Market Cap 155.87M
Revenue (ttm) 85.87M
Net Income (ttm) -8.31M
EPS (ttm) N/A
PE Ratio 0.00
Forward PE N/A
Profit Margin -9.68%
Debt to Equity Ratio -1.53
Volume 3,272,800
Avg Vol 470,854
Day's Range N/A - N/A
Shares Out 45.98M
Stochastic %K 92%
Beta 0.51
Analysts Sell
Price Target $5.92

Company Profile

Theratechnologies Inc., a biopharmaceutical company, focuses on the commercialization of various therapies to address the unmet medical needs in the United States, Canada, and Europe. The company offers EGRIFTA SV for the reduction of excess abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy; and Trogarzo for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral...

Industry: Biotechnology
Sector: Healthcare
Phone: 514 336 7800
Fax: 514 331 9691
Address:
2015 Peel Street, 11th Floor, Montreal, Canada
B2iDigital
B2iDigital Jan. 15 at 9:22 PM
OS Therapies. (NYSE American: $OSTX) announced positive biomarker data from its Phase 2b clinical trial of 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. The results showed that specific immune markers in patients’ blood could distinguish long-term survivors (≥2 years) from short-term survivors (<1 year). According to the company, this adds resolution to the clinical data and increases the interpretability of the 2-year overall survival results for regulatory agencies. The pathway analysis was pre-specified and based on data from a 118-patient canine osteosarcoma study published in February 2025. When the same pre-specified pathway was confirmed in humans, it validated what the company calls Comparative Oncology: using dog cancer research to inform human drug development. Regulatory approval targets remain: UK by end of Q2 2026, US by end of Q3 2026, and Europe by year-end 2026. If the company receives Accelerated Approval prior to September 30, 2026, it would become 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, MHP, Chairman & CEO noted: “Leveraging the power of Comparative Oncology, we were able to train and test potentially predictive biomarkers from the Canine Metastatic Osteosarcoma Trial in order to form a hypothesis to test in a pre-specified way in the Human Metastatic Osteosarcoma Trial. We believe the confirmation of this pre-specified pathway analysis in humans adds significant resolution to our clinical data, increasing the clinical interpretability of the 2-year overall survival data for regulatory agencies. The confirmation of a pre-specified canine biomarker pathway being upregulated in a comparable human clinical study population leveraged canine biomarker data to a generate hypothesis that was tested in a pre-specified way and confirmed as a surrogate marker of clinical efficacy. This biomarker data strengthens our pending Biologics License Application (BLA) submission.” See the announcement at: https://ir.ostherapies.com/news-events/press-releases/detail/97/os-therapies-announces-positive-biomarker-data-from-phase 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. $THTX, $CGTX, $XBI
2 · Reply
Another_Name_Change
Another_Name_Change Jan. 14 at 7:06 PM
$OSTX $THTX $CGTX $XBI $20.00 will rerate overnight when bla is filed. That prv is worth 160 million according to company filing. Loading the boat down here in full accumulation mode
1 · Reply
B2iDigital
B2iDigital Jan. 14 at 6:38 PM
OS Therapies (NYSE American: $OSTX) announced that its wholly owned subsidiary, OS Animal Health (OSAH), has filed a Form S-1 with the U.S. Securities and Exchange Commission in preparation for a proposed initial public offering. OSAH intends to list on either the NYSE American or Nasdaq Capital Markets in the first half of 2026. OS Therapies is a B2i Digital Featured Company. View the full company profile at https://b2idigital.com/os-therapies-1. Under the proposed structure, OS Therapies shareholders are expected to receive one share of OS Animal Health for every ten shares of OSTX owned as of a record date to be determined in the first half of 2026. OS Animal Health will operate as a standalone animal