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CytoDyn Inc (QB)

CytoDyn Inc (QB) (CYDY)

0.2265
0.0225
(11.03%)
Closed April 22 4:00PM
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Key stats and details

Current Price
0.2265
Bid
0.2229
Ask
0.23
Volume
1,808,468
0.20 Day's Range 0.235
0.1031 52 Week Range 0.4945
Market Cap
Previous Close
0.204
Open
0.204
Last Trade
220
@
0.2265
Last Trade Time
Financial Volume
$ 402,846
VWAP
0.222756
Average Volume (3m)
3,182,831
Shares Outstanding
1,228,232,000
Dividend Yield
-
PE Ratio
-5.67
Earnings Per Share (EPS)
-0.04
Revenue
-
Net Profit
-49.84M

About CytoDyn Inc (QB)

CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that... CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions. Show more

Sector
Pharmaceutical Preparations
Industry
Pharmaceutical Preparations
Website
Headquarters
Wilmington, Delaware, USA
Founded
-
CytoDyn Inc (QB) is listed in the Pharmaceutical Preparations sector of the OTCMarkets with ticker CYDY. The last closing price for CytoDyn (QB) was $0.20. Over the last year, CytoDyn (QB) shares have traded in a share price range of $ 0.1031 to $ 0.4945.

CytoDyn (QB) currently has 1,228,232,000 shares outstanding. The market capitalization of CytoDyn (QB) is $250.56 million. CytoDyn (QB) has a price to earnings ratio (PE ratio) of -5.67.

CYDY Latest News

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
10.01255.841121495330.2140.2350.19821407320.2039473CS
4-0.0235-9.40.250.25360.192516754760.21784482CS
12-0.0134-5.585660691950.23990.49450.176131828310.25598672CS
260.0765510.150.49450.103129972940.19714848CS
520.071546.12903225810.1550.49450.103127077150.1785612CS
156-0.0135-5.6250.241.30.103122195300.26884421CS
260-2.4235-91.45283018872.6510.010.103129616481.91759653CS

CYDY - Frequently Asked Questions (FAQ)

What is the current CytoDyn (QB) share price?
The current share price of CytoDyn (QB) is $ 0.2265
How many CytoDyn (QB) shares are in issue?
CytoDyn (QB) has 1,228,232,000 shares in issue
What is the market cap of CytoDyn (QB)?
The market capitalisation of CytoDyn (QB) is USD 250.56M
What is the 1 year trading range for CytoDyn (QB) share price?
CytoDyn (QB) has traded in the range of $ 0.1031 to $ 0.4945 during the past year
What is the PE ratio of CytoDyn (QB)?
The price to earnings ratio of CytoDyn (QB) is -5.67
What is the reporting currency for CytoDyn (QB)?
CytoDyn (QB) reports financial results in USD
What is the latest annual profit for CytoDyn (QB)?
The latest annual profit of CytoDyn (QB) is USD -49.84M
What is the registered address of CytoDyn (QB)?
The registered address for CytoDyn (QB) is 1209 ORANGE STREET, WILMINGTON, DELAWARE, 19801
What is the CytoDyn (QB) website address?
The website address for CytoDyn (QB) is www.cytodyn.com
Which industry sector does CytoDyn (QB) operate in?
CytoDyn (QB) operates in the PHARMACEUTICAL PREPARATIONS sector

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CYDY Financials

Financials

CYDY Discussion

View Posts
chumppunk chumppunk 10 hours ago
djjazzjeff- I believe your watching the same up n downs, same ticker symbol as long and shorts here. Btw- CYDY is holding itself within the market.
Chump
👍 1
djjazzyjeff djjazzyjeff 12 hours ago
Who cares if it goes up because idiot longs never sell on a pump they just watch it go up and come back down. They start recruiting yet?????
👍️0
Since 2012 Since 2012 12 hours ago
So you just posted it was down 50% over a week ago, now down to 30% over two months, where do you get your info, let’s see it
👍️0
fung_derf fung_derf 12 hours ago
You mean because the stock bounced back to the resistance line? Bully for you!
Resistance currently at .229. Let's see it finish the week above there first before getting too excited about you only being down about 30% from 2 months ago.
👍️0
nunaka nunaka 13 hours ago
Interesting, especially when the Dow is off over a thousand points, to be up 12% + and not a peep out of the usual pumpers and pissers???
👍️ 1
theswordman theswordman 1 day ago
did not want to offer coverage of certain preventive services, including PrEP medications for HIV. How does this play out for HIV meds?? Why wasn't the BLA ever filed?? Why wasn't the BTD for TNBC ever redone with the correct SOC?? Just to wait years and years for a poster?? Stop the nonsense--run the trial

The lawsuit was filed at the end of the first Trump administration by a Texas business and other individuals who did not want to offer coverage of certain preventive services, including PrEP medications for HIV, because of their religious and moral objections to those treatments.

