Whalatane
2 weeks ago
Thx The similarities with SLNO is that this is a rare disease market ...so will be very expensive ( but necessary ) drugs
Potential to Address Two Rare Disease Markets
• ~1,500 addressable cHI patients in US; equivalent patient population in Europe
• >500 islet cell tumor patients and >1,000 non-islet cell tumor patients addressable in the US
oHighly Concentrated Physician Base for cHI
• 60% of patients are diagnosed within 1 month of presentation
• 80% of addressable patients are seen by centers of excellence (many participating in sunRIZE study)
oTumor HI Patients Identified and treated by both Endocrinologists and Oncologists
oRegulatory Designations: Breakthrough Therapy (FDA), Orphan, Pediatric Rare Disease (FDA),
PRIME (EMA), ILAP (UK)
The drug is already being used in cell tumor patients on a compassionate use basis and has enabled these patients to leave in hospital care .
We're pretty much in a waiting game now until P 3 trial results
Re ARDX ... Mott ( chairman of the board ) is apparently still buying on the open market . I was planning to give them until mid year to work out a deal with CMS re Medicare coverage ...but so far nothings happened .
Once a position is down 20% from its recent high , or 20% below my purchase price I do a serious re evaluation and usually sell at least 50% .
With ARDX I exited completely .
I usually " sell the news "...eg FDA approval . This is because it usually takes longer and costs more than most expect , to get the new drug out into the market and break even . I sold most of my AMRN in Dec 2019 for that reason ......and more when it was down 20% from its high .
I dont plan on selling UNCY on FDA approval as I expect the drug launch will go better than most expect due to the way the new dialysis bundle works and that OLC will be distributed directly to the patients by the MD's in the dialysis clinic. No prior approval etc .
Re my " picks " . A lot of this is luck mixed in with hrs of DD and access to some MD's who treat these patients .
UNCY is likely to be under $5 or over $10 a week from now ....and I have no strong conviction on which way it's likely to break .
In fact I'm conflicted
If it's under $5 I'll be happy I can add on a sell off as I plan to hold until Q4 2026. If it's over $10 I'll be happy I've doubled my $ .
Hmmm ...looking at it that way I'll be happy either way ...
Theres something wrong with me :--)
Good luck
Kiwi
Whalatane
2 weeks ago
Handok Inc., along with Genexine, is a major shareholder in Rezolute, Inc., a U.S.-based biopharmaceutical company. As of January 2019, Handok and Genexine jointly held a 54% stake in Rezolute after investing $25 million. Additionally, Young-Jin Kim, Chairman and CEO of Handok and a director at Rezolute, indirectly holds 8,423,386 common shares through Handok and directly owns 149,950 shares, as reported in a $3.99 million share purchase in June 2025.
Handok also has a licensing agreement with Rezolute, signed in September 2020, granting exclusive rights to develop, import, and commercialize Rezolute’s products in South Korea.
This positions Handok as both a significant investor and a strategic partner in Rezolute’s operations.
Kiwi
Whalatane
2 months ago
Dont know why you think nothings happening with this Co
Recent Pipeline Progress and Anticipated Milestones
Congenital HI
sunRIZE, a Phase 3, multicenter, double-blind, randomized, controlled safety and efficacy registrational study, is ongoing and enrollment is expected to conclude in May 2025.
U.S. sites are activated and enrolling patients.
Topline results expected in December 2025.
Upon completion of an interim analysis in April 2025, an independent Data Monitoring Committee recommended continuation of the sunRIZE study as planned without an increase to the study sample size.
The analysis was intended to evaluate the study for futility or otherwise to inform a potential sample size increase, for purposes of optimizing the study power and statistical confidence in the final analysis outcomes.
The Company remains blinded to the results.
Tumor HI
In May 2025, FDA granted Breakthrough Therapy Designation (BTD) to ersodetug for the treatment of hypoglycemia due to tumor HI.
BTD was granted based on clinical trial data across the overall HI program and a recognition of the mechanistic applicability to tumor HI, further validated by real-world experience in tumor HI patients who have been successfully treated with ersodetug throughout the U.S. in the Company's Expanded Access Program.
A registrational study for ersodetug in patients with tumor HI, the “upLIFT” study, is anticipated to begin in the middle of 2025 with topline data expected in the second half of 2026.
