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, 01 Jun 2026 05:00:27 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/Corporate+News/Agios+licenses+blood+disorder+drug+from+Oscotec+for+%2425+million+upfront/26578031.html <p>Agios Pharmaceuticals Inc. (NASDAQ: AGIO) announced an exclusive global licensing agreement with South Korea-based Oscotec to develop and commercialize cevidoplenib, an oral drug candidate for treating immune thrombocytopenia, a rare blood disorder.</p> <p>Under the agreement, Agios will pay Oscotec $25 million upfront and up to $140 million in development and regulatory milestones across three indications in the U.S. and Europe. Oscotec will also receive commercial milestone payments and royalties ranging from high single digit to mid-teen percentages on future net sales.</p> <p>Cevidoplenib is a spleen tyrosine kinase inhibitor designed to prevent the destruction of platelets in patients with immune thrombocytopenia. The condition http://www.streetinsider.com/Corporate+News/Agios+licenses+blood+disorder+drug+from+Oscotec+for+%2425+million+upfront/26578031.html Mon, 01 Jun 2026 05:00:27 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Corporate+News/Agios+licenses+blood+disorder+drug+from+Oscotec+for+%2425+million+upfront/26578031.html <p>Agios Pharmaceuticals Inc. (NASDAQ: AGIO) announced an exclusive global licensing agreement with South Korea-based Oscotec to develop and commercialize cevidoplenib, an oral drug candidate for treating immune thrombocytopenia, a rare blood disorder.</p> <p>Under the agreement, Agios will pay Oscotec $25 million upfront and up to $140 million in development and regulatory milestones across three indications in the U.S. and Europe. Oscotec will also receive commercial milestone payments and royalties ranging from high single digit to mid-teen percentages on future net sales.</p> <p>Cevidoplenib is a spleen tyrosine kinase inhibitor designed to prevent the destruction of platelets in patients with immune thrombocytopenia. The condition http://www.streetinsider.com/Corporate+News/Agios+licenses+blood+disorder+drug+from+Oscotec+for+%2425+million+upfront/26578031.html Mon, 01 Jun 2026 05:00:27 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Corporate+News/Agios+licenses+blood+disorder+drug+from+Oscotec+for+%2425+million+upfront/26578031.html <p>Agios Pharmaceuticals Inc. (NASDAQ: AGIO) announced an exclusive global licensing agreement with South Korea-based Oscotec to develop and commercialize cevidoplenib, an oral drug candidate for treating immune thrombocytopenia, a rare blood disorder.</p> <p>Under the agreement, Agios will pay Oscotec $25 million upfront and up to $140 million in development and regulatory milestones across three indications in the U.S. and Europe. Oscotec will also receive commercial milestone payments and royalties ranging from high single digit to mid-teen percentages on future net sales.</p> <p>Cevidoplenib is a spleen tyrosine kinase inhibitor designed to prevent the destruction of platelets in patients with immune thrombocytopenia. The condition http://www.streetinsider.com/Corporate+News/Agios+licenses+blood+disorder+drug+from+Oscotec+for+%2425+million+upfront/26578031.html Mon, 01 Jun 2026 05:00:27 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Corporate+News/Agios+licenses+blood+disorder+drug+from+Oscotec+for+%2425+million+upfront/26578031.html <p>Agios Pharmaceuticals Inc. (NASDAQ: AGIO) announced an exclusive global licensing agreement with South Korea-based Oscotec to develop and commercialize cevidoplenib, an oral drug candidate for treating immune thrombocytopenia, a rare blood disorder.</p> <p>Under the agreement, Agios will pay Oscotec $25 million upfront and up to $140 million in development and regulatory milestones across three indications in the U.S. and Europe. Oscotec will also receive commercial milestone payments and royalties ranging from high single digit to mid-teen percentages on future net sales.</p> <p>Cevidoplenib is a spleen tyrosine kinase inhibitor designed to prevent the destruction of platelets in patients with immune thrombocytopenia. The condition http://www.streetinsider.com/Corporate+News/Agios+licenses+blood+disorder+drug+from+Oscotec+for+%2425+million+upfront/26578031.html Mon, 01 Jun 2026 05:00:27 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html <ul type="disc"><li>Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor <br/><br/></li><li>Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potential<br/><br/></li><li>Oscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net sales<br/><br/></li><li>Agios will host investor conference call and webcast today at 8:00 a.m. ET<br/><br/></li></ul> <p>CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced http://www.streetinsider.com/Press+Releases/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html Mon, 01 Jun 2026 05:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html <ul type="disc"><li>Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor <br/><br/></li><li>Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potential<br/><br/></li><li>Oscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net