performance: Regeneron’s stock has performed exceptionally well, particularly since 2014, when its revenue started to skyrocket from Eylea and Dupixent sales.
4. Vertex Pharmaceuticals (VRTX)
OTC Origins: Vertex started out in the late 1980s, and its early stock performance was often on the lower end of the spectrum.
Success: Vertex revolutionized cystic fibrosis treatment with its highly effective CFTR modulator drugs, such as Kalydeco and Trikafta.
Stock Price Performance: Vertex saw substantial stock price growth as its cystic fibrosis drugs generated billions in sales.
5. Biogen (BIIB)
OTC Origins: Biogen was founded in 1978 and, while it wasn’t initially traded as an OTC company, it did have humble beginnings before going public in the 1980s.
Success: Biogen became a leader in multiple sclerosis (MS) treatment, with drugs like Avonex and Tecfidera. More recently, its Alzheimer's treatment Aduhelm (despite controversy) has put Biogen in the spotlight.
Stock Price Performance: Over time, Biogen’s stock price surged, especially with the success of its MS therapies.
6. Moderna (MRNA)
OTC Origins: Moderna was founded in 2010 and initially had a less visible presence in the market before it went public in 2018.
Success: Moderna’s development of one of the most widely used COVID-19 vaccines, based on its mRNA technology, brought it global recognition.
Stock Price Performance: Moderna’s stock saw a meteoric rise during the pandemic, as the company’s vaccine became a cornerstone of global vaccine distribution.
7. Illumina (ILMN)
OTC Origins: Illumina started as a small, specialized company in the early 2000s in the genomic sequencing space and had early trading at relatively low prices.
Success: Illumina became a leader in genomic sequencing technology, crucial for various fields including diagnostics and personalized medicine.
Stock Price Performance: Illumina has seen dramatic growth in stock price as the genomic sequencing market has expanded, becoming one of the most significant biotech companies in the world.
8. NantKwest (NK)
OTC Origins: A smaller biotech firm originally focused on immunotherapy and oncology treatments, trading in OTC markets before eventually going public.
Success: While not as established as others on the list, NantKwest’s focus on immunotherapy and the promise of its NK cell-based cancer therapies led to notable stock performance, especially post-IPO.
Stock Price Performance: Though volatile, the company’s potential has intrigued investors, and its stock price surged after its IPO, although it’s had more ups and downs compared to the larger players.
9. Exelixis (EXEL)
OTC Origins: Exelixis was founded in the early 1990s and initially had a low profile before it became more prominent in the cancer treatment space.
Success: Exelixis gained attention with its cancer drugs like Cabometyx (for kidney cancer) and Cometriq (for thyroid cancer).
Stock Price Performance: Exelixis’ stock has seen significant increases as it advanced its cancer treatments, making it a leader in oncology.
10. Sarepta Therapeutics (SRPT)
OTC Origins: Sarepta started out in the 1990s, trading in smaller markets before it became more widely recognized.
Success: Sarepta is a leader in developing treatments for rare genetic diseases, especially Duchenne muscular dystrophy, with drugs like Exondys 51 and Vyondys 53.
Stock Price Performance: Sarepta's stock price has fluctuated significantly but rose sharply after its success with Duchenne treatments, making it a favorite for investors in the rare disease space.
These companies demonstrate how biotech firms, even if starting in less prominent markets or as smaller OTC stocks, can achieve significant success with breakthrough therapies. Their growth is often driven by scientific innovation, regulatory approval of high-demand treatments, and expanding market opportunities.
docj
6 일 전
The latest from MGK_2:
Evolving Course
Maybe we should try to prepare everybody. There is an endgame in town, and that game is to get this drug into play on the world stage. Big players seem to have come that they may take the reigns. Jay, Max, Gates, Trump. CytoDyn is about to embark on amazing transformations which could only come as a results of the honorable and dutiful effort of bringing forth this multifaceted molecule.
Here, I don't give dates as to when precisely, but do offer approximate time frames. I discuss more and look at various and different angles. I offer a little more in the way of reasoned thought than those who are just looking for information on the timing of things. Here, I try to look a bit forward, I try to see what is happening at the moment and try to make connections or alignments that make sense for the future.
