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) Wed, 22 Jul 2026 06:51:26 -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/Analyst+PT+Change/Agios+Pharma+%28AGIO%29+PT+Lowered+to+%2452+at+H.C.+Wainwright/26797912.html (Updated - July 22, 2026 6:51 AM EDT) <p>H.C. Wainwright analyst Emily Bodnar lowered the price target on Agios Pharma (NASDAQ: AGIO) to $52.00 (from $54.00) while maintaining a Buy rating.</p><p>The analyst commented: "This morning, Agios reported an update on the Phase 2 trial of tebapivat in SCD, announcing consistent Hb response as seen with mitapivat, with no evidence of a differentiated profile. Investors were highly anticipating the Phase 2 data update to potentially show a best-in-class profile vs mitapivat and Novo Nordisk's (NVO; not rated) etavopivat. Tebapivat was evaluated over a 12-week treatment period in a double-blind, placebo-controlled trial in http://www.streetinsider.com/Analyst+PT+Change/Agios+Pharma+%28AGIO%29+PT+Lowered+to+%2452+at+H.C.+Wainwright/26797912.html Wed, 22 Jul 2026 06:51:26 -0400 AGIO http://www.streetinsider.com/Analyst+Comments/Agios+Pharma+%28AGIO%29+PT+Lowered+to+%2452+at+H.C.+Wainwright/26797912.html (Updated - July 22, 2026 6:51 AM EDT) <p>H.C. Wainwright analyst Emily Bodnar lowered the price target on Agios Pharma (NASDAQ: AGIO) to $52.00 (from $54.00) while maintaining a Buy rating.</p><p>The analyst commented: "This morning, Agios reported an update on the Phase 2 trial of tebapivat in SCD, announcing consistent Hb response as seen with mitapivat, with no evidence of a differentiated profile. Investors were highly anticipating the Phase 2 data update to potentially show a best-in-class profile vs mitapivat and Novo Nordisk's (NVO; not rated) etavopivat. Tebapivat was evaluated over a 12-week treatment period in a double-blind, placebo-controlled trial in http://www.streetinsider.com/Analyst+Comments/Agios+Pharma+%28AGIO%29+PT+Lowered+to+%2452+at+H.C.+Wainwright/26797912.html Wed, 22 Jul 2026 06:51:26 -0400 AGIO http://www.streetinsider.com/FDA/Agios+drops+tebapivat+in+sickle+cell+after+Phase+2+falls+short/26791998.html <p>Agios Pharmaceuticals (NASDAQ: AGIO) said it will not advance tebapivat in sickle cell disease after a Phase 2 trial failed to establish a differentiated profile compared with other pyruvate kinase (PK) activators.</p> <p>The 12-week, double-blind, placebo-controlled trial enrolled 59 participants aged 16 and older, randomized to one of three once-daily tebapivat doses — 2.5 mg, 5.0 mg, or 7.5 mg — or placebo. The primary endpoint, a hemoglobin response of at least 1.0 g/dL increase from baseline, was achieved by 43.8%, 47.1%, and 29.4% of patients in the respective tebapivat arms, compared with 33.3% in the placebo arm.</p> <p>Agios said improvements in http://www.streetinsider.com/FDA/Agios+drops+tebapivat+in+sickle+cell+after+Phase+2+falls+short/26791998.html Tue, 21 Jul 2026 07:00:48 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/FDA/Agios+drops+tebapivat+in+sickle+cell+after+Phase+2+falls+short/26791998.html <p>Agios Pharmaceuticals (NASDAQ: AGIO) said it will not advance tebapivat in sickle cell disease after a Phase 2 trial failed to establish a differentiated profile compared with other pyruvate kinase (PK) activators.</p> <p>The 12-week, double-blind, placebo-controlled trial enrolled 59 participants aged 16 and older, randomized to one of three once-daily tebapivat doses — 2.5 mg, 5.0 mg, or 7.5 mg — or placebo. The primary endpoint, a hemoglobin response of at least 1.0 g/dL increase from baseline, was achieved by 43.8%, 47.1%, and 29.4% of patients in the respective tebapivat arms, compared with 33.3% in the placebo arm.</p> <p>Agios said improvements in http://www.streetinsider.com/FDA/Agios+drops+tebapivat+in+sickle+cell+after+Phase+2+falls+short/26791998.html Tue, 21 Jul 2026 07:00:48 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/FDA/Agios+drops+tebapivat+in+sickle+cell+after+Phase+2+falls+short/26791998.html <p>Agios Pharmaceuticals (NASDAQ: AGIO) said it will not advance tebapivat in sickle cell disease after a Phase 2 trial failed to establish a differentiated profile compared with other pyruvate kinase (PK) activators.</p> <p>The 12-week, double-blind, placebo-controlled trial enrolled 59 participants aged 16 and older, randomized to one of three once-daily tebapivat doses — 2.5 mg, 5.0 mg, or 7.5 mg — or placebo. The primary endpoint, a hemoglobin response of at least 1.0 g/dL increase from baseline, was achieved by 43.8%, 47.1%, and 29.4% of patients in the respective tebapivat arms, compared with 33.3% in the placebo arm.