Theratechnologies Inc T.TH

CYDY

[jeffm34]

CYDY phase 2 NASH trial results. Interesting endpoints they chose. Neither one can be used for FDA approval. 

 

CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.

The primary endpoint, PDFF (proton density fat fraction), is an MRI-derived biomarker for fatty deposition, while the secondary endpoint, cT1, is an iron-corrected T1 mapping representative of liver inflammation and fibrosis. These two values are used to evaluate the risk of NASH. CytoDyn’s Phase 2 clinical trial compared the changes from baselines in these endpoints. The leronlimab 350 mg dose versus placebo comparison for the primary endpoint PDFF was statistically significant. Leronlimab compared to placebo also reached near significance for the secondary endpoint cT1. There were no significant differences in treatment emergent adverse events between leronlimab and placebo groups.

[qwerty22]

To be fair for Ph2 the FDA do allow non-biopsy measures, biopsy only nessary for Ph3. "near significance" - got to love it! Not reporting the blinded 700mg group! Only the open label part. I wonder why?

[qwerty22]

Their Covid bubble definitely seems to be bursting.

[jfm1330]

0.70$ today, less than a year ago it was at 7.15$. So much for "promotion" I guess...

[SPCEO1]

Even with the inevitable happening to CYDY (and still in the process of happening - how much longer before their CEO flees the country I wonder), it still has a market cap of $463 million versus TH's $274 million. So, despite the insanity at CYDY, investors somehow value it more highly than TH. Life is weird - very, very weird!

[jfm1330]

The oddity is Cytodyn, not Thera. If Thera get excellent results in oncology and the SP barely moves, than I will blame the management for not being able to sell a real good story. At this point, oncology is hope of a good story based on educated guesses by us, but this is not a confirmed fact. Possibility of failure or mild results is there. And again, I looked at Sutro, and even with good

[scarlet1967]

Their efficacy results came with a price which was severe adverse effects at high dosage so the market didn't like it thus their SP got beat. If the safety is compromised no matter how good the efficacy is it won't matter! Now they most likely won't be able to carry on with those high dosings going forward would their drug still be effective at lower dosage?It shows how important a

[Bucknelly21]

weren't you the one who said Nash would have value after the protocols and fda accepted the phase 3?

[qwerty22]

To be fair it should go. Chat > fda accept > start dosing patients In THTX's case it's gone. Chat > harmonize > chat > change to general NASH > chat > may proceed letter > chat > final protocol > chat with some new guys > .... and still no needles in patients Every time they've appeared to take a step forward they've caveated it with a

[qwerty22]

CYDY seem(ed) to excel at churning stock, that's it. Everything else looks horrible IMO. The stock churning is only connected to the clinical business by an extraordinarily weird PR filter. I don't think you should judge the past stock performance by how well or badly the clinical business is going just by how well the management can stop the whole thing unravelling.

[Bucknelly21]

They still got there... so your point is not valid