Utilizing BTD, the Company plans to engage further with FDA to discuss the registrational trial, including the necessary data package to support a BLA filing and potential approval for the tumor HI indication.
Kiwi
BadCuda
2 months ago
Like I said I love company and it's people - MM's see what i see and will walk it down slowly until we get some news on the DME drug or ersodetug hits the market but they said it won't be finished til Xmas . Im not an expert but I've been watching/flipping this stock from 1.55 and there's a pattern MM's have of shorting , I've witnessed it several times - and the company just sold them another 21 million shares of common stock . KISS of death temporarily , more shortable shares - no real news for a few months - I would short it . First time they did this the price dropped from 5$ to 4$ overnight , second time was more of a slow walk down slowly leaking out more shares dropping the price . I was amazed it popped to 4.20 again sold it all as soon as they got those 20 million shares . I said to my self - Damm they're doing it again. So you can call it experience or luck but I seen this pony show and I held the first time but not again .when the technical signals change I'm first in lineAll in again , but the technical signals say stay away. Now DTREF is a gold/REEMine in in Cali closed in the 90's for environmental issues when gold was340/oz . Just got more funding and federal clearance/reguest to reopen . .028 currently 2.7 billion out standing 1.7 billion float approx . Rare earth elements are getting popular so that's where I'm at now , uplisting end of may . Technical indicators are so so but it's cheap down here and moving in the right direction . 100% owned by an Australia company . 1.1 million oz of gold confirmed back in the 90's ,6 miles from the lagest gold mine in Nevada - a 4 billion dollar gold mining operation .... hmmm .028 why not .
Whalatane
2 months ago
Re nothing going on this summer or fall .
They are launching their tumor trial ...now Breakthru status by FDA ,,,doubt they do anything with DME
Rezolute, Inc.
Registrational study in patients with tumor hyperinsulinism (HI) expected to commence mid-year
Designation underscores need for therapies to treat severe hypoglycemia in the oncology setting
REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by HI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to its investigational therapy, ersodetug, for the treatment of hypoglycemia caused by tumor HI.
Kiwi
Whalatane
2 months ago
FWIW. HC Wainwright & Co. Reiterates Buy on Rezolute, Maintains $14 Price Target
BENZINGA - 1:41 PM ET 4/28/2025
Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism, today announced that management will participate in the following investor conferences:
Event: The Citizens JMP Life Sciences Conference
Date: May 7-8, 2025
Event: H.C. Wainwright BioConnect Investor Conference
Date: May 20, 2025
Event: Craig-Hallum Institutional Investor Conference
Date: May 28, 2025
Event: Jefferies Global Healthcare Conference
Date: June 3-5, 2025
Management will be participating in one-on-one investor meetings throughout the conferences. Investors interested in scheduling a meeting with the Rezolute management team should contact their JMP, H.C. Wainwright, Craig-Hallum, and Jefferies representatives.
Meeting one on one with investors ...otherwise known as checking out any buy out interest .
Unlikely this Co launch their drug alone , once approved
JMO
Kiwi
Whalatane
2 months ago
They will need the $ for the Tumor HI P 3 trial thats about to ramp up.
Drug is currently in use at major research hospitals like Stanford
Rezolute’s EAP has demonstrated success in individual cases, particularly for tumor-mediated hyperinsulinism, leading to FDA clearance for a Phase 3 study in this indication. Patients in the EAP have experienced significant benefits, such as hospital discharge and resumed cancer therapy, highlighting the program’s role in addressing critical unmet needs.
The program operates under FDA’s expanded access framework, often called “compassionate use,” which allows access to investigational drugs like RZ358 (ersodetug), a monoclonal antibody that modulates insulin receptor activity to manage hypoglycemia.
Addressing critical unmet needs means fast tracked and high price for the drug on approval
Kiwi
Whalatane
2 months ago
Co's almost always raise $ within a day or two of positive data ...strike while the iron is hot etc . Yes ...implies no interest in their DME drug.
Groks take on the data
The interim analysis of Rezolute, Inc.'s (RZLT) Phase 3 sunRIZE study for ersodetug in congenital hyperinsulinism (HI), announced on April 23, 2025, provides significant insights into the trial's progress. Below is an evaluation based on available information, focusing on the implications of the Data Monitoring Committee's (DMC) recommendation and the trial's context.
