PTGX

NEWARK, Calif. (AP) — NEWARK, Calif. (AP) — Protagonist Therapeutics Inc. (PTGX) on Tuesday reported first-quarter profit of $3.8 million. The Newark, California-based company said it had profit of 5 cents per share. The results surpassed Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 65 cents per share. The biopharmaceutical company posted revenue of $56.4 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on PTGX at https://www.zacks.com/ap/PTGX

ICOTYDE™ (icotrokinra) approved by FDA in March for moderate-to-severe plaque psoriasis, triggering a $50 million milestone payment; Protagonist receives tiered royalties of 6% to 10% and is eligible for up to $580 million in future milestone payments Rusfertide NDA accepted and granted Priority Review by FDA, with a Prescription Drug User Fee Act target action date in the third quarter of 2026 Protagonist exercised its rusfertide opt-out right under the Takeda collaboration on April 28, triggering a $200 million opt-out fee payable to the Company; eligible for additional $200 million opt-out and $75 million milestone payments upon NDA approval, sales milestones of up to $775 million and worldwide royalties ranging from 14% to 29% PN-881 (oral IL-17 antagonist peptide) Phase 1 study completion by mid-2026 and Phase 2 initiation anticipated by year-end; PN-477sc and PN-477o (sc and oral triple GLP/GIP/GICG agonist) Phase 1 initiation expected in mid-2026 and Q1 2027, respectively Cash, cash equivalents and marketable securities of $620 million as of March 31, 2026, anticipated to provide cash runway through at least 2028 NEWARK, CA / ACCESS Newswire / May 5, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. "The first quarter of 2026 marked a series of landmark achievements for Protagonist, highlighted by the U.S. approval of ICOTYDE, FDA granting Priority Review for rusfertide, and advancement of our highly differentiated and fully-owned peptides PN-881 and PN-477," said Dinesh V. Patel, Ph.D., the Company's President and Chief Executive Officer. "These accomplishments, together with the additional financial resources afforded by our rusfertide opt-out election and future milestones and royalty payments from ICOTYDE and rusfertide, position Protagonist for meaningful near-, medium and long-term value creation through rapid progression of clinical stage assets and further expansion into new internal discovery programs. In addition, we look forward to implementing an efficient capital return strategy at the appropriate time." First Quarter 2026 Recent Developments and Upcoming Milestones Rusfertide On March 2, Takeda and Protagonist announced that the U.S. FDA accepted the New Drug Application for rusfertide and grant...

NEWARK, Calif. (AP) — NEWARK, Calif. (AP) — Protagonist Therapeutics Inc. (PTGX) on Wednesday reported a loss of $44.4 million in its fourth quarter. On a per-share basis, the Newark, California-based company said it had a loss of 69 cents. The results fell short of Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 53 cents per share. The biopharmaceutical company posted revenue of $7.4 million in the period, which also missed Street forecasts. Five analysts surveyed by Zacks expected $13.3 million. For the year, the company reported a loss of $130.1 million, or $2.05 per share. Revenue was reported as $46 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on PTGX at https://www.zacks.com/ap/PTGX

(This release updates the release that posted earlier on February 25, 2026 to update the sub headlines.) NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with potential launch this year PN-881 Phase 1 completion expected by mid-2026 Pre-clinical pipeline expanded with novel wholly-owned candidates PN-477, an oral and s.c. triple GLP-GIP-GCG agonist and PN-458, an oral and s.c. dual GLP-GIP agonist, and PN-8047, an oral hepcidin functional mimetic Cash, cash equivalents and marketable securities of $646 million as of December 31, 2025, anticipated to provide cash runway through at least end of 2028 NEWARK, CA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update. "In 2025, Protagonist reached new heights with multiple successful Phase 3 outcomes and two NDA filings of our partnered assets, ICOTYDE and rusfertide," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "We see the next 12 to 24 months as a period of significant growth and value creation for Protagonist, driven by a combination of the anticipated regulatory and commercial milestones and royalties from ICOTYDE and rusfertide and the continued advancement of our robust R&D pipeline comprised of the oral IL-17 peptide antagonist, our obesity dual and triple agonists, and our oral hepcidin functional mimetic. We are well equipped to fund all our internal wholly owned programs to clinical proof-of-concept with the cash on hand and potential revenue from the partnered assets." Fourth Quarter 2025 Recent Developments and Upcoming Milestones Rusfertide Under the terms of its License and Collaboration Agreement with Takeda Pharmaceuticals USA, Inc., Protagonist has the right to opt out of the 50:50 profit and loss sharing arrangement in the U.S. during the 90-day period beginning 120 days after filing of a New Drug Application with the FDA for Rusfertide for polycythemia vera. We currently expect to exercise that right in the se...

NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with  potential launch this year PN-881 Phase 1 completion expected by mid-2026 NEWARK, CALIFORNIA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a corporate update. "In 2025, Protagonist reached new heights with multiple successful Phase 3 outcomes and two NDA filings of our partnered assets, ICOTYDE and rusfertide," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "We see the next 12 to 24 months as a period of significant growth and value creation for Protagonist, driven by a combination of the anticipated regulatory and commercial milestones and royalties from ICOTYDE and rusfertide and the continued advancement of our robust R&D pipeline comprised of the oral IL-17 peptide antagonist, our obesity dual and triple agonists, and our oral hepcidin functional mimetic. We are well equipped to fund all our internal wholly owned programs to clinical proof-of-concept with the cash on hand and potential revenue from the partnered assets." Fourth Quarter 2025 Recent Developments and Upcoming Milestones Rusfertide Under the terms of its License and Collaboration Agreement with Takeda Pharmaceuticals USA, Inc., Protagonist has the right to opt out of the 50:50 profit and loss sharing arrangement in the U.S. during the 90-day period beginning 120 days after filing of a New Drug Application with the FDA for Rusfertide for polycythemia vera. We currently expect to exercise that right in the second quarter of 2026. ICOTYDETM (Icotrokinra) A U.S. regulatory decision is anticipated in 2026, followed by commercial launch this year, if FDA approval is granted. Primary endpoint enrollment completion is expected in 2026 for: The Phase 3 ICONIC-ASCEND multicenter, randomized, double-blind, placebo-controlled, and ustekinumab active comparator-controlled study to evaluate the efficacy and safety of icotrokinra for the treatment of participants with moderat...

Image source: The Motley Fool. Wednesday, March 10, 2021 at 10:12 p.m. ET Chief Executive Officer — Dinesh Patel Chief Medical Officer — Samuel Saks Chief Scientific Officer — David Liu Chief Development Officer — Suneel Gupta Chief Financial Officer — Don Kalkofen Need a quote from a Motley Fool analyst? Email [email protected] Dinesh Patel: Thank you, Tom. Good afternoon, everyone and thank you all for joining our conference call to discuss Protagonist Therapeutics’ financial results and corporate highlights for the fourth quarter and full year 2020. Don and I are joined on today’s call by Samuel Saks, our Chief Medical Officer; David Liu, our Chief Scientific Officer; and Suneel Gupta, Chief Development Officer. 2020 was an exceptional and transformative year for Protagonist during which we expanded our clinical pipeline and we now have five different new chemical entities or NCEs that are being advanced in six different clinical studies. And all of these studies are expected to be completed over the next 2 years. As many of you know, each of our clinical assets has been developed through our proprietary technology platform. And currently, we are developing novel therapeutic options across three distinct disease categories: one, various blood disorders influenced by excessive red blood cell production that is accessing erythrocytosis or by excessive iron overload conditions; two, inflammatory bowel disease, or IBD, such as Crohn’s disease and ulcerative colitis; and three, various inflammatory and autoimmune diseases that have already been clinically validated by the interleukin-23 or IL-23 pathway. I would like to start today’s call by reviewing rusfertide previously known as PTG-300. As a reminder, rusfertide is a peptide mimetic of the natural hormone hepcidin, which is a key regulator of iron homeostasis, as it controls the absorption, storage and distribution of iron in the body. Rusfertide was developed to have superior drug like properties, including its potency, half-life solubility, stability and ease of synthesis in comparison to the natural hormone. Our most advanced clinical program with this candidate is in patients with polycythemia vera, also known as PV, a rare and progressive blood disorder affecting about 160,000 patients in the United States alone. In May of 2020, we presented a very small, but robust dataset for 7 patients from our ongoing P...

NEWARK, Calif. (AP) — NEWARK, Calif. (AP) — Protagonist Therapeutics Inc. (PTGX) on Thursday reported a loss of $39.3 million in its third quarter. On a per-share basis, the Newark, California-based company said it had a loss of 62 cents. The results did not meet Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 59 cents per share. The biopharmaceutical company posted revenue of $4.7 million in the period, also missing Street forecasts. Three analysts surveyed by Zacks expected $10 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on PTGX at https://www.zacks.com/ap/PTGX

Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to the U.S. FDA in July, the European Medicines Agency (EMA) application was submitted in September Rusfertide granted breakthrough designation for patients in Polycythemia Vera (PV) and the subject of four presentations including 52-week results of the VERIFY Phase 3 Study at ASH, the 67th Annual American Society of Hematology (ASH) meeting in December First patient dosed in the Phase 1 trial of PN-881, a first-in-class oral IL-17 peptide antagonist IND-enabling studies progressing as planned with triple-GLP/GIP/GCG agonists PN-477sc and PN-477o Oral hepcidin development candidate expected to be nominated by year end Cash, cash equivalents and marketable securities of $678.8 million as of September 30, 2025, anticipated to provide cash runway through at least end of 2028 NEWARK, CA / ACCESS Newswire / November 6, 2025 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update. "2025 continues to be a highly productive year with significant accomplishments in both partnered and wholly owned programs," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "In addition to the NDA and EMA submissions for icotrokinra for psoriasis, we are pleased to see our partner Johnson and Johnson expand the ICONIC program into additional IL-23 pathway relevant and validated I&I indications, namely psoriatic arthritis, ulcerative colitis, and Crohn's disease. We, along with our partner Takeda, eagerly await the presentation of the rusfertide 52-week VERIFY data at ASH in December and the NDA filing for rusfertide by year end." "As icotrokinra and rusfertide move towards potential NDA approval and commercialization in 2026, we shift our attention to the next phase of assets emerging from our validated discovery and development platform. We are pleased to report that the first subject in the Phase 1 trial of oral IL-17 antagonist, PN-881, is dosed. Additionally, the oral and subcutaneous triple GLP/GIP/GCG agonists, PN-477o and PN-477sc, are progressing through IND-enabling studies as planned, and we remain on track to nominate a development candidate from the oral hepcidin program by year end. I am very proud of the consis...

