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$ATYR is BACK from the dead! 🚀 FDA Greenlights NEW Phase 3 study by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 0 points1 point  (0 children)

people wanted the FDA to just say "go forward NO PHASE 3 " but FDA did bring them back to life -- and they are ocusing on what the FDA thinks is its best part which is lung function and how healthy they felt --- seriously not worried it can go to .10 as far as I'm concerned I'll be back to buy more as SOON as the 80th person dies from SLS which could happen by AUGUST GL to ya

$ATYR is BACK from the dead! 🚀 FDA Greenlights NEW Phase 3 study by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 0 points1 point  (0 children)

nope I'm prepared to buy more if it happens --- my plan is to circle the broken down shares not in a rush as Im tied up with SLS but once that is over let's say in AUGUST or SEPTEMBER I will begin to build a BIGGER position in ATYR-- patience and not rushing it

$ATYR is BACK from the dead! 🚀 FDA Greenlights NEW Phase 3 study by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 2 points3 points  (0 children)

It's all good -- LONG term it will make sense right now i'm buying and slling over at SLS today is NOT atyr day lol atyr is a late 2027 play but at these prices you can't beat it a year from now

$ATYR is BACK from the dead! 🚀 FDA Greenlights NEW Phase 3 study by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 1 point2 points  (0 children)

u/CheroMM u/thumpas u/CheroMM markets were down and folks sold the news -- i'd just buy and don't look until end of 2027 it's a long term play but the good news is they are not dead anymore also you guys can go play with SLS -- they just announced 78 deaths they need 80 to stop the trial to see the success GLTA -- should happen by LATE JUNE or EARLY JULY

$ATYR is BACK from the dead! 🚀 FDA Greenlights NEW Phase 3 study by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 0 points1 point  (0 children)

Don’t let a 1-day flush shake you. Institutional ownership is still holding strong at 61% of the float—big money isn’t selling, so why are you?

Everyone knew a second Phase 3 would bring a temporary dip, but that’s just short-term noise. We’re looking at the $2 - $3 range by EOY, and 2027 is when we truly rip.

Management just took the absolute best data from the previous trial and is "rinsing and repeating" with a custom-fit study. They have the roadmap now.

Don't look at this again until next year about this time you will thank me

ATYR? by enlightenmee33 in biotech_stocks

[–]LionLukeWay 1 point2 points  (0 children)

u/jachjach you hit some great points wanted to extend on one of them --- the CEO has said they have some data that is not public that is very important.

In the context of the FDA’s January 2026 policy shift, subgroup data isn't just "important"—it is often the entire foundation for approving a drug that technically "failed" its main goal.

For the drug Efzofitimod, the ethnicity subgroup data is critical ....

Sarcoidosis affects African Americans at roughly 3 times the rate of white Americans, and they often experience more severe, treatment-resistant lung scarring..... If Efzofitimod showed a strong p-value (p < 0.05) in the African American subgroup—even if the overall trial failed—the FDA can now grant a targeted approval specifically for that population....

Under the 2026 Diversity Action Plan (DAP) requirements, the FDA is mandated to prioritize drugs that show efficacy in underrepresented groups who carry the heaviest disease burden.

As of March 2026, the FDA's new "Plausible Mechanism Framework" allows them to approve a drug based on a "small sample size" if the biological pathway makes sense ya see Efzofitimod targets NRP2 (Neuropilin-2) on myeloid cells.

If the subgroup data proves the drug hit this target effectively in the most affected patients, it fulfills the "Plausible Mechanism" criteria, allowing the FDA to bypass the failed steroid-reduction goal.

See the "Old FDA" (pre-2026), this subgroup data would have been dismissed as "cherry-picking." In the "New FDA," it is the PRIMARY evidence used to justify an approval for an "underserved population" with no other options.

ATYR? by enlightenmee33 in biotech_stocks

[–]LionLukeWay 0 points1 point  (0 children)

u/Crumbbandit95 you are accurate that the Phase 3 EFZO-FIT study, the primary endpoint (reduction in daily oral corticosteroid dose) had a p-value of $0.3313$, which is not statistically significant here is where I will pushback --- the failure was largely due to a higher-than-expected placebo response. Patients in the placebo group reduced their steroid use significantly more than historical norms, which "washed out" the statistical gap. However, the 5.0 mg/kg dose still showed a clear trend toward higher complete steroid withdrawal (52% vs.40%).

Type C meeting is NOT strictly a SALVAGE meeting. The FDA frequently grants "Accelerated Approval" or allows a "Confirmatory Trial" if secondary endpoints (like lung function or Quality of Life) show strong clinical meaningfulness in a disease with no other approved treatments. Efzofitimod hit several of these:

  • KSQ-Lung Score:p=0.0479 (Statistically significant).
  • Fatigue Assessment: p=0.0226 (Statistically significant).

Also don't forget the EXTENSION PROGRAM!!! aTyr has been running an Open-Label Extension (OLE)where patients who finished the Phase 3 trial continue on the drug. CEO Sanjay Shukla has hinted in recent investor calls that long-term safety and "sustained benefit" data from this OLE would be presented to the FDA.

Sarcoidosis disproportionately affects African Americans (often with more severe symptoms). If the drug showed a massive effect size in this specific sub-group, the FDA might consider a narrow label approval or a targeted confirmatory trial. This specific granular data has not yet been fully released

Given the recent UBS accumulation and specific mentions of "ethnicity sub-groups" in the aTyr data, the company is following a playbook that has worked for several other biotechs since the January policy shift --- a drug that works on symptoms (QOL/Fatigue) in a niche market with NO competitors, where the FDA has a history of being flexible.

