Latest news with #ProtagonistTherapeutics
USA Today
30-06-2025
- Business
- USA Today
Protagonist Announces Nomination of PN-477, an Oral and Injectable GLP-1R, GIPR, and GCGR Triple Agonist Peptide Development Candidate for Obesity
A novel oral peptide PN-477o with once-daily dosing, high potency and activation of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), and glucagon (GCG) receptors Company will also develop a subcutaneous version, PN-477sc, as a once-weekly injection IND-enabling studies underway, with Phase I study initiation expected in 2Q26 Webcast and conference call to be held today at 4:30 pm ET Protagonist Therapeutics, Inc. ('Protagonist' or the 'Company') today announced the selection of PN-477, a potential best-in-class GLP-1, GIP, GCG receptor triple agonist peptide with oral and subcutaneous routes of administration, as a development candidate for the treatment of obesity. The triple agonist PN-477 is designed to offer the optimal combination of total body weight loss, improved gastrointestinal (GI) tolerability and fat to lean mass ratio, with the dosing convenience of a once-daily oral agent and the added optionality of a once-weekly subcutaneous administration. 'We are very pleased to nominate development candidate PN-477, a promising potential best-in class oral GLP-1, GIP, GCG receptor tri-agonist peptide which has demonstrated optimal absolute and relative activity against all three hormone receptors in preclinical testing,' said Dinesh V. Patel, PhD, President and CEO of Protagonist. 'PN-477 is specifically engineered to be orally stable with attention to the relative balance of potencies against the three receptors to potentially leverage their beneficial effects on weight loss and optimal body composition while mitigating their adverse effects. As with our previous drug candidates and late-stage assets, PN-477 is a testament to the power of our peptide technology platform, including the ability to deliver first- and best-in-class targeted oral and injectable peptide therapeutics.' PN-477 has completed extensive preclinical evaluation including oral and metabolic stability, potency, pharmacokinetics and pharmacodynamics studies, and has demonstrated effects in preclinical models of obesity and glycemic control. PN-477 has shown potent in vitro activity in activating the GLP-1, GIP, and GCG receptors. PN-477 also demonstrated robust preclinical proof-of-concept in various animal studies including the diet induced obesity (DIO) preclinical mouse model, normal dogs, and cynomolgus monkeys. Overall, PN-477 has the right balance of potency, oral and in-vivo stability, and pharmacokinetic properties to enable parallel development both as a once-daily oral (PN-477o) and once-weekly injectable (PN-477sc) treatment options. IND enabling studies of PN-477 are underway and initiation of Phase 1 clinical studies is anticipated in the second quarter of 2026. 'While GLP-1 agonists have dominated the market thus far, there remains a broad opportunity for novel therapeutics with better body weight loss, higher ratio of fat to lean mass loss, tolerability and additional beneficial effects in obesity-related comorbidities. A triple GLP-1, GIP, GCG receptor agonist peptide that offers weight loss on par with the best injectable treatments options, as well as the optionality provided by both oral and injectable routes of administration, would be an important therapeutic breakthrough and represents another potential blockbuster drug opportunity for Protagonist,' added Dr. Patel. 'We look forward to moving PN-477 into first-in human clinical Phase 1 studies in the second quarter of 2026.' Conference Call and Webcast Details The dial-in numbers for Protagonist's investor update on Monday, June 30th at 4:30 pm ET are: US-based Investors: 1-877-407-0752 International Investors: 1-201-389-0912 Conference Call ID: 13754335 The webcast link for the event can be found here: A replay of the presentation will be available on the Company's Investor Relations Events and Presentations webpage following the event. About Protagonist Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA potentially in 2025. Icotrokinra (formerly, JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ('IL-23R') which is licensed to J&J Innovative Medicines ('JNJ'), formerly Janssen Biotech, Inc. Following icotrokinra's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and oral hepcidin. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of PN-477, and the timing of PN-477 clinical development. In some cases, you can identify these statements by forward-looking words such as 'anticipate,' 'believe,' 'may,' 'will,' 'expect,' or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading 'Risk Factors' contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release. Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors cdavis@ +1 212 915 2577 Media Relations Contact Virginia Amann ENTENTE Network of Companies virginiaamann@ +1 833 500 0061 ext. 1 SOURCE: Protagonist Therapeutics View the original press release on ACCESS Newswire
Associated Press
26-06-2025
- Business
- Associated Press
Protagonist Therapeutics to Host Conference Call to Announce an Oral Obesity Development Candidate
