PRVL Prevail Therapeutics Inc.

9.89
-0.38  -4%
Previous Close 10.27
Open 10.33
52 Week Low 9.02
52 Week High 19.96
Market Cap $338,697,222
Shares 34,246,433
Float 16,474,403
Enterprise Value $270,510,866
Volume 154,660
Av. Daily Volume 165,090
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Upcoming Catalysts

Drug Stage Catalyst Date
PR001 (PROPEL)
Parkinson’s disease with GBA1 mutation
Phase 1/2
Phase 1/2
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PR006 (PROCLAIM)
Frontotemporal Dementia Patients with GRN Mutations
Phase 1/2
Phase 1/2
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PR001 (PROVIDE)
Type 2 Gaucher disease
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
PR001
Type 3 Gaucher disease
Phase 1/2
Phase 1/2
Phase 1/2 trial postponed until additional clinical data from the PROPEL and PROVIDE trials is available to inform the clinical development strategy.

Latest News

  1. NEW YORK, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the European Commission has granted orphan designation for PR006 for the treatment of frontotemporal dementia (FTD). PR006 is an investigational AAV9 gene therapy delivering the GRN gene and is being developed as a potential therapy for patients with frontotemporal dementia with GRN mutations (FTD-GRN).

    "The European Commission's decision to grant orphan designation for PR006 is an important step in helping to advance this potential therapeutic option for patients with frontotemporal dementia with GRN

    NEW YORK, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the European Commission has granted orphan designation for PR006 for the treatment of frontotemporal dementia (FTD). PR006 is an investigational AAV9 gene therapy delivering the GRN gene and is being developed as a potential therapy for patients with frontotemporal dementia with GRN mutations (FTD-GRN).

    "The European Commission's decision to grant orphan designation for PR006 is an important step in helping to advance this potential therapeutic option for patients with frontotemporal dementia with GRN mutations," said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. "We are excited to progress clinical development of PR006 as part of our mission to deliver a potentially disease-modifying gene therapy to these patients as quickly as possible."

    The Company expects to initiate enrollment in the Phase 1/2 PROCLAIM trial of PR006 in the fourth quarter of 2020, and it currently anticipates it will provide a biomarker and safety analysis on a subset of patients in the PROCLAIM trial in 2021.

    The U.S. Food and Drug Administration has also granted Orphan Drug designation for PR006 for the treatment of FTD and Fast Track designation for FTD-GRN.

    About European Commission Orphan Designation

    Orphan designation is granted by the European Commission to encourage development of medicines intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the European Union. Orphan designation by the European Commission provides companies with certain benefits and incentives, including protocol assistance, reduced regulatory fees and 10 years of market exclusivity following regulatory approval.

    About Prevail Therapeutics

    Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The Company is developing PR001 for patients with Parkinson's disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

    Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson's with GBA and OrbiMed, and is headquartered in New York, NY.

    Forward-Looking Statements Related to Prevail

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning Prevail's mission to deliver a potentially disease-modifying gene therapy to patients with FTD-GRN as quickly as possible; the potential benefits of orphan designation by the European Commission; and the anticipated timing of enrollment and of reporting of interim data on a subset of patients from the PROCLAIM trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevail's novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevail's gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in Prevail's filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" sections of the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Media Contact:

    Lisa Qu

    Ten Bridge Communications



    678-662-9166

    Investor Contact:



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  2. NEW YORK, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the United States Patent and Trademark Office (USPTO) on November 17, 2020 issued a composition of matter patent, U.S. Patent No. 10,837,028, with claims directed to the AAV vector used in PR001, Prevail's experimental gene therapy program for the treatment of Parkinson's disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD). The base patent term extends until October 3, 2038, excluding patent term extensions or coverage in additional related patent filings.

    "We are excited to make…

    NEW YORK, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the United States Patent and Trademark Office (USPTO) on November 17, 2020 issued a composition of matter patent, U.S. Patent No. 10,837,028, with claims directed to the AAV vector used in PR001, Prevail's experimental gene therapy program for the treatment of Parkinson's disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD). The base patent term extends until October 3, 2038, excluding patent term extensions or coverage in additional related patent filings.

