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Category: Today’s Highlights

Reata Pharmaceuticals Stock Soared

Reata Pharmaceuticals Stock is Flying High Here is another example of why analysts can no longer use the same old measures to evaluate the biotechnology firms. They cannot continue to ignore the values of the firms’ technologies and very promising...

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June 11, 2020

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BridgeBio Pharma Has Promising News

BridgeBio Pharma Granted Fast Track Designation for Encaleret BridgeBio Pharma ( BBIO ) announced the U.S. FDA granted Fast Track designation for Encaleret – a treatment of autosomal dominant hypocalcemia ( ADH1 ), on World Hypoparathyroidism Awareness Day, an annual...

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June 2, 2021

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AstraZeneca Saphnelo Approved in Japan for Adult Patients with SLE

AstraZeneca Saphnelo Approved by Japanese Ministry of Health, Labor and Welfare Developed by AstraZeneca ( AZN ) , Saphnelo is a first-in-class type I interferon receptor antibody shown to reduce overall disease activity in patients with systemic lupus erythematosus. The approval...

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September 28, 2021

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Intellia Therapeutics Gene Editing Product NTLA-2001 - A Dream on its Way to Becoming Reality

Focus on Intellia Therapeutics Upcoming Presentation for NTLA-2001 Data to offer insight into safety and pharmacodynamics of NTLA-2001, the first-ever systemically administered in vivo CRISPR therapy candidate Late-breaking abstract selected for oral presentation on June 26 Intellia Therapeutics NTLA-2001 for People Living with...

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June 4, 2021

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Reata Pharmaceuticals Plans to Submit Omaveloxolone NDA for Friedreich’s Ataxia in Q1 2022

Reata Pharmaceuticals to Submit Omaveloxolone for NDA in Early 2022 In a press release following the completion of pre-NDA meeting with the FDA,  Reata Pharmaceuticals ( RETA ) stated that the purpose of the pre-NDA meeting was to discuss the...

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September 30, 2021

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The FDA Lifts the Clinical Holds on bluebird bio Gene Therapies in Clinical Trials

Clinical Holds on bluebird bio Gene Therapies were Lifted by the FDA The U.S. FDA has lifted the clinical holds on the bluebird bio ( BLUE ) Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell...

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June 7, 2021

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The U.S. FDA Approves Vertex Pharmaceuticals TRIKAFTA for Children with Cystic Fibrosis Aged 6 to 11 with Certain Mutations

Vertex Pharmaceuticals Receives FDA Approval for TRIKAFTA ® Vertex Pharmaceuticals ( VRTX ) announced the U.S. FDA approved the expanded use of TRIKAFTA® to include children with cystic fibrosis ( CF ) ages 6 through 11 years who have at least...

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June 9, 2021

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The Time Has Come for Agenus to Excel. See Also: Why Evoke Pharma Traded UP Today

Agenus Has Two Separate Press Releases In the First Press Release from Agenus: Agenus ( AGEN ) announced that it will be making a scientific presentation today on optimal anti-cancer combinations with Fc enhanced anti-CTLA-4, AGEN1181 at the American Association...

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June 22, 2020

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Veracyte Inc: Exciting News About nmCRPC Published Online

Veracyte Inc Decipher® Prostate Test Veracyte Inc ( VCYT ) : New data that demonstrated the prognostic utility of its Decipher® Prostate genomic classifier in men with non-metastatic castration-resistant prostate cancer ( nmCRPC ) has been published online in JAMA...

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June 14, 2021

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Jounce Therapeutics Inc Achieves First Milestone in Exclusive License Agreement with Gilead Sciences for JTX-1811

Jounce Therapeutics Inc: US FDA Cleared IND Application for JTX-1811 Targeting CCR8 Jounce Therapeutics Inc ( JNCE ) - a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced that the U.S. Food...

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June 15, 2021

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