What a twist--the T rump admin defending Obamacare (ever notice the "repeal Obamacare" nonsense has disappeared??)

https://www.cnn.com/2025/04/20/politics/obamacare-affordable-care-act-supreme-court-rfk-jr/index.html
👍️ 1
theswordman theswordman 2 days ago
Save the monkeys
https://thehill.com/homenews/5256937-research-monkeys-entangled-in-trump-harvard-dispute-get-reprieve/
👍️0
Monroe1 Monroe1 2 days ago
From Reddit r/Livimmune

23 hr. ago
BuildGoodThings
Grit

Yes that’s what most CytoDyn (CYDY) investors display! We’ve been though far more than most investors. The details are a very long story, so let’s cut to the chase.

The “why are we here” is what I want to discuss. For me it starts with the data of how people with serious conditions got better and had fewer serious side effects. First it was in HIV, then the severe Covid patients in ICU, and now it’s the Breast Cancer patient data that is about to hit the international fan. This stuff is IMO incredible and it’s going to become better known.

Right up there with the science, is that we all know people who have suffered with diseases that CytoDyn may be able to treat, and we yearn for our friends, family and ourselves to have better options.

Lastly, if the science data stays on track, the number of people who may want the drug, will explode to enormous numbers which translates to potentially indescribable profits.

I’m here for all three reasons, but to be honest, I also want some serious recognition after what happened to the company and its investors from 2020-2023.

My tale in that period is that Covid basically killed off 2 of my 3 main investments, bankrupted my employer, and forced me to more or less watch a parent die through a window.

Countless others have stories that are far worse which leave me speechless.

The purpose of this note? To tell you that I’m proud to know people with grit and I see a lot of that here!
👍️ 3 💯 1
Monroe1 Monroe1 4 days ago
aye Mate twas a great day for trading thanks to all pigeons.... green is so good. Up strong for the year!
Looking forward to Christmas in June.
👍️ 1 😂 1
Since 2012 Since 2012 5 days ago
Yea, you have a good wknd also, green till Monday, thanks for playing
👍️ 1 🤣 1
Niknak1 Niknak1 5 days ago
I personally feel after the conference in mid-May within 30 days after that we will have at least in my opinion three big pharma companies knocking at our door. After all we do have something to offer for mankind, women kind, children kind, and who knows what else at this point. Of course it would be animals. Thank you all you longs for hanging in there You will be well rewarded IMO. YOU KILL JOY BASHERS NEED TO TAKE A LONG WALK OFF OF A SHORT PAIR WHEN THE OCEAN IS REALLY CHURNING UP. OR GO PLAY IN THE FREEWAY TRAFFIC. THERE'S A COUPLE OF YOU THAT I WISH YOU'D DO THAT RIGHT AWAY. AND YOU KNOW WHO YOU ARE!!
👍️ 1 💯 1
kgromax kgromax 5 days ago
A “DIP” ONLY FOR BAGHOLDERS LOL
👍️0
kgromax kgromax 5 days ago
NICE FALL BEFORE THE WEEK-END
👍️0
Monroe1 Monroe1 5 days ago
Love it. Thanks to pigeons I play these dips. Love my green bags that keep getting larger.

Looking forward to that huge European Cancer Conference. The notoriety is going to be superb.

Semana Santa is here... Good Friday long weekend.

Maybe I will get another good fill today.

