Canada markets closed

Theratechnologies Inc. (TH.TO)

Toronto - Toronto Real Time Price. Currency in CAD
Add to watchlist
4.0900+0.1600 (+4.07%)
At close: 4:00PM EST
Sign in to post a message.
  • d
    david
    Quick Summary
    The legacy drugs
    The company is Optimistic on Egrifta’s sales for instance the visceral fat increases the severity of COVID19 so they will be using that methodology among other marketing efforts to increase the sales of Egrifta also the F8 will be having a positive effect on Egrifta sales. 
    They will be using the social media more often to reach out to patients going forward for both drugs. As per Paul the MDR opportunities are increasing. The reimbursement of Trogarzo restarts as soon as lockdowns are lifted in the Europe. They are not happy with sales in 2020 despite the record sales and will be working hard to increase the sales post pandemic. Over 200 attendees when they launched in Germany only. They are lining up a number of patients to have access to Trogarzo as soon the lockdowns are lifted in Europe. The phase 3 IV push for Trogarzo will be completed by end of 2021, also the phase 2/3 for IM will be starting in coming weeks. The investment they have done to change the sale’s marketing will have a lasting effect post pandemic. 
    R&D Programs
    They reconfirmed their R&D trails are on schedule for both oncology and NASH phase 3.
    Fast track designation for oncology based on preclinical is unique.
    They are in final discussions with both agencies and plan to meet up with both FDA and EMA to align the protocol for NASH phase 3 so both agencies are board for the scheduled trial by end of Q3. A Common program to be finalized by mid-year for NASH.
    SGNA in line in the next fiscal year possibly a bit higher due to reimbursement of Trogarzo in the Europe.
  • R
    RICH
    I see no reasons why this stock does not go back at $6-7$ by year end, where it should be. Agree that something’s cooking. So many good products in the pipeline, no surprise that FDA gave them fast track designation!
  • K
    Kev
    not the best Earning Report but the revenues are there...big volume again and not much selling something good is cooking guys..hold😁😁
  • P
    Paul
    Interesting reaction today to what must have been the written interview of our CEO, Paul, that was released. Not sure why people took it for sell worthy news. It is true, they'll need more cash, but the company will be in a very different position by the time those additional dollars are necessary. And there are other financing options available in that case.
  • d
    david
    Trogarzo is cost effective
    The company seems to be more proactive, this was published initially on PharmacoEconomics and republished on Springer. (academic access only).

    Ibalizumab cost effective for multidrug-resistant HIV-1 infection in USA?
    PharmacoEconomics & Outcomes News volume 872, page17(2021)Cite this article
     
    Metricsdetails
     
    Ibalizumab may be cost effective for the treatment of multidrug-resistant (MDR) HIV-1 infection in the US, according to findings of a Theratechnologies-funded study published in PharmacoEconomics.
     
    A Markov model populated with data from phase II and III trials and market uptake projections was used to evaluate the cost effectiveness of final-line antiretroviral therapy with ibalizumab plus optimised background therapy (OBT) versus OBT alone in adults with MDR HIV-1, from a US healthcare sector perspective over a lifetime time horizon. Budget impact analysis was also performed to estimate the impact of the introduction of add-on ibalizumab on the payer budget of a hypothetical commercial health plan during the first 3 years, and from a Medicare health plan perspective. The assumed cost of ibalizumab was $125 555Footnote1 in the first year and $118 445 per year thereafter, and the assumed annual cost of OBT was $52 850.
     
    It was estimated that ibalizumab plus OBT would increase survival by 1.47 years compared with OBT alone, achieving an incremental gain of 1.45 QALYs at an incremental cost of $192 476, resulting in an incremental cost-effectiveness ratio of $133 040 per QALY gained.
     
    In a commercial health plan with 1 million members, the addition of ibalizumab to OBT was estimated to increase the budget by $217 260 ($0.018 per member per month [PMPM]) in year 1, $385 245 ($0.032 PMPM) in year 2 and $560 310 ($0.47 PMPM) in year 3.
     
    Probabilistic sensitivity analysis found that ibalizumab plus OBT was cost effective versus OBT alone in 73.4% of simulations at a willingness-to-pay threshold of $150 000 per QALY gained.
     
    In budget-impact scenario analysis, the budget impact of ibalizumab was found to be greater in a Medicare population ($0.054 PMPM in year 3) but, under all scenarios evaluated, the annual budget impact was less than $0.07 PMPM.
     