sales<br/><br/></li><li>Agios will host investor conference call and webcast today at 8:00 a.m. ET<br/><br/></li></ul> <p>CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced http://www.streetinsider.com/Press+Releases/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html Mon, 01 Jun 2026 05:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html <ul type="disc"><li>Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor <br/><br/></li><li>Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potential<br/><br/></li><li>Oscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net sales<br/><br/></li><li>Agios will host investor conference call and webcast today at 8:00 a.m. ET<br/><br/></li></ul> <p>CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced http://www.streetinsider.com/Press+Releases/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html Mon, 01 Jun 2026 05:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html <ul type="disc"><li>Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor <br/><br/></li><li>Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potential<br/><br/></li><li>Oscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net sales<br/><br/></li><li>Agios will host investor conference call and webcast today at 8:00 a.m. ET<br/><br/></li></ul> <p>CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced http://www.streetinsider.com/Press+Releases/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html Mon, 01 Jun 2026 05:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Globe+Newswire/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html <ul type="disc"><li>Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor <br/><br/></li><li>Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potential<br/><br/></li><li>Oscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net sales<br/><br/></li><li>Agios will host investor conference call and webcast today at 8:00 a.m. ET<br/><br/></li></ul> <p>CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced http://www.streetinsider.com/Globe+Newswire/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html Mon, 01 Jun 2026 05:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Globe+Newswire/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html <ul type="disc"><li>Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor <br/><br/></li><li>Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potential<br/><br/></li><li>Oscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net sales<br/><br/></li><li>Agios will host investor conference call and webcast today at 8:00 a.m. ET<br/><br/></li></ul> <p>CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced http://www.streetinsider.com/Globe+Newswire/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html Mon, 01 Jun 2026 05:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Globe+Newswire/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html <ul type="disc"><li>Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor <br/><br/></li><li>Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potential<br/><br/></li><li>Oscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net sales<br/><br/></li><li>Agios will host investor conference call and webcast today at 8:00 a.m. ET<br/><br/></li></ul> <p>CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced http://www.streetinsider.com/Globe+Newswire/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html Mon, 01 Jun 2026 05:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Globe+Newswire/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html <ul type="disc"><li>Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor <br/><br/></li><li>Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1 billion in peak U.S. sales potential<br/><br/></li><li>Oscotec will receive $25.0 million upfront, with future payments tied to development, regulatory, and commercial milestones, as well as tiered royalties on future net sales<br/><br/></li><li>Agios will host investor conference call and webcast today at 8:00 a.m. ET<br/><br/></li></ul> <p>CAMBRIDGE, Mass., June 01, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced http://www.streetinsider.com/Globe+Newswire/Agios+Enters+Exclusive+Global+License+Agreement+with+Oscotec+to+Develop+and+Commercialize+Next-Generation+SYK+Inhibitor+Cevidoplenib/26578030.html Mon, 01 Jun 2026 05:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Analyst+PT+Change/Agios+Pharma+%28AGIO%29+PT+Lowered+to+%2459+at+Leerink/26572312.html <p>Leerink analyst Andrew Berens lowered the price target on Agios Pharma (NASDAQ: AGIO) to $59.00 (from $60.00) while maintaining a Outperform rating.</p> http://www.streetinsider.com/Analyst+PT+Change/Agios+Pharma+%28AGIO%29+PT+Lowered+to+%2459+at+Leerink/26572312.html Fri, 29 May 2026 10:42:08 -0400 AGIO http://www.streetinsider.com/FDA/Agios+halts+tebapivat+development+for+blood+cancer+indication/26570694.html <p>Agios Pharmaceuticals Inc (NASDAQ: AGIO) announced it will discontinue development of tebapivat for lower-risk myelodysplastic syndromes after the drug failed to meet predefined efficacy thresholds in a Phase 2b trial.