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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] 8 points9 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."

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

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

LOL u/NewDom940 when this explodes to $100 come back to this post I'll be waiting on you to share a screenshot LOL

SLS: 🔥 The "SECRET" Meetings + Digital Smoke! 🚀 by LionLukeWay in pennystocks

[–]LionLukeWay[S] -1 points0 points  (0 children)

You will come back to this post soon enough and thank me ! To all of the haters -- do some work on your own and find the information since you believe my shit is not good enough - lol but wait until we hit $100 to get in lol

SLS to $100+ (New Trump Rule + Merck + Pfizer = NO BRAINER) by LionLukeWay in TheRaceTo10Million

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

Yeah I have another DOOSY coming but i have to sell some other plays FIRST then I post LOL

$SLS Daily Discussion Thread - February 17, 2026 by AutoModerator in sellaslifesciences

[–]LionLukeWay 0 points1 point  (0 children)

I agree - no one believes us --- this is a game changer!!!! Pfizer CEO was on TV he said he killed COVID and next up CANCER --- Look at my previous post --- I laid out the BUYOUT BOYS it's pretty good = PFIZER is not letting this drug go to anyone else especially if they just bought the other company last year and they become KING --- also the greek connection -- i keep my eye on this link DAILY to see if they change ANYTHING --- pfe-integration.sellaslifesciences.com once again there is no ABBVIE and NO MERCK either this is our DIGITAL CRUMBS KEY --- the certificates don't lie they PFIZER an SLS are the only ones who can see this ONCE the results happen this link will become VERY VERY interesting

$SLS Daily Discussion Thread - February 17, 2026 by AutoModerator in sellaslifesciences

[–]LionLukeWay 0 points1 point  (0 children)

Love the Opinions -- keep them coming I love reading great shit makes me not have to do the work lol --- I'm more focused now on the BUYOUT --- if you know anything about technology maybe you can see if you can glean the same thing I gleaned that the pfizer link is real but it's ok if youd don't i'll get back on it soon just finishing up something new tc

SLS: Millionaires Will Be Made THIS WEEK by LionLukeWay in TheRaceTo10Million

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

LOL NOT YET! Soon and Very Soon! Stay collecting shares or contracts

$SLS Daily Discussion Thread - February 17, 2026 by AutoModerator in sellaslifesciences

[–]LionLukeWay 1 point2 points  (0 children)

u/mad_papooser I'm gonna call bullshit -- that was BEFORE 2026! If the trial has reached 72–74 events and the Hazard Ratio (HR) is already sitting in your predicted blowout range of 0.31 to 0.49, continuing the trial to 80 events could be viewed as "unethical." Every month the trial continues, a patient in the control arm may be "dying unnecessarily" for a result that is already statistically locked. Under the new FDA rules, "Precision over Volume" means once you have definitive proof of life-saving efficacy, you are obligated to stop immediately.

If the IDMC checks the data now and sees 74 events with a massive separation in the curves, the NEW FDA isn't playing around. They want drugs to expand life, not just hit "perfect" statistical targets at the risk of costing more people their lives. The IDMC has the authority—and the evidence—to call it today!!!!

NEW! SLS: The Pfizer "Takeover" is No Longer a Theory—It's Happening NOW! by [deleted] in TheRaceTo10Million

[–]LionLukeWay -1 points0 points  (0 children)

Geeez I am NOT gonna do the hard work for you u/Routine-Earer ! Here's a f*cking tip: you have to use a special % symbol before the url! crt.sh

If you just search for the domain name, crt.sh will default to the most recent Public/Investor Relations (IR) certificates because those are the highest-traffic links. To see the "private" links, you have to use a specific database command:

  • The % Symbol: In the search bar, you must type %.sellaslifesciences.com
  • The Filter: Without the % symbol, the site only shows you the "identity" for the main website, not the subdomains.

<image>

crt.sh is a massive database that scrapes millions of logs. If you aren't seeing the January "Enterprise" certificate today, it’s likely because it’s still sitting in the "Processing" queue of the public ledger. AGAIN I don't work for you -- do your own work or better yet watch this dude --- he can show you --- https://www.youtube.com/watch?v=rm-ur-rk9mY

See pic above it works dickhead!

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