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Overview
Protagonist Therapeutics (PTGX) is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel, peptide-based therapeutics. Employing a proprietary constrained peptide technology platform, the company is focused on creating potentially first-in-class oral treatments that address significant unmet medical needs. By targeting complex biological pathways with high specificity, Protagonist has positioned itself in the competitive landscape of peptide therapeutics, especially in areas such as inflammatory diseases, autoimmune conditions, and hematologic disorders.
Innovative Technology Platform
At the core of Protagonist's operations is a cutting-edge discovery platform that enables the design and optimization of constrained peptides. This platform not only facilitates the rapid identification of novel chemical entities but also ensures enhanced stability and bioavailability when administered orally. The science behind constrained peptides allows the company to interfere with biological pathways in a manner similar to that of injectable antibodies, yet with the convenience and potential safety advantages of an oral formulation.
Pipeline and Product Candidates
Protagonist's pipeline exemplifies the application of its advanced peptide platform. Key candidates include:
- Icotrokinra (JNJ-2113): A targeted oral peptide engineered to selectively block the interleukin-23 (IL-23) receptor. This therapeutic approach is designed to address chronic inflammatory conditions such as plaque psoriasis and ulcerative colitis by modulating specific immune pathways.
- Rusfertide: A mimetic of the natural hormone hepcidin, developed as a potential treatment in the field of hematology for conditions like polycythemia vera (PV). By normalizing hematocrit levels and reducing the need for conventional therapies, rusfertide aims to provide a novel treatment option with a favorable tolerability profile.
Strategic Collaborations and Clinical Development
Protagonist Therapeutics leverages strategic partnerships and licensing agreements to strengthen its clinical development efforts and market reach. Collaborations with leading pharmaceutical companies such as Takeda and Johnson & Johnson underscore the company's commitment to translating its peptide-based discoveries into viable therapeutic options. Through these partnerships, Protagonist not only advances its flagship candidates into advanced clinical trials but also gains the expertise and resources necessary to navigate complex regulatory environments.
Market Position and Competitive Landscape
Operating in the highly competitive biopharmaceutical sector, Protagonist differentiates itself through its innovative approach to oral peptide drug development. Unlike traditional therapies that rely on large protein biologics administered via injection, the company’s philosophy centers on creating small, stable peptide drugs that mimic the efficacy of biologics while offering the benefits of oral dosing. This distinct competitive edge, combined with a robust research and development framework, positions Protagonist as a key player in tackling some of today’s most challenging clinical conditions.
Research, Clinical Evidence, and Efficacy
Protagonist’s research emphasizes demonstrable efficacy and safety from early-phase to advanced clinical studies. The company’s approach to designing oral therapies is supported by rigorous preclinical studies and clinical trial data that highlight improvements in disease parameters such as skin clearance in psoriasis or hematocrit control in polycythemia vera. The scientific rationale behind its candidates—grounded in selective receptor antagonism and precise immune modulation—underscores a deep commitment to overcoming the limitations of current therapies.
Corporate Stability and Long-term Strategy
While the clinical development of novel therapeutics inherently carries risk, Protagonist Therapeutics maintains a robust operational framework through diversified revenue streams including milestone and license payments from its collaborative agreements. This financial model, coupled with a strong cash position, reinforces the company’s ability to invest in early-stage discoveries and advance them into clinical proof-of-concept studies without compromising on safety or efficacy.
Conclusion
In summary, Protagonist Therapeutics embodies the convergence of innovative peptide science and strategic biopharmaceutical development. With its proprietary oral peptide platform, the company is advancing a portfolio of promising candidates designed to transform treatment paradigms in inflammation, autoimmune disorders, and hematology. The integration of advanced discovery methods, strong industry collaborations, and a focus on patient-centric outcomes solidifies Protagonist’s position as a noteworthy contributor to next-generation therapeutics.
Protagonist Therapeutics announced PN-881, a potential best-in-class oral peptide IL-17 antagonist, as a development candidate for immune-mediated skin diseases. The drug has shown superior potency compared to anti-IL-17 oral small molecules and comparable effectiveness to injectable antibody treatments. PN-881 demonstrated effective blockade of all three therapeutically relevant IL-17 dimers, with approximately 100-fold greater potency than secukinumab. The company plans to initiate Phase 1 clinical trials in Q4 2025, with potential expansion into psoriatic arthritis, hidradenitis suppurativa, and axial spondyloarthropathies based on psoriasis study results.
Protagonist Therapeutics has scheduled a conference call and webcast for November 21st at 4:30 pm ET to announce their new oral peptide IL-17 antagonist development candidate. During the presentation, the company will share in vitro and pre-clinical proof-of-concept study results.
US investors can dial 1-877-407-0752, while international investors can access the call at 1-201-389-0912 using Conference ID 13750274. The webcast will be available through a provided link, and a replay will be accessible on the Company's Investor Relations Events and Presentations webpage after the event.
