OSTX OS Therapies Inc

$OSTX This will launch soon enough target is around $8 then once FDA approves who knows where it will be at that point north of $20

$OSTX in for 1k shares to begin. This appears to be the most under the radar bio now with impending rerate potential. Bone cancer is just about the worst thing to deal with.

$OSTX Next up: RMAT decision, MHRA CMAA submission, pre-BLA meeting and progress toward Phase 3 init.

$OSTX This is great news. This will expose many more investors to the $OSTX story. The company is gearing up for a huge Q4 2026 and a massive 2027!

$OSTX Once the stock gets to$5 plus (the penny stock threshhold), we can expect some institutional buying that will keep the stock price moving upwards. A few positive press releases, along with the help of our new public relations firm, should get us to $5 plus sooner than later!

$OSTX Oh and just to cheer everyone else up. My broker Vanguard is giving a 100% buy recommendation. In terms of biotech investments Vanguard has been very good to me. You just need to be patient, like always when it comes to biotech. And cheers to ! You made me aware of this one a few months back. I am still building my position. I also have a nice stash in my IRA Roth. That's how convinced I am.

$OSTX A very interesting Project Orbis fact for OSTX holders 🇬🇧🇺🇸 According to OS Therapies’ latest update, since 2021, 29 oncology products led by the UK’s MHRA under Project Orbis have gone on to receive FDA approval — 29 out of 29. That’s a 100% historical record for those 29 MHRA-led oncology products. This does NOT mean FDA approval is automatic, and it certainly doesn’t guarantee the outcome for OST-HER2. But I think the historical record is worth knowing: MHRA-led Project Orbis cases since 2021: 29 → FDA-approved: 29 Historical success rate: 100% And now OST-HER2 is being coordinated under MHRA leadership within Project Orbis. For me, this is not a prediction. It’s simply a historical fact that gives me a little more confidence in the regulatory path ahead. 💪🧬 Let’s keep our feet on the ground — but this is definitely an encouraging piece of data for OSTX holders. 🚀

$OSTX So what happened today?! Typical young biotech craziness. We had a big win but there was a lot of confusion...for a reason. The company pivoted. OSTX scheduled the type C meeting to try to get the historical control approved for the BLA using 2.5 year OS data in order to file the BLA immediately. But the FDA balked at the 2.5 year OS data (same as all the other agencies) so the company pivoted and instead of walking away empty handed, used the meeting to get a big win, convincing the FDA to officially approve the global phase 3 adaptive trial design including control set and stats methods, and approve entry into Orbis. Now the stats methods, control set issue gets pushed to the Type B pre-BLA meeting which will be triggered by the 3-year OS submission. Once those final 2 patients check-in (Oct 3 is the final appointment), the data will be complete and the dominoes begin to fall. GLTA longs.

$OSTX Frank Knuettel II, Chief Financial Officer of OS Therapies, noted, "With the progress we have made at both OS Therapies and OSAH, we are now in a position to evaluate strategic and/or direct capital alternatives for OSAH, directly benefiting OS Therapies shareholders. Canine osteosarcoma is one of the leading causes of death in large breed canines and we believe there is substantial value in our gene-edited, cancer immunotherapy platform for companion animal health. OST-HER2 has the potential to be the first HER2-targeted therapy in companion animal cancer treatment."

$OSTX just a simple request for next week to Jefferies or shorts or management… whoever… let’s just let this thing fly a little huh? Let’s let it run it to 3ish and see how that feels for a bit! Thanks in advance!

$OSTX Just to be clear - upon receiving Accelerated Approval from the FDA, which will happen within the next 6 months or so (worst case scenario being June 2027, best case scenario being January 2027); OS Therapies will at that same time also receive a priority review voucher worth some $200 million upon sale. AA is same as full approval except that phase 3 will be ongoing and confirmatory; the treatment will be fully commercialized upon AA (ie in 6 months or so)!

$OSTX Nice additions. I know Frank personally. Highly intelligent with a lot of integrity. Definitely adding to the watchlist.

