Provention Bio Inc.

$PRVB
Biotechnology: Pharmaceutical Preparations
Health Care

Provention Bio, Inc., a clinical stage biopharmaceutical company, focuses on the development and commercialization of therapeutics and solutions to intercept and prevent immune-mediated diseases. Its products candidates include PRV-031 teplizumab and monoclonal antibodies (mAb) that is in Phase III clinical trial for the interception of type one diabetes (T1D); PRV-6527, an oral CSF-1R inhibitor, which has completed Phase IIa clinical trial for the treatment of Crohn's disease; PRV-3279, which has completed Phase Ib clinical trial for the treatment of lupus; PRV-101, a coxsackie virus B (CVB) vaccine for the prevention of acute CVB infections and onset of T1D; and PRV-015, which is in phase IIb clinical trial for the treatment of gluten-free diet non-responding celiac disease. The company has a license and collaboration agreement with Amgen Inc. for PRV-015, a novel anti-IL-15 monoclonal antibody being developed for the treatment of gluten-free diet non-responsive celiac disease; and a strategic collaboration with Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. to develop and commercialize PRV-3279, a bispecific antibody-based molecule targeting the B cell surface proteins CD32B and CD79B in Greater China. The company was incorporated in 2016 and is headquartered in Red Bank, New Jersey.

IPO Year: 2018

Exchange: NASDAQ

Website: proventionbio.com

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Recent Analyst Ratings for Provention Bio Inc.

DatePrice TargetRatingAnalyst
9/20/2022$10.00Buy
Jefferies
11/23/2021Neutral → Outperform
SMBC Nikko
8/6/2021$18.00 → $16.00Outperform
Oppenheimer
8/6/2021$27.00 → $25.00Buy
HC Wainwright & Co.
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Provention Bio Inc. Press Releases

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  • Press Release: Hart-Scott-Rodino waiting period expires for Sanofi's acquisition of Provention Bio, Inc.

    Hart-Scott-Rodino waiting period expires for Sanofi's acquisition of Provention Bio, Inc. Paris, France – April 26, 2023 – Sanofi announced today that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), applicable to Sanofi's proposed acquisition of Provention Bio, Inc. (("Provention Bio", NASDAQ:PRVB) has expired. On March 24, 2023, Sanofi commenced a cash tender offer (the "Offer") to purchase all outstanding shares of common stock of Provention Bio (the "Shares"), for $25.00 per Share, to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law. As a result of the expiration of

    $PRVB
    Biotechnology: Pharmaceutical Preparations
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  • Provention Bio Cancels Fourth Quarter and Full Year 2022 Earnings Release and Conference Call

    RED BANK, N.J., March 13, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced it has cancelled the release of its fourth quarter and full year financial results for the period ended December 31, 2022 due to the announcement earlier today that Provention has entered into a definitive agreement to be acquired by Sanofi, Provention's U.S. TZIELD co-promotion partner, subject to customary regulatory and other closing conditions. In addition, Provention will no longer hold its fourth quarter and full year results conference call that had been scheduled for 8:00 am E.T. Thursday, Marc

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio Announces the Grant of Inducement Awards

    RED BANK, N.J., March 3, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that the Company granted stock options to a new  non-executive employee to purchase an aggregate of 10,000 shares of common stock. The stock options were granted without stockholder approval as inducements, material to the new non-executive employee entering into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4) and were approved by the Company's compensation committee of the board of directors.

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio to Report Fourth Quarter and Full Year 2022 Financial Results on March 16, 2023

    RED BANK, N.J., Feb. 23, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it will report its fourth quarter and full year 2022 financial results on Thursday, March 16, 2023, before the opening of the U.S. financial markets. Subsequently, at 8:00 am E.T., the company will host a conference call to discuss its financial results and provide a corporate update. To access the call, please dial 1-888-347-7861 (domestic) or 1-412-902-4247 (intern

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio Announces Completion of $35 Million Equity Investment from Sanofi US

    Companies collaborating to expand access to TZIELD™ (teplizumab-mzwv), the first approved disease-modifying therapy for type 1 diabetes RED BANK, N.J., Feb. 13, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the closing of the $35 million equity investment from Sanofi US under the previously announced Co-Promotion Agreement and Securities Purchase Agreement (the "Purchase Agreement"). "Our Sanofi co-promotion agreement, together with this equ

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio to Present at the SVB Securities Global Biopharma Conference

    RED BANK, N.J., Feb. 8, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that management will participate in a fireside chat presentation at the SVB Securities Global Biopharma Conference on Wednesday, February 15th, 2023 at 11:20am EST. The presentation will be webcast live and can be accessed by visiting the Events and Webcasts section of the Company's website: http://investors.proventionbio.com/events. The webcast will be archived on the Company's website f

