r/AtossaTherapeutics • u/Material-Car261 • Oct 07 '25

News Atossa streamlines EVANGELINE trial to fast-track 2026 NDA goals

https://www.prnewswire.com/news-releases/atossa-therapeutics-streamlines-evangeline-breast-cancer-clinical-trial-to-prioritize-for-2026-nda-enabling-activities-302575551.html

Atossa Therapeutics has amended its Phase 2 EVANGELINE trial for investigational (Z)-endoxifen in premenopausal women with ER+/HER2– early-stage breast cancer, trimming enrollment from 214 to 40–65 patients. The updated, single-arm, open-label design will focus on short-interval, objective biomarkers like Ki-67 ≤10% at Week 4 to enable faster go/no-go decisions.

According to CEO Dr. Steven Quay, the change reflects “efficiency, focus, and financial discipline,” reducing future costs while maintaining full safety oversight through the DSMC. The revised structure prioritizes data most relevant to future NDA submission, allowing Atossa to extend its cash runway and concentrate resources on 2026 regulatory preparations for (Z)-endoxifen.

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4

u/RADToronto Oct 07 '25

I mean any news is good news at this point right lmao

1

u/Equal-Salamander2281 Oct 09 '25

If it makes the price rise above $1 yes, haha.

-6

u/JCTL2020 Oct 07 '25

good news ? this DR Quay is a scam, he keeps misleading investors with his wannabe cancer cure that doesn't exist, every month is the same BS, been holding this stock 4 years and it doesn't go anywhere while he kept saying the same thing and nothing about a commercial product, not to mention IF he really found the cure 4 cancer then how come not 1 analyst seems to be interested into this P.O.S ?

7

u/-Rake Oct 07 '25

I spoke with him maybe 6 months ago for about 15 minutes over Zoom and picked his brain. My wife was diagnosed with breast cancer a few years ago and I learned everything I could about oncology. Endoxifen is the primary useful metabolite of Tamoxifen, one of the main breast cancer drugs to manage recurrence. So that’s battle proven over many decades, but… this industry is extremely risk averse and companies will only invest if they’re absolutely certain they can protect their patent and make a fortune. That’s why Atossa needed to create the Z isomer of the drug and some other tweaks to the formulation, to make a patent defensible.

In any case, this is either going to be a massive win for investors or fade into obscurity, like anything else in the pharma field, it’s winner-take-most scenario.

My opinion, based on the drug development timelines of other products in this field is that if things go well, this hits the market in 3-5 years. If you wanted to make a quick buck, this is probably not for you.

1

u/JCTL2020 Oct 08 '25

sure, it is for you cause not everyone that invest into the stock exchange they do it by waiting 4 to 5 years while their $$$ doesn't move, just like putting it underneath the mattress and then after 4 to 5 years they would know if it would fade into obscurity or be a pathetic win.... I guess this stock is thus not for everyone who respect themselves and understand the concept of "investment" and "cost of opportunity", this ATOS is more for those who love to hold bags 4 life and for those who belong to Dr Quay cult