$OSTX you know that OST-HER2 is being used to treat osteosarcoma and you may know that the platform was originally developed at the University of Pennsylvania. But did you know that it was originally developed specifically for breast cancer? In the late 1990s/2000s Herceptin came along and changed things in breast cancer treatment. The market became intensely crowded and forced researchers to pivot the platform to the extreme unmet need in osteosarcoma. $OSTX now envisions the platform being used as an adjuvant treatment in breast cancer—given to patients who are in remission or have had their tumors surgically removed, as a "safety net" to prevent recurrence.

$OSTX Somebody knows something. I have a feeling tomorrow is going to be a day for the ages

$OSTX Because OSTX is actively pursuing accelerated approval in multipled jurisdictions (EU, UK, US, OZ) catalysts and newsflow will be frequent in the months ahead... your post should be pinned to the top of the OSTX board...

$OSTX Each PR brings our timeline more and more into focus. OSTX — realistic timeline (not including conferences) * Oct. 5-16: 📊 3-year data lock/ final analysis * Oct. 8–20: 🚨 Final 3-year OS data PR * Oct. 8–23: 🧪 FDA official minutes RMAT/Rolling Review updates * Oct. 13–31: 🇺🇸 FDA Type B Pre-BLA meeting / final BLA alignment The company says the Pre-BLA follows submission of the clinical section containing the 3-year OS data. * Oct. 15–31: 🇬🇧 MHRA CMAA submission OSTX said the complete CMAA was expected “in the coming weeks” and later said MHRA CMAA would precede the U.S. BLA. * Late Oct.–mid Nov.: 🇺🇸 U.S. BLA completed/submitted under Accelerated Approval * Nov.–Dec.: 🇪🇺🇦🇺 EMA + Australia CMAA submissions * Mid-Q4: 🧬 UK Phase 3 initiation — company currently says mid-Q4, following Phase 2b drug-product requalification. * Nov.–Dec.: 🔄 FDA/MHRA/EMA regulatory review activity + additional meetings * Late Q4 2026 → Q1 2027: 🏛️ Potential early-market-access regulatory decisions

$OSTX Just bought a 1000 shares before opening. Saw this on my Fidelity news this morning. Best of luck to us all and have a beautiful day!!

$OSTX - FDA alignment on adaptive Phase 3 design for OST-HER2 metastatic osteosarcoma. - Project Orbis participation via MHRA sponsorship to harmonize multi-country oncology review. - Multiple expedited designations for OST-HER2 from FDA (ODD, FTD, RPDD) and EMA (ODD, FTD, ATMP). - Potential Priority Review Voucher eligibility under RPDD if OST-HER2 BLA is approved; the most recent PRV sale in August 2026 was for $220 million

$OSTX SHORTS MAY BE GETTING TRAPPED? 👀 Pure speculation, but something interesting is developing. OSTX’s short borrow fee has historically been around 1–2%. It has now jumped to 9%+, while available shares to borrow have tightened significantly. That can indicate that short sellers are paying substantially more to maintain positions while the stock sits in front of potentially major FDA catalysts. Some shorts may already be in the red and holding, hoping for a price drop so they can cover at lower levels. The risk for them? If favorable FDA news hits before they cover, they could be forced to buy shares back into a rising market. That creates the potential for a short-covering squeeze on top of genuine catalyst-driven buying. Not saying a squeeze will happen—but the combination of tight borrow + sharply higher fees + elevated short interest + imminent FDA catalysts is definitely something OSTX investors should be watching.

$OSTX Seeing the big picture helps to see today in a positive light: The final 3-year OS data was the last major clinical domino standing between OSTX and the regulatory filings investors have been waiting for. The company now has the final endpoint: 72.7% 3-year OS vs 45.8% historical control, p=0.0006. MHRA/EMA have already aligned on the historical-control approach and CMAA pathway, while the FDA BLA process was already initiated in January. The company explicitly said it was waiting for the final 3-year data before completing the broader filings. So today’s huge volume may simply be weak hands handing shares to stronger longs before the next dominoes fall: CMAA → BLA → Phase 3 → regulatory decisions. And tomorrow? BioJapan Oct. 7–9, with management/BD meetings. The clinical hurdle is now cleared. The regulatory race begins. We have so much more news coming that will continue to build. At some point very soon the market will undoubtedly start to price in the PRV at minimum.