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio Announces the Grant of Inducement Awards

    RED BANK, N.J., Feb. 3, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that the Company granted stock options to 8 non-executive employees to purchase an aggregate of 124,000 shares of common stock. The stock options were granted without stockholder approval as inducements, material to the new non-executive employees entering into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4) and were approved by the Company's compensation committee of the board of directors. The stock options were granted with a 10-year term and an exercise price

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio Announces Closing of Second Tranche with Hercules Capital to Support U.S. Commercial Launch of TZIELD®

    RED BANK, N.J., Feb. 2, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the close of the $40 million second tranche under the previously announced term loan facility of up to $125 million with Hercules Capital, Inc. (NYSE:HTGC), a leader in customized financing for companies in life sciences. "Exercising the second tranche of this term loan facility provides the anticipated additional capital to advance the commercial launch of TZIELD® as we c

    $HTGC
    $PRVB
    Investment Managers
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  • AGC Biologics Supports Commercial Production of Provention Bio's New Type 1 Diabetes (T1D) Therapy, TZIELD™

    The Global CDMO's Seattle site continues work on this new T1D treatment, the first and only treatment approved to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new commercial manufacturing project at its Seattle protein biologics manufacturing site. The CDMO is producing TZIELD™ (teplizumab-mzwv), a new T1D treatment from Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitati

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio Announces the Grant of Inducement Awards

    RED BANK, N.J., January 6, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that the Company granted stock options to 58 non-executive employees to purchase an aggregate of 763,000 shares of common stock. The stock options were granted without stockholder approval as inducements, material to the new non-executive employees entering into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4) and were approved by the Company's compensation committee of the board of directors.

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care

Provention Bio Inc. Analyst Ratings

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Provention Bio Inc. Insider Trading

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Provention Bio Inc. SEC Filings

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Provention Bio Inc. FDA approvals

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  • FDA Approval for TZIELD issued to PROVENTION BIO INC

    Submission status for PROVENTION BIO INC's drug TZIELD (ORIG-1) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 11/17/2022. Application Category: BLA, Application Number: 761183, Application Classification:

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care

Provention Bio Inc. Leadership Updates

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  • Provention Bio Announces Appointment of Rita Jain, M.D., to Board of Directors

    RED BANK, N.J., Jan. 5, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the appointment of Rita Jain, M.D., to the Company's Board of Directors. Dr. Jain is a biotechnology industry veteran with more than two decades of experience in pharmaceutical development across her time with ChemoCentryx, Inc., AbbVie, Abbott Laboratories, and G.D. Searle and Co. prior to the latter's merger with Pharmacia & Upjohn and subsequent acquisition by Pfizer. "

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio Appoints Jan Hillson, M.D., as Senior Vice President of Clinical Development

    RED BANK, N.J., Nov. 17, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the appointment of Jan Hillson, M.D., as Senior Vice President of Clinical Development. Dr. Hillson bolsters the Company's clinical development leadership group with significant experience in all phases of clinical development across various autoimmune disorders, including systemic lupus erythematosus, which is the lead target indication for PRV-3279, a DART® (bispecific antibody-based molecule) targeting the B cell surface proteins CD32B and CD79B.

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio Appoints Miguel Sanjuan, Ph.D. as Senior Vice President of Research and Early Development

    RED BANK, N.J., Nov. 5, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the appointment of Miguel Sanjuan, Ph.D. as Senior Vice President of Research and Early Development. Dr. Sanjuan further strengthens the Company's internal expertise in the core areas of immunomodulatory therapy, translational medicine and autoimmune disease. "As we continue to grow as an organization pioneering early interception and prevention of debilitating and life-threatening autoimm

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio Announces Appointment of Thierry Chauche as Chief Financial Officer

    RED BANK, N.J., Nov. 4, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that Thierry Chauche will become Chief Financial Officer effective December 1, 2021 and Andrew Drechsler will be retiring, following a career of nearly 30 years in the financial and life sciences industry, most notably, the past four years at Provention Bio. Mr. Drechsler will continue to serve as a special advisor to the CEO and consultant through the middle of 2022. "On behalf of the Boa

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care

Provention Bio Inc. Financials

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  • Provention Bio Cancels Fourth Quarter and Full Year 2022 Earnings Release and Conference Call

    RED BANK, N.J., March 13, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced it has cancelled the release of its fourth quarter and full year financial results for the period ended December 31, 2022 due to the announcement earlier today that Provention has entered into a definitive agreement to be acquired by Sanofi, Provention's U.S. TZIELD co-promotion partner, subject to customary regulatory and other closing conditions. In addition, Provention will no longer hold its fourth quarter and full year results conference call that had been scheduled for 8:00 am E.T. Thursday, Marc