    "We are excited to make important progress this year with PR001, which is being evaluated in the Phase 1/2 PROPEL trial for patients with Parkinson's disease with GBA1 mutations and in the Phase 1/2 PROVIDE trial for patients with Type 2 Gaucher disease," said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. "We are advancing clinical development of PR001 to make a potentially transformative difference for these patients who currently have no approved treatment options."

    The Company recently announced that patient dosing has continued in the Phase 1/2 PROPEL clinical trial of PR001 for PD-GBA patients, and it expects to provide the next biomarker and safety analysis on a subset of patients in the PROPEL trial by mid-2021. The Company expects to initiate enrollment of the Phase 1/2 PROVIDE clinical trial of PR001 for Type 2 Gaucher disease patients in the fourth quarter of 2020 and currently anticipates it will provide the next update on PR001 biomarker and safety data for nGD in 2021.

    The U.S. Food and Drug Administration has granted Fast Track designations for PR001 for the treatment of PD-GBA and nGD. In addition, the FDA granted PR001 Rare Pediatric Disease designation for the treatment of nGD, and Orphan Drug designation for the treatment of patients with Gaucher disease.

    About Prevail Therapeutics

    Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The Company is developing PR001 for patients with Parkinson's disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

    Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson's with GBA and OrbiMed, and is headquartered in New York, NY.

    Forward-Looking Statements Related to Prevail

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning the potential for Prevail's gene therapy candidates to make a transformative difference for patients with neurodegenerative diseases; the expected timing of reporting additional interim data on a subset of patients from the PROPEL trial; and the anticipated timing of enrollment of and the next update on data from the PROVIDE trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevail's novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevail's gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in Prevail's filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" sections of the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Media Contact:

    Lisa Qu

    Ten Bridge Communications



    678-662-9166

    Investor Contact:

     



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  3. Patient Dosing Continues in the Phase 1/2 PROPEL Trial of PR001 for Parkinson's Disease with GBA1 Mutations

    Phase 1/2 PROVIDE Trial of PR001 for Type 2 Gaucher Disease and Phase 1/2 PROCLAIM Trial of PR006 for Frontotemporal Dementia with GRN Mutations Expected to Initiate Enrollment in Fourth Quarter of 2020

    PR001 Receives U.S. FDA Fast Track Designation for Neuronopathic Gaucher Disease

    NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today reviewed recent clinical and business updates and reported financial results for the third quarter ended September 30, 2020.

    Patient Dosing Continues in the Phase 1/2 PROPEL Trial of PR001 for Parkinson's Disease with GBA1 Mutations

    Phase 1/2 PROVIDE Trial of PR001 for Type 2 Gaucher Disease and Phase 1/2 PROCLAIM Trial of PR006 for Frontotemporal Dementia with GRN Mutations Expected to Initiate Enrollment in Fourth Quarter of 2020

    PR001 Receives U.S. FDA Fast Track Designation for Neuronopathic Gaucher Disease

    NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today reviewed recent clinical and business updates and reported financial results for the third quarter ended September 30, 2020.

    "We're pleased to be making significant progress across our pipeline as we seek to develop urgently needed disease-modifying gene therapy treatments for patients with neurodegenerative diseases," said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. "We are encouraged by the continuation of patient dosing in our Phase 1/2 PROPEL trial of PR001 for Parkinson's disease with GBA1 mutations, and we are excited to advance our PROVIDE and PROCLAIM clinical trials for Type 2 Gaucher disease and frontotemporal dementia with GRN mutations, respectively, this year."

    Recent Business Updates

    Patient Dosing Continues in Phase 1/2 PROPEL Trial of PR001 for Parkinson's disease with GBA1 mutations (PD-GBA): Enrollment in the Phase 1/2 PROPEL clinical trial for PD-GBA has resumed following implementation of modifications to the clinical protocol. As previously announced, Prevail elected to modify the immunosuppression regimen in the clinical protocol for PROPEL and has adapted the trial design to be open-label. The Company expects to provide the next biomarker and safety analysis on a subset of patients in the PROPEL trial by mid-2021.

