http://new.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Fri, 28 Aug 2026 18:40:17 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://new.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html <p>Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) has received U.S. Food and Drug Administration approval for Mimrylo (rusfertide), a treatment for erythrocytosis in adults with polycythemia vera (PV), a blood cancer affecting approximately 90,000 people in the U.S.</p> <p>Mimrylo is described as a first-in-class hepcidin mimetic, administered once weekly via subcutaneous injection. It is designed to regulate iron distribution and reduce red blood cell overproduction to help maintain hematocrit levels below 45%, which is the primary treatment goal in PV. Protagonist originally discovered and developed the drug through Phase 3; Takeda holds exclusive global development and commercialization rights.</p> <p>The approval was supported http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html Fri, 28 Aug 2026 18:40:17 -0400 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html <p>Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) has received U.S. Food and Drug Administration approval for Mimrylo (rusfertide), a treatment for erythrocytosis in adults with polycythemia vera (PV), a blood cancer affecting approximately 90,000 people in the U.S.</p> <p>Mimrylo is described as a first-in-class hepcidin mimetic, administered once weekly via subcutaneous injection. It is designed to regulate iron distribution and reduce red blood cell overproduction to help maintain hematocrit levels below 45%, which is the primary treatment goal in PV. Protagonist originally discovered and developed the drug through Phase 3; Takeda holds exclusive global development and commercialization rights.</p> <p>The approval was supported http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html Fri, 28 Aug 2026 18:40:17 -0400 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html <p>Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) has received U.S. Food and Drug Administration approval for Mimrylo (rusfertide), a treatment for erythrocytosis in adults with polycythemia vera (PV), a blood cancer affecting approximately 90,000 people in the U.S.</p> <p>Mimrylo is described as a first-in-class hepcidin mimetic, administered once weekly via subcutaneous injection. It is designed to regulate iron distribution and reduce red blood cell overproduction to help maintain hematocrit levels below 45%, which is the primary treatment goal in PV. Protagonist originally discovered and developed the drug through Phase 3; Takeda holds exclusive global development and commercialization rights.</p> <p>The approval was supported http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html Fri, 28 Aug 2026 18:40:17 -0400 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html <p>Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) has received U.S. Food and Drug Administration approval for Mimrylo (rusfertide), a treatment for erythrocytosis in adults with polycythemia vera (PV), a blood cancer affecting approximately 90,000 people in the U.S.</p> <p>Mimrylo is described as a first-in-class hepcidin mimetic, administered once weekly via subcutaneous injection. It is designed to regulate iron distribution and reduce red blood cell overproduction to help maintain hematocrit levels below 45%, which is the primary treatment goal in PV. Protagonist originally discovered and developed the drug through Phase 3; Takeda holds exclusive global development and commercialization rights.</p> <p>The approval was supported http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html Fri, 28 Aug 2026 18:40:17 -0400 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html <p>Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) has received U.S. Food and Drug Administration approval for Mimrylo (rusfertide), a treatment for erythrocytosis in adults with polycythemia vera (PV), a blood cancer affecting approximately 90,000 people in the U.S.</p> <p>Mimrylo is described as a first-in-class hepcidin mimetic, administered once weekly via subcutaneous injection. It is designed to regulate iron distribution and reduce red blood cell overproduction to help maintain hematocrit levels below 45%, which is the primary treatment goal in PV. Protagonist originally discovered and developed the drug through Phase 3; Takeda holds exclusive global development and commercialization rights.</p> <p>The approval was supported http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html Fri, 28 Aug 2026 18:40:17 -0400 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html <p>Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) has received U.S. Food and Drug Administration approval for Mimrylo (rusfertide), a treatment for erythrocytosis in adults with polycythemia vera (PV), a blood cancer affecting approximately 90,000 people in the U.S.</p> <p>Mimrylo is described as a first-in-class hepcidin mimetic, administered once weekly via subcutaneous injection. It is designed to regulate iron distribution and reduce red blood cell overproduction to help maintain hematocrit levels below 45%, which is the primary treatment goal in PV. Protagonist originally discovered and developed the drug through Phase 3; Takeda holds exclusive global development and commercialization rights.</p> <p>The approval was supported http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html Fri, 28 Aug 2026 18:40:17 -0400 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html <p>Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) has received U.S. Food and Drug Administration approval for Mimrylo (rusfertide), a treatment for erythrocytosis in adults with polycythemia vera (PV), a blood cancer affecting approximately 90,000 people in the U.S.</p> <p>Mimrylo is described as a first-in-class hepcidin mimetic, administered once weekly via subcutaneous injection. It is designed to regulate iron distribution and reduce red blood cell overproduction to help maintain hematocrit levels below 45%, which is the primary treatment goal in PV. Protagonist originally discovered and developed the drug through Phase 3; Takeda holds exclusive global development and commercialization rights.</p> <p>The approval was supported http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html Fri, 28 Aug 2026 18:40:17 -0400 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html <p>Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) has received U.S. Food and Drug Administration approval for Mimrylo (rusfertide), a treatment for erythrocytosis in adults with polycythemia vera (PV), a blood cancer affecting approximately 90,000 people in the U.S.</p> <p>Mimrylo is described as a first-in-class hepcidin mimetic, administered once weekly via subcutaneous injection. It is designed to regulate iron distribution and reduce red blood cell overproduction to help maintain hematocrit levels below 45%, which is the primary treatment goal in PV. Protagonist originally discovered and developed the drug through Phase 3; Takeda holds exclusive global development and commercialization rights.</p> <p>The approval was supported http://www.streetinsider.com/FDA/FDA+approves+Takeda%27s+Mimrylo+for+rare+blood+cancer+polycythemia+vera/26999305.html Fri, 28 Aug 2026 18:40:17 -0400 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Press+Releases/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html <ul class="bwlistdisc"> <li> <b><i>MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)</i></b> </li> <li> <b><i>MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue</i></b> </li> <li> <b><i>Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32</i></b> </li> </ul> <p> OSAKA, Japan &amp; CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (<a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2Foverview%2F&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=TSE%3A4502%2FNYSE%3ATAK&amp;index=1&amp;md5=49212a5fd1e3ab4e4efa55068fb4c23b" shape="rect">TSE:4502/NYSE:TAK</a>)<b> </b>announced <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder&amp;esheet=54593875&amp;newsitemid=20260824773270&amp;lan=en-US&amp;anchor=U.S.+Food+and+Drug+Administration+%28FDA%29+approval&amp;index=2&amp;md5=2473e553a61c44e1adf5f561299c5cd7" shape="rect">U.S. Food and Drug Administration (FDA) approval</a> of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment http://www.streetinsider.com/Business+Wire/Takeda+Receives+U.S.+FDA+Approval+of+MIMRYLO%E2%84%A2+%28rusfertide%29%2C+Marking+a+Potential+Shift+in+the+Treatment+Paradigm+for+Polycythemia+Vera/26999302.html Fri, 28 Aug 2026 18:40:00 -0400 4502 4502 A.06822034 A.33519386 O.00987337 O.05065998 O.05887791 O.20026344 TAK