</p> <p>The 24-week study evaluated three dose levels of the oral pyruvate kinase activator in 65 patients with lower-risk myelodysplastic syndromes and anemia. The primary endpoint was transfusion independence, defined as eight consecutive weeks without transfusion during the treatment period.</p> <p>While tebapivat showed evidence of biological activity, clinical benefit was not observed in sufficient patients to warrant continued development for this indication, according to the company's statement. The drug was well tolerated across http://www.streetinsider.com/FDA/Agios+halts+tebapivat+development+for+blood+cancer+indication/26570694.html Fri, 29 May 2026 07:00:40 -0400 AGIO O.07489851 http://www.streetinsider.com/FDA/Agios+halts+tebapivat+development+for+blood+cancer+indication/26570694.html <p>Agios Pharmaceuticals Inc (NASDAQ: AGIO) announced it will discontinue development of tebapivat for lower-risk myelodysplastic syndromes after the drug failed to meet predefined efficacy thresholds in a Phase 2b trial.</p> <p>The 24-week study evaluated three dose levels of the oral pyruvate kinase activator in 65 patients with lower-risk myelodysplastic syndromes and anemia. The primary endpoint was transfusion independence, defined as eight consecutive weeks without transfusion during the treatment period.</p> <p>While tebapivat showed evidence of biological activity, clinical benefit was not observed in sufficient patients to warrant continued development for this indication, according to the company's statement. The drug was well tolerated across http://www.streetinsider.com/FDA/Agios+halts+tebapivat+development+for+blood+cancer+indication/26570694.html Fri, 29 May 2026 07:00:40 -0400 AGIO O.07489851 http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2b+Trial+of+Tebapivat+in+Lower-Risk+Myelodysplastic+Syndromes/26570682.html <ul type="disc"><li>Results did not meet predefined threshold to support further development in LR-MDS<br/></li><li>Tebapivat was well tolerated, with no new safety signals observed</li></ul> <p>CAMBRIDGE, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that it will not advance tebapivat, a next-generation oral pyruvate kinase (PK) activator, in lower-risk myelodysplastic syndromes (LR-MDS). This decision follows results from its Phase 2b trial that did not meet the company’s predefined threshold to support further development in this indication.</p> <p>The open-label, multicenter, http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2b+Trial+of+Tebapivat+in+Lower-Risk+Myelodysplastic+Syndromes/26570682.html Fri, 29 May 2026 07:00:00 -0400 AGIO O.07489851 http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2b+Trial+of+Tebapivat+in+Lower-Risk+Myelodysplastic+Syndromes/26570682.html <ul type="disc"><li>Results did not meet predefined threshold to support further development in LR-MDS<br/></li><li>Tebapivat was well tolerated, with no new safety signals observed</li></ul> <p>CAMBRIDGE, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that it will not advance tebapivat, a next-generation oral pyruvate kinase (PK) activator, in lower-risk myelodysplastic syndromes (LR-MDS). This decision follows results from its Phase 2b trial that did not meet the company’s predefined threshold to support further development in this indication.</p> <p>The open-label, multicenter, http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2b+Trial+of+Tebapivat+in+Lower-Risk+Myelodysplastic+Syndromes/26570682.html Fri, 29 May 2026 07:00:00 -0400 AGIO O.07489851 http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2b+Trial+of+Tebapivat+in+Lower-Risk+Myelodysplastic+Syndromes/26570682.html <ul type="disc"><li>Results did not meet predefined threshold to support further development in LR-MDS<br/></li><li>Tebapivat was well tolerated, with no new safety signals observed</li></ul> <p>CAMBRIDGE, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that it will not advance tebapivat, a next-generation oral pyruvate kinase (PK) activator, in lower-risk myelodysplastic syndromes (LR-MDS). This decision follows results from its Phase 2b trial that did not meet the company’s predefined threshold to support further development in this indication.</p> <p>The open-label, multicenter, http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2b+Trial+of+Tebapivat+in+Lower-Risk+Myelodysplastic+Syndromes/26570682.html Fri, 29 May 2026 07:00:00 -0400 AGIO O.07489851 http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2b+Trial+of+Tebapivat+in+Lower-Risk+Myelodysplastic+Syndromes/26570682.html <ul type="disc"><li>Results did not meet predefined threshold to support further development in LR-MDS<br/></li><li>Tebapivat was well tolerated, with no new safety signals observed</li></ul> <p>CAMBRIDGE, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that it will not advance tebapivat, a next-generation oral pyruvate kinase (PK) activator, in lower-risk myelodysplastic syndromes (LR-MDS). This decision follows results from its Phase 2b trial that did not meet the company’s predefined threshold to support further development in this indication.