CYDY: This Penny Stock Keeps Looking Better Coming Into Summer
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TM Editors' note: This article discusses a penny stock and/or microcap. Such stocks are easily manipulated; do your own careful due diligence.
PENNY STOCKS THAT HAVE GOTTEN PAST THE DE-RISKING REWARD VERSUS RISKS (CYDY)
Tables next to graphs and charts can say volumes with trying to keep the Wow Factor clearly in sight for the readers.
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What was new? |
Why it matters |
Source |
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1. First mechanistic evidence that leronlimab “inflames” cold tumors. 15 of 17 (88 %) evaluable mTNBC patients showed a ≥2-fold rise in PD-L1 on their circulating-tumor cells within 30-90 days of starting weekly ≥525 mg leronlimab. |
Turning a PD-L1-low (“cold”) tumor micro-environment into a PD-L1-high (“hot”) state is the pre-requisite for benefit from today’s immune-checkpoint inhibitors (ICIs). The data provide a biologic explanation for the long-term responders seen in earlier trials and open a pathway for combination regimens. |
CytoDyn |
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2. Real-world combination signal. Every patient (5/5) who had the PD-L1 surge and subsequently received any ICI is still alive; 4/5 show no evidence of disease, the 5th has stable disease beyond 48 months. |
Although the sample is small, 100 % survival and four complete responses in heavily pre-treated mTNBC are unprecedented and strongly hypothesis-generating for a leronlimab + ICI strategy. |
Biospace, Cytodyne |
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3. Updated long-term survival cohort. CytoDyn now tracks ≥48-month survivors from its prior Phase Ib/II mTNBC studies: 4 patients NED, 1 stable. Earlier pooled analysis already showed survival at 12, 24 and 36 months far above historical controls. |
Confirms durability: typical median overall survival after third-line chemo in mTNBC is ~6–9 months. Having multiple 4-year survivors after leronlimab is a clinically meaningful outlier. |
Cytodyne |
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4. Pipeline knock-on: protocol amendment in ongoing colorectal-cancer (CRC) trial to prospectively collect PD-L1 data. |
Signals management’s intent to validate the “cold-to-hot” effect in a second solid-tumor type and to position leronlimab as an immune-priming backbone. |
Cytodyne |
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5. Public release of the full ESMO poster (Munich, 14-17 May 2025). |
Allows investors and clinicians to scrutinize methodology; restores scientific transparency after prior CRO-data dispute. |
Cytodyne |
Why this ESMO update moves the needle
- Mechanism now matches the clinical signal. Survival outliers alone were intriguing; showing a biologically plausible PD-L1 up-regulation connects the dots and makes the data harder to dismiss as chance.
- Transforms leronlimab’s positioning:
- From “possible salvage mono-therapy in mTNBC”
- → to “tumor-micro-environment modulator that could broaden the addressable ICI market” (patients with PD-L1-low tumors currently derive little benefit from pembrolizumab, atezolizumab, etc.).
- Regulatory impact: A clearer MoA plus long-term survival may strengthen CytoDyn’s case for Fast Track re-engagement with FDA once the longstanding partial clinical hold (safety-pharmacokinetics questions) is finally resolved.
- Commercial upside: If the cold-to-hot effect is confirmed prospectively in CRC (and other solid tumors), leronlimab could be combined with existing ICIs in >$30 B/yr indications, materially enlarging its oncology TAM beyond triple-negative breast cancer.
- Near-term catalysts now in focus (next 6-12 mo):
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- Prospective PD-L1 data read-out from the amended CRC study.
- Negotiations with ICI partners (Merck, BMS, Roche) for combination trials.
- FDA feedback on clinical-hold lifts and potential Type-C meeting to discuss an mTNBC confirmatory study aligned with the new MoA.
In short, the critical takeaway from CytoDyn’s ESMO showing is that the company delivered, for the first time, a coherent mechanistic explanation (PD-L1 induction via CCR5 blockade) that dovetails with its extraordinary long-term survival anecdotes. This elevates leronlimab from an interesting case series to a candidate with a testable, potentially platform-wide value proposition in solid-tumor oncology. This Biotech Company is also preparing to launch and join some of the other companies currently selling their shares between ranges $3.25 - $17.85 a share. The explosive potential for Cytodyne to one day be seen as a Penny Stock and in the same day be trading in the multiple dollars per share.
You see me always driving the same strong bull argument for Capricor CAPR and Mesoblast MESO, the ticker symbols. CAPR I have all the current CFA’s with an average Price Target near term of $43 dollars with a high of $77 dollars, with MESO having a near-term price target of $30 dollars a share. The reason they are on my bullish Strong Buy and Long Term holding these are for the high potential of being taken as M&A due to their being highly de-risked within this new FDA standards; that we continue to believe, it’s has been a long time coming, especially for helping those with the rare diseases needing a quicker FDA turnaround and partnerships in helping these smaller, but now more substantial biotech firms to make it to BLA market before the big drug companies block them or swallow them up not letting these potential life saving treatments and cures to reach these patients prayerful they can try something then being offered nothing, but this is why this writer is fully confident in the policies being reliable and trustworthy as transparent as the director Dr. Marty Makary is establishing with Robert F. Kennedy Jr. is mandating throughout all HHS.
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Disclosure: I currently have acquired now over 1,000,000 million shares of this stock and holding it as a Long Term Strong Buy With Multiple Price Targets in Playing with the Houses Money as I always ...
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