RED BANK, N.J. , May 12, 2022 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it will host an investor event on Thursday, May 19, 2022 focused on the potential commercial launch of teplizumab in the second half of this year. The event is scheduled to take place from 1:00 p.m. to approximately 2:30 p.m. ET in a virtual format.
The agenda will include a discussion of the Company's planned commercial strategy for teplizumab, an anti-CD3 monoclonal antibody currently under review by the U.S. Food and Drug Administration (FDA) for the delay of clinical type 1 diabetes (T1D) in at-risk individuals. The FDA has assigned a user fee goal date of August 17, 2022. In addition to presentations from the Provention Bio commercial leadership team, the event will feature a presentation from the following guest speaker:
The live webcast and accompanying slide presentation can be accessed via the investor relations section of Provention Bio's website at https://investors.proventionbio.com/. An archived webcast will be available on the Company's website for 30 days following the presentation.
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 Biologics License Application (BLA) for teplizumab, its lead investigational drug candidate, for the delay of progression to Stage 3 clinical type 1 diabetes in at-risk individuals has been filed by the U.S. Food and Drug Administration (FDA). 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.
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 F.D. 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.
Certain statements in this press release are forward-looking, including but not limited to, statements relating to the FDA's review and potential approval of teplizumab and potential commercialization timeline;. These statements may be identified by the use of forward-looking words such as "will," and "may," 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 approval for teplizumab or in the development plans for the Company's other Company product candidates and the potential for noncompliance with FDA regulations and requirements; any inability to successfully work with the FDA to find a satisfactory solution to address its concerns in a timely manner or at all, including during the FDA's review of the teplizumab BLA resubmission; any inability of the BLA resubmission or our response to FDA requests to satisfactorily address other matters cited in the CRL including relating to PK comparability, product quality, the safety update required by the FDA or any other FDA requirements for an approval of teplizumab; 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 quarterly report on Form 10-Q for the first quarter ended March 31, 2022 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.
Robert Doody, VP of Investor Relations
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SOURCE Provention Bio, Inc.