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Now is a great time , hehehe
I got back in a little early but it’s all gambling , good product , good investors and solid company . What’s a drug like this gonna do to the market , what’s its potential market size ? Not sure but it’ll help with valuation to predict target price .
RMB. In the CC the Co thought the difference between the 400 mg and 200 mg dose was that there were more with advanced DME in the 200 mg dose .
So those with limited DME ...more of them in the 400 mg cohort ...saw limited benefit as not a lot to improve on.
So the challenge is to recruit those with moderate DME who aren't yet taking the eye injections
Kiwi
EOT was the data they stopped taking the drug . Then there was a 2 wk follow up to see if there was any lingering benefit ....which they recorded for the 200 mg dose .
The problem is that they say there was probably full cell penetration at the 200 mg dose so there was no benefit from a larger dose ...however ...if there was full cell penetration at the 200 dose ...and the 400 dose ...those graphs should be the same or close .
But they aren't
Kiwi
Thanks Kiwi. I am a little confused. I assume EOT means end of trial but it seems there is data (or some kind of extrapolation or estimation) past that. Also, not sure if they are surprised that the 400mg dosage results not what it was expected to be.
4th option is to run a larger P2b trial for 6 mths with DME patients confirmed in decline .
Aim would be to see at what pt BCVA ( visual acuity ) improved .
Co maintains 3 mths is to short a time to see improvement in these patients ...but 6 mths on treatment should do it.
Benefit from the injections kicks in fairly fast
anti-VEGF agents like ranibizumab and aflibercept can lead to rapid and significant visual acuity gains in patients with DME, with responses largely established by 3 months of treatmen
RMB. some skepticism over the results ...expressed on Twitter ( X )
$RZLT
https://x.com/BiotechElmo/status/1793035993991266771/photo/1
Kiwi
One would think that “monumental” data would garner some interest in at least a partner. Of course the doc may have used that term with his company hat on rather than a pure scientist but who knows
RZLT.
Cash, cash equivalents and investments in marketable securities were $81.6 million as of March 31, 2024,
Huge volume - which is usually at peaks and change of direction. Hopefully, though a lot of volume is coming in after the price drop but I don’t know.
At the 50 day and rsi beyond belief. Tripling down here.
RMB ..re those comments ...which is why I'm stunned by the markets reaction ...which apparently is " sell the news " on steroids
Kiwi
I am guessing that these past two months there has been constant upward pressure on the stock (causing me to not be able to get in) and so everyone got long prior to data release. Profit taking snowballing but have to see when dust settles.
How do you like the comment the results:
““The results are monumental for the DME community,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Professor of Pediatrics at the Stanford University School of Medicine, and a member of Rezolute’s Scientific Advisory Board. “
Good luck to you. The seller will lift.
Good luck . I didn't expect this sell off. Co is going to sell or partner for the DME indication and market is saying the data may not be good enough to attract BP interest.
Here we have the first oral drug that may delay the need for eye injections in treating DME ....and the stock tanks !!!!!
Kiwi
Just dipped my toes in here at 2.88.
RZLT CC. key pts
1) Co is unlikely to advance drug themselves ( so probably no capital raise after this :--). Mgt says to big a market to take on by themselves .
2( They would expect to see BCVA improvement by 6 mths ...theres a lag response to reducing retinal thickness .
3) Retinal specialists say multiple eye disease indications may benefit from this drug RZ402 ...far larger / longer trials with 3 mth , 6 mth and 12 mth data warranted . They want to start RZ402 early to delay need for eye injections and then later use with the injections if needed. Many ways to use the drug ...standalone and in combination.
Kiwi
This is the first safe oral therapy that I'm aware of that reduces retinal thickening and is likely to at least enable these patients to retain their visual clarity if treatment is started early enough.
Without a drug like this , patients require injections into their eye usually every 3 mths.
The problem with selling a Co like this ...with a drug that appears to be a major advance in therapy ...is trying to time when to get back in .
Kiwi
“The results are monumental for the DME community,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, and Professor of Medicine and Professor of Pediatrics at the Stanford University School of Medicine, and a member of Rezolute’s Scientific Advisory Board. “I am impressed by the significant reduction in CST in this study across all three dosages as retinal thickness is the key biomarker to determine whether a therapy may offer a potential benefit to patients.