Of late, I have made mention of various reasons for discussions between CytoDyn and potential collaboration efforts. At the very last minute, and in 180 degree polar opposite opposition to what it originally claimed it was intending on doing, CytoDyn stealthily pulled out of its presentation of its initial murine study in MASH at the MASH-TAG conference. I offered up a few reasoned possibilities for why that may have occurred. In addition, we have learned of a 3-hour long conversation which took place between Bill Gates and President Trump regarding the cure of HIV. Most recently, there are now statements coming from Schwab and other reputable trading institutions that there is now 19.86% Institutional Ownership in CytoDyn when just a week or two prior, there was almost none.
No doubt, CytoDyn has been hard at work in all of its endeavors to advance this molecule. As I've listed in Almost There, the clinical indications which are most paramount are only briefly described there in so as not to make the post too lengthy or arduous. All of those indications are CytoDyn's hot spots, while there are certainly more that could have been listed, I did not want that post to go on and on, nor did I want it to be too inclusive of every little bit, but rather, wanted it to be more sort of an introduction to much of what is happening here at CytoDyn. CytoDyn has taken great effort on multiple fronts to confront each and every one of those listed indications and the gaps are certainly closing as can be appreciated in that post.
Dr. Lalezari spoke in December, that CytoDyn share holders may expect the results of CytoDyn's confirmatory murine study in MASH in January, 2025.
"In September, CytoDyn launched two follow up studies to confirm and expand on these preliminary results. The first follow-up study seeks to confirm the observations of the original study with larger cohorts of mice (12 versus the original 8/group) and will compare leronlimab with a GLP-1 agonist (Semaglutide) in addition to confirming the comparisons with Resmetirom. The second follow-up study involves the administration of CCL4, a drug that directly causes liver fibrosis in mice. This study will clarify if the observed reversal of liver fibrosis is restricted to the MASH/fat deposition pathway or might occur independently of the etiology of fibrosis (e.g. alcohol, viral hepatitis, etc.). The results from both follow-up studies will become available in January. "
At the time of the writing of this post, there are only 5 trading days left in January and Dr. Lalezari is a man of his word.
CytoDyn has excellent intentions, but speaks softly. They do carry a big stick though. Phase 1 is over and done. CytoDyn got over the clinical hold and have made tremendous headway towards the point they are at right now. Signs now point to some sort of partnership being established which should be announced in the very proximal future. Combine that with CytoDyn pulling out of MASH-TAG and Gate's recent conversation with Trump. 20% institution ownership has just been uncovered in the past week, when prior to that there was none? Yeah, with the assortment of all of these notes into a medley, I'd say this is the beginning of Phase 2. Ownership of stock marks the start date.
We can begin to ask some questions. What is the agreement and with who? Which Institution bought 20% CYDY? Will there be board seats which must be created for this investment? What are their interests? Is it with an institution with only one goal in mind such as the Gate's Foundation for an HIV Cure or like Madrigal for MASH, or could it be with an institution that has a broad spectrum of goals in mind, like GSK? With whoever it is with, they have had over a minimum of 6 weeks to discuss their plans, possibly even 3-4 months. The Shareholder meeting was on 12/17 and CytoDyn's intention was to present. However, by Christmas, those plans were shot down. Something happened and today, CytoDyn has 20% Institutional Ownership without any details surrounding that claim. That information has to come out within 10 days of that claim, so therefore, it's coming.
The deal though doesn't appear to be a licensing deal which we have so far discussed. It seems more to be an investment into CytoDyn itself, which seems to be somewhere around $40 million for about 250 million shares at about $0.15/share. These are just approximate figures and really, I'm only surmising. There is no documentation on any of this, but hopefully, there will be soon. This is not a typical partnership either and certainly, nor is it a buy out. It seems to be an investment into CytoDyn. But it exceeds 5%, so, if you might remember, that 5% is what 13D needed to exceed to be able to overthrow the CEO. Maybe, the terms of this agreement that were agreed to might have eliminated that possibility.
