PTGX - Earnings announcements

Rusfertide plus current standard of care more than doubled clinical response rates across high- and low-risk PV groups, significantly reducing phlebotomy eligibility compared to placebo plus current standard of care, which was the primary endpoint All key secondary endpoints met with statistical significance, including a nearly three-fold reduction in the proportion of patients requiring phlebotomy and a four-fold improvement in hematocrit control in rusfertide arm compared to placebo arm, as well as improvements in patient-reported outcomes No serious adverse events considered related to rusfertide were reported Rusfertide has received Orphan Drug designation and Fast Track desig

− Study met the primary endpoint, with a significantly higher proportion of clinical responders on rusfertide compared to placebo − All four key secondary endpoints were met, including EU primary endpoint and patient-reported outcomes − Rusfertide was generally well tolerated; no new safety findings were observed in the study Protagonist Therapeutics, Inc. ("Protagonist") ((PTGX) and Takeda ((TAK) today announced positive topline results for the Phase 3 VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV) were randomized to treatment with either rusfertide or placebo, as an add-on to standard of care treatment. The study met its primary endpoint and all fou

Oral peptide with biologics-like high potency and spectrum of activity against three therapeutically relevant dimeric forms of IL-17 (AA, AF and FF)IND enabling studies underway, with Phase I initiation expected in Q425Webcast and conference call to be held today at 4:30 pm ET NEWARK, CA / ACCESSWIRE / November 21, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced the selection of PN-881, a potential best-in-class oral peptide interleukin-17 (IL-17) antagonist, as a development candidate for the treatment of immune-mediated skin diseases."We are extremely pleased to nominate development candidate PN-881, a promising potential best-in-class oral peptide IL

Webcast and conference call to be held be on Thursday, November 21st at 4:30 pm ET, dial in information belowNEWARK, CA / ACCESSWIRE / November 19, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced that the company will host a conference call and webcast to announce its oral peptide IL-17 antagonist development candidate and to share in vitro and pre-clinical proof-of-concept study results.Conference Call and Webcast DetailsThe dial-in numbers for Protagonist's investor update on Thursday, November 21st at 4:30 pm ET are:US-based Investors: 1-877-407-0752International Investors: 1-201-389-0912Conference Call ID: 13750274The webcast link for the event can

Takeda Will Be Protagonist's Co-Development, U.S. Co-Commercialization Partner With 50:50 Profit Share, and With Exclusive Ex-U.S. Global Rights to Commercialize Rusfertide, Protagonist's Investigational Injectable Hepcidin Mimetic Currently in Development for the Treatment of Polycythemia Vera (PV)Takeda Will Make an Upfront Payment of $300 Million at ClosingPartnership Combines Protagonist's Leadership in Pharmaceutical Peptide Drug Development With Takeda's Commercial Expertise and 70-Plus Year Legacy of Driving Innovation Within the Rare Hematology CommunityProtagonist to Host Conference Call and Webcast Today at 4:30 PM ETOSAKA, JAPAN, CAMBRIDGE, MA, and NEWARK, CA / ACCESSWIRE / Januar

PN-943 achieved 27.5% clinical remission with a delta of 13% versus placebo, with strong concordance across all key proxies including histological and endoscopic endpoints for efficacy, in the twice daily 150 mg dose arm Achieved clinical proof-of-concept and validation for oral, gut-restricted approach for ulcerative colitis via blockade of the alpha-4-beta-7-integrin pathway  Plans underway for a registrational Phase 3 study anchored around twice daily 150 mg dose of PN-943, pending regulatory guidance Protagonist to host a conference call today at 6:00 p.m. ET NEWARK, Calif., April 25, 2022 /PRNewswire/ -- Protagonist Therapeutics (NASDAQ:PTGX) today announced topline results from the P

NEWARK, Calif., Oct. 11, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today announced that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on the Company's rusfertide clinical studies, announced on September 17, 2021. Per the FDA, dosing in all clinical studies of rusfertide may be resumed. The Company provided the FDA with all requested information as the basis for a Complete Response and subsequent removal of the clinical hold. In particular, the Company provided the requested individual patient clinical safety reports, updated the investigator brochure and patient informed consent forms, performed a comp

NEWARK, Calif., July 28, 2021 /PRNewswire/ -- Protagonist Therapeutics, Inc. (NASDAQ:PTGX) ("Protagonist" or "the Company") today announced its entry into an amended collaboration agreement (the "Restated Agreement") with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, relating to research, development, manufacture and commercialization of multiple oral Interleukin (IL)-23 receptor antagonist drug candidates. The compounds currently in development are PTG-200, an oral IL-23 receptor antagonist in Phase 2 development for the treatment of Crohn's disease (CD), and PN-232 and PN-235, two second-generation oral IL-23 receptor antagonist candidates. PN-232

NEWARK, Calif., Dec. 2, 2020 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq:PTGX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PTG-300 in the treatment of polycythemia vera, a rare disease characterized by the excessive production of red blood cells. PTG-300 is an injectable synthetic peptide mimetic of the natural hormone hepcidin that has demonstrated the ability to dramatically decrease the requirement for phlebotomy in an ongoing Phase 2 study in polycythemia vera patients. PTG-300 has previously received orphan drug designation for the treatment of polycythemia vera from the U.S. FDA. "Fast Track designation reflects t