    Phase 1/2 PROVIDE Trial Expected to Initiate Enrollment in Fourth Quarter of 2020: Initiation of patient enrollment remains on track for the fourth quarter of 2020 for the Phase 1/2 PROVIDE clinical trial of PR001 for Type 2 Gaucher disease. The optimized immunosuppression regimen used in the amended PROPEL trial will also be implemented in the PROVIDE trial. The Company currently anticipates it will provide the next update on PR001 biomarker and safety data for neuronopathic Gaucher disease (nGD) in 2021.

    Phase 1/2 PROCLAIM Trial Expected to Initiate Enrollment in Fourth Quarter of 2020: Initiation of patient enrollment remains on track for the fourth quarter of 2020 for the Phase 1/2 PROCLAIM clinical trial of PR006 for frontotemporal dementia with GRN mutations (FTD-GRN). The optimized immunosuppression regimen used in the amended PROPEL trial will also be implemented in the PROCLAIM trial. The Company currently anticipates it will provide a biomarker and safety analysis on a subset of patients in the PROCLAIM trial in 2021.

    PR001 Granted U.S. FDA Fast Track Designation for nGD: The U.S. Food and Drug Administration (FDA) granted Fast Track designation for PR001 for the treatment of nGD. The FDA previously granted PR001 Rare Pediatric Disease designation for the treatment of nGD, and Orphan Drug designation for the treatment of patients with Gaucher disease. In addition, the FDA has granted Fast Track designation for PR001 for the treatment of PD-GBA.

    Strengthened Leadership with Board Appointment: Prevail has appointed William H. Carson, M.D., to its Board of Directors. Dr. Carson was most recently the President and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), leading the development and regulatory approvals of Otsuka's global compounds. Before joining Otsuka, he held several roles in the CNS Research and Development department at Bristol Myers Squibb. Dr. Carson currently serves as Chairman of the Board of Directors of OPDC and is also the Chairman of the Board of the Sozosei Foundation, a newly established Otsuka charitable organization with a main focus on decriminalization of mental illness. He is a Board Member of Excision Biotherapeutics and Trustee of the non-profit Internet2. He is a Distinguished Fellow of the American Psychiatric Association, the National Medical Association and the Executive Leadership Council. Prior to joining the pharmaceutical industry, Dr. Carson, a board-certified psychiatrist, was an Associate Professor in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina.

    Favorable Decision Received in Alector Arbitration: Prevail announced a favorable decision in the arbitration proceeding brought in 2019 by Alector Inc. against Prevail's Founder and Chief Executive Officer, Asa Abeliovich, M.D., Ph.D. The arbitrator rejected Alector's claims against Dr. Abeliovich that Alector confidential information was used in connection with his work on behalf of Prevail and that Alector had rights to Prevail's patents and patent applications. The arbitrator found that Dr. Abeliovich did not breach his confidentiality obligations to Alector under his consulting agreement. Prevail was not a party to this arbitration.

    Third Quarter 2020 Financial Results

    • Cash Position: Cash, cash equivalents and investments were $114.3 million as of September 30, 2020, as compared to $131.2 million and $168.1 million as of June 30, 2020 and December 31, 2019, respectively. The Company continues to anticipate that its cash runway will extend into the first half of 2022.

       
    • R&D Expenses: R&D expenses were $12.3 million for the third quarter of 2020 compared to $16.8 million for the third quarter in 2019. The decrease was primarily due to a decrease of $3.9 million in external manufacturing costs due to the timing of production of clinical and preclinical supply, a decrease of $1.5 million in direct clinical trial costs, and a decrease of $0.5 million related to external preclinical studies. These decreases were partially offset by an increase of $1.4 million in employee-related costs, resulting from an increase in research and development employees hired to execute the development of our clinical-stage product candidates and preclinical pipeline.

