Tag: Regeneron

FDA Approves First-in-class Evkeeza® (evinacumab-dgnb) for Young Children with Ultra-rare Form of High Cholesterol

Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH), an inherited condition characterized by extremely high low-density lipoprotein cholesterol (LDL-C) 48% reduction in LDL-C from baseline at week 24 when Evkeeza was added to other […]

Intellia and Regeneron Announce Initial Data from the Cardiomyopathy Arm of Ongoing Phase 1 Study of NTLA-2001, an Investigational CRISPR Therapy for the Treatment of Transthyretin (ATTR) Amyloidosis

Interim data from the cardiomyopathy arm of the Phase 1 study of NTLA-2001 showed deep and sustained mean serum transthyretin (TTR) reductions of 93% and 92% at 0.7 mg/kg and 1.0 mg/kg doses, respectively, at day 28 NTLA-2001 was generally […]

Regeneron Reports Fourth Quarter and Full Year 2021 Financial and Operating Results

TARRYTOWN, N.Y., Feb. 4, 2022 /PRNewswire/ — Fourth quarter 2021 revenues increased 104% to $4.95 billion versus fourth quarter 2020 including $2.30 billion attributable to REGEN-COV®(2); revenues excluding REGEN-COV(1) increased 17% Full year 2021 revenues increased 89% to $16.07 billion compared to full year 2020 including $6.19 billion attributable to REGEN-COV(2); revenues excluding REGEN-COV(1) increased […]

Regeneron and Ultragenyx Collaborate to Commercialize Evkeeza® (evinacumab) Outside the United States

Evkeeza is a first-in-class medicine approved by the U.S. Food and Drug Administration (FDA) and European Commission (EC) to treat an ultra-rare inherited form of high cholesterol TARRYTOWN, N.Y. and NOVATO, Calif., Jan. 7, 2022 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Ultragenyx Pharmaceutical Inc. […]

FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol

TARRYTOWN, N.Y., Aug. 12, 2020 /PRNewswire/ — Homozygous familial hypercholesterolemia affects approximately 1,300 patients in the U.S., the vast majority of whom are unable to reach target LDL-C levels with currently available therapies Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food […]

Regeneron to Report Second Quarter 2020 Financial and Operating Results and Host Conference Call and Webcast on August 5, 2020

TARRYTOWN, N.Y., July 8, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its second quarter 2020 financial and operating results on Wednesday, August 5, 2020, before the U.S. financial markets open.  The Company will host a conference call and simultaneous […]

Regeneron Announces American College of Cardiology Presentation of Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol

TARRYTOWN, N.Y., March 30, 2020 /PRNewswire/ — Results from separate positive Phase 3 trial of Praluent® (alirocumab) in patients with HoFH also presented; FDA regulatory submission planned for Q2 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that detailed Phase 3 results of evinacumab were presented […]