</p> <p>Agios said improvements in http://www.streetinsider.com/FDA/Agios+drops+tebapivat+in+sickle+cell+after+Phase+2+falls+short/26791998.html Tue, 21 Jul 2026 07:00:48 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/FDA/Agios+drops+tebapivat+in+sickle+cell+after+Phase+2+falls+short/26791998.html <p>Agios Pharmaceuticals (NASDAQ: AGIO) said it will not advance tebapivat in sickle cell disease after a Phase 2 trial failed to establish a differentiated profile compared with other pyruvate kinase (PK) activators.</p> <p>The 12-week, double-blind, placebo-controlled trial enrolled 59 participants aged 16 and older, randomized to one of three once-daily tebapivat doses — 2.5 mg, 5.0 mg, or 7.5 mg — or placebo. The primary endpoint, a hemoglobin response of at least 1.0 g/dL increase from baseline, was achieved by 43.8%, 47.1%, and 29.4% of patients in the respective tebapivat arms, compared with 33.3% in the placebo arm.</p> <p>Agios said improvements in http://www.streetinsider.com/FDA/Agios+drops+tebapivat+in+sickle+cell+after+Phase+2+falls+short/26791998.html Tue, 21 Jul 2026 07:00:48 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html <ul><li>Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease</li><li>Safety and tolerability of tebapivat were consistent with prior sickle cell disease trials</li><li>sNDA for mitapivat, company’s foundational PK activator, is under FDA Priority Review in sickle cell disease; PDUFA goal date is November 1, 2026<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 21, 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 topline http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html Tue, 21 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html <ul><li>Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease</li><li>Safety and tolerability of tebapivat were consistent with prior sickle cell disease trials</li><li>sNDA for mitapivat, company’s foundational PK activator, is under FDA Priority Review in sickle cell disease; PDUFA goal date is November 1, 2026<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 21, 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 topline http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html Tue, 21 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html <ul><li>Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease</li><li>Safety and tolerability of tebapivat were consistent with prior sickle cell disease trials</li><li>sNDA for mitapivat, company’s foundational PK activator, is under FDA Priority Review in sickle cell disease; PDUFA goal date is November 1, 2026<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 21, 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 topline http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html Tue, 21 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html <ul><li>Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease</li><li>Safety and tolerability of tebapivat were consistent with prior sickle cell disease trials</li><li>sNDA for mitapivat, company’s foundational PK activator, is under FDA Priority Review in sickle cell disease; PDUFA goal date is November 1, 2026<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 21, 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 topline http://www.streetinsider.com/Press+Releases/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html Tue, 21 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html <ul><li>Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease</li><li>Safety and tolerability of tebapivat were consistent with prior sickle cell disease trials</li><li>sNDA for mitapivat, company’s foundational PK activator, is under FDA Priority Review in sickle cell disease; PDUFA goal date is November 1, 2026<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 21, 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 topline http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html Tue, 21 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html <ul><li>Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease</li><li>Safety and tolerability of tebapivat were consistent with prior sickle cell disease trials</li><li>sNDA for mitapivat, company’s foundational PK activator, is under FDA