uniQure

uniQure NV engages in the discovery, development, and commercialization of innovative gene therapies. Its discoveries intend to treat hemophilia, Huntington's disease, glybera, and cardiovascular problems. The company was founded by Sander J. van Deventer in 1998 and is headquartered in Amsterdam, the Netherlands.

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uniQure (QURE) delivered earnings and revenue surprises of 128.85% and 85.55%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

UniQure (QURE) Tops Q4 Earnings and Revenue Estimates

~ Achieved U.S. and European Commission marketing approvals of first and only gene therapy for adults with hemophilia B ~

uniQure Announces 2022 Financial Results and Highlights Recent Company Progress

~ Data follow the historic approval of the first gene therapy for hemophilia B, which has been shown in clinical trials to reduce the rate of annual bleeds, reduce or eliminate the need for prophylactic therapy and generate elevated and sustained factor IX levels for years after a one-time infusion ~

uniQure Announces HOPE-B Clinical Trial Data Published in the New England Journal of Medicine, Demonstrating Durability and Other Benefits of HEMGENIX® (etranacogene dezaparvovec-drlb)

CSL Ltd

Data follow the historic approval of the first gene therapy for hemophilia B, which reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion 18-month data support the efficacy and safety of HEMGENIX® and the ongoing benefit of this treatment HEMGENIX® is approved for adults with hemophilia B in the United States, European Union and European Economic Area KING OF PRUSSIA, Penn. , Feb. 23, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) today announced the publication in the New England Journal of Medicine (NEJM) (Vol.

CSL's HOPE-B Data Published in the New England Journal of Medicine, Demonstrating Efficacy and Durability of HEMGENIX® (etranacogene dezaparvovec-drlb)

~ Historic approval represents the first gene therapy in Europe to treat hemophilia B and provides a new treatment option for patients that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy, and generates elevated and sustained factor IX levels ~

uniQure announces the European Commission approval of the first gene therapy for adults with hemophilia B

HEMGENIX® underscores CSL's promise to deliver life-changing innovations that have the potential to help patients lead full lives MARBURG, Germany , Feb. 20, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) today announced that the European Commission has granted conditional marketing authorization (CMA) for HEMGENIX® (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. In the ongoing clinical trial, HEMGENIX® reduced the rate of annual bleeds with a single infusion by delivering a functional gene that acts as a blueprint for coagulation Factor IX, a protein important for blood clotting.1 It is the first approved gene therapy for hemophilia B in the European Union (EU) and European Economic Area (EEA).

First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission

Hemgenix was approved by FDA. uniQure appears undervalued based on the value of milestones and royalties due to the company.

uniQure: An FDA Approval, An Advancing Pipeline And A Critical Data Readout

~ License of APB-102 further strengthens uniQure's pipeline of innovative gene therapies to treat neurological disorders and miRNA-based gene silencing programs ~

uniQure and Apic Bio enter into global licensing agreement for APB-102, a clinical stage gene therapy for patients with ALS caused by mutations in SOD1

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If approved, etranacogene dezaparvovec would be the first licensed gene therapy in Europe for people living with hemophilia B If approved, etranacogene dezaparvovec would be the first licensed gene therapy in Europe for people living with hemophilia B

uniQure announces positive CHMP opinion for etranacogene dezaparvovec – gene therapy for adults with hemophilia B

Recent approval of Hemgenix therapy creates alpha opportunity. Market has responded swiftly and we see upside targets of $31.5 and then $49.

uniQure: Hemgenix Approval Key Catalyst To Move The Needle, Rate Buy

FDA approval of uniQure N.V.'s Hemgenix for the treatment of adults with Hemophilia B achieved. There is potential to receive European approval of Hemgenix for the treatment of adults with Hemophilia B in 2023 on standard review timeline.

uniQure: FDA Approval Achieved, Along With AMT-130 Moving Forward

~ IND Submission and Clinical Development Expected to Begin in 2023 ~

uniQure Highlights Therapeutic Potential of AMT-260 in Refractory Temporal Lobe Epilepsy (rTLE) at Virtual Research & Development Event

A big approval for a gene therapy sent the biotech's stock higher.