    "This analysis suggests that ibalizumab treatment may be cost-effective considering willingness-to-pay thresholds for rare diseases and that including ibalizumab on either a commercial or a Medicare health plan formulary may result in a relatively low budget impact," concluded the authors.
  • d
    david
    THTX for retail investors
    The company’s CEO  have bachelor of science in biochemistry, CFO has master of business science, CMO has Ph.D. in biochemistry and General Manager in EU has Bachelor’s and Master’s degrees Between just four of them they have over 100 years of management experience in the industry.
    Their research and development programs includes Cancer programs and None Alcoholic Steatohepatitis NASH (fatty liver disease).
    ONCOLOGY
    Their cancer drugs TH 1902 and TH 1904 are peptides (small proteins), the innovative approach for the cancer programs is based on a technology to deliver therapeutic agents to the organs. These peptides bind to anticancer agents they also bind to receptors (sortilin) which are commonly presented in many cancer types, this receptor get attached and surrounded by cancer cell membrane and enter the cell and form a spherical structure, later on the skin of that structure breaks down and release the receptor inside the cancer cells so the anticancer agents kill the cancer cells. The advantage of this technique versus other anticancer approaches is as a portion of other drugs will be resisted by cell membrane therefore it will be less concentration of their drugs which manages to enter the cancer cells.
    Also their cancer technology inhibits vascular mimicry which is the progress the tumor cells organize themselves to a channel to provide blood to other cancer cells.
    The beauty of this technology is that it can deliver other therapeutic agents to the targeted cell although the company now only exploring this mechanism of action on anti-cancer agents.
    This technology can be used to treat various cancer types such as Melanoma(market size $12 billion by 2025), Pancreatic cancer( market size $4 billion by 2025) Colorectal cancer(market size $17billion by 2025) Endometrial cancer(market size 12 billion by 2027), Triple Negative Breast Cancer (Market size $55 billion by 2027) , Ovarian cancer(market size $3 billion by 2022) Neuroendocrine tumors(market size over 2 $ billion), Lung cancer(market size $37 billion), Soft tissue cancer( market size $3,6 billion) so between now and 2027 the combined market opportunity would be about $146 billion! The company recently got Fast Track Designation which only be approved by FDA for drugs which are under development for unmet conditions, this designation accelerate the trial progress and finally the potential approval will be faster and sooner. They are scheduled to start the trial in March this year.
     
    NASH
     
    Tesamorelin directly stimulate production of Growth Hormone which reduces Visceral fat (fat round the body’s organ), decreases storage of fat, improve energy production by cells, decreases inflammation. 
    The drug indirectly also stimulate production of Insulin-like Growth factor-1 in liver which decrease insulin resistance( less liver fat), decreases liver inflammation and deactivate liver cells which cause infection.
    Also it was recently proved that Tesamorelin has inhibiting effect on pro inflammatory proteins causing inflammation if untreated causing infections. Their treatment approach is innovative while other approaches have failed for more than a decade.
    NASH is a lethal disease with growing prevalence globally with no approved drug to date, as per company’s presentation only in the US there were over 16 million NASH patients in 2019 which is projected to reach 27 million patients by 2030. NASH market size globally was over $1 billion in 2017 and projected to reach over 21 billion in 2025.
    The have patent coverage for Tesamorelin in NASH in the US and Europe and considering extending the protection to other parts of the world.
    The company is scheduled to start the Phase 3 NASH trial by end of third quarter this year.
     
    LEGACY DRUGS
     
    They have two approved drugs currently commercialized, Trogarzo is an antiviral drug with long lasting effect treating patients with HIV and is currently commercialized in the US and Germany, will be launched in 4 other European countries and Israel.
    Tesamorelin is treating Liodysrophyfor HIV patients (abnormal amount/distribution of fat) currently commercialized in the North America.
    Last quarter they had record sales despite the Covid19 pandemic and projected to increase the sales by over %240 in the next 4 years.
  • d
    david
    They send all 6 cancer results so the FDA gave them the fast track designation as they had enough information to be  given that designation based on only animal research which sounds like the agency liked their MOA.
    If show safety and efficacy in P1 cancer, the 2 and 3 will move a lot faster given unmet need.
    50 to 60 percent of patients who died of cancer had over expressed sortilin.
    $12 billion revenue for advanced stage cancer which can be much higher if they start treating early-stage cancers ! CEO answered my question.
    They will make announcement whenever they have data available to the whole world.
    Cash is $70 million.
    They will be adjusting the NASH protocol to approach both FDA and EMA.
    They are looking for new investors and work hard for excising shareholders( first time I heard anyone on company saying that)
    Sort1 technology has no competition, with IP protection.
  • K
    Kenneth
    PRESS RELEASE: Paid content from Globe Newswire
    Press release content from Globe Newswire. The AP news staff was not involved in its creation.
    Theratechnologies’ Lead Peptide Drug Conjugate TH1902 Receives FDA Fast Track Designation for ...
    Theratechnologies
    30 minutes ago
    MONTREAL, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, is pleased to announce that the United States Food and Drug Administration (FDA) has granted fast track designation to TH1902 as a single agent for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy.
    “Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ Technology™ and further supports the future development of TH1902. The designation, which applies to all solid tumours expressing sortilin, also highlights the broad applicability and immense medical need for innovative, targeted, and potentially more effective and better-tolerated therapies for cancer,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies.
  • K
    Kev
    big day tomorrow🤞
  • R
    RICH
    Shareholders, this Biotech is strong, efficient, very well managed. Be patient, you won’t regret.
  • B
    Ben From the North
    This is a stock to leave alone for a few months. Even more. Come back in 1 or 2 year.
  • M
    Mike
    This is an interesting stock. I've done some research and see the Canadian pension fund has it a sizeable portion of their portfolio and they have some promising drugs in the pipeline as well as some FDA drugs that have decent sales. I wonder what the stock could be worth minus the pipeline drugs. It seems like they have a viable business and some of the profit is going towards R&D for the pipeline. I think the current drug sales would warrant a good price by itself but I don't know what a good price would be.
  • K
    Kenneth
    Institutional short sellers have been driving potential gains down, as it relates to many companies’ stocks; therefore, if THTX can maintain any gains received by its most recent news regarding the FDA, in the wake of the short interest in the stock, we can see the stock price increase exponentially; but first it has to prove its resilience against the shorts. I believe it can.
  • M
    Mkang
    great news.ran upto 3.9 before market open
  • P
    Paul
    You guys from the stockhouse bullboard are doing a great job analyzing THTX. Please keep cross posting and sharing the observations.
  • B
    Benjamin
    My broker is TD, everyday they update the insider transactions for each individual stocks. i checked TH today, insiders loading in the last couple of days.
  • B
    Ben From the North
    Patience will pay with this one
  • d
    david
    New weapon against refractory cancers
    Quebec biotech Theratechnologies has received approval from the U.S. Food and Drug Administration (FDA) to begin Phase 1 clinical trials on TH1902, an anti-cancer drug developed from a therapeutic platform developed by Professor Borhane Annabi of the Department of Chemistry and his team at UQAM's Molecular Oncology Laboratory. Trials will begin in the coming months in patients with advanced endometrial, ovarian, colon, pancreatic and triple negative breast cancers that are resistant to available treatments.
     