health company focused on the re-establishment of USDA conditional approval and commercialization of OST-HER2 for canine osteosarcoma and other HER2-positive cancers in animals. From a scientific standpoint, the company highlighted growing evidence supporting the relevance of naturally occurring canine osteosarcoma as a translational model for human disease. Multiple OST-HER2 canine studies have demonstrated immune biomarker activation associated with improved clinical outcomes, with additional peer-review research currently under submission. In parallel with the planned OS Animal Health IPO, OS Therapies reiterated that biomarker data from its Phase 2b OST-HER2 trial in human pulmonary metastatic osteosarcoma will be released on January 15, 2026. These data are expected to support the company’s upcoming Biologics Licensing Application submission to the U.S. FDA under the Accelerated Approval pathway. Commenting on the announcement, Paul Romness, Chairman & CEO of OS Therapies and Interim-CEO of OS Animal Health, stated: “As parent company OS Therapies diligently pursues a Biologics Licensing Application (BLA) under the Accelerated Approval Program (Accelerated Approval) for OST-HER2 in human osteosarcoma, we have been relying heavily on data generated from naturally occurring osteosarcoma in domestic canines to generate key immune biomarker signature hypotheses that we are using to pre-specify treatment outcomes biomarkers in our human OST-HER2 metastatic osteosarcoma program. Two (2) separate research studies in different disease settings of canine osteosarcoma have shown improved patient outcomes in response to OST-HER2 treatment, with specific immune biomarkers being associated with antitumor immunity and improved clinical outcomes. There is a significant market opportunity for a novel treatment such as OST-HER2 that has demonstrated strong immune activation and treatment outcomes in canine osteosarcoma.” Read the full announcement: https://ir.ostherapies.com/news-events/press-releases/detail/96/os-therapies-announces-filing-form-s-1-of-os-animal-health-subsidiary 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. $THTX, $CGTX, $XBI
1 · Reply
BillBtheBull
BillBtheBull Oct. 9 at 5:20 PM
$THTX took an almost $40K loss here and wasted almost 4 years holding this turd. I’ve since recouped those losses x4 at CRML and UURAF. This company is run by morons and all they have is a cancer drug that doesn’t work and aids. FU Thera 🖕🏻
0 · Reply
nesanmano
nesanmano Oct. 7 at 4:32 PM
$THTX guys what happened after acquisition. Did you get money
0 · Reply
Love_To_Learn
Love_To_Learn Oct. 7 at 10:07 AM
$THTX need u !
0 · Reply
NVDAMillionaire
NVDAMillionaire Sep. 29 at 12:26 PM
$THTX Great piece that accurately captures THTX's current position. So if you want to refresh your understanding of THTX or learn about THTX for the first time, this is essential reading. https://beyondspx.com/quote/THTX/analysis/theratechnologies-a-strategic-acquisition-validates-niche-innovation-and-commercial-strength-nasdaq-thtx
0 · Reply
TwongStocks
TwongStocks Sep. 18 at 6:27 PM
$THTX NASDAQ Equity Corporate Actions Alert # 2025 - 517 Information Regarding the Plan of Arrangement of Theratechnologies Inc. (THTX) https://www.nasdaqtrader.com/TraderNews.aspx?id=ECA2025-517 At a special meeting held on September 12, 2025, the shareholders of Theratechnologies Inc. (THTX) approved a Plan of Arrangement involving CB Biotechnology, LLC, an affiliate of Future Pak, LLC. The arrangement is tentatively scheduled to close on September 25, 2025. Merger consideration: THTX shareholders will receive $3.01 and one (1) contingent value right (CVR) for each share held.
0 · Reply
QRNAKQARNUI
QRNAKQARNUI Sep. 15 at 10:16 AM
$THTX is there anything good with this stock or we sell it
1 · Reply
h8ster
h8ster Sep. 12 at 8:39 PM
$THTX Now we just sit back and wait for the CVR's to meet milestones over the next 3 years.
2 · Reply
Latest News on THTX
Theratechnologies Reports on its Annual Meeting of Shareholders

May 29, 2025, 2:00 PM EDT - 8 months ago

Theratechnologies Reports on its Annual Meeting of Shareholders


Theratechnologies Provides Update on Sale Process

Apr 15, 2025, 6:00 PM EDT - 10 months ago

Theratechnologies Provides Update on Sale Process


Soleus Capital Issues Letter to The Board of Theratechnologies

Apr 12, 2025, 8:46 AM EDT - 10 months ago

Soleus Capital Issues Letter to The Board of Theratechnologies


Theratechnologies Inc. (THTX) Q1 2025 Earnings Call Transcript

Apr 9, 2025, 10:28 AM EDT - 10 months ago

Theratechnologies Inc. (THTX) Q1 2025 Earnings Call Transcript


Theratechnologies Inc. (THTX) Q4 2024 Earnings Call Transcript

Feb 26, 2025, 1:21 PM EST - 11 months ago

Theratechnologies Inc. (THTX) Q4 2024 Earnings Call Transcript


Theratechnologies Resumes Distribution of EGRIFTA SV®

Feb 13, 2025, 7:45 PM EST - 1 year ago

Theratechnologies Resumes Distribution of EGRIFTA SV®


Theratechnologies Provides Update on EGRIFTA SV® Supply

Jan 9, 2025, 5:05 PM EST - 1 year ago

Theratechnologies Provides Update on EGRIFTA SV® Supply


Theratechnologies Inc. (THTX) Q3 2024 Earnings Call Transcript

Oct 10, 2024, 10:48 AM EDT - 1 year ago

Theratechnologies Inc. (THTX) Q3 2024 Earnings Call Transcript


Theratechnologies Inc. (THTX) Q2 2024 Earnings Call Transcript

Jul 10, 2024, 10:05 AM EDT - 1 year ago

Theratechnologies Inc. (THTX) Q2 2024 Earnings Call Transcript


B2iDigital
B2iDigital Jan. 15 at 9:22 PM
OS Therapies. (NYSE American: $OSTX) announced positive biomarker data from its Phase 2b clinical trial of 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. The results showed that specific immune markers in patients’ blood could distinguish long-term survivors (≥2 years) from short-term survivors (<1 year). According to the company, this adds resolution to the clinical data and increases the interpretability of the 2-year overall survival results for regulatory agencies. The pathway analysis was pre-specified and based on data from a 118-patient canine osteosarcoma study published in February 2025. When the same pre-specified pathway was confirmed in humans, it validated what the company calls Comparative Oncology: using dog cancer research to inform human drug development. Regulatory approval targets remain: UK by end of Q2 2026, US by end of Q3 2026, and Europe by year-end 2026. If the company receives Accelerated Approval prior to September 30, 2026, it would become 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, MHP, Chairman & CEO noted: “Leveraging the power of Comparative Oncology, we were able to train and test potentially predictive biomarkers from the Canine Metastatic Osteosarcoma Trial in order to form a hypothesis to test in a pre-specified way in the Human Metastatic Osteosarcoma Trial. We believe the confirmation of this pre-specified pathway analysis in humans adds significant resolution to our clinical data, increasing the clinical interpretability of the 2-year overall survival data for regulatory agencies. The confirmation of a pre-specified canine biomarker pathway being upregulated in a comparable human clinical study population leveraged canine biomarker data to a generate hypothesis that was tested in a pre-specified way and confirmed as a surrogate marker of clinical efficacy. This biomarker data strengthens our pending Biologics License Application (BLA) submission.” See the announcement at: https://ir.ostherapies.com/news-events/press-releases/detail/97/os-therapies-announces-positive-biomarker-data-from-phase 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. $THTX, $CGTX, $XBI
2 · Reply
Another_Name_Change
Another_Name_Change Jan. 14 at 7:06 PM
$OSTX $THTX $CGTX $XBI $20.00 will rerate overnight when bla is filed. That prv is worth 160 million according to company filing. Loading the boat down here in full accumulation mode
1 · Reply
B2iDigital
B2iDigital Jan. 14 at 6:38 PM
OS Therapies (NYSE American: $OSTX) announced that its wholly owned subsidiary, OS Animal Health (OSAH), has filed a Form S-1 with the U.S. Securities and Exchange Commission in preparation for a proposed initial public offering. OSAH intends to list on either the NYSE American or Nasdaq Capital Markets in the first half of 2026. OS Therapies is a B2i Digital Featured Company. View the full company profile at https://b2idigital.com/os-therapies-1. Under the proposed structure, OS Therapies shareholders are expected to receive one share of OS Animal Health for every ten shares of OSTX owned as of a record date to be determined in the first half of 2026. OS Animal Health will operate as a standalone animal health company focused on the re-establishment of USDA conditional approval and