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Provention Bio, Inc. (Nasdaq: PRVB) will release its fourth quarter and full year 2021 financial results on February 24, 2022, before U.S. markets open. A conference call is scheduled for 8:00 AM ET the same day to discuss these results and provide a corporate update. The company focuses on investigational therapies for immune-mediated diseases, including type 1 diabetes and lupus. Investors are encouraged to access the call via phone or through an audio webcast on the company's website.
Provention Bio, Inc. (Nasdaq: PRVB) announced its participation in a fireside chat at the SVB Leerink 11th Annual Global Healthcare Conference on February 16, 2022, at 10:00am EST. The event will be available via live webcast on the Company’s website, with an archive accessible for 30 days post-event. Provention Bio focuses on developing therapies for immune-mediated diseases, targeting conditions like type 1 diabetes and lupus. More information can be found on their website.
Provention Bio, Inc. (Nasdaq: PRVB) announced the grant of stock options on February 1, 2022, to a new non-executive employee for 30,000 shares. The options, part of the 2020 Inducement Plan, have an exercise price of $5.30, equal to the closing stock price on the grant date. They will vest 25% after one year and the remaining 75% in equal monthly installments over four years. This grant was made without stockholder approval, aligning with Nasdaq Listing Rule 5635(c)(4), and was approved by the Company's compensation committee.
Provention Bio, Inc. (Nasdaq: PRVB) announced plans to resubmit the Biologics License Application (BLA) for teplizumab targeting type 1 diabetes in at-risk individuals, following a meeting with the FDA. The FDA provided feedback indicating prior pharmacokinetic data did not support drug comparability. The company will adjust its dosing regimen to align with FDA standards and address prior concerns regarding product quality. The BLA resubmission is expected in Q1 2022, with the FDA aiming to complete its review within six months.
Provention Bio, Inc. (Nasdaq: PRVB) has initiated the Phase 2a PREVAIL-2 study for PRV-3279, an investigational bispecific DART molecule targeting the B-cell proteins CD32B and CD79B. The study aims to evaluate the efficacy and safety of PRV-3279 in patients with moderate-to-severe systemic lupus erythematosus (SLE). Approximately 100 patients will receive either PRV-3279 or a placebo for six months, with primary efficacy results expected at 24 weeks. Previous studies have shown PRV-3279's tolerability and its potential to reduce B-cell function, supporting its evaluation in SLE.
Provention Bio, Inc. (Nasdaq: PRVB) announced the grant of stock options to Randy Anderson, Senior VP of Biometrics, for 130,000 shares of common stock. This grant, approved by the compensation committee, was made without stockholder approval in accordance with Nasdaq Listing Rule 5635(c)(4). The options have a 10-year term with an exercise price of $5.95, the closing price on January 3, 2022. Vesting occurs 25% after one year and monthly thereafter over four years, contingent on continued employment. Provention Bio focuses on therapies for immune-mediated diseases.
Provention Bio, Inc. (Nasdaq: PRVB) is set to present at the virtual H.C. Wainwright BioConnect 2022 Conference from January 10-13, 2022. The management will deliver a pre-recorded fireside chat, accessible starting January 10 at 7:00 am E.T. Participants can view the presentation on the company's website, where it will be archived for 30 days. Provention Bio specializes in developing therapies to intercept and prevent immune-mediated diseases, with a pipeline that includes candidates for autoimmune conditions like type 1 diabetes and lupus.
Provention Bio, Inc. (NASDAQ: PRVB) has appointed Christina Yi as Chief Operations Officer and Benedict Osorio as Chief Quality Officer. These appointments aim to enhance manufacturing, supply chain, and quality management as the company advances its clinical pipeline towards potential U.S. marketing approval for teplizumab. Yi brings over 20 years of experience from Vaxxinity and Amgen, while Osorio has been with Provention since 2020. Additionally, Yi was granted a stock option to acquire 300,000 shares, vesting upon performance milestones associated with teplizumab.
Provention Bio, Inc. (Nasdaq: PRVB) has granted stock options totaling 550,000 shares to two new executives: Chief Financial Officer Thierry Chauche received 375,000 options, while Senior VP of Clinical Development Jan Hillson was awarded 175,000. The options, granted without stockholder approval, have a 10-year term with an exercise price of $6.95, the closing price from the previous day. Chauche's options vest based on performance milestones, while Hillson's vest primarily based on time, both requiring continued employment for vesting.
Provention Bio (Nasdaq: PRVB) announced updates regarding the FDA's Complete Response Letter from July 2, 2021, concerning teplizumab, aimed at preventing Type 1 Diabetes (T1D). After a Type A meeting with the FDA on November 18, 2021, the agency approved the use of a population pharmacokinetic model for comparing the commercial and clinical product. Preliminary results indicate significant comparability, although these findings are under FDA review. The FDA also expressed concurrence for a Type B meeting to discuss the Biologics License Application (BLA) resubmission.