$CYDY$
CytoDyn Stock Price Performance

5 Day
Performance
-4.29%
1 Month
Performance
-15.37%
3 Month
Performance
+33.29%
6 Month
Performance
+39.87%
Year-To-Date
Performance
+83.23%
1 Year
Performance
+35.81%
👍️0
theswordman theswordman 5 days ago
Anything to deflect from the new dilution. Dr J needs to explain 100% why shares are not sold ATM
The shares with free warrants--the Fife nonsense--Why is this the funding??. Get full mkt value. To heck w Tonya and her protection of private investors. Enough bleed

Start the R C T. Stop standing around pretending mice and monkeys will get partners. Stop hiring firing hiring Dr Pestell yo yo--and pretending standing by some poster is the greatest thing ever. We heard the same thing about NASH. Covid. Brazil. Phillipines. We hear Bill Gates is evil--then Bill Gates is savior. We hear amawrecks do fantastic job. We hear minimal dilution. We hear insiders can never buy shares on open mkt. We hear 13D evil. S T F U

Start the R C T--ends in 2028. Was sched to start FEB 2025.
👍️ 1
djjazzyjeff djjazzyjeff 6 days ago
Dude the stock is barely trading at all. There's a billion shares and look at this volume. It's 50% down from its recent pump. It's over.
👍️0
chumppunk chumppunk 6 days ago
Gotta like this trading range holding , indicative of some news surfacing. In a hold pattern.
Chump
👍️ 1
Monroe1 Monroe1 6 days ago
Macro environment is looking UP! https://www.zerohedge.com/news/2025-04-03/can-moderna-or-rest-vaccine-makers-survive-rfks-vaccine-crackdown-during-global
👍️0
theswordman theswordman 7 days ago
Is this "link" about the NASH/MASH partnership you post about??
No one will find that link
👍️0
theswordman theswordman 7 days ago
Its possible that person does not know/understand --For the avoidance of doubt, Chicago Venture Partners (“CVP”) currently holds two notes with Borrower
– one in the name of Uptown Capital, LLC and another in the name of Streeterville Capital, LLC – and the
Monthly Payment Amount will accrue and be applicable to one of the two notes on a monthly basis. CVP may,
at its discretion, choose which of the two notes it would like to apply the Monthly Payment Amount to on a
month-by-month basis..

BUT you would "think" they could grasp --on some level--
LENDER: Streeterville Capital, LLC
By: /s/ John M. Fife
John M. Fife, President
BORROWER: CytoDyn, Inc.
By: /s/ Mitch Cohen
Name: Mitch Cohen
Title: Interim CFO

LENDER: Uptown Capital, LLC
By: /s/ John M. Fife
John M. Fife, President
BORROWER: CytoDyn, Inc.
By: /s/ Mitch Cohen
Name: Mitch Cohen
Title: Interim CFO




But NEVER let FACT get in the way of opinion
👍️ 1
Since 2012 Since 2012 7 days ago
Yea, those lawsuits are scary stuff I tell ya
👍️0
kgromax kgromax 7 days ago
And the latest 10Q filing by the company proves again that I was correct, and that you were wrong - Fife is bleeding dry this dead horse:

Extension(s) to April 2, 2021 and April 23, 2021 Notes
In April 2025, the Company and the holders of convertible notes issued by the Company on April 2, 2021 and April 23, 2021 (the
“Noteholders”) agreed to extend the maturity date of each of the notes by one year (the ”Extension Period”). The Company agreed to a total
monthly payment of $750,000 covering both notes until the extended maturity date. During the Extension Period, the Company will issue
shares of common stock equal in value to the $750,000 monthly payment calculated based on the lower of (i) the previous trading day’s
closing price, or (ii) the average of the five previous trading day closing prices. The interest rate for each note was also lowered to 6% as
part of the extension.
https://www.cytodyn.com/investors/sec-filings/all-sec-filings/content/0001558370-25-004774/0001558370-25-004774.pdf
👍️0
kgromax kgromax 7 days ago
On January 29, 2024, two purported stockholders filed a purported derivative lawsuit against certain of the Company’s former officers,
certain current and former directors, and the Company as a nominal defendant, in the Delaware Court of Chancery. The complaint generally
makes allegations similar to those set forth in the Consolidated Derivative Suit and asserts that the individual defendants breached their
fiduciary duties by allowing the Company to make false and misleading statements and by failing to maintain an adequate system of
oversight and controls. The complaint also asserts claims against certain individual defendants for breach of fiduciary duty arising from
alleged insider trading.

A side note for current shareholders. Always fun to remember these lawsuits are still pending.
👍️0
Yahsho Yahsho 1 week ago
Wow scary stuff lol

Yawn 🥱
👍️ 1
Yahsho Yahsho 1 week ago
"strategic partnerships" for inflammation.

HIV faint for a reason.