commercialization of OST-HER2 for canine osteosarcoma and other HER2-positive cancers in animals. From a scientific standpoint, the company highlighted growing evidence supporting the relevance of naturally occurring canine osteosarcoma as a translational model for human disease. Multiple OST-HER2 canine studies have demonstrated immune biomarker activation associated with improved clinical outcomes, with additional peer-review research currently under submission. In parallel with the planned OS Animal Health IPO, OS Therapies reiterated that biomarker data from its Phase 2b OST-HER2 trial in human pulmonary metastatic osteosarcoma will be released on January 15, 2026. These data are expected to support the company’s upcoming Biologics Licensing Application submission to the U.S. FDA under the Accelerated Approval pathway. Commenting on the announcement, Paul Romness, Chairman & CEO of OS Therapies and Interim-CEO of OS Animal Health, stated: “As parent company OS Therapies diligently pursues a Biologics Licensing Application (BLA) under the Accelerated Approval Program (Accelerated Approval) for OST-HER2 in human osteosarcoma, we have been relying heavily on data generated from naturally occurring osteosarcoma in domestic canines to generate key immune biomarker signature hypotheses that we are using to pre-specify treatment outcomes biomarkers in our human OST-HER2 metastatic osteosarcoma program. Two (2) separate research studies in different disease settings of canine osteosarcoma have shown improved patient outcomes in response to OST-HER2 treatment, with specific immune biomarkers being associated with antitumor immunity and improved clinical outcomes. There is a significant market opportunity for a novel treatment such as OST-HER2 that has demonstrated strong immune activation and treatment outcomes in canine osteosarcoma.” Read the full announcement: https://ir.ostherapies.com/news-events/press-releases/detail/96/os-therapies-announces-filing-form-s-1-of-os-animal-health-subsidiary 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. $THTX, $CGTX, $XBI
1 · Reply
BillBtheBull
BillBtheBull Oct. 9 at 5:20 PM
$THTX took an almost $40K loss here and wasted almost 4 years holding this turd. I’ve since recouped those losses x4 at CRML and UURAF. This company is run by morons and all they have is a cancer drug that doesn’t work and aids. FU Thera 🖕🏻
0 · Reply
nesanmano
nesanmano Oct. 7 at 4:32 PM
$THTX guys what happened after acquisition. Did you get money
0 · Reply
Love_To_Learn
Love_To_Learn Oct. 7 at 10:07 AM
$THTX need u !
0 · Reply
NVDAMillionaire
NVDAMillionaire Sep. 29 at 12:26 PM
$THTX Great piece that accurately captures THTX's current position. So if you want to refresh your understanding of THTX or learn about THTX for the first time, this is essential reading. https://beyondspx.com/quote/THTX/analysis/theratechnologies-a-strategic-acquisition-validates-niche-innovation-and-commercial-strength-nasdaq-thtx
0 · Reply
TwongStocks
TwongStocks Sep. 18 at 6:27 PM
$THTX NASDAQ Equity Corporate Actions Alert # 2025 - 517 Information Regarding the Plan of Arrangement of Theratechnologies Inc. (THTX) https://www.nasdaqtrader.com/TraderNews.aspx?id=ECA2025-517 At a special meeting held on September 12, 2025, the shareholders of Theratechnologies Inc. (THTX) approved a Plan of Arrangement involving CB Biotechnology, LLC, an affiliate of Future Pak, LLC. The arrangement is tentatively scheduled to close on September 25, 2025. Merger consideration: THTX shareholders will receive $3.01 and one (1) contingent value right (CVR) for each share held.
0 · Reply
QRNAKQARNUI
QRNAKQARNUI Sep. 15 at 10:16 AM
$THTX is there anything good with this stock or we sell it
1 · Reply
h8ster
h8ster Sep. 12 at 8:39 PM
$THTX Now we just sit back and wait for the CVR's to meet milestones over the next 3 years.
2 · Reply
Mergerbrief
Mergerbrief Sep. 12 at 12:00 PM
$THTX / CB Bio - Shareholder Vote $THTX MergerBrief.com
0 · Reply
h8ster
h8ster Aug. 22 at 5:32 PM
$THTX Whats interesting now, with he FDA approval yesterday, is there is now time for another company to swoop in and make an unsolicited counter offer. I've been a part of a few of those instances. Then of course, Future Pak, parent of CB has the right to match. Depends on how good of a deal CB's $3.01 cash + $1.19 in CVRs actually is and if somebody thinks they can do better. You never know. Anything can happen in this sector.
0 · Reply
buzzkiller
buzzkiller Aug. 21 at 10:24 PM
$THTX hey Theratechnologies, you might want to remove the "investment" calculator from your website. No long term investor in your garbage company has made a cent.
1 · Reply
Stockinvestor73
Stockinvestor73 Aug. 21 at 8:53 PM