    "It's amazing to have been involved in the development of a new drug from A to Z, from the early stages of research to early clinical trials," says Borhane Annabi. We are very proud, especially since the FDA has just granted us the"fast track"designation, which means that our file has passed at the top of the pile. This has a lot of weight and will help in patient recruitment."
     
    The"fast track"designation is intended to facilitate the development and expedite the review process of drugs designed for the treatment of serious medical conditions and to allow patients to access new drugs more quickly, Theratechnologies said in a statement issued on February 4.
     
    This FDA recognition of TH1902 highlights "the vast field of applicability and enormous medical need for innovative, targeted, potentially more effective and better tolerated treatments for cancer," said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer at Theratechnologies.
     
    TH1902 combines docetaxel, a drug already part of the cancer therapeutic arsenal, and a peptide that specifically targets sortilin receptors (SORT1). This new drug vectoring platform is based on inventions by Borhane Annabi's team, developed at UQAM in collaboration with Professor Emeritus Richard Bliveau. The technology specifically targets overexpressed proteins on cancer cells, the sortilin receptors, which serve as a gateway to bring the drug inside these cells.
     
    Several types of cancers express the sortilin receptor (SORT1). Promising preclinical results have already been obtained for triple negative breast cancer, ovarian cancer and, more recently, colon, pancreatic, endometrial and skin cancers. The preclinical assessment of TH1902 is still ongoing for melanoma.
     
    "In animals, treatment has been shown to slow down tumor growth, or even completely eradicat, without causing weight loss or neutropenia, deleterious side effects often associated with chemotherapy," says Borhane Annabi. Now it's all about clinical trials."
     
    The first Phase 1 trial in humans will assess, among other things, the safety of the drug and the maximum tolerated dose. TH1902 will be administered once every three weeks to patients at the MD Anderson Cancer Center at the University of Texas, one of the largest cancer treatment and research centers in the United States.
     
    Patients (in many cases, patients) with advanced and recurrent solid tumors expressing the sortilin receptor and resistant to standard treatments will be able to participate in the study. "These are patients who can no longer be treated, who no longer respond or very little to current treatments," says Borhane Annabi. For those people to whom medicine no longer has much to offer, the trials that are about to begin are a great hope."
     
    The Canadian Cancer Society (CCS) and the Quebec government, through the Quebec Consortium on Drug Discovery (CQDM), will contribute a total of $1.4 million to support ongoing research.
     
    "This is a great partnership between cutting-edge biomedical research and industry, between UQAM and its partners Theratechnologies, CCS and CQDM, who believed in the project and funded it," concludes Borhane Annabi. We hope to be laying the groundwork for a possible success story."
    https://www.actualites.uqam.ca/2021/nouvelle-arme-contre-des-cancers-refractaires-aux-traitements-conventionnels
    Le TH1902, un médicament conçu à partir de recherches menées à l’UQAM, a reçu l’approbation de la Food and Drug Administration aux États-Unis pour une première phase d’essais cliniques.
    Le TH1902, un médicament conçu à partir de recherches menées à l’UQAM, a reçu l’approbation de la Food and Drug Administration aux États-Unis pour une première phase d’essais cliniques.
    www.actualites.uqam.ca
  • D
    Dipak
    Ready for jump back
  • B
    Black$wan
    we just need a little volume guys...buy if you can
    13k shares here and holding..