Protagonist Therapeutics announced positive Phase 3 results for icotrokinra (JNJ-2113) in treating plaque psoriasis. The ICONIC-LEAD study showed 64.7% of patients achieved clear/almost clear skin (IGA 0/1) and 49.6% achieved PASI 90 at week 16, compared to 8.3% and 4.4% on placebo. By week 24, these rates increased to 74.1% and 64.9% respectively. The ICONIC-TOTAL study also met its primary endpoint. Safety data aligned with Phase 2 results, with similar adverse event rates between treatment and placebo groups. The company earned a $165 million milestone payment, with potential for additional $630 million in future milestones and 6-10% royalties on worldwide sales.
Protagonist Therapeutics (PTGX) reported Q3 2024 financial results with key upcoming milestones. The company expects top-line results for JNJ-2113 Phase 3 trials in psoriasis in Q4 2024, Phase 2b in ulcerative colitis in Q1 2025, and rusfertide Phase 3 in polycythemia vera in Q1 2025. Financial highlights include cash position of $583.3 million, expected to last through 2027. Q3 2024 showed revenue of $4.7 million, R&D expenses of $36 million, and net loss of $33.2 million ($0.54 per share). The company recognized $263.8 million in revenue for the nine months ended September 30, 2024, largely from the Takeda collaboration agreement.
Protagonist Therapeutics announced that final data from the Phase 2 REVIVE study of rusfertide in polycythemia vera will be presented at the 66th Annual American Society of Hematology (ASH) Meeting. The presentation, titled 'Final Results from the Phase 2 Revive Study Investigating the Hepcidin Mimetic Rusfertide in Patients with Polycythemia Vera (PV),' will be delivered by Dr. Aaron Gerds from Cleveland Clinic on December 9, 2024, in San Diego.
Protagenic Therapeutics (Nasdaq:PTIX) has announced a private placement offering with expected gross proceeds of $1.275 million. The company will issue 1,948,295 shares of common stock (or pre-funded warrants), along with series A and B warrants to purchase additional shares. The purchase price is set at $0.64 per share ($0.89 for insiders). Series A warrants have an 18-month term while Series B warrants extend to 5 years, both with a $0.64 exercise price. The offering, expected to close by November 4, 2024, will be used for working capital purposes. Brookline Capital Markets is serving as the sole placement agent.
Protagonist Therapeutics (NASDAQ:PTGX) has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference in New York, NY, scheduled for September 9-11, 2024. The company's President and CEO, Dinesh V. Patel, Ph.D., will engage in a fireside chat on Tuesday, September 10 at 1:30 P.M. ET.
The fireside chat will be accessible via webcast, providing an opportunity for investors and interested parties to gain insights into Protagonist's developments and strategies. Additionally, the company will be available for one-on-one meetings during the conference, offering a more personalized interaction for attendees.
This participation underscores Protagonist's commitment to engaging with the investment community and sharing updates on its progress in the biotechnology sector.
Protagonist Therapeutics (NASDAQ:PTGX) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. JNJ-2113 Phase 3 trials in psoriasis and Phase 2b trial in ulcerative colitis expected to complete primary endpoint portions in Q4 2024.
2. Rusfertide Phase 3 VERIFY study topline results expected in Q1 2025.
3. Cash position of $595.4M as of June 30, 2024, providing runway through end of 2027.
4. Q2 2024 financial results: License and collaboration revenue of $4.2M, R&D expenses of $33.5M, G&A expenses of $9.4M, and net loss of $30.6M.
5. Six-month 2024 results show net income of $176.7M, primarily due to the $300M upfront payment from the Takeda collaboration agreement.
Protagonist Therapeutics announced the publication of preclinical and phase 1 clinical data on JNJ-2113 in Scientific Reports. JNJ-2113 is the first-in-class targeted oral peptide inhibitor of the IL-23 receptor in clinical development. The study demonstrated JNJ-2113's high potency, selectivity, and efficacy in various models. Key findings include:
1. Single-digit picomolar affinity binding to IL-23R
2. Efficacy in skin inflammation and colitis models
3. Dose-proportional pharmacokinetics in humans
4. Well-tolerated in healthy volunteers
JNJ-2113 is currently in Phase 3 trials for psoriasis and Phase 2b for ulcerative colitis, with results expected in 3-9 months.
Protagonist Therapeutics (NASDAQ:PTGX) has appointed Newman Yeilding, M.D. as Chief Scientific Advisor, effective August 1, 2024. Dr. Yeilding, an accomplished physician-scientist with expertise in inflammatory and immunologic diseases, joins from Janssen Pharmaceutical Companies of Johnson & Johnson. He brings 17 years of experience in R&D and commercialization of novel therapeutics in the I&I space.
As Chief Science Advisor, Dr. Yeilding will provide leadership in discovery, pre-clinical, and translational research to maximize the impact of Protagonist's peptide platform. His appointment aligns with the company's goal to expand its pipeline with drug candidates having blockbuster potential, including the oral peptide IL-17 antagonist program.