Os Therapies Incorporated (OSTX)

$OSTX https://www.rarecoalition.com/2026/02/03/rare-disease-company-coalition-statement-on-passage-of-mikaela-naylon-give-kids-a-chance-act/

$OSTX https://www.biospace.com/policy/rare-pediatric-disease-vouchers-reauthorized-pbm-reform-funded-in-narrowly-passed-spending-bill

$OSTX Trump has finally signed the PRV bill. Sunset is now September 30, 2029.

$OSTX The final vote on the appropriations bill happens tomorrow and it will pass from what I’ve read. Our PRV legislation is in this bill so we are looking at a new sunset date of 2029! Once this is official we will hopefully start to see some of this value translate over to our stock price. The main obstacle for getting the PRV was time, and that appears to no longer be the case. 🎉🎉🎉

$OSTX Something to watch for. A close above $1.55 with relatively high volume would confirm a double bottom at $1.31 and push the price to $1.75-$1.80 in the near term. A bullish price reversal would be confirmed if we can close above that neckline. I’m super early on this so it could easily breakdown, but I’m hopeful we get confirmation and this insanely undervalued stock can start its march upward. 📈📈📈

$OSTX nice!

$OSTX strange

$SLS $OSTX $IBRX $MAIA

$OSTX The global non-small cell lung cancer (NSCLC) market is experiencing rapid growth, valued between $21.X billion and $38 billion in 2024-2025 and projected to reach over $70 billion by 2034. and we supposed to have phase 2 in second quarter meeting with FDA. Think about it.

$OSTX just a matter of time

OS Therapies Inc. (NYSE American: $OSTX ) announced that it has formally initiated a Biologics License Application submission to the US FDA for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma. OS Therapies is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/os-therapies-1. A request for Rolling Review was submitted on January 30, 2026, along with the Non-Clinical and CMC (chemistry, manufacturing, and controls) modules of the BLA. Following a December 2025 Type C meeting, FDA invited OS Therapies to request a Type D meeting, now expected in March 2026, to review Comparative Oncology biomarker data from both the Phase 2b human clinical trial and a similar trial in spontaneous osteosarcoma in canines. The final clinical BLA module is expected to be submitted by end of March 2026 after that meeting. In a concurrent filing, OS Therapies updated its Regenerative Medicine Advanced Therapy (RMAT) designation request to FDA with recent biomarker data. RMAT designation, if granted, would shorten the BLA review timeline and expedite patient access. Approval is anticipated by September 30, 2026, which would make OS Therapies eligible to receive a Priority Review Voucher under the Rare Pediatric Disease Designation program. The most recent PRV sale, in January 2026, was valued at $200 million. Paul Romness, MPH, Chairman & CEO noted: “We are delighted in the FDA’s interest in reviewing OST-HER2 Comparative Oncology Data. There is strong demand for compassionate use of OST-HER2 from the patient community, underscoring the urgent need for new therapies in Human Metastatic Osteosarcoma. We remain committed to bringing OST-HER2 to market as expeditiously as possible and are grateful for FDA’s engagement as we finalize the biomarker data package that will be submitted as part of Type D meeting preparations to support our request for a BLA under the Accelerated Approval Program.” See the announcement at: https://ir.ostherapies.com/news-events/press-releases/detail/98/os-therapies-initiates-us-fda-bla-filing-for-ost-her2-in Led by CEO Paul Romness and an executive team that includes Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), Jack Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies is focused on advancing immunotherapies for osteosarcoma and other solid tumors. Learn more at https://www.ostherapies.com and visit B2i Digital for updates. For investor-related questions, please see OS Therapies’ Investor Relations page or email [email protected]. Disclosure: David Shapiro, CEO of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted OSTX stock. B2i Digital, Inc. is not a broker-dealer or investment adviser. This post is for informational purposes only and is not an offer to sell or a solicitation to buy any security. Investors should conduct their own research and consult with a qualified financial adviser before making any investment decisions. See the complete disclosure in the Risks and Disclosures section of https://b2idigital.com/disclaimer. $XBI $IBB $FDA $PRV $ONC $RD

$OSTX - Type D meeting requested for March 2026 to review biomarker data - Clinical BLA module expected by end of March 2026 - Eligibility to receive Priority Review Voucher if approved by 09/30/2026

$OSTX Bought some more

$OSTX the BLA filing will be 100% complete and FDA-compliant by end of the next month. The company is being very thorough and working very diligently with the FDA. I can easily live with all of that!

$OSTX short sellers coming in with their bs, hopefully they will choke soon

Nothing substantial: $OSTX keeps going down the $IOBT way

$OSTX This is a major turning point. The PRV is still on track with the current sunset date of 9/30/26. It seems highly probable that the program will get extended until 2029 which makes this payday all but guaranteed. Now be on the lookout for Warrant inducement to close. 📈📈📈

$OSTX https://www.newsfilecorp.com/release/282344/OS-Therapies-Initiates-US-FDA-BLA-Filing-for-OSTHER2-in-the-Prevention-or-Delay-of-Recurrent-Fully-Resected-Pulmonary-Metastatic-Osteosarcoma

$OSTX OS Therapies Initiates US FDA BLA Filing for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma NEWSFILE CORP 5:00 AM ET 2/2/2026

$OSTX the market doesnt care about the bla pr??

$OSTX OST-HER2 has received FDA Orphan Disease Designation (ODD) and Fast Track Designation from FDA & EMA and has received Rare Pediatric Disease Designation (RPDD) from FDA. Under the RPDD program, if the Company receives Accelerated Approval prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The most recent PRV sale, valued at $200 million, occurred in January 2026.