PRVB Provention Bio Inc.

14.15
-0.71  -5%
Previous Close 14.86
Open 14.75
52 Week Low 4.72
52 Week High 20.05
Market Cap $887,741,158
Shares 62,737,891
Float 57,461,620
Enterprise Value $793,282,986
Volume 1,183,147
Av. Daily Volume 778,280
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Upcoming Catalysts

Drug Stage Catalyst Date
PRV-031 (teplizumab)
Type 1 diabetes
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
PRV-015
Celiac disease
Phase 2b
Phase 2b
Phase 2b trial initiation announced August 31, 2020.
PRV-3279
Systemic Lupus Erythematosus (SLE) and Lupus nephritis (LN)
Phase 1/2
Phase 1/2
Phase 1b data released March 12, 2020 - well tolerated. Phase 2a portion to commence 1H 2021.
PRV-6527
Crohn's disease
Phase 2a
Phase 2a
Phase 2a data did not meet primary endpoint - October 22, 2019.
PRV-300
Ulcerative Colitis
Phase 1b
Phase 1b
Phase 1b top-line data May 8, 2019 noted primary safety and tolerability endpoint met but efficacy and other secondary endpoints were not met.

Latest News

  1. BILTHOVEN, Netherlands, Jan. 19, 2021 /PRNewswire/ -- Intravacc, a world leader in translational research and development of vaccines, today announced that a candidate polyvalent inactivated coxsackievirus B (CVB) vaccine it developed and manufactured for Provention Bio in less than 36 months, has entered into a first in human Phase I clinical study called PROVENT (PROtocol for coxsackievirus Vaccine in healthy volunteers) .

    Intravacc Logo

    Provention Bio is clinical stage biopharmaceutical company, that selected Intravacc in 2018 to lead product development and manufacturing of clinical study material for Provention's vaccine candidate (PRV-101). This CVB vaccine candidate is developed for the intended prevention of acute CVB infection and the potential delay…

    BILTHOVEN, Netherlands, Jan. 19, 2021 /PRNewswire/ -- Intravacc, a world leader in translational research and development of vaccines, today announced that a candidate polyvalent inactivated coxsackievirus B (CVB) vaccine it developed and manufactured for Provention Bio in less than 36 months, has entered into a first in human Phase I clinical study called PROVENT (PROtocol for coxsackievirus Vaccine in healthy volunteers) .

    Intravacc Logo

    Provention Bio is clinical stage biopharmaceutical company, that selected Intravacc in 2018 to lead product development and manufacturing of clinical study material for Provention's vaccine candidate (PRV-101). This CVB vaccine candidate is developed for the intended prevention of acute CVB infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease. Intravacc used its proprietary and regulatory approved Vero cell platform to develop a cGMP-grade viral vaccine production process for the polyvalent CVB vaccine candidate.

    CVB is a common enterovirus that frequently causes acute morbidity such as respiratory disease, meningitis, pericarditis and otitis. CVB is also the leading cause of viral myocarditis, a common condition that can cause fatal arrythmia and lead to a serious chronic myocarditis that often needs heart transplantation. In addition, persistent CVB infection is significantly associated with the development of T1D and celiac disease. With currently no preventive or disease modifying treatments available for T1D, its complications present a serious unmet medical need and up to 2.3 million people may be at risk of T1D globally. PRV-101 has the potential to be the first vaccine to prevent up to ~50% of T1D and ~20% of celiac disease.

    Dr. Jan Groen, Intravacc's CEO, said:

    "We are very proud to have been able to successfully complete the contract development and manufacturing project for Provention Bio in such a short period of time and to attribute substantially to the first preventive candidate vaccine for T1D and celiac disease. This project provides further validation of Intravacc's Vero cell platform."

    PROVENT is a placebo-controlled, double-blind, randomized Phase I first-in-human clinical study being conducted at the Clinical Research Services Turku - CRST Oy, a clinical trial unit in Turku, Finland. The study's primary endpoint is the safety of two dose levels of PRV-101 in healthy adult volunteers provided three administrations with 4-week intervals. Tolerability and immunogenicity will also be evaluated. Results of PROVENT are expected in the second half of 2021.

    About PRV-101

    PRV-101 is an investigational polyvalent vaccine being developed for the prevention of acute coxsackievirus B (CVB) infection and the potential delay or prevention of type 1 diabetes (T1D) and celiac disease. It is specifically designed to prevent autoimmunity by the primary prevention of a putative infectious trigger. PRV-101 has the potential to be the first vaccine to prevent CVB as well as up to approximately 50% of T1D and approximately 20% of celiac disease. Patents covering the use of PRV-101 in these indications have been licensed by Provention Bio from Vactech Oy. Netherlands-based Intravacc was selected to lead product development and manufacturing of clinical trial material for PRV-101.

    About Provention Bio, Inc.

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. The Company has submitted a BLA to the FDA for its lead investigational drug candidate, teplizumab, for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals. The Company's pipeline includes additional clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus. Visit www.ProventionBio.com for more information. Twitter: @ProventionBio.

    About Intravacc's Vero cell platform

    Intravacc's viral vaccine production process is based on a cGMP-grade, regulatory approved, Vero cell line. This proprietary platform is being used for routine large-scale commercial vaccine manufacturing by Intravacc's customers world-wide. In addition, virus seed lots and clinical batches have regularly been produced and validated on the Vero cells, for example Poliovirus, Enterovirus (EV71), and Respiratory Syncytial Virus (RSV).

    About Intravacc

    Intravacc, located at Utrecht Science Park Bilthoven in the Netherlands, is a leading global contract development and manufacturing organization of innovative vaccines against infectious diseases. As an established independent CDMO with over 100 years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology related to polio vaccines, measles vaccines, DPT vaccines, Hib vaccines and influenza vaccines around the world. Around 40% of childhood disease vaccines are based on Intravacc's proprietary technology. Intravacc offers a wide range of expertise for independent vaccine development, from concept to Phase I/II clinical studies for partners around the world, including universities, public health organizations (WHO, Bill & Melinda Gates Foundation), biotech and pharmaceutical companies. For more information, please visit www.intravacc.nl.

    Contacts:

    Intravacc

    Dr. Jan Groen, CEO

    P: +31 30 7920 454

    Mirjam Hartman, Media relations

    P: +31 6 115 969 94

    E:

    LifeSpring Life Sciences Communication, Amsterdam

    Leon Melens

    P: +31 6 538 16427

    E:  

    Logo: https://mma.prnewswire.com/media/1334670/Intravacc_Logo.jpg

    Cision View original content:http://www.prnewswire.com/news-releases/intravacc-announces-completion-of-formulation-and-manufacturing-process-development-of-prv-101-vaccine-candidate-for-provention-bio-301210217.html

    SOURCE Intravacc B.V.

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  2. RED BANK, N.J., Jan. 13, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the pricing of its previously announced underwritten public offering of 6,250,000 shares of its common stock at a public offering price of $16.00 per share. Gross proceeds to Provention Bio from the offering are expected to be $100 million, before deducting underwriting discounts and commissions and other offering expenses payable by Provention Bio. In addition, Provention Bio has granted the underwriters a 30-day option to purchase up to an additional 937,500 shares of its common stock, at the public offering price less underwriting discounts and…

    RED BANK, N.J., Jan. 13, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced the pricing of its previously announced underwritten public offering of 6,250,000 shares of its common stock at a public offering price of $16.00 per share. Gross proceeds to Provention Bio from the offering are expected to be $100 million, before deducting underwriting discounts and commissions and other offering expenses payable by Provention Bio. In addition, Provention Bio has granted the underwriters a 30-day option to purchase up to an additional 937,500 shares of its common stock, at the public offering price less underwriting discounts and commissions. All of the shares in the offering are being sold by Provention Bio. The offering is expected to close on or about January 19, 2021, subject to customary closing conditions.

    SVB Leerink and Cantor Fitzgerald & Co. are acting as joint bookrunning managers for the public offering. Oppenheimer & Co. Inc. is acting as lead manager and H.C. Wainwright & Co. and SMBC Nikko are acting as co-managers for the public offering.

    Provention Bio intends to use its net proceeds from the public offering for (i) pre-commercial activities, potential commercial activities, potential milestone or royalty payments, clinical development, and regulatory and manufacturing activities for PRV-031; (ii) development activities for PRV-015, PRV-101, and PRV-3279; (iii) the potential acquisition or in-licensing of other product candidates; and (iv) for other general corporate purposes.

    An automatic shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") on January 12, 2021 and automatically became effective under SEC rules. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering was filed with the SEC and is available on the SEC's website at www.sec.gov. An electronic copy of the final prospectus supplement and accompanying base prospectus relating to the offering, when filed, will be available on the SEC's website at www.sec.gov and may also be obtained, when available, by contacting SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6132, or by email at or by contacting Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by e-mail at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Provention Bio, Inc.

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company has submitted a Biologics License Application (BLA) to the FDA for its lead investigational drug candidate, PRV-031, for the delay or prevention of clinical type 1 diabetes in at-risk individuals. The Company's pipeline includes additional clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking, including but not limited to, statements relating to Provention Bio's expectations regarding the completion, timing and size of the proposed public offering and the intended use of net proceeds therefrom. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements involve risks and uncertainties, many of which are beyond Provention Bio's control, including risks and uncertainties related to the satisfaction of customary closing conditions related to the proposed public offering. Provention Bio may be unable to complete the public offering on the anticipated terms or at all. Applicable risks also include those that are included in the "Risk Factors" section of Provention Bio's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and any subsequent SEC filings, including the prospectus supplement related to the proposed offering to be filed with the SEC. Any forward-looking statement in this press release represents Provention Bio's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Provention Bio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by applicable law.

    Investor Contacts:

    Robert Doody, VP of Investor Relations



    484-639-7235

    Sam Martin, Argot Partners



    212-600-1902

    Media:

    Lori Rosen, LDR Communications



    917-553-6808

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/provention-bio-announces-pricing-of-100-million-public-offering-of-common-stock-301208002.html

    SOURCE Provention Bio, Inc.

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  3. RED BANK, N.J., Jan. 12, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it has commenced an underwritten public offering of 6,000,000 shares of its common stock. All of the shares to be sold in the offering are to be sold by Provention Bio. In connection with the offering, Provention Bio intends to grant the underwriters a 30-day option to purchase up to an additional 900,000 shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    RED BANK, N.J., Jan. 12, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it has commenced an underwritten public offering of 6,000,000 shares of its common stock. All of the shares to be sold in the offering are to be sold by Provention Bio. In connection with the offering, Provention Bio intends to grant the underwriters a 30-day option to purchase up to an additional 900,000 shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    SVB Leerink and Cantor Fitzgerald & Co. are acting as joint bookrunning managers for the public offering.

    Provention Bio intends to use its net proceeds from the public offering for (i) pre-commercial activities, potential commercial activities, potential milestone or royalty payments, clinical development, and regulatory and manufacturing activities for PRV-031; (ii) development activities for PRV-015, PRV-101, and PRV-3279; (iii) the potential acquisition or in-licensing of other product candidates; and (iv) for other general corporate purposes.

    An automatic shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") on January 12, 2021 and automatically became effective under SEC rules. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. An electronic copy of the preliminary prospectus supplement and accompanying base prospectus relating to the offering, when filed, will be available on the SEC's website at www.sec.gov and may also be obtained, when available, by contacting SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6132, or by email at or by contacting Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by e-mail at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Provention Bio, Inc.

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated diseases. The Company has submitted a Biologics License Application (BLA) to the FDA for its lead investigational drug candidate, PRV-031, for the delay or prevention of clinical type 1 diabetes in at-risk individuals. The Company's pipeline includes additional clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus.

    Forward-Looking Statements

    Certain statements in this press release are forward-looking, including but not limited to, statements relating to Provention Bio's expectations regarding the completion, timing and size of the proposed public offering and the intended use of net proceeds therefrom. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements involve risks and uncertainties, many of which are beyond Provention Bio's control, including risks and uncertainties related to market conditions and the satisfaction of customary closing conditions related to the proposed public offering. Provention Bio may be unable to complete the public offering on the anticipated terms or at all. Applicable risks also include those that are included in the "Risk Factors" section of Provention Bio's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and any subsequent SEC filings, including the prospectus supplement related to the proposed offering to be filed with the SEC. Any forward-looking statement in this press release represents Provention Bio's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Provention Bio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by applicable law.

    Investor Contacts:

    Robert Doody, VP of Investor Relations



    484-639-7235

    Sam Martin, Argot Partners



    212-600-1902

    Media:

    Lori Rosen, LDR Communications



    917-553-6808

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/provention-bio-announces-proposed-public-offering-of-common-stock-301206935.html

    SOURCE Provention Bio, Inc.

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  4. RED BANK, N.J., Jan. 6, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that management will participate in a fireside chat presentation at the H.C. Wainwright BioConnect 2021 Conference, being held virtually January 11-14, 2021.

    A replay of the pre-recorded fireside chat will be available beginning Monday, January 11, at 6:00 am E.T. 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 for 30 days following the presentation.