Most companies do not follow such a path to gain partnership. This investment at a very low and special price, at a volume in excess of 5% seems to be more along the lines of a Foundational Investment. Something more along the lines of what the Gate's Foundation would venture into. It does not seem to be something another company like Madrigal or GSK would enter into because there would be too much political influence for another Pharmaceutical to own 20% of another pharmaceutical.
What would CytoDyn gain from such investment by the GF? I would understand that CytoDyn would gain the optimization and fast tracking of all of their current indications with the help and experience of the Gate's Foundation. Certainly, the GF's primary concern is HIV Cure, but if they're 20% invested in CYDY, then, they would want all of CytoDyn's indications to succeed. By gaining the support of the GF, CytoDyn becomes well equipped to take on the challenges they face in getting HIV Cured, in proving out leronlimab in MSS mCRC and all the rest of their challenges. Those obstacles no longer become road blocks. The experience of both Max and those at the GF, dismantle these rocks in the road, driving around pot holes or filling them in with asphalt as they arise and surmount these problems with far more ease than had CytoDyn been alone. So this is where I think this is headed.
So Phase 2 has already begun, because there is 20% Institutional Investment, but we just don't know it yet, because it hasn't been announced. How many Phases are there? 3? 4? What could Phase 3 be, $400 million? CytoDyn would need more shares, but let's not consider that right now. That stage has not yet been agreed upon, but this Phase 2 has been. The details of Phase 2 should be coming out in near future. Nothing else has changed. The license deal I mentioned with Novo Nordisk might still be in play. But, in addition, I do suspect an investment by the GF and then it is back to business as usual, now however, with the assistance of the GF in overcoming obstacles in the effort to reach shared goals.
Now, with this in place, when G attacks CytoDyn, they would also be attacking the GF. Remember, the GF also has Trump and his minions backing their efforts, or is that Phase 3? Lalezari remains CEO, at the helm and is on the offensive. Now, with this substantial investment and backing, he is only that much more powerful. As the obstacles arise and present themselves to him, he brings them up to his collaborating partners for their analysis and their strategy to overcome this persistent resistance.
So, I believe that the GF wants very much to be a massive part of the HIV Cure. I also believe that Trump wants very much to be a significant contributor to the HIV Cure. Currently, and still only hypothetically, they own only 20% of CYDY and that 20%, my suspicion shall not be sufficient for purposes of their ego. But, at this early point, they are not yet quite ready to go for it all. They need more proof. So once the proof is made, then Phase 3 goes into action. Could that be when Trump enters? Regardless, that's where the real money comes in.
How hard does CytoDyn run towards their end goals? What changes does this Phase 2 investment bring? How great a resistance is made against any progression towards these goals? Remember, any time in the past that CytoDyn met resistance, it has always overcome it and has come out on top. That doesn't change. Lalezari remains in control, that is at least until shareholders own less than 50%, and Jay shall see it through to completion. There shall be a hefty price to pay for 100% of the shares, but that might be Phase 4 or 5, but, he won't let it be completely bought out until he knows the drug shall obtain approval.
Provided this investment into CytoDyn takes root and does begin to grow, as in progress made towards an HIV Cure, then Phase 3 assuredly, is down the road. But if no headway is made and failure in the goal near term is met, then the GF might want to pull out if they are not that interested in the other indications. But, who then would be interested in the other indications? I think then, it could go back to GSK who for many reasons, share the same ideology as CytoDyn and who has a great familiarity with Max Lataillade.
But if there is progress and it does come to Phase 3, that would be to the point where an HIV Cure is just about definite, does the GF settle for only 49%? I don't believe CytoDyn can let go of 51% or more and be left with 49% or less, because CytoDyn needs to have control. But would only 49% be satisfactory for the GF? They may just have to make an offer for 100% at that point when the destiny of the other indications is better understood. It seems to me that considering the vast number of indications that leronlimab can handle, it becomes harder and harder to understand why Lalezari could choose to give up CytoDyn's right to control the rest of them.
