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StreetInsider.com News Articles http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Mon, 02 Mar 2026 06:09:00 -0500 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif StreetInsider.com News Articles http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday Form 6-K TAKEDA PHARMACEUTICAL For: Mar 02 http://www.streetinsider.com/SEC+Filings/Form++6-K++++++++TAKEDA+PHARMACEUTICAL+++++For%3A+Mar+02/26086292.html si-local-file:///var/storage/secattach/20260302/26086292.html http://www.streetinsider.com/SEC+Filings/Form++6-K++++++++TAKEDA+PHARMACEUTICAL+++++For%3A+Mar+02/26086292.html Mon, 02 Mar 2026 06:09:00 -0500 4502 O.05065998 TAK Form 6-K TAKEDA PHARMACEUTICAL For: Mar 02 http://www.streetinsider.com/SEC+Filings/Form++6-K++++++++TAKEDA+PHARMACEUTICAL+++++For%3A+Mar+02/26086292.html si-local-file:///var/storage/secattach/20260302/26086292.html http://www.streetinsider.com/SEC+Filings/Form++6-K++++++++TAKEDA+PHARMACEUTICAL+++++For%3A+Mar+02/26086292.html Mon, 02 Mar 2026 06:09:00 -0500 4502 O.05065998 TAK Form 6-K TAKEDA PHARMACEUTICAL For: Mar 02 http://www.streetinsider.com/SEC+Filings/Form++6-K++++++++TAKEDA+PHARMACEUTICAL+++++For%3A+Mar+02/26086292.html si-local-file:///var/storage/secattach/20260302/26086292.html http://www.streetinsider.com/SEC+Filings/Form++6-K++++++++TAKEDA+PHARMACEUTICAL+++++For%3A+Mar+02/26086292.html Mon, 02 Mar 2026 06:09:00 -0500 4502 O.05065998 TAK FDA accepts rusfertide application with priority review for blood disorder http://www.streetinsider.com/Corporate+News/FDA+accepts+rusfertide+application+with+priority+review+for+blood+disorder/26085680.html <p>The U.S. Food and Drug Administration has accepted the new drug application for rusfertide, an investigational treatment for polycythemia vera, and granted it priority review status. Takeda (NYSE:TAK) and Protagonist Therapeutics (NASDAQ:PTGX) announced the FDA set a target action date in the third quarter of this year under the Prescription Drug User Fee Act.</p><p>Rusfertide is designed as a first-in-class hepcidin mimetic peptide for treating adults with polycythemia vera, a blood disorder characterized by overproduction of red blood cells that can lead to life-threatening blood clots. The drug has previously received breakthrough therapy, orphan drug and fast track designations from the http://www.streetinsider.com/Corporate+News/FDA+accepts+rusfertide+application+with+priority+review+for+blood+disorder/26085680.html Mon, 02 Mar 2026 06:01:00 -0500 PTGX TAK FDA accepts rusfertide application with priority review for blood disorder http://www.streetinsider.com/Corporate+News/FDA+accepts+rusfertide+application+with+priority+review+for+blood+disorder/26085680.html <p>The U.S. Food and Drug Administration has accepted the new drug application for rusfertide, an investigational treatment for polycythemia vera, and granted it priority review status. Takeda (NYSE:TAK) and Protagonist Therapeutics (NASDAQ:PTGX) announced the FDA set a target action date in the third quarter of this year under the Prescription Drug User Fee Act.</p><p>Rusfertide is designed as a first-in-class hepcidin mimetic peptide for treating adults with polycythemia vera, a blood disorder characterized by overproduction of red blood cells that can lead to life-threatening blood clots. The drug has previously received breakthrough therapy, orphan drug and fast track designations from the http://www.streetinsider.com/Corporate+News/FDA+accepts+rusfertide+application+with+priority+review+for+blood+disorder/26085680.html Mon, 02 Mar 2026 06:01:00 -0500 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Press+Releases/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html <ul class="bwlistdisc"> <li> <b><i>Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study</i></b> </li> <li> <b><i>Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies</i></b> </li> <li> <b><i>Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year</i></b> </li> </ul> <p> OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=1&md5=b4e70436bf1421005fd02220f838362c" shape="rect">TSE:4502/NYSE:TAK</a>) and Protagonist Therapeutics, Inc. (“Protagonist”) (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.protagonist-inc.com%2F&esheet=54436160&newsitemid=20260301580219&lan=en-US&anchor=NASDAQ%3APTGX&index=2&md5=118d979df77be64363f3689d569513d7" shape="rect">NASDAQ:PTGX</a>) http://www.streetinsider.com/Business+Wire/Takeda+and+Protagonist+Announce+U.S.+Food+and+Drug+Administration+Accepts+New+Drug+Application+and+Grants+Priority+Review+for+Rusfertide+as+a+Potential+First-in-Class+Therapy+for+Polycythemia+Vera/26085231.html Mon, 02 Mar 2026 02:00:00 -0500 4502 4502 A.06822034 A.13262510 A.33519386 A.50213784 O.00635368 O.00987337 O.05065998 O.05887791 O.07203885 O.08407916 O.20026344 PTGX TAK