       
    • G&A Expenses: G&A expenses were $6.3 million for the third quarter of 2020, compared to $4.5 million for the third quarter of 2019. The increase was primarily due to a $1.3 million increase in employee related costs, resulting from an increase in general and administrative employees to support our expanded operations and establish capabilities to operate as a public company, a $0.8 million increase in legal fees, offset by a decrease of $0.2 million in other professional services and facilities cost.

       
    • Net Loss: Net loss was $18.6 million, or $0.55 loss per share, for the third quarter of 2020, compared to $20.3 million, or $0.62 loss per share, for the third quarter of 2019.

    About Prevail Therapeutics

    Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The Company is developing PR001 for patients with Parkinson's disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

    Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson's with GBA and OrbiMed, and is headquartered in New York, NY.

    Forward-Looking Statements Related to Prevail

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning the potential for Prevail's gene therapy candidates to modify the course of neurodegenerative diseases; the anticipated timing of Prevail's clinical trials of PR001 in PD-GBA and in Type 2 Gaucher disease and Prevail's clinical trial of PR006 in FTD-GRN; the expected timing of reporting of additional interim data for a subset of patients from the PROPEL trial; and expectations regarding Prevail's cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevail's novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevail's gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in Prevail's filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" section of the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Prevail Therapeutics Inc.

    Statements of Operations

    (Unaudited)

    (in thousands, except share and per share data)

      Three Months Ended September

    30,
        Nine Months Ended

    September 30,
     
      2020    2019    2020    2019 
    Operating Expenses:                      
    Research and development $12,321    $16,836    $36,681    $37,202 
    General and administrative  6,303     4,452     23,373     10,050 
    Total operating loss  (18,624)    (21,288)    (60,054)    (47,252)
    Other income            210      
    Interest income, net  37     989     582     1,905 
    Total other income  37     989     792     1,905 
    Net loss $(18,587)   $(20,299)   $(59,262)   $(45,347)
    Other comprehensive income  5          4      
    Comprehensive loss $(18,582)   $(20,299)   $(59,258)   $(45,347)
    Net loss per share, basic and diluted $(0.55)   $(0.62)   $(1.77)   $(1.68)
    Weighted average shares outstanding, basic and diluted  33,636,651     32,864,156     33,457,768     26,950,854 
     
     

    Prevail Therapeutics Inc.

    Balance Sheets

    (Unaudited)

    (in thousands, except share and per share data)

      September 30,

    2020
      December 31,

    2019
     
             
    ASSETS        
    CURRENT ASSETS:        
    Cash and cash equivalents $81,732  $168,051 
    Investments  9,755    
    Prepaid expenses and other current assets  4,839   6,410 
    Total current assets  96,326   174,461 
    Property and equipment, net  2,746   2,549 
    Investments  22,861    
    Operating lease right-of-use assets  9,023   10,001 
    Other long-term assets  3,068    
    Restricted cash  91   91 
    TOTAL ASSETS $134,115  $187,102 
    LIABILITIES AND STOCKHOLDERS' EQUITY        
    CURRENT LIABILITIES:        
    Accounts payable $2,597  $5,162 
    Accrued expenses and other current liabilities  8,651   5,330 
    Operating lease liabilities  1,500   1,341 
    Total current liabilities  12,748   11,833 
    Long-term operating lease liabilities  8,787   9,927 
    TOTAL LIABILITIES  21,535   21,760 
    COMMITMENTS AND CONTINGENCIES (Note 13)        
    STOCKHOLDERS' EQUITY        
    Preferred stock - $0.0001 par value, 10,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively; no shares issued as of September 30, 2020 and December 31, 2019, respectively      
    Common stock - $0.0001 par value, 200,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively, 34,245,433 and 34,138,750 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively  3   3 
    Additional paid-in capital  255,937   249,441 
    Accumulated deficit  (143,364)  (84,102)
    Accumulated other comprehensive income  4    
    Total stockholders' equity  112,580   165,342 
    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $134,115  $187,102 
             



    Media Contact:

    Lisa Qu

    Ten Bridge Communications



    678-662-9166

    Investor Contact:

     

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  4. NEW YORK, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail, will participate in the following virtual investor conferences in November and December:

    • Guggenheim Healthcare Talks Idea Forum 2nd Annual Neuro/Immunology Day on Monday, November 16, 2020.

    • Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020 at 10:40-11:10 a.m. ET.

    • Piper Sandler 32nd Annual Virtual Health Care Conference on Tuesday, December 1, 2020.

    Webcasts of the presentations will be available under "Events…

    NEW YORK, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail, will participate in the following virtual investor conferences in November and December:

    • Guggenheim Healthcare Talks Idea Forum 2nd Annual Neuro/Immunology Day on Monday, November 16, 2020.



    • Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020 at 10:40-11:10 a.m. ET.



    • Piper Sandler 32nd Annual Virtual Health Care Conference on Tuesday, December 1, 2020.

    Webcasts of the presentations will be available under "Events and Presentations" in the Investors and Media section of the Company's website at ir.prevailtherapeutics.com following the presentations.

    About Prevail Therapeutics

    Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The Company is developing PR001 for patients with Parkinson's disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

    Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson's with GBA and OrbiMed, and is headquartered in New York, NY.

    Media Contact:

    Lisa Qu

    Ten Bridge Communications



    678-662-9166

    Investor Contact:

    Primary Logo

    View Full Article Hide Full Article
  5. NEW YORK, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced a decisive victory in the arbitration proceeding brought in 2019 by Alector Inc. against Prevail's founder and Chief Executive Officer, Asa Abeliovich, M.D., Ph.D.

    The arbitrator rejected all of Alector's principal claims against Dr. Abeliovich, including all claims alleging misappropriation or misuse of trade secrets. Significantly, the arbitrator rejected Alector's claims that Dr. Abeliovich used Alector trade secrets or confidential information in connection with his work on behalf of Prevail, as well as…

    NEW YORK, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Prevail Therapeutics Inc. (NASDAQ:PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced a decisive victory in the arbitration proceeding brought in 2019 by Alector Inc. against Prevail's founder and Chief Executive Officer, Asa Abeliovich, M.D., Ph.D.

    The arbitrator rejected all of Alector's principal claims against Dr. Abeliovich, including all claims alleging misappropriation or misuse of trade secrets. Significantly, the arbitrator rejected Alector's claims that Dr. Abeliovich used Alector trade secrets or confidential information in connection with his work on behalf of Prevail, as well as Alector's claim that it has rights to Prevail's patents and patent applications. Prevail was not a party to this arbitration.

    "We appreciate the arbitrator's thorough and independent review of this matter. This decision vindicates Dr. Abeliovich and rules in his favor on all significant issues," said Francois Nader, M.D., Non-Executive Chairman of Prevail. "With this positive outcome, Prevail is looking forward to advancing our pipeline for the benefit of patients."

    "I am pleased with the decision, which confirms Prevail's ownership of its intellectual property," said Dr. Abeliovich. "Our team continues to advance our pipeline and remains committed to our critical mission of developing novel, urgently needed therapies for patients with neurodegenerative disorders such as Parkinson's disease and frontotemporal dementia."

    The only relief granted to Alector by the arbitrator was permission to seek reimbursement for a portion of Alector's out-of-pocket costs and fees in connection with certain document retention-related claims. Alector will need to provide sufficient proof of such amounts.

    About Prevail Therapeutics

    Prevail is a clinical stage gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The company is developing PR001 for patients with Parkinson's disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

    Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson's with GBA and OrbiMed, and is headquartered in New York, NY.

    Forward-Looking Statements Related to Prevail

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning the amount of costs and legal fees that Prevail may be required to reimburse. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevail's novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevail's gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in Prevail's filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the period ended June 30, 2020, filed with the SEC on August 11, 2020, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Media Contact

    Gina Nugent

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