CMC ironclad for ***. Some of the money went to CRC. The rest went to THE…

.4 mill for CRC rough math and then the other .557 mill was used for ⚡️

.735 mill on partner R&D. 40 percent jump……
👍️0
djjazzyjeff djjazzyjeff 1 week ago
EhhHhehehehe cydy must pay $750,000 a month in stock for the next year, guaranteeing ongoing dilution. Great investment longs!!!!
👍️0
djjazzyjeff djjazzyjeff 1 week ago
Not only did CYDY knock the exercise price down to 9 cents they gave over 24 million FREE BONUS shares to get people to exercise their warrants!!!! God I love going through this so many funny factoids!
👍️ 1
djjazzyjeff djjazzyjeff 1 week ago
Also how long have they been working on that stupid long lasting lerloonimab and still nothing? Lol longs.
👍️0
djjazzyjeff djjazzyjeff 1 week ago
CYDY has increased the number of shares by 15% since last year. What a good investment guyzzzz lololol meeeeeeeeeeeenimal dilution. You guys are their piggy bank lol
👍️0
Monroe1 Monroe1 1 week ago
LOL, Expected as much. How about the extension of debt and lowering of interest rate?
One thing for sure, we have more support than ever and are not broke. Yawn

Who will be the first of our partners?
How high that pr takes the stock is the great unknown..if in oncology and a sizeable pharma....hang on tight. The rest of you can yawn and watch in awe.

$CYDY$ Incoming
💯 1
FooBarAndGrill FooBarAndGrill 1 week ago
10-Q out. Yawn.
👍️0
Monroe1 Monroe1 1 week ago
And the pigeons? Monkeys and mice, animals no more per directive from Dept. of Health.
Finally a win for the sub humans!! No more animal testing!! Have you ever seen them In a lab
before where they are experimented upon? It is really quite sad.
👍️0
djjazzyjeff djjazzyjeff 1 week ago
Poster presentations are absolutely useless. Cydy has been doing it for years and you silly longs keep thinking they are some super catalyst
👍️0
chumppunk chumppunk 1 week ago
Two dates of coming note for CYDY May 15th in Europe and July 7th . Get ready!
CytoDyn’s Integrated Biomarker Strategy: Tracking the Impact of Leronlimab : r/Livimmune

11th World Congress on CANCER RESEARCH AND THERAPY July 7-8, 2025 : r/Livimmune

Potency of Presentation : r/Livimmune

Anktiva + Leronlimab : r/Livimmune

The Role and Therapeutic Targeting of CCR5 in Breast Cancer
Chump
👍️ 2
Monroe1 Monroe1 1 week ago
With Young Adult Cancer on the Rise, New Therapies Spark Investor Buzz

PR Newswire - 10:15 AM ET 4/14/2025 Investment News



VANCOUVER, BC, April 14, 2025 /PRNewswire/ -- Equity Insider News Commentary – Routine medical appointments or cancer screenings—critical for catching the disease in earlier, more treatable stages—has dropped to just over 50% of the population. At the same time, doctors are raising alarm bells over a noticeable increase in cancer diagnoses among younger adults, especially women. With proposed funding cuts to the NIH now on the table and new estimates suggesting that drug tariffs could add $10,000 or more to treatment costs, the path forward may rely less on government programs and more on private-sector breakthroughs


Remember our CEO and others have mentioned... we are really an oncology company. Following the European Conference in a few weeks, a significant notoriety among European and elsewhere will occur in the recognition of leronlimab. More attention and European Pharma competition won't hurt at all.

This is our year. $$$2025$$$
👍 2
kgromax kgromax 1 week ago
Right "bro". I remember "brother" who would write exactly that each and every day. He has cowardly fled away from CYDY, never heard from him, after losing >95% on this stock.

Everyday he would "take screenshots" and claimed to have had "very interesting exchanges with the SEC". For a couple years. Which...ahem...was not very mature.

It's childish. Grow.
👍️0
kgromax kgromax 1 week ago
LOL when it goes your way it's the "science", otherwise it's "manipulation".

I am a scientist and have never seen something more biased than that.