$THTX i bet they announce after 8pm
1 · Reply
Ericb760
Ericb760 Aug. 15 at 1:07 AM
$THTX Could be time to buy in again.
0 · Reply
B2iDigital
B2iDigital Aug. 7 at 1:50 PM
OS Therapies (NYSE-A: $OSTX) announced that the company held a successful Scientific Advice Meeting with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in July and submitted an Innovative Licensing and Access Pathway (ILAP) application to advance regulatory approval for OST-HER2 in preventing or delaying 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. The MHRA recommended applying for Project Orbis when submitting for regulatory approval to align the UK’s Marketing Authorization Application process with the US FDA’s Biologics Licensing Application (BLA) Accelerated Approval Program. Project Orbis is an FDA-led global initiative that enables simultaneous submission and review of oncology products across multiple countries, potentially accelerating patient access to promising cancer treatments. Highlights from today’s news release include: - Positive feedback received from the UK MHRA Scientific Advice Meeting held in July 2025. - ILAP application submitted to begin UK regulatory approval process for OST-HER2. - European Medicines Agency rapporteur meeting scheduled for October 2025 to initiate EU-wide Marketing Authorization via the Centralized Procedure. Paul Romness, MPH, CEO of OS Therapies, remarked, “We are pleased with the outcome of our meeting with MHRA in the UK and are working to ensure that we provide FDA and MHRA everything they need to be able to rapidly approve OST-HER2 for metastatic osteosarcoma patients. We have officially begun the regulatory process in Europe as the next part of our regulatory strategy to bring this novel immunotherapy to osteosarcoma patients worldwide.” Read the full release at: https://ir.ostherapies.com/news-events/press-releases/detail/71/os-therapies-receives-positive-feedback-from-uk-mhra Led by CEO Paul Romness and an experienced executive team that includes Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), John Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers. Learn more about OS Therapies’ work 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: The management of B2i Digital owns unrestricted shares of OSTX stock purchased in the open market. This post is not intended to solicit the sale of OSTX or any security, and it is not intended to offer any opinion on OSTX as an investment. Conduct your own research and consult with your own professional advisors prior to making any investment decisions. See the full disclosure in the Risks and Disclosures section of https://b2idigital.com/os-therapies-1 $THTX $CGTX
2 · Reply
B2iDigital
B2iDigital Aug. 7 at 1:43 PM
OS Therapies (NYSE-A: $OSTX) reported statistically significant positive 2-year overall survival results from an interim analysis of its Phase 2b trial of its off-the-shelf immunotherapy candidate OST-HER2 for preventing or delaying 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. The company also announced its NYSE American listing has been added to the Russell Microcap, Russell Microcap Value, and Russell Microcap Growth indexes. FTSE Russell determines membership for its Russell indexes based on objective, market-capitalization rankings, and style attributes. Investment managers and institutional investors widely use Russell indexes for index funds and as benchmarks for active investment strategies. Highlights from today’s news release include: - 66.6% of patients treated with OST-HER2 (18/27) reached 2-year overall survival versus 40% in historical controls (p = 0.0046). - The FDA issued a Biologics License Application (BLA) number for OST-HER2 ahead of the anticipated filing following the pending August 27, 2025, End of Phase 2 Meeting. - The company is working with the FDA to align metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy Designation (BTD), and BLA through the Accelerated Approval pathway. Paul Romness, MPH, Chairman & CEO of OS Therapies, remarked, “We are seeking to bring this novel immunotherapy to market to improve the survival rates in pulmonary metastatic osteosarcoma, and today’s updated interim overall survival data continues to show a statistically significant benefit for OST-HER2-treated patients compared with control. We believe that continued statistically significant outperformance in overall survival of OST-HER2 treated patients compared with historical control, together with the statistically significant positive 12-month Event Free Survival data presented at MIB Factor in June 2025, will provide the necessary scientific and medical basis to support a BLA under the FDA’s Accelerated Approval Program.” Read