None of this was understood on the day of the Shareholder's letter, 12/17/24. But, today, we are beginning to understand, that there appears to be collaborative efforts which are materializing in such a way as to result in the cure of HIV and the establishment of leronlimab as an approved medication in the fight against cancer, MASH and many more inflammatory diseases, provided that these efforts do progress to their next interval step which does require the success of the preceding phasic effort.
Provided the collaboration is successful, it won't be long before there is an approved HIV Cure. Could be as soon as mid 2027 if everything goes right. That would be 3 years ahead of Trump's HIV-2030 goal and Trump would eat that notoriety up, that HIV was cured under his watch and under his investment. The massive investment made by the GF would also not go unnoticed. So, that is the end game, which is just beginning now, which is the signing off of Phase 2, the beginning of a collaboration to get serious about an actual HIV Cure. The next few years to get there, are like a new era of time. The work is yet to begin and the work shall begin. How long? Everything like this takes time, but with the help of the GF, the Trump assistance and Max's experience, it takes a lot less time than it would have otherwise without them.
The direction is changing Folks, from what it has been. This is where, to me at least, it seems to be going, but as I see it, this seems to be an evolving new course.
docj
7 일 전
Another summary from MGK_2:
Almost There
Almost There, Aren't We? This post really is meant to bring new investors up to speed as to the various avenues of interest that CytoDyn is currently pursuing.
All of that which we expect as CYDY shareholders is simply that which leronlimab is capable of, and we hope and believe that those laboring souls at CytoDyn do their absolute best to make each of these expectations a reality. The feeling of positivity emanates as many of us are expecting good news in the proximal future.
We are aware that there are plenty of temporary treatments out there for HIV, but there are zero cures. Those treatments work for a certain period of time, but if you stop or fail to take the next dose, HIV returns back to the body and would lead to AIDS unless the medication is taken again. That is because the medications are not a cure. There is a massive interest to insure that the disease itself doesn't go away, that HIV is never cured. If HIV is cured, then tens to hundreds of billions of dollars would be lost in recurrent annual revenue, therefore, there is immense pressure to insure that HIV doesn't go anywhere. Treatments for the disease do abound, but there exists not one cure.
CytoDyn however, is the one and only company actually working towards and getting extremely close to establishing a viable cure for HIV.
Jonah Sacha, Ph.D., who is a professor at OHSU's Oregon National Primate Research Center, and who also sits on CytoDyn's Scientific Advisory Board, is currently working on several projects aimed at curing HIV:
Reverse-engineering stem cell transplant cure: Sacha studies the molecular mechanisms and immune responses behind the five known cases of HIV cure via stem cell transplant. This research aims to develop HIV-specific immunotherapies that could lead to a widespread cure.
Gene therapy using leronlimab: Sacha leads a preclinical study funded by a $5 million NIH grant to develop a single-injection gene therapy based on leronlimab. This approach aims to provide a "functional cure" for HIV, allowing sustained viral suppression without lifelong medication.
Nonhuman primate studies: Sacha has successfully cured two nonhuman primates of the monkey form of HIV using stem cell transplants. This research provides valuable insights into the mechanisms of HIV cure and informs efforts to make the cure applicable to more people.
AAV vector-based gene therapy: Sacha is involved in research to develop novel AAV vectors for gene therapy to cure HIV. This work aims to establish long-term antibody-based competitive CCR5 inhibition as a potential cure mechanism.
Sacha is involved in a study investigating the transplacental transfer of leronlimab. The study aims to test the hypothesis that FcRn-enhancing mutations can lead to increased and prolonged levels of antibodies crossing the placenta. This research is part of Sacha's broader work on developing HIV cures and treatments. While not explicitly stated as an HIV cure, this study explores a potential method for preventing HIV transmission from mother to child during pregnancy. The use of LS mutations (likely referring to FcRn-enhancing mutations) is being investigated to improve the efficacy of leronlimab in crossing the placental barrier.