These data are very encouraging and are supportive of the potential for a new first-line, non-invasive treatment for DME.”
HC Wainwright & Co. analyst Douglas Tsao reiterates Rezolute (RZLT.NaE) with a Buy and maintains $14 price target.
RMB. P2 DME data due this month ( May ) . Long shot but theres some leading edge eye disease KOL's involved with this trial
Kiwi
Diabetic Macular Edema (DME)
Completed patient dosing for Phase 2 U.S., multi-center clinical study in 94 participants with DME who are naïve to or have received limited anti-VEGF injections.
Primary endpoints include (i) stabilization of disease and/or change in study eye macular central subfield thickness, as measured by Spectral Domain Ocular Coherence Tomography, (ii) change in study eye visual acuity as measured by the early treatment diabetic retinopathy scale, (iii) the repeat dose pharmacokinetics of RZ402 in patients with DME, and (iv) the safety and tolerability of RZ402.
Topline results expected in May 2024.
We have also completed dosing of patients with diabetic macular edema for our Phase 2 multi-center clinical study of RZ402 and we expect to announce topline results from that study this month,”
Where do you see that?
Someone shorted 5.67% of the float that’s why we tumbled -1.7 million shares last week …… why , what do they know we don’t
They had a PES conference to discuss the phase-2 resulted may 2-5 where they may have released the info but I can’t find it anywhere . But may 7th was a high volume day so someone bought a lot of shares between 3-3.40$
First they were saying the 9th, then they said the 16th - now it’s the 13th after close . Then there’s a JPM securities life science conference on the 14th and annual stock holders meeting on the 16th . As far as I know - I do a lot of research and call the company occasionally
I thought phase II results were coming out mid May?
Low volume , grab some cheap ones - gotta wait til it plummets -2.50-2.60 maybe good luck . Quarterly report is now may 13 3:00 - hoping it’s great , should at least be good beat by .03
Wow , got some cheap 2.88 today got some 3’s yesterday . Guess we gotta wait and see . No news til may 14th ,quarterly
Gonna run today IMO , strong day yesterday - nice dip , got some cheap one for flipping . Let the games begin
I posted this on biotech values board last week
RZLT. ..follow up to my Feb 20th pitch
My guess is that they have completed the P 2 DME trial and will publish results in May 2024 .
I'm up over 100% on this position so have sold half (. Ala bulls make $ but pigs get slaughtered ...or something to that effect )
Will hold the remaining 50% thru read out .
RZLT dippers. Strong stock on the rise.
Oh I’m not selling! I look at this drop as an opportunity to buy more.
We are up 189% over the last 3 mths . To reduce exposure after this run is simply good risk management .
A large enough sell order to reduce exposure ,can trigger a cascade of stop loss orders .
Market will be looking at near term P2 DME data as next major catalyst .
JMO
Kiwi
Multi-Center, Randomized, Double-Masked, Placebo-Controlled Parallel-Arm Study
o 94 participants enrolled in the US
• Newly diagnosed treatment naïve DME patients
• CST of =320 µm
• BCVA of =78 ETDRS letters (=20/25 on Snellen chart)
o Dosing regimen
• Once daily oral administration for 3 months
• Three active arms (50mg, 200mg, 400mg) compared to placebo
o Study endpoints
• Primary endpoints: safety; change in CST
• Secondary endpoints
• Change in BCVA; change in DRSS; changes in non-study eye
• Repeat dose pharmacokinetics
o Study goals
• Improvement vs placebo in CST, BCVA
• Dose-response
• Binocular (2-eye) composite responses
o Topline data expected Q2 2024
RZLT...........................................https://stockcharts.com/h-sc/ui?s=RZLT&p=W&b=5&g=0&id=p86431144783
Can’t seem to buy any shares under 3.25 , looks Like its trading between 3.30-3.50 . No big pull back but lower volume ?? Get what you can I guess
Sorry earning are farther out not 5/9/24
With this decent volume pull back , price should drop below 3 tomorrow or the next couple days . Time to reload 2.70-2.80 gap . If your playing it
- if your holding it wait for 8-10$ imo
Earnings 5/9/24
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