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Eli Lilly (NYSE: LLY) has successfully completed its acquisition of Prevail Therapeutics (NASDAQ: PRVL) for $22.50 per share, plus a contingent value right (CVR) potentially adding $4.00 per share based on regulatory approvals by December 31, 2024. This acquisition establishes a gene therapy program targeting neurodegenerative diseases. Approximately 79.8% of Prevail’s shares were tendered, and the deal will not alter Lilly's 2021 financial guidance. Prevail's stock will be delisted from NASDAQ following the merger.
Prevail Therapeutics (Nasdaq: PRVL) has initiated the Phase 1/2 PROCLAIM clinical trial, marking a significant milestone in developing PR006, an AAV9 gene therapy targeting frontotemporal dementia (FTD) in patients with GRN mutations. The trial will assess the safety and tolerability of PR006, enrolling up to 15 patients. FDA has granted Orphan Drug and Fast Track designations for PR006, emphasizing its potential to be a disease-modifying therapy. Approximately 50,000 to 60,000 individuals in the U.S. suffer from FTD, highlighting the urgent need for effective treatments.
Prevail Therapeutics (Nasdaq: PRVL) announced that the European Commission has granted orphan designation for its investigational gene therapy, PR006, to treat frontotemporal dementia (FTD) associated with GRN mutations. This designation is pivotal for advancing treatment for this condition. The company plans to initiate the Phase 1/2 PROCLAIM trial in Q4 2020 and aims to provide interim biomarker and safety analysis in 2021. Additionally, PR006 has received Orphan Drug and Fast Track designations from the FDA. These designations may offer regulatory benefits and support therapeutic development.
Prevail Therapeutics (Nasdaq: PRVL) announced that the USPTO issued U.S. Patent No. 10,837,028 for the AAV vector used in PR001, a gene therapy for Parkinson's disease with GBA1 mutations and neuronopathic Gaucher disease. The patent is valid until October 3, 2038. CEO Asa Abeliovich highlighted the ongoing clinical trials for PR001, including the PROPEL trial for PD-GBA and the upcoming PROVIDE trial for Type 2 Gaucher disease. The FDA has granted Fast Track and other designations for PR001, enhancing its development prospects.
Prevail Therapeutics (PRVL) has made notable advancements in its clinical pipeline, particularly in the ongoing Phase 1/2 PROPEL trial for PR001, targeting Parkinson's disease with GBA1 mutations. The company also plans to initiate enrollment for the PROVIDE trial for Type 2 Gaucher disease and the PROCLAIM trial for frontotemporal dementia by Q4 2020. Additionally, PR001 has received FDA Fast Track Designation for neuronopathic Gaucher disease. Financially, Prevail reported a net loss of $18.6 million for Q3 2020, with cash reserves of $114.3 million, projected to last into H1 2022.
Prevail Therapeutics (Nasdaq: PRVL) announced participation in upcoming virtual investor conferences, featuring CEO Asa Abeliovich. The events include the Guggenheim Healthcare Talks on November 16, 2020, the Stifel 2020 Virtual Healthcare Conference on November 18, 2020, and the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1, 2020. Webcasts of the presentations will be accessible on their website. Prevail focuses on developing AAV-based gene therapies for neurodegenerative diseases, with key products in development for Parkinson’s disease and frontotemporal dementia.
Prevail Therapeutics announced a favorable ruling in the arbitration case brought by Alector Inc., confirming the integrity of its intellectual property and vindicating Dr. Asa Abeliovich. The arbitrator dismissed all significant claims from Alector regarding misappropriation of trade secrets and affirmed Prevail’s ownership of its patents. The only relief granted to Alector was to seek reimbursement for specific costs. Dr. Abeliovich expressed optimism about advancing the company's pipeline for therapies targeting neurodegenerative diseases such as Parkinson's.
Prevail Therapeutics (Nasdaq: PRVL) announced FDA Fast Track designation for its gene therapy, PR001, aimed at treating neuronopathic Gaucher disease. This designation highlights the urgent need for effective treatments for a condition with no current approved therapies. The company plans to start the PROVIDE Phase 1/2 clinical trial for Type 2 Gaucher disease in late 2020. PR001 is also recognized for its potential in treating Parkinson’s disease with GBA1 mutations. Prevail's commitment to developing innovative gene therapies positions it as a key player in addressing severe neurodegenerative diseases.
Prevail Therapeutics (Nasdaq: PRVL) announced its participation in two upcoming virtual investor conferences this October. Asa Abeliovich, M.D., Ph.D., the company's CEO, will engage in discussions at the Jefferies Gene Therapy/Editing Virtual Summit on October 1, 2020, and present at Chardan’s 4th Annual Genetic Medicines Conference on October 6, 2020. Prevail focuses on developing AAV-based gene therapies for neurodegenerative diseases, including therapies for Parkinson’s disease and frontotemporal dementia.
On September 18, 2020, Prevail Therapeutics (Nasdaq: PRVL) announced that its CEO, Asa Abeliovich, will present at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2020, at 2:30 p.m. ET. The presentation will focus on the company's innovative AAV-based gene therapies aimed at treating neurodegenerative diseases. Interested parties can access the webcast on the company's website, where it will be available for 90 days post-event.
Prevail is developing therapies for conditions including Parkinson’s disease and frontotemporal dementia.