</p> <p>The open-label, multicenter, http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2b+Trial+of+Tebapivat+in+Lower-Risk+Myelodysplastic+Syndromes/26570682.html Fri, 29 May 2026 07:00:00 -0400 AGIO O.07489851 http://www.streetinsider.com/Corporate+News/PYRUKYND+gets+EU+approval+for+thalassaemia+treatment/26539549.html <p>The European Commission has granted marketing authorization for PYRUKYND (mitapivat), an oral pyruvate kinase activator, for treating anemia in adults with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia.</p><p>Agios Pharmaceuticals Inc. (NASDAQ: AGIO) developed the treatment, which will be commercialized and distributed in Europe by Avanzanite Bioscience under an exclusive agreement signed in June 2025. The drug received orphan medicinal product designation.</p><p>The approval marks PYRUKYND's second indication in the EU, following its 2022 approval for adults with pyruvate kinase deficiency. The European Medicines Agency Committee for Medicinal Products for Human Use had previously issued a positive opinion supporting the authorization.</p><p>The approval is http://www.streetinsider.com/Corporate+News/PYRUKYND+gets+EU+approval+for+thalassaemia+treatment/26539549.html Fri, 22 May 2026 10:18:46 -0400 AGIO http://www.streetinsider.com/FDA/PYRUKYND+gets+EU+approval+for+thalassaemia+treatment/26539549.html <p>The European Commission has granted marketing authorization for PYRUKYND (mitapivat), an oral pyruvate kinase activator, for treating anemia in adults with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia.</p><p>Agios Pharmaceuticals Inc. (NASDAQ: AGIO) developed the treatment, which will be commercialized and distributed in Europe by Avanzanite Bioscience under an exclusive agreement signed in June 2025. The drug received orphan medicinal product designation.</p><p>The approval marks PYRUKYND's second indication in the EU, following its 2022 approval for adults with pyruvate kinase deficiency. The European Medicines Agency Committee for Medicinal Products for Human Use had previously issued a positive opinion supporting the authorization.</p><p>The approval is http://www.streetinsider.com/FDA/PYRUKYND+gets+EU+approval+for+thalassaemia+treatment/26539549.html Fri, 22 May 2026 10:18:46 -0400 AGIO http://www.streetinsider.com/Press+Releases/Avanzanite+Bioscience%E2%80%99s+Partner+Agios+Announces+PYRUKYND%C2%AE+%28mitapivat%29+Approval+in+the+European+Union+for+Adults+with+Thalassaemia/26539545.html <ul class="bwlistdisc"> <li> Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios </li> <li> Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia </li> </ul> <p> AMSTERDAM--(BUSINESS WIRE)-- Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, http://www.streetinsider.com/Press+Releases/Avanzanite+Bioscience%E2%80%99s+Partner+Agios+Announces+PYRUKYND%C2%AE+%28mitapivat%29+Approval+in+the+European+Union+for+Adults+with+Thalassaemia/26539545.html Fri, 22 May 2026 10:18:00 -0400 A.60012004 AGIO O.01304637 O.07489851 http://www.streetinsider.com/Press+Releases/Avanzanite+Bioscience%E2%80%99s+Partner+Agios+Announces+PYRUKYND%C2%AE+%28mitapivat%29+Approval+in+the+European+Union+for+Adults+with+Thalassaemia/26539545.html <ul class="bwlistdisc"> <li> Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios </li> <li> Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia </li> </ul> <p> AMSTERDAM--(BUSINESS WIRE)-- Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, http://www.streetinsider.com/Press+Releases/Avanzanite+Bioscience%E2%80%99s+Partner+Agios+Announces+PYRUKYND%C2%AE+%28mitapivat%29+Approval+in+the+European+Union+for+Adults+with+Thalassaemia/26539545.html Fri, 22 May 2026 10:18:00 -0400 A.60012004 AGIO O.01304637 O.07489851 http://www.streetinsider.com/Press+Releases/Avanzanite+Bioscience%E2%80%99s+Partner+Agios+Announces+PYRUKYND%C2%AE+%28mitapivat%29+Approval+in+the+European+Union+for+Adults+with+Thalassaemia/26539545.html <ul class="bwlistdisc"> <li> Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios </li> <li> Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia </li> </ul> <p> AMSTERDAM--(BUSINESS WIRE)-- Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, http://www.streetinsider.com/Press+Releases/Avanzanite+Bioscience%E2%80%99s+Partner+Agios+Announces+PYRUKYND%C2%AE+%28mitapivat%29+Approval+in+the+European+Union+for+Adults+with+Thalassaemia/26539545.html Fri, 22 May 2026 10:18:00 -0400 A.60012004 AGIO O.01304637 O.07489851 http://www.streetinsider.com/Press+Releases/Avanzanite+Bioscience%E2%80%99s+Partner+Agios+Announces+PYRUKYND%C2%AE+%28mitapivat%29+Approval+in+the+European+Union+for+Adults+with+Thalassaemia/26539545.html <ul class="bwlistdisc"> <li> Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios </li> <li> Avanzanite is committed to collaborating with local authorities in the EU to enable access to PYRUKYND for adult patients with thalassaemia </li> </ul> <p> AMSTERDAM--(BUSINESS WIRE)-- Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, http://www.streetinsider.com/Press+Releases/Avanzanite+Bioscience%E2%80%99s+Partner+Agios+Announces+PYRUKYND%C2%AE+%28mitapivat%29+Approval+in+the+European+Union+for+Adults+with+Thalassaemia/26539545.html Fri, 22 May 2026 10:18:00 -0400 A.60012004 AGIO O.01304637 O.07489851