Protagonist Therapeutics (PTGX) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biopharmaceutical company is expected to post quarterly loss of $0.59 per share in its upcoming report, which represents a year-over-year change of -9.3%. Revenues are expected to be $10 million, up 113.7% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 3.31% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ES...

NDA for icotrokinra for the treatment of adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO) submitted to U.S. FDA in July ANTHEM Phase 2b trial data of icotrokinra in ulcerative colitis scheduled for an oral presentation at the 33rd United European Gastroenterology Week (UEGW) on October 7th Phase 3 VERIFY trial data set of rusfertide in polycythemia vera (PV) presented during plenary session at ASCO; U.S. NDA filing on track for Q4 Cash, cash equivalents and marketable securities of $673.0 million as of June 30, 2025, anticipated to provide cash runway through at least end of 2028 NEWARK, CA / ACCESS Newswire / August 6, 2025 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the second quarter ended June 30, 2025, and provided a corporate update. "Thus far, 2025 has been a year of breakthrough accomplishments for Protagonist, as we saw rusfertide the topic of the prestigious ASCO Plenary Session in May, the announcement of an oral and injectable triple agonist anti-obesity peptide development candidate in June, and most recently the first ever NDA filing of icotrokinra for psoriasis last month," said Dinesh V. Patel, Ph.D., the Company's President and CEO. "Over the coming months, we look forward to the NDA filing of rusfertide for polycythemia vera, and advancing our wholly owned early-stage assets PN-881 and PN-477 into clinical and IND-enabling studies respectively." Second Quarter 2025 Recent Developments and Upcoming Milestones Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders The full data set from the positive Phase 3 VERIFY trial of rusfertide in PV was presented during the prestigious plenary session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, June 1st. The Company hosted an investor conference call on Monday, June 2nd discussing data shared during the plenary presentation. A replay of the call and accompanying presentation is available on the Company's Investor Relations Events and Presentations webpage here. Rusfertide U.S. NDA filing for treatment of patients with PV, by partner Takeda Pharmaceuticals, expected in Q4 of this year. Icotrokinra (JNJ-2113): Oral IL-23 Receptor Antagonist On July 21st, the Company and its partner Johnson and Johnson an...

NEWARK, Calif. (AP) — NEWARK, Calif. (AP) — Protagonist Therapeutics Inc. (PTGX) on Wednesday reported a loss of $34.8 million in its second quarter. The Newark, California-based company said it had a loss of 55 cents per share. The results did not meet Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 53 cents per share. The biopharmaceutical company posted revenue of $5.5 million in the period, which also did not meet Street forecasts. Three analysts surveyed by Zacks expected $10.4 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on PTGX at https://www.zacks.com/ap/PTGX

Protagonist Therapeutics Inc. (NASDAQ:PTGX) is one of the best mid cap growth stocks to invest in now. Just as June began, Protagonist Therapeutics and Takeda Pharmaceutical Company Limited (NYSE:TAK) announced the full 32-week results from their Phase 3 VERIFY study of rusfertide in patients with polycythemia vera/PV. The detailed results were presented as a late-breaking oral presentation/LBA3 at the 61st ASCO Annual Meeting Plenary Session on June 1. The study successfully met its primary endpoint and all key secondary endpoints. PV is a blood disorder characterized by the overproduction of red blood cells, which can lead to increased blood viscosity and potentially life-threatening thrombotic events like stroke, deep vein thrombosis, and pulmonary embolism. Patients often experience debilitating symptoms such as severe fatigue, difficulty concentrating, night sweats, and pruritus. A research scientist wearing a lab coat working with precision in a biopharmaceutical laboratory. The primary treatment goal in PV is to achieve and maintain controlled hematocrit levels below 45% to prevent thrombotic events and alleviate symptoms. However, many patients struggle to achieve adequate control with the current standard of care treatments. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic that aims to regulate iron homeostasis and red blood cell production to control hematocrit levels in PV patients. Protagonist Therapeutics Inc. (NASDAQ:PTGX) is a biopharmaceutical company that develops peptide therapeutics for hematology & blood disorders, and inflammatory & immunomodulatory diseases. Takeda Pharmaceutical Company Limited (NYSE:TAK) researches, develops, manufactures, markets, and out-licenses pharmaceutical products in Japan and internationally. While we acknowledge the potential of PTGX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey.