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Provention Bio, Inc. (Nasdaq: PRVB) reported financial results for Q2 2021, showcasing significant progress in its teplizumab program aimed at delaying clinical type 1 diabetes. The FDA advisory committee voted in favor of teplizumab's benefits over risks, although a Complete Response Letter raised concerns about pharmacokinetic comparability. The company maintains a cash reserve of $176.4 million, with a net loss of $29.1 million for the quarter. Provention is also advancing trials for other autoimmune therapies and expects strong catalysts within 24 months.
Provention Bio, Inc. (Nasdaq: PRVB) will release its Q2 2021 financial results on August 5, 2021, prior to U.S. market opening. A conference call is scheduled for 8:00 AM E.T. to discuss the results and provide corporate updates. Investors can participate by dialing in or accessing the audio webcast on the company's website. Provention Bio is focused on developing therapies to intercept immune-mediated diseases, with a pipeline targeting conditions such as type 1 diabetes, celiac disease, and lupus.
Provention Bio, Inc. has received an Innovation Passport for its investigational drug teplizumab, aimed at delaying clinical type 1 diabetes (T1D) onset in at-risk individuals. This designation, granted under the UK's Innovative Licensing and Access Pathway (ILAP), allows for accelerated development and access to new medicines. Teplizumab demonstrated a median delay of at least two years in insulin-dependent disease in the pivotal TN-10 Study. With over 400,000 people affected by T1D in the UK, teplizumab offers a potential breakthrough in treatment, noting that no previous disease-modifying therapies exist for T1D.
Provention Bio (Nasdaq: PRVB) announced on July 6, 2021, that the FDA issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for teplizumab, aimed at delaying clinical type 1 diabetes (T1D) in at-risk individuals. The FDA's CRL highlighted the need for pharmacokinetic comparability data between the planned commercial product and existing clinical trial product. Additional product quality considerations also need addressing, but no clinical deficiencies were cited. The company aims to collect further data from its Phase 3 PROTECT trial and is committed to collaborating with the FDA for potential resubmission.
Provention Bio (Nasdaq: PRVB) has granted stock options to two new employees, allowing them to purchase a total of 40,000 shares at an exercise price of $7.65, equal to the previous day's closing price. The options have a 10-year term and will vest 25% after one year, with the remaining 75% vesting monthly over the next three years. This grant is part of the company's 2020 Inducement Plan and was approved by the compensation committee without stockholder approval, aligning with Nasdaq Listing Rule 5635(c)(4).
Provention Bio, Inc. (Nasdaq: PRVB) announces its participation in the Jefferies Virtual Healthcare Conference on June 3, 2021, at 10:30 AM E.T.. The session 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, notably their lead candidate teplizumab, which aims to delay type 1 diabetes in at-risk individuals. More details can be found on their website.
Provention Bio, Inc. (Nasdaq: PRVB) announced that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-7 in favor of teplizumab, an investigational drug aimed at delaying clinical type 1 diabetes (T1D). The decision was based on data from the pivotal TN-10 Study, which showed a median delay of over two years in insulin-dependent disease for presymptomatic Stage 2 T1D patients. Teplizumab is under Priority Review by the FDA, with a decision expected by July 2, 2021. While the vote is favorable, potential delays in approval timelines are anticipated.
Provention Bio (Nasdaq: PRVB) announced that the FDA has posted briefing documents for the May 27, 2021, Advisory Committee meeting to evaluate the Biologics License Application (BLA) for teplizumab, aimed at delaying clinical Type 1 diabetes (T1D) in at-risk individuals. The BLA, based on data from the TN-10 Study, shows that a single 14-day course of teplizumab can delay the onset of T1D by at least two years. The FDA has set a PDUFA action date for July 2, 2021, with teplizumab having received Breakthrough Therapy Designation.
Provention Bio (Nasdaq: PRVB) reported its Q1 2021 financial results, highlighting a net loss of $32.4 million, or $0.52 per share, compared to a net loss of $12.6 million, or $0.26 per share in Q1 2020. Cash and equivalents stood at $207.2 million, expected to fund operations for at least 12 months. The company is focused on the BLA filing for teplizumab scheduled for FDA Advisory Committee review on May 27, aiming to address Type 1 diabetes unmet needs. Recent data showed teplizumab delayed clinical disease onset by a median of 32.5 months in at-risk patients.