Priority Review in sickle cell disease; PDUFA goal date is November 1, 2026<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 21, 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 topline http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html Tue, 21 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html <ul><li>Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease</li><li>Safety and tolerability of tebapivat were consistent with prior sickle cell disease trials</li><li>sNDA for mitapivat, company’s foundational PK activator, is under FDA Priority Review in sickle cell disease; PDUFA goal date is November 1, 2026<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 21, 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 topline http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html Tue, 21 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html <ul><li>Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease</li><li>Safety and tolerability of tebapivat were consistent with prior sickle cell disease trials</li><li>sNDA for mitapivat, company’s foundational PK activator, is under FDA Priority Review in sickle cell disease; PDUFA goal date is November 1, 2026<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 21, 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 topline http://www.streetinsider.com/Globe+Newswire/Agios+Provides+Update+on+Phase+2+Trial+of+Tebapivat+in+Sickle+Cell+Disease/26791992.html Tue, 21 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++AGIOS+PHARMACEUTICALS%2C++++For%3A+Jul+08++Filed+by%3A+Backstrom+Jay+T./26757538.html si-local-file:///var/storage/secattach/20260710/26757538.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++AGIOS+PHARMACEUTICALS%2C++++For%3A+Jul+08++Filed+by%3A+Backstrom+Jay+T./26757538.html Fri, 10 Jul 2026 16:18:00 -0400 AGIO O.07489851 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++AGIOS+PHARMACEUTICALS%2C++++For%3A+Jul+08++Filed+by%3A+Backstrom+Jay+T./26757538.html si-local-file:///var/storage/secattach/20260710/26757538.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++AGIOS+PHARMACEUTICALS%2C++++For%3A+Jul+08++Filed+by%3A+Backstrom+Jay+T./26757538.html Fri, 10 Jul 2026 16:18:00 -0400 AGIO O.07489851 http://www.streetinsider.com/Analyst+PT+Change/Agios+Pharma+%28AGIO%29+PT+Raised+to+%2432+at+RBC+Capital/26738633.html RBC Capital analyst Luca Issi raised the price target on Agios Pharma (NASDAQ: AGIO) to $32.00 (from $28.00) while maintaining a Sector Perform rating. http://www.streetinsider.com/Analyst+PT+Change/Agios+Pharma+%28AGIO%29+PT+Raised+to+%2432+at+RBC+Capital/26738633.html Tue, 07 Jul 2026 07:55:47 -0400 AGIO http://www.streetinsider.com/Analyst+PT+Change/Agios+Pharma+%28AGIO%29+PT+Raised+to+%2441+at+Truist+Securities/26738269.html Truist Securities analyst Greg Renza raised the price target on Agios Pharma (NASDAQ: AGIO) to $41.00 (from $36.00) while maintaining a Buy rating. http://www.streetinsider.com/Analyst+PT+Change/Agios+Pharma+%28AGIO%29+PT+Raised+to+%2441+at+Truist+Securities/26738269.html Tue, 07 Jul 2026 07:08:40 -0400 AGIO http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Agios%27+mitapivat+for+sickle+cell+disease/26738203.html <p>Agios Pharmaceuticals (Nasdaq: AGIO) announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease, granting it Priority Review. The FDA's PDUFA goal date is November 1, 2026.</p> <p>The sNDA was submitted under the FDA's accelerated approval pathway. Priority Review designation shortens the standard review timeline from 10 months to six months and is granted to applications for medicines that may offer significant improvements in safety or efficacy for serious conditions.</p> <p>The application is based on data from the RISE UP Phase 2 and Phase 3 trials, which were global, randomized, http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Agios%27+mitapivat+for+sickle+cell+disease/26738203.html Tue, 07 Jul 2026 07:00:54 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Agios%27+mitapivat+for+sickle+cell+disease/26738203.html <p>Agios Pharmaceuticals (Nasdaq: AGIO) announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease, granting it Priority Review. The FDA's PDUFA goal date is November 1, 2026.</p> <p>The sNDA was submitted under the FDA's accelerated approval pathway. Priority Review designation shortens the standard review timeline from 10 months to six months and is granted to applications for medicines that may offer significant improvements in safety or efficacy for serious conditions.