Provention Bio

189 articles about Provention Bio

• Provention Bio to Participate in the H.C. Wainwright Virtual BioConnect Conference

  1/6/2021

   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 .

• Provention Bio Announces U.S. 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

  1/4/2021

  -FDA sets PDUFA goal date of July 2, 2021- -If approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes-

• Provention Bio Announces Addition to NASDAQ Biotechnology Index

  12/21/2020

  Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that it has been added to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective prior to market open today.

• Provention Bio Initiates First-in-Human Study of Coxsackievirus B Vaccine Candidate PRV-101

  12/15/2020

  - Potential to be the first vaccine for the prevention of coxsackievirus B, a presumed infectious trigger in the development of type 1 diabetes and celiac disease -

• Provention Bio to Present at the Stifel Virtual Healthcare Conference

  11/11/2020

   Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing autoimmune disease, today announced that management will present at the Stifel Virtual Healthcare Conference on Wednesday, November 18, 2020 , at 8:00 am E.T.

• Provention Bio Reports Third Quarter 2020 Financial Results and Provides Business Update

  11/5/2020

  - Completed rolling submission of the Biologics License Application (BLA) for teplizumab in the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals - - Launched two closely-aligned national T1D early-stage disease and screening education campaigns -

• Provention Bio Completes Rolling Submission of the Biologics License Application (BLA) for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-risk Individuals

  11/2/2020

  - Submission of chemistry, manufacturing and controls (CMC) and administrative information modules represent completion of the Company's BLA submission for teplizumab -

• Provention Bio to Report Third Quarter 2020 Financial Results and Host Conference Call on Thursday, November 5, 2020

  10/29/2020

   Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing autoimmune disease, today announced that it will report its third quarter 2020 financial results on Thursday, November 5, 2020.

• Celiac Disease Foundation Partners with Provention Bio on Its Phase 2b Study of Celiac Disease Therapeutic PRV-015

  10/7/2020

  Building on its role as the nation's leading celiac disease patient advocacy organization and the largest nonprofit patient recruiter for celiac disease clinical trials and studies, the Celiac Disease Foundation is pleased to announce its partnership with Provention Bio, Inc.

• Provention Bio Announces National Effort to Redefine Patient Care in Type 1 Diabetes (T1D)

  10/1/2020

  Provention Bio, Inc. (Nasdaq:PRVB), a biopharmaceutical company dedicated to intercepting and preventing autoimmune disease, yesterday launched a national effort to redefine patient care in type 1 diabetes (T1D) with t

• Provention Bio Files Clinical Module for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals

  9/30/2020

  Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the submission of the clinical module of the Company's Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab (PRV-031),

• Provention Bio to Present at Upcoming Virtual Investor Conferences

  9/8/2020

  Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that management will present at three upcoming virtual investor conferences in September:

• Provention Bio Announces Initiation of Phase 2b PROACTIVE Study of PRV-015 (anti-IL-15) in Non-responsive Celiac Disease

  8/31/2020

  Potential to be the first approved therapeutic for the treatment of Non-responsive Celiac Disease PRV-015 (anti-interleukin-15) is the first investigational product to show both a reduction in gluten-induced symptoms and in markers of intestinal inflammation in a placebo-controlled trial in celiac subjects

• John K. Jenkins, MD Joins Provention Bio Board of Directors

  8/11/2020

  -Former Director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, brings extensive regulatory expertise and experience to Provention-

• Provention Bio Reports Second Quarter 2020 Financial Results and Provides Business Update

  8/6/2020

  - Completed commercial-scale drug substance PPQ campaign ahead of schedule, enabling the expected on-time completion of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 - - Expect to submit clinical module of rolling BLA for teplizumab in Q3 2020 - - Extended follow-up results from the pivotal "At-Risk" TN-10 Study presented at ADA demonstrated that teplizumab significantly delays the onset of insulin-dependent T1D by a median of

• Provention Bio Appoints Heidy Abreu King-Jones as Chief Legal Officer

  8/3/2020

  Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, announced the appointment of Heidy Abreu King-Jones to the newly created role of Chief Legal Officer.

• Provention Bio to Report Second Quarter 2020 Financial Results and Host Conference Call on Thursday, August 6, 2020

  7/30/2020

  Provention Bio, Inc., a clinical-stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, announced that it will report its second quarter 2020 financial results on Thursday, August 6, 2020.

• Provention Bio Announces Change to a Virtual Meeting Format for the 2020 Annual Meeting of the Stockholders

  6/30/2020

  Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, announced today a change in the format of its 2020 Annual Meeting of Stockholders (the "Annual Meeting") from in-person to a virtual-only meeting format due to the continuing public health impact of COVID-19 and to support the health and safety of the Company's stockholders and attendees.

• Provention Bio Announces Inclusion in the Russell 3000 Index and Russell 2000 Index

  6/29/2020

  Provention Bio, Inc., a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, announced that it has been added to the broad-market Russell 3000® Index and the small-cap Russell 2000® Index as part of the Russell US Indexes annual reconstitution.

• Provention Bio Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters' Option to Purchase Additional Shares

  6/22/2020

  Provention Bio, Inc., (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, announced today the closing of the previously announced public offering of 7,590,000 shares of common stock, including 990,000 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares, at a public offering price of $14.50 per share