Agios Pyrukynd for rare blood disorder gets US FDA approval

11:00am, Friday, 18'th Feb 2022 Seeking Alpha
The U.S. Food and Drug Administration ((FDA)) approved Agios Pharmaceuticals'' (AGIO) Pyrukynd (mitapivat) to treat hemolytic anemia in adults with pyruvate kinase ((PK))…
The FDA approved Agios Pharmaceuticals Inc''s (NASDAQ: AGIO ) Pyrukynd (mitapivat) for hemolytic anemia in adults with pyruvate kinase (PK) deficiency. Pyruvate kinase deficiency is an inherited metabolic disorder of the enzyme pyruvate kinase that affects red blood cells'' survival. The company notes that Pyrukynd is a first-in-class, oral PK activator and the first approved disease-modifying … Full story available on Benzinga.com
The FDA approved Agios Pharmaceuticals Inc's (NASDAQ: AGIO) Pyrukynd (mitapivat) for hemolytic anemia in adults with pyruvate kinase (PK) deficiency. Pyruvate kinase deficiency is an inherited meta
– Approval Based on Results from ACTIVATE and ACTIVATE-T Phase 3 Studies, Supports Treatment of Adults with PK Deficiency Regardless of Transfusion Status –
Agios Pharmaceuticals has won FDA approval for Pyrukynd (mitapivat), its oral treatment for hemolytic anemia in patients with pyruvate kinase deficiency.

Earnings Preview: Agios Pharmaceuticals (AGIO) Q4 Earnings Expected to Decline

08:03pm, Thursday, 17'th Feb 2022 Zacks Investment Research
Agios Pharmaceuticals (AGIO) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Here's a roundup of top developments in the biotech space over the last 24 hours: Stocks In Focus Amylyx's ALS Treatment Regulatory Application To Be Reviewed By FDA Panel In Late March Amylyx Pharma
Biotech stocks moved back and forth amid some volatility before finishing the week ending Feb. 11 modestly lower, reversing the gains from the previous week. Earnings news flow continued to dominate
Biotech stocks moved back and forth amid some volatility before finishing the week ending Feb. 11 modestly lower, reversing the gains from the previous week. Earnings news flow continued to dominate proceedings, and the week also witnessed presentations at conferences and a couple of initial public offerings. Pfizer, Inc.''s (NYSE: PFE ) fourth-quarter topline growth trailed expectations, exerting downward pressure on the stock. Modular Medical, Inc. (NASDAQ: MODD ) and TC BioPharm (Holdings) plc American Depositary Shares (NASDAQ: TCBP ) debuted on Wall Street following their IPOs. Novavax, Inc. (NASDAQ: NVAX ) came under pressure midweek after a report suggested that the company is lagging very much behind its COVID-19 delivery commitments. Here are the key catalysts that can move stocks in the biotech space in the coming week: Conferences SVB Leerink Global Healthcare Conference (virtual event): Feb. 14-18 17th Congress Of European Crohn''s and Colitis Organization, or ECCO (virtual event): Feb. 16-19 ASCO Genitourinary Cancers Symposium (hybrid event): Feb. 17-19, in Moscone Center, San Francisco, California and online PDUFA Dates The Food and Drug Administration is scheduled to rule on Agios Pharmaceuticals, Inc.''s (NASDAQ: AGIO ) new drug application for mitapivat, its most advanced drug candidate, as a treatment option for pyruvate kinase deficiency.

Agios Pharmaceuticals Inc. (AGIO) Has A Potential Gold Mine

12:30pm, Saturday, 12'th Feb 2022 Stocks Register
Agios Pharmaceuticals Inc. (NASDAQ:AGIO) price on Friday, February 11, rose 0.90% above its previous days close as an upside momentum from buyers pushed the stocks value to $31.33. A look at the stocks price movement, the close in the last trading session was $31.05, moving within a range at $30.91 and $32.33. The beta value Agios Pharmaceuticals Inc. (AGIO) Has A Potential Gold Mine Read More »
CAMBRIDGE, Mass., Feb. 10, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, to
CAMBRIDGE, Mass. , Feb. 10, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced the company will host a conference call and live webcast on Thursday, Feb.
CAMBRIDGE, Mass., Feb. 10, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, toda
After a fairly robust 2021, the new year started on a mixed note as far as regulatory decisions are concerned. About three new molecular entities, or NMEs, were approved during the month, including Im
After a fairly robust 2021, the new year started on a mixed note as far as regulatory decisions are concerned. About 3 new molecular entities, or NMEs, were approved during the month, including Immunocore Holdings plc''s (NASDAQ: IMCR ) Kimmtrak for certain patients with advanced eye melanoma and Pfizer, Inc.''s (NYSE: PFE ) atopic dermatitis treatment Cibinqo. NME approval is an important indicator to measure innovation in drug research. NME approvals totaled 50 in 2021, almost equaling the numbers of the previous year. Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN )- Sanofi (NASDAQ: SNY ), however, failed to get the nod for expanding the Libtayo label to include cervical cancer. Pfizer also faced rejection for its pediatric growth hormone deficiency treatment Somatrogon. A PDUFA date is the date/period by which the Food and Drug Administration is required to announce its verdict on a sponsor company''s regulatory application. This will determine the fate of millions of dollars invested in developing the treatment from the preclinical-stage to clinical testing.
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