Key Points from the Interim Analysis
DMC Recommendation:
The independent DMC reviewed unblinded interim data after approximately half of the enrolled patients completed primary assessments, focusing on hypoglycemia events as the primary endpoint.
The DMC recommended continuing the trial as planned without increasing the sample size. This suggests that the observed effect size and variability align with the statistical assumptions used in the original trial design, indicating the study is likely adequately powered to detect the pre-specified treatment effect.
Trial Status and Timeline:
Enrollment is on track to be completed by May 2025, with topline data expected in December 2025.
U.S. clinical sites are actively enrolling patients, expanding the global study’s reach.
Rezolute remains blinded to the interim data and statistical outputs, maintaining trial integrity.
Supporting Evidence:
The DMC’s recommendation aligns with prior Phase 2 RIZE study outcomes, real-world observations from Rezolute’s Expanded Access Program, and pharmacokinetic data from the sunRIZE study’s open-label arm. This consistency strengthens confidence in ersodetug’s potential efficacy.
Market and Sentiment Impact:
Posts on X reflect positive sentiment, with users noting the DMC’s recommendation as a procedural milestone and viewing the stock as undervalued, especially after a recent capital raise. However, some expressed mild concern about the timing of the raise diluting shares.
The announcement was seen as de-risking the trial, as no sample size adjustment was needed, reinforcing investor confidence.
Implications for Statistical Power and Trial Success
Adequate Powering: The DMC’s decision not to increase the sample size strongly suggests that the interim data showed an effect size and variability consistent with the trial’s design. In clinical trials, interim analyses assess whether the study remains on track to detect a statistically significant effect with the planned sample size. The lack of a sample size adjustment implies the trial is likely sufficiently powered, assuming no major deviations in the remaining data.
Efficacy Signals: While specific interim results (e.g., p-values or effect sizes) were not disclosed to maintain blinding, the DMC’s endorsement without modifications indirectly supports the hypothesis that ersodetug is performing as expected, especially given alignment with Phase 2 and real-world data.
Risk of Futility or Harm: The DMC did not recommend stopping for futility or safety concerns, which is a positive signal. In trials, DMCs may halt studies early if the treatment shows no chance of achieving significance (futility) or poses safety risks. The absence of such recommendations reduces these risks.
Potential Risks and Considerations
Interim Data Limitations: Interim analyses are based on partial data, and results can change as more patients are enrolled. For example, literature notes that interim results may overestimate treatment effects compared to final outcomes, and premature conclusions should be avoided.
Statistical Risks: Multiple interim analyses increase the risk of type I errors (false positives) unless adjusted for, though the sunRIZE study’s protocol likely includes methods like O’Brien-Fleming or Pocock to control this. The announcement did not specify the statistical approach, but adherence to rigorous standards is assumed.
Market Expectations: Positive sentiment on X could inflate expectations, but topline data in December 2025 will be the true test. If final results underperform interim signals, stock volatility could follow.
Rare Disease Context: Congenital HI is a rare condition, which may limit patient recruitment and generalizability. However, active U.S. site enrollment mitigates some recruitment concerns.
Comparison to Broader Clinical Trial Context
Similar Trials: In contrast to the HOVON 132 trial, where Bayesian interim analyses signaled futility early but the trial continued to a negative final outcome, RZLT’s DMC recommendation suggests a more promising trajectory.
Adaptive Designs: The sunRIZE study appears to follow a group-sequential design, common in Phase 3 trials, allowing interim checks without compromising statistical integrity. The lack of sample size adjustment contrasts with trials requiring increases due to lower-than-expected effect sizes.
Conclusion
The interim analysis of RZLT’s Phase 3 sunRIZE study is a positive milestone, as the DMC’s recommendation to continue without increasing the sample size indicates the trial is likely adequately powered and on track to detect a statistically significant effect on hypoglycemia events. Consistency with Phase 2 and real-world data further supports ersodetug’s potential efficacy, and the absence of futility or safety concerns reduces key risks. However, interim results are not definitive, and final topline data in December 2025 will determine success. Investors and stakeholders should remain cautiously optimistic, mindful of statistical risks and the rare disease context. For further details, refer to Rezolute’s official announcements or clinical trial registries.
I'm really impressed with the Grok AI
U still on the high seas ?
Kiwi
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