Webcast and conference call to be held on Monday, June 30th at 4:30 pm ET, dial in information below NEWARK, CA / ACCESS Newswire / June 26, 2025 / Protagonist Therapeutics, Inc. ('Protagonist' or the 'Company') today announced that the company will host a conference call and webcast to announce its oral obesity development candidate and to share in vitro and pre-clinical proof-of-concept study results. Conference Call and Webcast Details The dial-in numbers for Protagonist's investor update on Monday, June 30th at 4:30 pm ET are: US-based Investors: 1-877-407-0752 International Investors: 1-201-389-0912 Conference Call ID: 13754335 The webcast link for the event can be found here: A replay of the presentation will be available on the Company's Investor Relations Events and Presentations webpage following the event. About Protagonist Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA potentially in 2025. Icotrokinra (formerly, JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ('IL-23R') which is licensed to J&J Innovative Medicines ('JNJ'), formerly Janssen Biotech, Inc. Following icotrokinra's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, oral hepcidin program, and oral obesity program. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 [email protected] Media Contact Virginia Amann, Founder/CEO ENTENTE Network of Companies +1 833 500 0061 ext 1 [email protected] SOURCE: Protagonist Therapeutics press release
Yahoo
25-06-2025
- Business
- Yahoo
Protagonist Therapeutics, Takeda Pharmaceutical Announce Positive Phase 3 Rusfertide Results for Polycythemia Vera
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 . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
22-06-2025
- Business
- Yahoo
Citi Rates Protagonist Therapeutics (PTGX) as Buy Protagonists Drugs Opportunity
Protagonist Therapeutics, Inc. (NASDAQ:PTGX) is one of the 10 biotech stocks screaming a buy. On June 17, Citi initiated coverage of the stock with a 'Buy' rating and a $72 price target. The research firm remains bullish about the company's prospects owing to the strong potential of its drug candidates. A scientist in a lab coat examining a Petri dish containing a biopharmaceutical culture. The company's partnership with Takeda on Rusfertide to treat polycythemia Vera (PV) and oral IL-23 (icotrokinra) is one of the developments that underscore the research firm's favorable rating. Rusfertide demonstrated strong potential in PV patients in phase 3 trials, affirming its potential to address unmet needs. Citi is especially bullish about adding Rusfertide to existing therapies to expand its use case. In addition, the firm echoed the company's strategic partnership with Johnson & Johnson for multiple inflammation indications. According to Citi, Protagonist Therapeutics shares have outperformed over the past three months, going up by a 40% gain compared to a 2% gain of the S&P 500. It expects the company's combined revenues to climb to $700 million by 2032, above consensus estimates of $680 million. Protagonist Therapeutics, Inc. (NASDAQ:PTGX) is a biopharmaceutical company that develops peptide-based drugs to treat various diseases, including rare and prevalent ones. Its pipeline includes treatments for blood disorders like polycythemia Vera and inflammatory conditions like ulcerative colitis and psoriasis. 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: 13 Best Software Stocks to Buy Now and 11 Must-Buy AI Stocks Analysts Are Betting On. Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18-06-2025
- Business
- Yahoo
Citi initiates coverage on biotech amid improving sentiment in sector
-- Citi initiated coverage on small- and mid-cap biotechnology companies on early signs of improving sentiment in a sector weighed down this year by policy uncertainty and weak investor interest. The brokerage launched with Buy ratings on Acumen, Amylyx, Arcellx, NewAmsterdam Pharma, and Protagonist Therapeutics (NASDAQ:PTGX), and a Sell rating on Novavax (NASDAQ:NVAX). It pointed to deep pipelines and catalysts expected in the second half of 2025 as reasons for optimism in selected stocks despite broader sector underperformance. Biotech shares have lagged the broader market, with the SPDR S&P Biotech (NYSE:XBI) ETF down over 9% year-to-date, while the S&P500 has gained nearly 3%. Citi said persistent concerns around U.S. drug pricing policy have weighed on the group but noted signs of "policy fatigue" among investors and a shift back toward company fundamentals. While large-cap biopharma names such as Eli Lilly (NYSE:LLY), Vertex (NASDAQ:VRTX) and Gilead (NASDAQ:GILD) have led recent gains, Citi said small- and mid-cap stocks may begin to benefit if sentiment continues to recover. Recent deal activity and partnerships suggest a pickup in business development interest, and expectations of a U.S. interest rate cut in September could support further momentum, it added. Citi emphasized the potential of U.S.-based biotechs in areas such as immunology, cardiology, oncology, and rare neurological diseases. It cautioned against companies focused on respiratory vaccines, citing seasonality and political risk. Related articles Citi initiates coverage on biotech amid improving sentiment in sector MS starts coverage of at Equal-Weight on balanced risk-reward Caterpillar's E&T segment is likely a core driver to the next EPS cycle: BofA Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
