Welcome to our dedicated page for Protagonist Therapeutics news (Ticker: PTGX), a resource for investors and traders seeking the latest updates and insights on Protagonist Therapeutics stock.
Protagonist Therapeutics, Inc. (NASDAQ: PTGX) is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to discover and develop novel peptide-based drugs. The company's primary focus is on creating first-in-class oral targeted therapies that inhibit biological pathways currently addressed by injectable antibody drugs. This innovative approach aims to treat significant unmet medical needs, particularly in the areas of inflammatory bowel disease (IBD) and other autoimmune diseases.
Protagonist's lead peptide product candidates, PTG-100 and PTG-200, are designed to transform treatment paradigms for conditions such as ulcerative colitis and Crohn's disease. PTG-100, an oral peptide alpha-4-beta-7 integrin antagonist, is in a global Phase 2b clinical trial for moderate-to-severe ulcerative colitis. PTG-200, a first-in-class oral interleukin-23 receptor antagonist, is also progressing through clinical trials.
Another key asset, JNJ-2113 (formerly PN-235), achieved primary and secondary endpoints in the Phase 2b FRONTIER 1 trial for moderate-to-severe plaque psoriasis. This drug is part of an extensive clinical development program, including multiple Phase 3 studies under the ICONIC program. JNJ-2113 is also being evaluated in a Phase 2b ANTHEM-UC study for ulcerative colitis.
Protagonist's pipeline also includes Rusfertide (PTG-300), an injectable hepcidin mimetic currently in Phase 3 development for polycythemia vera. The REVIVE Phase 2 study demonstrated that rusfertide effectively maintains hematocrit control and reduces the need for phlebotomies in patients.
The company has established significant partnerships to further its clinical programs. Notably, Protagonist collaborates with Johnson & Johnson and Takeda Pharmaceuticals to co-develop and co-commercialize its lead candidates, expanding its reach and impact in the biopharmaceutical landscape.
Protagonist continues to drive innovation with its ongoing discovery efforts, aiming to develop additional oral peptides targeting validated biological pathways. With a robust pipeline and strategic collaborations, Protagonist Therapeutics is poised to make substantial contributions to the treatment of autoimmune and hematological diseases.
Protagonist Therapeutics announced its participation in the 7th Annual Evercore ISI HealthCONx Conference scheduled for December 3-5, 2024, in Coral Gables, Florida. Dinesh V. Patel, Ph.D., President and CEO, will engage in a fireside chat on Tuesday, December 3 at 8:45 A.M. ET. The presentation will be accessible via webcast, and the company will also conduct one-on-one meetings during the conference. A replay of the fireside chat will remain available on the company's Investor Relations Events and Presentations webpage for one year after the event.
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 and only targeted oral peptide inhibitor of the IL-23 receptor in clinical development. The study demonstrated that JNJ-2113 is a highly potent and selective peptide that inhibits IL-23 signaling with minimal impact on other pathways.
Key findings include:
- Efficacy in preclinical models of skin inflammation and colitis
- Dose-proportional pharmacokinetics in humans
- Robust inhibition of IL-23 signaling in ex vivo assays
- Well-tolerated in healthy volunteers
JNJ-2113 is currently in Phase 3 trials for psoriasis and a Phase 2b trial for ulcerative colitis, with results expected in the next 3 to 9 months.
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