Why Shares of uniQure Rose 14.61% on Wednesday

uniQure (QURE) shares rise after its partner CSL Limited received FDA nod for one-time gene therapy, Hemgenix, for treating adults with Hemophilia B.

uniQure (QURE) Partner Gets FDA Nod for Hemophilia B Gene Therapy

The FDA just approved the most expensive drug ever — a hemophilia gene therapy from Carlisle and UniQure — and QURE stock popped Wednesday. The post The FDA Just Approved The Most Expensive Drug Ever — Sending UniQure Stock On A Warpath appeared first on Investor's Business Daily.

The FDA Just Approved The Most Expensive Drug Ever — Sending UniQure Stock On A Warpath

~ Historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy, and generates elevated and sustained factor IX levels ~

uniQure announces FDA approval of first gene therapy for adults with hemophilia B

-  This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion -  With the approval of HEMGENIX, CSL now offers an even more comprehensive portfolio of treatments for people living with hemophilia B, ushering in a new era of treatment options KING OF PRUSSIA, Pa. , Nov. 22, 2022 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) today announced that the U.S. Food and Drug Administration (FDA) approved HEMGENIX® (etranacogene dezaparvovec-drlb), the first and only one-time gene therapy for appropriate adults with hemophilia B.

U.S. Food and Drug Administration approves CSL's HEMGENIX® (etranacogene dezaparvovec-drlb), the first gene therapy for hemophilia B

~ Event to be Webcast Live on uniQure's Corporate Website at 8:30 a.m. EST ~

uniQure to Host Virtual Research & Development Event on Tuesday, November 29, 2022

AMSTERDAM--(BUSINESS WIRE)--VectorY Therapeutics, a biotech company developing innovative vectorized antibody approaches for the treatment of neurodegenerative diseases, today announces the appointment of Sander van Deventer, co-founder and formerly Chief Technology Officer, as Chief Executive Officer.

VectorY Appoints Sander van Deventer as CEO and Makes Key Appointments to Its Leadership Team

Pipeline advancements and investment in innovation and disruptive technologies to help fuel sustainable, profitable growth for CSL's three businesses, CSL Behring, CSL Seqirus and CSL Vifor, in the decades ahead MELBOURNE, Australia and KING OF PRUSSIA, Pa. , Nov. 2, 2022 /PRNewswire/ -- At its annual R&D investor briefing today, global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) demonstrated how its growing, innovative pipeline is well-positioned to meet the current and future needs of patients and public health.

Next-Generation mRNA, Gene Therapy, Plasma Products, Monoclonal Antibodies, and Recent Acquisitions and Collaborations Highlight CSL R&D Day 2022

uniQure (QURE) delivered earnings and revenue surprises of 8.11% and 86.46%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

UniQure (QURE) Reports Q3 Loss, Misses Revenue Estimates

~ Patient enrollment at the higher dose of AMT-130 to resume in European Phase Ib/II study following  Data Safety Monitoring Board recommendation ~ ~ U.S. and European pre-approval inspections of Company's Lexington, MA manufacturing site completed with EMA issuing Good Manufacturing Certificate ~ ~ Virtual investor event focused on next pipeline program, AMT-260 investigational gene therapy for refractory temporal lobe epilepsy, to be held on Tuesday, November 29, 2022 ~

uniQure Announces Third Quarter 2022 Financial Results and Highlights Recent Company Progress

UniQure (QURE) 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.

Analysts Estimate uniQure (QURE) to Report a Decline in Earnings: What to Look Out for

Eight Posters Highlighting Pre-Clinical Programs and Leading Gene Therapy Manufacturing and Administration Capabilities Eight Posters Highlighting Pre-Clinical Programs and Leading Gene Therapy Manufacturing and Administration Capabilities

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