</p> <p>The application is based on data from the RISE UP Phase 2 and Phase 3 trials, which were global, randomized, http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Agios%27+mitapivat+for+sickle+cell+disease/26738203.html Tue, 07 Jul 2026 07:00:54 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Agios%27+mitapivat+for+sickle+cell+disease/26738203.html <p>Agios Pharmaceuticals (Nasdaq: AGIO) announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease, granting it Priority Review. The FDA's PDUFA goal date is November 1, 2026.</p> <p>The sNDA was submitted under the FDA's accelerated approval pathway. Priority Review designation shortens the standard review timeline from 10 months to six months and is granted to applications for medicines that may offer significant improvements in safety or efficacy for serious conditions.</p> <p>The application is based on data from the RISE UP Phase 2 and Phase 3 trials, which were global, randomized, http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Agios%27+mitapivat+for+sickle+cell+disease/26738203.html Tue, 07 Jul 2026 07:00:54 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Agios%27+mitapivat+for+sickle+cell+disease/26738203.html <p>Agios Pharmaceuticals (Nasdaq: AGIO) announced that the U.S. Food and Drug Administration has accepted its supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease, granting it Priority Review. The FDA's PDUFA goal date is November 1, 2026.</p> <p>The sNDA was submitted under the FDA's accelerated approval pathway. Priority Review designation shortens the standard review timeline from 10 months to six months and is granted to applications for medicines that may offer significant improvements in safety or efficacy for serious conditions.</p> <p>The application is based on data from the RISE UP Phase 2 and Phase 3 trials, which were global, randomized, http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Agios%27+mitapivat+for+sickle+cell+disease/26738203.html Tue, 07 Jul 2026 07:00:54 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/U.S.+FDA+Grants+Priority+Review+to+Agios%E2%80%99+sNDA+for+Mitapivat+in+Sickle+Cell+Disease/26738195.html <ul type="disc"><li>FDA’s PDUFA goal date is November 1, 2026<br/><br/></li><li>If approved, mitapivat is positioned to become the first oral PK activator for patients with sickle cell disease<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 07, 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 the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease with a Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for http://www.streetinsider.com/Press+Releases/U.S.+FDA+Grants+Priority+Review+to+Agios%E2%80%99+sNDA+for+Mitapivat+in+Sickle+Cell+Disease/26738195.html Tue, 07 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/U.S.+FDA+Grants+Priority+Review+to+Agios%E2%80%99+sNDA+for+Mitapivat+in+Sickle+Cell+Disease/26738195.html <ul type="disc"><li>FDA’s PDUFA goal date is November 1, 2026<br/><br/></li><li>If approved, mitapivat is positioned to become the first oral PK activator for patients with sickle cell disease<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 07, 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 the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease with a Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for http://www.streetinsider.com/Press+Releases/U.S.+FDA+Grants+Priority+Review+to+Agios%E2%80%99+sNDA+for+Mitapivat+in+Sickle+Cell+Disease/26738195.html Tue, 07 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344 http://www.streetinsider.com/Press+Releases/U.S.+FDA+Grants+Priority+Review+to+Agios%E2%80%99+sNDA+for+Mitapivat+in+Sickle+Cell+Disease/26738195.html <ul type="disc"><li>FDA’s PDUFA goal date is November 1, 2026<br/><br/></li><li>If approved, mitapivat is positioned to become the first oral PK activator for patients with sickle cell disease<br/><br/></li></ul> <p>CAMBRIDGE, Mass., July 07, 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 the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease with a Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for http://www.streetinsider.com/Press+Releases/U.S.+FDA+Grants+Priority+Review+to+Agios%E2%80%99+sNDA+for+Mitapivat+in+Sickle+Cell+Disease/26738195.html Tue, 07 Jul 2026 07:00:00 -0400 A.06822034 AGIO O.07489851 O.20026344