the full release at: https://ir.ostherapies.com/news-events/press-releases/detail/72/os-therapies-announces-statistically-significant-positive Led by CEO Paul Romness and an experienced executive team that includes Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), John Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other hard-to-treat cancers. Learn more about OS Therapies’ work 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: The management of B2i Digital owns unrestricted shares of OSTX stock purchased in the open market. This post is not intended to solicit the sale of OSTX or any security, and it is not intended to offer any opinion on OSTX as an investment. Conduct your own research and consult with your own professional advisors prior to making any investment decisions. See the full disclosure in the Risks and Disclosures section of https://b2idigital.com/os-therapies-1 $THTX $CGTX
1 · Reply
d00bie
d00bie Jul. 14 at 4:31 PM
$THTX ready to pop
0 · Reply
CCTVon
CCTVon Jul. 14 at 12:49 AM
$THTX will be acquired by CB Biotech and expected to close 11/30/25. Weekly and Daily charts suggest this is a hold till then.
0 · Reply
B2iDigital
B2iDigital Jul. 10 at 4:04 PM
OS Therapies (NYSE-A: $OSTX) announced a series of clinical and regulatory milestones today. The company has secured an End-of-Phase 2 meeting with the U.S. Food and Drug Administration on 27 August 2025 to discuss a rolling Biologics License Application for its lead candidate, OST-HER2, in recurrent, pulmonary-metastatic osteosarcoma; it has also lined up parallel Scientific Advice meetings with the European Medicines Agency and the UK Medicines & Healthcare products Regulatory Agency to advance OST-HER2 through centralized EU and ILAP pathways. In addition, all patients in the Phase 1 study of OST-504 for second-line prostate cancer have completed treatment, with updated data expected later in 2025. OS Therapies is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/os-therapies-1 The update highlights management’s plan to secure U.S. approval before the Rare Pediatric Disease Priority Review Voucher program sunsets, potentially generating non-dilutive capital from a future PRV sale to fund OST-HER2 commercialization and advance additional pipeline candidates. Highlights from the news release include: - FDA End-of-Phase 2 meeting for OST-HER2 set for 27 August 2025, with the goal of agreeing on a rolling BLA submission under Accelerated Approval. - Scientific Advice engagements secured with EMA and UK regulators, paving the way for EU centralized approval and UK Conditional Marketing Authorization via ILAP. - Phase 1 OST-504 prostate-cancer trial fully treated; clinical data expected in the second half of 2025. Paul Romness, MPH, Chairman & CEO of OS Therapies, noted, “We are making significant progress towards our primary objective of obtaining regulatory approval for OST-HER2 in recurrent, pulmonary metastatic osteosarcoma prior to the sunsetting of the rare pediatric disease priority review voucher (“PRV”) program. If successful, we expect to receive significant non-dilutive funding from the sale of the PRV which we would then be able to deploy in commercializing OST-HER2 osteosarcoma and other HER2 expressing cancers, as well as advance the other clinical candidates in our pipeline, including OST-504 in prostate cancer. We strongly believe in the promise of the listeria immunotherapy platform to help prevent and treat cancer, and intend to judiciously deploy our capital to focus on the OST-HER2 approval while advancing our other clinical programs without deploying significant capital or running other clinical studies while we wait for the OST-HER2 approval and related PRV sale.” Full release: https://ir.ostherapies.com/news-events/press-releases/detail/69/os-therapies-provides-clinical-global-regulatory-updates. Led by Paul Romness and an experienced executive team that includes Christopher Acevedo, Robert Petit, John Doll, and Gerald Commissiong, OS Therapies is focused on driving its pipeline forward to deliver potentially transformative treatments for osteosarcoma and other cancers. Disclosure: The management of B2i Digital owns unrestricted shares of OSTX stock purchased in the open market. This post is not intended to solicit the sale of OSTX or any security, and it is not intended to offer any opinion on OSTX as an investment. Conduct your own research and consult with your own professional advisors prior to making any investment decisions. See the full disclosure in the Risks and Disclosures section of https://b2idigital.com/os-therapies-1. $THTX, $CGTX
1 · Reply
GRASSCUT9
GRASSCUT9 Jul. 9 at 12:13 PM
$THTX SUGP contract big win!!
0 · Reply