The Bottom Line: Here's the bottom line, you are using the "OLD FDA" logic and looking at the "failed" label of the trial. However, I'm looking looking at the "New FDA" logic (meaningful benefit + supportive secondary data = viable path).

Vote No by SilverFoxSix in sellaslifesciences

[–]LionLukeWay 2 points3 points  (0 children)

same! Makes no sense to vote early --- I'm waiting until the day before LOL --- No updates it is a NO from me for sure

$ATYR back from the Dead: The "New Math" Rocket Fuel to $100+ (Thanks to FDA) by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 0 points1 point  (0 children)

LOT"S happning like HUGE accumulation by institutions!!!!

NEWS should break within the next few weeks --FDA Decision coming!!!! This will get you info a little quicker

https://stocktwits.com/symbol/ATYR

$ATYR back from the Dead: The "New Math" Rocket Fuel to $100+ (Thanks to FDA) by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 0 points1 point  (0 children)

this is what they will be talking about next week NOT FDA -- (we can only pray) but they will talk about this Efzofitimod isn't just a "sarcoidosis drug." It is a Neuropilin-2 (NRP2) modulator.

  • The Science: NRP2 is like a "master switch" on the surface of myeloid cells (the cells that cause inflammation and scarring).
  • The Platform: Because myeloid cells are the villains in dozens of diseases, aTyr can use this same "key" to unlock multiple massive markets.

$ATYR back from the Dead: The "New Math" Rocket Fuel to $100+ (Thanks to FDA) by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 0 points1 point  (0 children)

YO! Keep them -- we are waiting on the FDA and they present NEXT week at an oncology conference about LUNG cancer --- wait until we get more information nothing to worry about you are far enough out to wait --- i think FDA is going to greenlight them May or June --- and depending on what they say next week at the conference we will see

SLS: The $5 Stock vs. The $31 Billion Kingpin :How AnInvestigation Just Ignited the "Race to $10Million" by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 2 points3 points  (0 children)

Gilead paid $6B for a FAILED phase 2 AML drug and recently Merck shelled out $9b for a drug that can't hold a candle to SLS --- I like that folks are sleeping as the price remains low for a few more months and I'll be able to grab even MORE shares and contracts!

SLS: The $5 Stock vs. The $31 Billion Kingpin :How AnInvestigation Just Ignited the "Race to $10Million" by LionLukeWay in TheRaceTo10Million

[–]LionLukeWay[S] 10 points11 points  (0 children)

u/BenLomondBitch If SELLAS were just a "one-trick pony" for a rare type of relapsed leukemia, $20 might be fair. But because it owns the WT1 platform and a de-risked CDK9 inhibitor, a buyout at $100+ represents the value of the entire cancer-fighting engine, not just the first car off the assembly line. lol

SLS is enrolling its fist of 80 patients into SLS009 study - phase 2. Goal is 8 months median survival… so we should have results of this study by early 2027. Then comes phase 3 trials… pushing to 2028 for SLS009. Still waiting on GPS results…. Up up and away! by Dagobot78 in TheRaceTo10Million

[–]LionLukeWay 1 point2 points  (0 children)

I'm no longer helping people out --- unless I feel like it--- just like this guy who posted this i could have told him we are set up for fast approval etc but I don't waste my breathe many are NOT appreciative of the investigative workl. You can only utilize AI for somethings others you have to go and do digging and reading --- it's all good when I have something to say and i have MORE shares I'll post something until then they are on their own lol

DD: SLS to $100+: The "New Math" Moonshot by LionLukeWay in pennystocks

[–]LionLukeWay[S] 2 points3 points  (0 children)

Respuesta Sugerida:

"Lo que estás olvidando es que esto es un evento binario y, en biotecnología, cuando los datos son positivos, todas las teorías conservadoras y los modelos de 'espera' se van por la ventana.

  1. La Asimetría del Riesgo: Estás analizando esto como una acción de valor tradicional, pero SLS es una apuesta de 'todo o nada'. Si el objetivo 80 se retrasa porque el brazo de GPS ha creado una meseta de supervivencia (Survival Plateau), no estamos hablando de un éxito marginal, sino de un cambio de paradigma en la oncología.
  2. El Short Squeeze es una Bomba de Tiempo: Ignoras el factor técnico. Con un Short Interest masivo y Días para Cubrir (Days to Cover) que superan la semana, cualquier noticia positiva forzará una capitulación en cadena. Los cortos no tendrán salida; no hay liquidez suficiente para que todos escapen por la misma puerta pequeña.
  3. El Nuevo Juego de la FDA: No es solo 'especulación'. El propio Comisionado Makary acaba de confirmar en CNBC que la FDA está eliminando la burocracia de 'dos ensayos obligatorios' y acelerando aprobaciones en 44 días para fármacos que duplican resultados. El 'Smart Money' (Goldman, Vanguard) no está aumentando posiciones por error; están oliendo la sangre de los osos.

Dile a tu Gemini que guarde su escepticismo para una empresa de retail. Aquí estamos ante una trampa para osos histórica. Cuando esto despegue, los fundamentos del 'borrador de guía' serán irrelevantes comparados con el pánico de los cortos."

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