CYDY is an OTC stock, nothing more. Enjoy the bag!
All that red, red, red on your hands...
👍️0
chumppunk chumppunk 1 week ago
blueheel1- you haven’t posted in awhile but you’ve been on board a long time. Gd to see you post.
Chump
👍️ 1
fung_derf fung_derf 1 week ago
I wasn't selecting an exact day. I was referring to the 3rd week of Feb. ...the 24th if you need an exact day. The exact date isn't important though (unless you want to go back and see who was stating what on that day)
If I owned the stock I'd be wondering why the stock price dropped in half (it's actually 57.5%) since the last bit of reported "good news".
Do you think anyone here was selling into that?...perhaps while they were telling everyone that everything is great.
👍️0
Blueheel1 Blueheel1 1 week ago
docj - thanks for your great work on the board. You are providing relevant information, and playing an important role.

I've been off the board for quite awhile, and even missed the March letter as I've been busy with other things. But I thought the letter was powerful. My key take-aways:

1. We have sufficient cash. This is the real key at this point, given the darker tone of the markets - fundraising for pre-revenue biotechs will only get tougher.

2. We have found the critical path in terms of indications. (TNBC snd CLC, the 2 highest potential return indications). Much of my concerns over time have been the scatter-gun approach to chasing too many indications. Jay and the team seem to have found the critical path - and Pestell is highly respected in this field.

3. The mention of partnerships in the near term. For the first time, i feel we likely have material discussions at a stage where they could result in a partnership this year. If it's a well respected company, this would be huge.

To be clear, we still have to execute, and I think the risks (especially given the market backdrop) remain high. But I personally are more excited about the near / intermediate term for this investment than I have been in a long time.
👍️ 4
docj docj 1 week ago
Pristine_Hunter_9506

CytoDyn’s Integrated Biomarker Strategy: Tracking the Impact of Leronlimab
Abstract CytoDyn has dedicated significant resources to the identification, tracking, and interpretation of biomarkers in its clinical and preclinical programs. Central to these efforts is the development of leronlimab—a CCR5-blocking monoclonal antibody—and its impact on processes such as RANTES-mediated inflammation, tumor metastasis, and fibrosis. This article reviews the company’s work in monitoring biomarkers to optimize patient selection, evaluate treatment responses, and support regulatory submissions.

Introduction Biomarkers play an essential role in modern drug development by linking a therapeutic agent’s mechanism of action to clinical outcomes. In the case of leronlimab, tracking key biomarkers such as RANTES levels, CCR5 expression, and other inflammatory mediators has become a cornerstone of CytoDyn’s development strategy. Through a series of rigorous preclinical studies and clinical trials, CytoDyn aims to demonstrate that modulation of these biomarkers corresponds with meaningful therapeutic benefits in areas ranging from oncology and HIV to fibrotic liver diseases.

Clinical Applications and Biomarker Tracking Oncology Studies CytoDyn has integrated biomarker tracking into its clinical evaluations of leronlimab in oncology. Notably:

Investigator-Initiated Studies in Triple-Negative Breast Cancer (TNBC): In a humanized TNBC xenograft model led by researchers at MD Anderson Cancer Center, CytoDyn’s study has utilized immunohistochemistry (IHC) to assess CCR5 expression as a key biomarker. This work aims to correlate changes in the tumor microenvironment, including the modulation of RANTES and other cytokines, with anti-tumor activity. The study’s goals include identifying immunological biomarkers that not only validate leronlimab’s mechanism of action but might also prove useful for patient stratification in future trials .

Phase II Studies in Colorectal Cancer: In recent work, CytoDyn completed an FDA meeting regarding its Phase II study in microsatellite stable metastatic colorectal cancer (mCRC). This trial employs IHC and next-generation sequencing (NGS) to detect CCR5 expression on tumor cells. By doing so, the company seeks to determine whether elevated CCR5 in tumors can predict a more robust response to leronlimab when used in combination with standard agents, such as TAS-102 and bevacizumab .

Fibrosis and Inflammatory Pathways Preclinical Models of Liver Fibrosis: In collaboration with SMC Laboratories, CytoDyn has published findings from preclinical studies that demonstrated statistically significant fibrosis reversal in animal models of metabolic dysfunction-associated steatohepatitis (MASH) and chemically induced liver fibrosis. In these models, biomarker tracking—through both histological examinations and molecular assays—was fundamental to showing that leronlimab’s binding to CCR5 may downregulate pathways leading to liver fibrosis. These results are promising for future clinical applications in fibrotic diseases of the liver and potentially other organs .

Infectious Diseases and Immune Modulation COVID-19 and Inflammatory Biomarkers: Beyond oncology and fibrosis, early compassionate use studies during the COVID-19 pandemic suggested that leronlimab could reduce inflammatory mediators such as RANTES. This effort involved serial biomarker assessments to monitor the drug’s effect on cytokine levels, thereby lending support to its potential role in modulating the immune response during severe viral infections.