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio to Report Fourth Quarter and Full Year 2022 Financial Results on March 16, 2023

    RED BANK, N.J., Feb. 23, 2023 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it will report its fourth quarter and full year 2022 financial results on Thursday, March 16, 2023, before the opening of the U.S. financial markets. Subsequently, at 8:00 am E.T., the company will host a conference call to discuss its financial results and provide a corporate update. To access the call, please dial 1-888-347-7861 (domestic) or 1-412-902-4247 (intern

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • TZIELD™ (teplizumab-mzwv) approved by FDA as the first and only treatment indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D

    TZIELD is the first disease-modifying therapy in T1D, a life-threatening autoimmune diseaseIn a clinical trial, in Stage 2 T1D patients, TZIELD delayed the median onset of Stage 3 T1D by 25 months, or approximately 2 years, compared to placeboStage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threateningPatients who progress to Stage 3 T1D eventually require insulin injections for lifeInvestor Conference call at 8:00am ET tomorrowRED BANK, N.J., Nov. 17, 2022 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio Reports Third Quarter 2022 Financial Results and Provides Business Update

    Continues to Advance Preparations for Potential U.S. Commercial Launch of Teplizumab Ahead of November 17th FDA User Fee Goal Date RED BANK, N.J., Nov. 3, 2022 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the third quarter ended September 30, 2022 and provided a business update. "Throughout the third quarter, we have continued to interact with the FDA in support of our resubmitted, breakthrough therapy designated, teplizumab BLA for the dela

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio to Report Third Quarter 2022 Financial Results on November 3, 2022

    RED BANK, N.J., Oct. 13, 2022 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that it will report its third quarter 2022 financial results on Thursday, November 3, 2022, before the opening of the U.S. financial markets. The company will host a conference call at 8:00am E.T. to discuss its financial results and provide a company update. To access the call, please dial 1-888-347-7861 (domestic) or 1-412-902-4247 (international) ten minutes prior to the start time and

    $PRVB
    Biotechnology: Pharmaceutical Preparations
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  • Provention Bio Reports Second Quarter 2022 Financial Results and Provides Business Update

    -Teplizumab Biologics License Application (BLA) user fee goal date extended to November 17, 2022- -Company completes $60.0 million private placement- RED BANK, N.J., Aug. 4, 2022 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the second quarter ended June 30, 2022, and provided a business update. "Throughout the second quarter we remained sharply focused on teplizumab's potential approval for the delay of clinical type 1 diabetes in at-risk in

    $PRVB
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Provention Bio to Report Second Quarter 2022 Financial Results on August 4, 2022

    RED BANK, N.J., July 28, 2022 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that it will report its second quarter 2022 financial results on Thursday, August 4, 2022, before the opening of the U.S. financial markets. Subsequently, at 8:00 am E.T., the company will host a conference call to discuss its financial results and provide a company update. To access the call, please dial 1-888-347-7861 (domestic) or 1-412-902-4247 (international) ten minutes prior to the

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  • Provention Bio Reports First Quarter 2022 Financial Results and Provides Business Update

    -Teplizumab Biologics License Application (BLA) resubmission accepted for review by FDA and user fee goal date set for August 17, 2022- -Company to host teplizumab commercial launch investor event on Thursday, May 19, 2022- RED BANK, N.J., May 5, 2022 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the first quarter ended March 31, 2022, and provided a business update. "The first quarter of 2022 was highlighted by the FDA acceptance for review

    $PRVB
    Biotechnology: Pharmaceutical Preparations
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  • Provention Bio to Report First Quarter 2022 Financial Results on May 5, 2022

    RED BANK, N.J., April 28, 2022 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that it will report its first quarter 2022 financial results on Thursday, May 5, 2022, before the opening of the U.S. financial markets. Subsequently, at 8:00 am E.T., the company will host a conference call to discuss its financial results and provide a company update. To access the call, please dial 1-888-347-7861 (domestic) or 1-412-902-4247 (international) ten minutes prior to the st

    $PRVB
    Biotechnology: Pharmaceutical Preparations
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  • Provention Bio Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

    RED BANK, N.J., Feb. 24, 2022 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today reported financial results for the fourth quarter and full year ended December 31, 2021, and provided a business update. "Our priorities in the second half of 2021 focused predominantly on addressing the FDA's pharmacokinetic (PK) comparability considerations, culminating in our recent resubmission of the teplizumab BLA for the delay of clinical type 1 diabetes in at-risk individuals. Throughout th

    $PRVB
    Biotechnology: Pharmaceutical Preparations
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Provention Bio Inc. Large Ownership Changes

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