Sacha is involved in a groundbreaking study that combines early antiretroviral therapy (ART) with broadly neutralizing antibodies (bNAbs) and leronlimab to potentially achieve sustained viral control in HIV infection. This study was presented at the 5th annual HIV Research for Prevention Conference in October 2024. Key aspects of the study include:
Objective: To assess whether the combination of early ART initiation with bNAbs and leronlimab could provide sustained viral control in infant rhesus macaques, potentially reducing or eliminating the need for lifelong daily medication. This research represents a significant step forward in the quest for an HIV cure, combining multiple therapeutic approaches to achieve sustained viral control without the need for continuous ART.
Methodology: Eighteen infant rhesus macaques were infected with Simian Human Immunodeficiency Virus (SHIV) and then treated with various combinations of ART, bNAbs, and leronlimab. The study evaluated the efficacy of these treatments over a 27-week period, followed by a treatment interruption to monitor virus rebound.
Results: The combination of ART, bNAbs, and leronlimab showed promising outcomes, with no virus rebound observed in any of the treated animals. This suggests a potential for durable viral control and a significant advancement towards minimizing or eliminating the need for ongoing ART.
Significance: Dr. Sacha noted that the results demonstrate a previously unappreciated synergy between CCR5 blockade (via leronlimab) and antibody neutralization, opening the door to a new approach for an HIV cure.
Collaboration: The study was funded by an NIH grant awarded to Oregon Health & Science University (OHSU) and led by Dr. Nancy Haigwood, Dr. Sacha, and their collaborators.
Together, these projects collectively represent a multi-faceted approach to developing an HIV cure, ranging from basic science to translational research and clinical applications. Their efforts towards this end are proving successful as they now have multiple monkeys with eradicated SHIV vius and not taking ART therapy in excess of 1 year.
During his first term as president, Donald Trump launched a program aimed at ending the HIV epidemic in the United States by 2030. This initiative, called "Ending the HIV Epidemic: A Plan for America" (EHE), was announced in 2019. The EHE plan had four main pillars: diagnose, treat, prevent, and respond. It focused on providing additional resources and funding to areas most affected by HIV, including 48 counties, Washington D.C., San Juan, Puerto Rico, and seven states with high rural HIV rates. Key aspects of Trump's HIV/AIDS program included:
Increased funding: The administration awarded grants to strengthen efforts in combating HIV, including $1 million in Ryan White HIV/AIDS Program grants.
Focus on prevention: The plan promoted expansion of pre-exposure prophylaxis (PrEP) and secured a donation of HIV preventive medication for eligible patients.
Global efforts: Trump continued support for PEPFAR (President's Emergency Plan for AIDS Relief), signing the PEPFAR Extension Act in 2018.
While the program aimed to end the HIV epidemic rather than specifically "cure" AIDS, it represented a significant commitment to addressing HIV/AIDS in the United States. COVID came along in 2020 and put a real damper on this initiative, but the plan remains underway.
As of late, Bill Gates recently had a three-hour dinner meeting with President Donald Trump, during which they discussed several global health issues, including efforts to develop a cure for HIV. Gates shared that he spoke extensively about HIV and the work his foundation is doing to find a cure. He emphasized that the Bill and Melinda Gates Foundation is "literally working on a cure for that," although they are still in the early stages of this research. During their conversation, Gates drew a parallel between the accelerated vaccine development during the COVID-19 pandemic under Trump's administration and the potential for similar progress in HIV research. He asked Trump if a similar approach could be applied to HIV cure efforts, stating, "So I was asking him if maybe the same kind of thing could be done here". Gates reported that both he and Trump became excited about the possibility of accelerating HIV cure research. He noted that Trump showed genuine interest in the topics discussed and appeared energized about driving innovation in this area. The Microsoft co-founder expressed that he was "frankly impressed" with how well Trump demonstrated interest in the issues he brought up, including the potential for advancing HIV cure research.
Given that Max Lataillade, SVP is simultaneously the Head of Clinical Development at CytoDyn while also the Head of HIV Drug Development at the Gate's Foundation, it is also given that Max had likely informed Bill of all the accomplishments Jonah Sacha, PhD has achieved in regards to an HIV cure. My understanding would permit me to believe that Gate's understanding from Max allowed him to communicate to Trump that an HIV cure utilizing leronlimab could become an FDA approved reality by ~early-mid of 2027 provided proper funding is obtained now. If the proper amount of investment and provisions were made, such a possibility would then place Trump's HIV-2030 plan way ahead of schedule. Trump was more than responsive.