Strategic Advantages of Biomarker Integration The depth of CytoDyn’s biomarker research confers several strategic advantages:

Enhanced Patient Selection: By identifying patients with high CCR5 expression or elevated inflammatory markers, CytoDyn’s trials can enroll the most responsive patient populations. This targeted approach can improve the signal-to-noise ratio in clinical endpoints.

Adaptive Trial Designs: Biomarker data support the incorporation of adaptive designs, where interim analyses of biomarker trends (such as reductions in RANTES) inform adjustments in dosing, patient stratification, or even modifications of trial endpoints. Such flexibility can accelerate the clinical development timeline.

Regulatory Engagement: Consistent and reproducible biomarker data strengthen the argument for a drug’s mechanism of action. Regulators increasingly see value in surrogate endpoints, particularly when they reliably predict clinical outcomes. CytoDyn’s extensive biomarker tracking is being positioned as a linchpin to its regulatory strategy.

Conclusion CytoDyn’s commitment to tracking biomarkers has been a driving force in the development of leronlimab. From using immunohistochemistry to evaluate CCR5 expression in tumor tissues to monitoring cytokine profiles in clinical trials, the company’s integrated biomarker strategy is central to demonstrating the drug’s impact on key pathological processes. This rigorous biomarker-driven approach not only aids in optimizing patient selection and dosing but also lays a solid foundation for future regulatory approval and clinical success across multiple therapeutic areas.

By continually refining their assays and integrating adaptive trial designs, CytoDyn is well positioned to leverage biomarker data as a surrogate for clinical efficacy, thereby accelerating the path for leronlimab’s broader acceptance as a transformative therapeutic option.

Would you like to dive deeper into specific assay methodologies or examine further case studies on how biomarker tracking has influenced other drug approvals?

Advances in Assay Methodologies for Biomarker Tracking

Immunohistochemistry (IHC) Application: IHC remains one of the most widely used techniques for visualizing protein expression in tissue sections. For CytoDyn, IHC can be used to assess CCR5 expression on tumor cells or infiltrating inflammatory cells in biopsy samples. When evaluating leronlimab’s efficacy, researchers can compare the intensity and distribution of CCR5 or associated markers (like RANTES) before and after treatment.

Advantages: IHC provides spatial context, allowing researchers to understand not only if the target is present, but also its localization within the tumor microenvironment or inflammatory sites. This approach is particularly important in oncology, where the expression profile can vary widely within a tumor.

2. Enzyme-Linked Immunosorbent Assays (ELISA) Application: ELISAs are well-suited for quantitative measurement of soluble biomarkers in blood or other bodily fluids. In the context of leronlimab, ELISA can be used to track changes in serum RANTES levels over time. Frequent sampling during clinical trials helps determine the pharmacodynamic impact of CCR5 blockade.

Advantages: ELISA is highly sensitive, specific, and can be standardized easily, making it an excellent method for routine monitoring in both preclinical and clinical settings. Its quantitative nature facilitates correlation with clinical endpoints.

3. Multiplex Assays Application: Multiplex platforms, including bead-based assays, allow for the simultaneous measurement of multiple cytokines and chemokines (e.g., RANTES, other inflammatory markers) in a single sample. This approach helps capture a holistic view of the inflammatory pathway modulation.

Advantages: By tracking several biomarkers at once, researchers can identify patterns of response and better understand the broader immunomodulatory effects of leronlimab. Multiplexing enhances efficiency and provides deep insights into pathway networks.

4. Next-Generation Sequencing (NGS) and RT-PCR Application: NGS and quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) can be used to assess gene expression levels of CCR5, RANTES, and related inflammatory genes. Such studies are vital for confirming that observed protein-level changes are reflected in mRNA levels.

Advantages: These methods offer high sensitivity and specificity, enabling the detection of subtle shifts in gene expression in response to treatment. They are especially useful in developing companion diagnostics to predict which patients might benefit most from therapy.

Case Studies: Biomarker Tracking Influencing Drug Approvals

Trastuzumab (Herceptin) for HER2-Positive Breast Cancer Companion Diagnostic: One of the hallmark examples of successful biomarker-driven therapy is the use of trastuzumab in HER2-positive breast cancer patients. The approval of trastuzumab was tightly linked to IHC and Fluorescence In Situ Hybridization (FISH) assays that reliably determined HER2 overexpression or gene amplification.

