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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~ 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

CSL Ltd

-  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

uniQure Announces Multiple Presentations at the Upcoming Annual Meeting of The European Society of Gene and Cell Therapy (ESGCT)

LEXINGTON, Mass. and AMSTERDAM, Oct. 03, 2022 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced its participation in the following upcoming investor and scientific conferences:

uniQure to Participate in Upcoming Industry Conferences in October

uniQure outlicensed AMT-061, EtranaDez, to CSL Behring who will market the gene therapy for hemophilia B. EtranaDez has a PDUFA date in November and if approved, uniQure will collect a $175 m milestone payment upon commercial launch strengthening their cash position.

uniQure: Clinical Risk, A Critical Upcoming Catalyst And A Cash Cushion

LEXINGTON, Mass. and AMSTERDAM, Sept. 06, 2022 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced its participation in the following upcoming investor and scientific conferences:

uniQure to Participate in Upcoming Industry Conferences in September

uniQure N.V. has U.S. and European approvals possible of etranacogene dezaparvovec for treatment of Hemophilia B before end of 2022 and early 2023 respectively. uniQure N.V. has already tapped a partner that is licensed and will help commercialize the drug by the name of CSL Behring.

uniQure N.V.: 2 Possible Regulatory Approvals Makes This A Must Watch

uniQure (QURE) delivered earnings and revenue surprises of 12.50% and 97.47%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?

UniQure (QURE) Reports Q2 Loss, Lags Revenue Estimates

~ Announced 12-month data on the lower-dose cohort of AMT-130 in Huntington's disease showed the investigative gene therapy was generally well tolerated at this dose with a mean reduction of 53.8% of mutant Huntingtin protein (mHTT) observed in cerebral spinal fluid (CSF) ~

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

This can be attributed to the company reporting positive findings from clinical trials for its Huntington's Disease treatment - AMT-130.

News for uniQure Stock (QURE)