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Provention Bio, Inc. (Nasdaq: PRVB) announced the grant of stock options to 22 new employees totaling 423,800 shares. These options, granted without stockholder approval under Nasdaq Listing Rule 5635(c)(4), were approved by the Company's compensation committee. Each option has a 10-year term with an exercise price of $7.17, equal to today’s closing price. The vesting schedule allows for 25% vesting after one year and the remainder in equal installments over the next three years. This initiative aims to attract talent to advance Provention's mission in immune-mediated diseases.
Provention Bio, Inc. (Nasdaq: PRVB) will release its first quarter 2021 financial results on May 6, 2021, before U.S. markets open. Following the earnings announcement, a conference call will take place at 8:00 am E.T. to discuss the results and provide corporate updates. The company is focused on developing therapies for immune-mediated diseases, with its lead candidate, teplizumab, having a Biologics License Application filed with the FDA to delay clinical type 1 diabetes progression in at-risk individuals.
Provention Bio, Inc. (Nasdaq: PRVB) announced an informal meeting with the FDA on April 23, 2021, regarding the teplizumab Biologic License Application (BLA) for delaying clinical type 1 diabetes (T1D). The FDA reported that the pharmacokinetic profiles of the proposed product and the historical product were not comparable and emphasized the need for a clearer understanding of clinical efficacy. The company expects delays in approval timelines and is working with the FDA to resolve these issues. An Advisory Committee meeting is scheduled for May 27, 2021.
Provention Bio (Nasdaq: PRVB) announced receiving a notification from the FDA regarding deficiencies in its Biologic License Application (BLA) for teplizumab, aimed at delaying or preventing type 1 diabetes. The FDA noted that these deficiencies prevent discussion of labeling and post-marketing commitments. Additionally, the FDA indicated that the pharmacokinetic profiles of teplizumab from two production sources were not comparable, requiring further data. Despite these setbacks, Provention remains optimistic and plans to address the FDA's concerns while continuing the review process, with an Advisory Committee meeting set for May 27, 2021.
Provention Bio, Inc. (Nasdaq: PRVB) has announced its participation in two virtual investor conferences in March 2021. CFO Andrew Drechsler will present at the H.C. Wainwright Global Life Sciences Conference on March 9, 2021, at 7:00 am E.T. CEO Ashleigh Palmer will engage in a fireside chat at the Oppenheimer & Co. 31st Annual Healthcare Conference on March 16, 2021, at 1:10 pm E.T. Both presentations will be available via webcast on the company’s website and archived for 30 days.
Provention Bio, Inc. (Nasdaq: PRVB) announced extended follow-up data from the pivotal "At-Risk" TN-10 Study published in Science Translational Medicine. Teplizumab (PRV-031) demonstrated a median delay of 32.5 months in the onset of clinical type 1 diabetes (T1D) in at-risk patients, doubling the time free of clinical T1D compared to placebo. The treatment showed improved beta cell function and was well tolerated. The FDA is reviewing the Biologics License Application (BLA) for teplizumab, with a decision expected by July 2, 2021.
Provention Bio reported its fourth quarter and full year 2020 financial results, highlighting a pivotal year with the FDA's filing of their Biologics License Application (BLA) for teplizumab, aimed at delaying or preventing type 1 diabetes (T1D). The FDA granted Priority Review, with a decision expected by July 2, 2021. Provention also initiated a first-in-human study for their CVB vaccine candidate, PRV-101, and announced a strategic collaboration with Huadong Medicine for PRV-3279, securing $6 million upfront and potential milestone payments. Despite a net loss of $32.6 million in Q4 2020, they anticipate sufficient cash to sustain operations for 12 months.
Provention Bio, Inc. (Nasdaq: PRVB) will announce its fourth quarter and full year 2020 financial results on February 25, 2021, before the U.S. market opens. A conference call will follow at 8:00 am E.T. to discuss these results and provide a corporate update. Additionally, Provention Bio will participate in a fireside chat during the 2021 SVB Leerink Global Healthcare Conference on the same day at 1:40 pm E.T. The company focuses on therapies for immune-mediated diseases, including its lead candidate, teplizumab, which aims to delay type 1 diabetes.
Provention Bio (Nasdaq: PRVB) has formed a strategic collaboration with Huadong Medicine to develop and commercialize PRV-3279, a bispecific antibody targeting autoimmune diseases, in Greater China. Provention Bio will retain rights outside this region and begin a Phase 2a trial for systemic lupus erythematosus in late 2021. The agreement includes a $6 million upfront payment and potential funding of $11.5 million over three years, plus milestone payments of up to $172 million. This partnership aims to leverage Huadong's capabilities to access the significant Chinese pharmaceutical market.
Provention Bio, Inc. (Nasdaq: PRVB) announced results from a pre-clinical study of PRV-3279, a bispecific antibody targeting CD32B and CD79B in a murine model for Pompe disease. The study showed that PRV-3279 reduced anti-AAV9 antibodies, potentially enhancing the safety and efficacy of gene therapies. Additionally, combined with sirolimus, PRV-3279 increased GAA enzyme expression in skeletal muscle. The company anticipates submitting study data for presentation at a medical conference in 2021.