Impact: Integration of these diagnostic tests ensured that only patients with a demonstrated overexpression of HER2 received the treatment, significantly increasing the drug’s efficacy and safety profile in the targeted population.

2. Pembrolizumab (Keytruda) for PD-L1-Positive Tumors Companion Diagnostic: Pembrolizumab’s approval in several cancers was accompanied by the development of a companion diagnostic assay that measures PD-L1 expression. This biomarker was crucial for selecting patients most likely to respond to immunotherapy.

Impact: The ability to stratify patients based on PD-L1 expression strengthened the clinical trial results, reduced heterogeneity in patient responses, and led to a more accelerated regulatory review process.

3. CAR T-Cell Therapies in Hematologic Malignancies Biomarker Integration: In the development of CAR T-cell therapies for certain leukemias and lymphomas, biomarkers, such as specific cell surface antigens (e.g., CD19), are used both for patient selection and for monitoring therapeutic effectiveness post-infusion.

Impact: Tracking these biomarkers has contributed to understanding the durability of responses and has driven further refinements in therapy design, ultimately paving the way for regulatory approvals.

Conclusion and Future Directions CytoDyn’s approach to tracking biomarkers leverages a multi-method strategy—ranging from IHC and ELISA to multiplex assays and NGS—to comprehensively monitor the impact of leronlimab on pathways driven by CCR5 and RANTES. The success stories from drug approvals that depend on companion diagnostics, such as trastuzumab and pembrolizumab, serve as guiding examples. These case studies illustrate how robust biomarker tracking not only enhances patient selection and assesses therapeutic efficacy but also significantly impacts the regulatory landscape by providing tangible surrogate endpoints.

Going forward, a combined strategy that incorporates adaptive trial designs with rigorous biomarker monitoring could position leronlimab favorably for achieving broader approval. Continuous refinement in assay methodologies and further integration of real-world evidence will also be key in demonstrating sustained clinical benefits and solidifying the drug’s place in precision medicine.
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moneycrew moneycrew 1 week ago
Thats funny, the SEC thinks it's great not "pathetic and dumb" . I'm sure the corruption, manipulation will end soon with this stock. I personally can't wait to see exactly who is who and what role they played. The SEC has really nice offices by the way
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djjazzyjeff djjazzyjeff 1 week ago
Lol are you seriously threatening to send a post to the SEC? Lol you longs are so pathetic and dumb
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moneycrew moneycrew 1 week ago
Quite the opposite, hope you're short, you're going to lose big time. Nice try at trying to cause a selloff though, the SEC refers to that as " manipulation". I'll be sure to let them see your attempt with a screenshot
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kgromax kgromax 1 week ago
SOMETHING BAD BREWING FOR CYDY THIS WEEK

Old-timers know what this is
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chumppunk chumppunk 1 week ago
Fung_derf. I’m getting 2 months from today .20, feb 11th. How’d u get 50% down?
Chump
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djjazzyjeff djjazzyjeff 2 weeks ago
You been saying that for months if not years. When you gonna realize you're the sucker here
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theswordman theswordman 2 weeks ago
Well so far the only things getting eaten are time and $$$.

Did you give up on the chain letter with chuckles ,misssuisie, leo and some of the others?? Novel idea but realize that ONLY real trials--with humans--and legit data from using a real CRO and supervised by a real CEO that results in legit data in correct form and analysis and proper submission to FDA will get to "PREVAIL" land

All the chain letters--hate of 13D--love for skelly--support of fraud by khazemporhassan will do ZERO in that regard. Same as mice--airlines--meta analysis--data dredge--monkeys--defending felons--hating Dr Patterson--hating Dr Pestell. Just ridiculous waste
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fung_derf fung_derf 2 weeks ago
Do you have a deadline date for this laughing? I mean, is there a date where bashers are allowed to laugh at you?
Also, why wouldn't you think any bashers could change their minds between now and then?
The stock is down 50% just in the last 2 months by the way.
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Niknak1 Niknak1 2 weeks ago
Bashers bashers bashers. In my opinion you're going to end up eating crow. Just watch!! And I'm going to laugh all the way to the bank!!!! And you bashers are going to really be singing the BLUES 💙 IMO. HANG IN THERE ALL YOU LONGS WE WILL PREVAIL!!! IMO.
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