So, this could have been the topic of this 3-hour long discussion that has taken place, and I suspect that we can expect more like it. What might be the fruit of these discussions? A collaboration between CytoDyn, the Gate's Foundation and the Federal Government for an HIV cure that could be approved by mid-2027. That is 30 months from now.
//LATCH
In HIV, CytoDyn is also advancing its LATCH (Leronlimab in Allogenic stem cell Transplant to Cure HIV) program, which aims to use leronlimab in an innovative approach to potentially cure HIV. The company has two notable developments in this area:
Primary LATCH Study: CytoDyn is partnering with the American Foundation for AIDS Research (amfAR) to sponsor the main LATCH study. This trial will:
Use leronlimab to protect CCR5+ donor immune cells from HIV infection
Aim for a HIV cure in the setting of bone marrow transplant to an HIV positive recipient
Complete final protocol updates were completed by the end of December 2024
Launch in 2025
Berlin LATCH Study: Following a successful HIV cure announcement by German investigators using donor cells heterozygous for the CCR5-delta 32 mutation, CytoDyn has been approached to expand the LATCH program:
The same German investigators have requested to run a similar LATCH study at their research center in Berlin
CytoDyn is makeing this opportunity a reality
The company is optimistic about the LATCH program's potential success, given the recent breakthrough in Germany. This dual-track approach with studies in multiple locations could accelerate research and potentially lead to groundbreaking advancements in HIV cure strategies.
What else does CytoDyn have going on?
//MSS mCRC
The MSS mCRC clinical trial has begun. This trial is the only clinical trial that CytoDyn is actually currently funding, the remainder are being sponsored by 3rd parties. CytoDyn's Phase II clinical trial for leronlimab in colorectal cancer has begun patient enrollment in January, 2025. The company has received FDA clearance for the trial, which evaluates the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer. A trial kickoff meeting was completed late November 2024, and patient screening is expected to start in early 2025. The trial is conducted in partnership with Syneos Health, which CytoDyn has engaged as the contract research organization (CRO) for this study. This Phase II oncology trial represents an important step for CytoDyn in advancing leronlimab's potential as a treatment for colorectal cancer, with the company's CEO emphasizing that investigating leronlimab in oncology remains their top priority.
//MASH
CytoDyn has probably already received the MASH murine results of its second confirmatory MASH murine study. CytoDyn has commissioned two follow-up studies following preliminary study with SMC Laboratories to confirm and extend the observation of fibrosis reversal seen in their initial preclinical study concluded in September 2024. These follow-up studies are likely complete, with results expected in January, 2025. These follow-up, confirmatory studies were initiated after promising initial results from the September 2024 study, which showed that leronlimab monotherapy (700 mg) demonstrated statistically significant fibrosis reversal compared to a control group. One of the current studies is using the STAM mouse model again. Dr. Melissa Palmer, an internationally renowned hepatologist, has been appointed as the lead consultant in hepatology to oversee these follow-up studies with SMC Laboratories. The studies compare leronlimab alone and in combination with other therapies, building on the findings from the previous research. Given the current date, it's likely that these studies are in their final stages, with results anticipated to be released soon.
//Pulmonary Fibrosis
CytoDyn's potential involvement in a pulmonary fibrosis pilot trial is contingent on the positive outcomes of their ongoing studies, particularly in the area of fibrosis reversal. While there is no direct mention of a pulmonary fibrosis trial for CytoDyn, the company's recent findings in liver fibrosis studies suggest promising applications for leronlimab in fibrotic conditions. The preliminary results from CytoDyn's study with SMC Laboratories showed that leronlimab demonstrated significant fibrosis reversal in a liver model:
Leronlimab monotherapy (700 mg) showed statistically significant fibrosis reversal compared to a control group (p
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