    About Provention Bio, Inc.:

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. The Company has submitted a Biologics License Application (BLA) to the FDA for its lead investigational drug candidate, teplizumab, for the delay or prevention of clinical type 1 diabetes in at-risk individuals. The Company's pipeline includes additional clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

    Internet Posting of Information:

    Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    Investor Contact:

    Sam Martin, Argot Partners



    212-600-1902

    Media Contact:

    Lori Rosen, LDR Communications



    917-553-6808

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/provention-bio-to-participate-in-the-hc-wainwright-virtual-bioconnect-conference-301202297.html

    SOURCE Provention Bio, Inc.

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  5. RED BANK, N.J., Jan. 4, 2021 /PRNewswire/ -- Provention Bio, Inc. (NASDAQ:PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the Biologics License Application (BLA) for teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA). The FDA also granted Provention's request for Priority Review and assigned a user fee goal date of July 2, 2021, under the Prescription Drug User-Fee Act (PDUFA).

    "The FDA's acceptance of our BLA represents a significant achievement for Provention Bio in our mission to deliver the first potential disease-modifying T1D therapy and drive a paradigm shift in how individuals at risk of developing the disease are treated," stated Ashleigh Palmer, CEO and Co-Founder, Provention Bio. "We intend to work closely with the FDA to support their review while also preparing for a potential product launch in the third quarter of 2021."

    In its acceptance letter, the FDA stated that it is currently planning to hold an advisory committee meeting, tentatively scheduled for May 27, 2021.

    Priority Review is afforded to drugs that, if approved, would represent a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. Under the PDUFA, a Priority Review targets a review time of six months compared to a standard review time of ten months. The FDA previously granted teplizumab Breakthrough Therapy Designation.

    About Teplizumab (PRV-031):

    Teplizumab is an investigational anti-CD3 monoclonal antibody (mAb) with a filed BLA under Priority Review by the FDA for the delay or prevention of clinical T1D in at-risk individuals. More than 800 patients have received teplizumab in multiple clinical studies involving more than 1,000 subjects. In previous studies of newly diagnosed patients, teplizumab consistently demonstrated the ability to preserve beta-cell function, a measure of endogenous insulin production, and correspondingly reduced the need for exogenous insulin use. Teplizumab has been granted Breakthrough Therapy Designation by the FDA and PRIME designation by the European Medicines Administration. Provention Bio has submitted a Biologic License Application (BLA) to the FDA for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals.  Provention is currently also evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT study).

    About Provention Bio, Inc.:

    Provention Bio, Inc. (NASDAQ:PRVB) is a biopharmaceutical company focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease. The Company has submitted a Biologics License Application (BLA) to the FDA for its lead investigational drug candidate, teplizumab, for the delay or prevention of clinical type 1 diabetes in at-risk individuals. The Company's pipeline includes additional clinical-stage product candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus. Visit www.ProventionBio.com for more information and follow us on Twitter: @ProventionBio.

    Internet Posting of Information:

    Provention Bio, Inc. uses its website, www.proventionbio.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company's website in the "News" section. Accordingly, investors should monitor this portion of the Company's website, in addition to following its press releases, SEC filings and public conference calls and webcasts.

    Forward Looking Statements:

    Certain statements in this press release are forward-looking, including but not limited to, statements relating to regulatory review of the BLA submission for teplizumab and the potential approval and commercial launch of teplizumab, including timelines relating to the same and the potential therapeutic effects of teplizumab and the Company's product candidates. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," and "intend," among others. These forward-looking statements are based on the Company's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to delays in, or failure to obtain FDA approvals for teplizumab or other Company product candidates and the potential for noncompliance with FDA regulations; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance;  uncertainties of patent protection and litigation; the Company's dependence upon third parties; substantial competition; the Company's need for additional financing and the risks listed under "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2019, quarterly reports on form 10-Q, and any subsequent filings with the Securities and Exchange Commission. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Provention does not undertake an obligation to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. The information set forth herein speaks only as of the date hereof.

    Investor Contact:

    Sam Martin, Argot Partners

       

    212-600-1902

    Media Contact:

    Lori Rosen, LDR Communications

     

    917-553-6808

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/provention-bio-announces-us-fda-filing-of-a-biologics-license-application-bla-and-priority-review-for-teplizumab-for-the-delay-or-prevention-of-clinical-type-1-diabetes-in-at-risk-individuals-301199992.html

    SOURCE Provention Bio, Inc.

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